Track Trace With SAP Solutions SH

Track Trace with SAP Solutions
&
Author
Stefan Hockenberger
Printed and bounded in Germany 2012
ISBN 978-3-00-039041-8
Page
Table of figures
Track & Trace wiTh saP soluTions
i high level inTroducTion To Track & Trace
10
12
Introduction
13
Which industries are affected and why
21
ii saPs vision of Track & Trace
22
Trends Why traceability?
23
Different ways of Traceability
25
2.1
Traceability Types Traceability domain
25
2.2
UnifiedTraceability
26
2.3
Internal Traceability
28
2.4
External Traceability
28
2.5
Deployment of internal and external Traceability
30
SAPs Track & Trace Solution Portfolio today
31
3.1
SAP Global Batch Traceability
35
3.2
SAP Event Management
38
3.3
SAP Object Event Repository
39
Scenarios as to how the Track & Trace domain may develop
41
4.1
New technologies
42
4.2
Value Chain traceability
43
iii gs1 sTandards for Track & Trace

1
44
Welcome to the world of GS1 Standards - Managing complexity

and ensuring compliance
45
HowtheStandardswork
46
Traceability Models
47
Table of Content
Page
4
GS1 EPCIS
50
4.1
Introduction to GS1 EPCIS
50
4.2
EPCIS-Bridgingthephysicalflowandtheinformationflow
52
GS1 Standards in the pharmaceutical industry
54
5.1
GS1 Healthcare - Leveraging global standards to enable

pharma traceability
54
5.2
Traceability in Healthcare - Regulatory developments
55
Advancingaunifiedapproach
57
iv drivers of Track & Trace
58
Legislations
59
1.1
PharmaceuticalIndustry
60
1.2
TobaccoIndustry
68
1.3
Explosives
71
Beyondcompliance:potentialbenefitsofTrack&Trace
74
2.1
Improved operations
75
2.1.1
Process standardization and harmonization
75
2.1.2 GainproductionperformanceKPIs
76
2.1.3 GainwarehouseperformanceKPIs
76
2.2
Competitive advantage
77
2.2.1
Customer consumption, alerts, monitoring
78
2.2.2 E-Leafletsandtargetedillnessorproductinfo
78
2.2.3
Increased customer loyalty
78
2.2.4
Establishing a direct dialog with consumers
79
2.3
Better Waste Management
80
2.3.1
Waste statistics (Intelligence)
80
2.3.2
Avoid waste to revert to Supply Chain
81
2.4
Visibility in parallel trading
81
Page
2.5
Avoid brand damage
82
2.5.1
Avoid consumption of recalled batches
82
2.5.2
Avoid anti-counterfeits
83
2.5.3
Avoid consumption of expired product
83
2.6
ImprovedrecallManagement
83
2.6.1 Fasterandpartialbatchrecalls
84
2.6.2 Fasterversionreplacement
84
2.6.3 Theftstocksrecalls
84
2.7
Shipment visibility and alerting
85
2.7.1
3 PL performance measurements
85
2.7.2
Error-free pick & pack
85
2.8
OptimizedInventory
86
2.9
Additional aspects to consider
87
v sofTware comPonenTs for Track & Trace and Their feaTures
88
Requirements for Track & Trace Software Components
89
1.1
Introduction
89
1.2
Process example to explain the software requirements
92
1.3
Summary of the necessary components and requirements
97
1.4
Short Description of necessary de facto standard components
Architecture examples of implemented Track & Trace
100
software landscapes
103
Detailed description of the software components
107
3.1
Printing Technologies for T&T related marking activities
107
3.1.1
Introduction
107
3.1.2
Available printing Technologies
108
3.1.3
Conclusion
112
Table of Content
Page
3.2
Processes, Considerations and Software at production/packaging lines 113
3.2.1
Quick Overview of the Systech Software Components
113
3.2.2
Serialization walkthrough old view, new view
115
3.2.3
Serialization Requirements/Considerations
117
3.2.4
How it works/How it should work
117
3.2.5
Protect data/packaging integrity and ensuring data accuracy
119
3.2.6 Protectpackaginglineefficiencyandthroughput
120
3.2.7
121
Serialization Considerations
3.2.8 BenefitsofSystechSerializedProductTracking(SPT)
122
3.2.9
The Bottom Line
129
3.3
SAP AII - Consolidation software/Edge Server
132
3.3.1 FunctionsandFeaturesofSAPAII
132
3.4
142
SAP OER - Global Track & Trace Repository (EPCIS)
3.4.1 ClassificationofSAPOERinaglobalTrack&Traceenvironment
142
3.4.2 FunctionsandFeaturesofSAPOER
144
3.5
SAPProcessIntegration(SAPPI)
168
3.6
MobileScanningSolution
168
3.6.1 MovilizerforTrack&TraceArchitecture
169
3.6.2 TechnicalFeaturesofMovilizerforTrack&Trace
170
3.6.3 SupportedProcesses
171
3.6.4 SecurityofMovilizer
180
3.6.5 SampleScreenshotsofthemobileApplication
184
vi besT PracTices - how To sTarT a global Track & Trace ProjecT
186
Disconnection of serialization and Track & Trace
187
Business Blueprint of a global Track & Trace System
188
2.1
BusinessBlueprint&FunctionalSpecifications&TechnicalMapping
189
2.1.1 BusinessBlueprint&FunctionalSpecifications
190
Page
2.1.2
Technical mapping of the requirements
191
Movilitas Add-Ons for SAP Track & Trace
192
3.1
Randomization Add-On
193
3.2
Data Reconciliation cockpit Add-On
195
3.3
Authorities Reporting Add-On
197
3.4
The special events Add-On
200
3.5
The Performance Test Add-On
202
3.6
TheArchivingAdd-On
204
3.7
ECPIS Repository migration Add-On
205
3.8
TheIndustrialmobilescanningAdd-On
206
3.9
Themobileappforeventcapturing,IDverification
and more
208
3.10
The logistics label printing Add-On
209
3.11
The lean Track & Trace Add-On
211
3.12
The 2cd level support package Add-On
213
auThors
214
definiTions, acronyms and abbreviaTions
218
aPPendix
225
Track & Trace Survey - Overview
225
OverviewSurveyQuestions
226
Track & Trace Survey Static Result
229
Track&TraceSurvey-DynamicResult
246
Table of Content
Page
fig. 1
HighLevelProcessFlowTrack&Trace
19
fig. 2
Pressures driving investments in traceability
24
fig. 3 Conceptofunifiedtraceabilitylevelsofinterrelated
traceability trajectories with an example service layer
fig. 4
Differentiates internal traceability from two external

traceability scenarios
fig. 5
29
Mapping of internal and external traceability example

domains to On Premise and On Demand solutions
fig. 6
27
30
Solution Domains addressed by SAPs Track & Trace

Solution Portfolio
31
fig. 7
SAP Track & Trace Solutions at a quick glance
34
fig. 8
SAP Global Batch Traceability (SAP GBT)
35
fig. 9
SAP GBT Search Batches
36
fig. 10
SAP GBT - Traceability Network Graphic
37
fig. 11
One-up, One-down Model
48
fig. 12
Pharma Serialization Deadlines
60
fig. 13
BigPicture:PotentialbenefitsofTrack&Trace
73
fig. 14
Overview Track & Trace process steps
91
fig. 15
High Level Software Architecture SAP AIE
101
fig. 16
Architecture example 1 SAPs standard proposition
104
fig. 17
Architecture example 2 No Edge Server (SAP AII)
105
fig. 18
Architecture example 3 Global Edge Server (SAP AII)
106
fig. 19
Traditional Packaging Paradigm
115
fig. 20
Serialization Packaging Paradigm
116
fig. 21
Timeline of changes in regards to EPC Global and GS1 standards 126
TableofFigures
Page
fig. 22
Configurationflexibilityofpackaginghierarchiesandnumber
association
fig. 23
Scalability of Sentri, Advisor and Guardian (pharmaceutical view) 128
fig. 24
Bi-directionalDataFlow
130
fig. 25
High Level Overview SAP AII
135
fig. 26
Rules&ActivitiesFrameworkinSAPAII
136
fig. 27
Screenshot: Application Log
140
fig. 28
MainFeaturesofSAPOER
143
fig. 29
Transaction SPROXY
145
fig. 30
View of the Integration Engine (Part of SAP PI stack

integrated in SAP OER)
147
fig. 31
SPROtransactiontoconfigurefieldsfordisplayandselection.
149
fig. 32
Sample of standard web report (Web Transaction)
149
fig. 33
Event Handler
151
fig. 34
Standard Event Handler in SAP OER - Header data
152
fig. 35
One Event Handler can handle multiple events
153
fig. 36
One Event Handler handling multiple hierarchies at different

points in time
127
TableofFigures
154
Page
fig. 37
Graphicaltool(wizard)forruledefinitionintheSAPOER
configurationworkbench(TransactionSPRO)
156
fig. 38
Multichannel alerting
159
fig. 39
Central Number Range Management
161
fig. 40
Effort for dicing-type methods in relation to number

range exploitation
162
fig. 41
Movilizer for Track & Trace - Architecture
169
fig. 42
Overview supported Processes
171
fig. 43
Sample Hierarchy in SAP OER
172
fig. 44
Sample screenshots of a Marketing/Change Management

and communications app
fig. 45
176
Sample screenshots of a Marketing/Change Management

and communications app
178
fig. 46
Source system customer - Movilizer Cloud
182
fig. 47
Movilizer client - Movilizer Cloud
183
fig. 48
Sample Screenshots of the mobile application for Track & Trace
185
fig. 49
Serial Number Lifecycle
188
Track Trace
with
SAP Solutions
&
functions & features, standards, best

Practices, Benefits and other hints and
tips for starting a Track & Trace project.
10
Track & Trace with SAP Solutions
Special Acknowledgements
Special thanks to jasmin sipahi and jonathan wildermuth
for building most of the graphics and making this look like a real book!
Special thanks to Pedram mohebbi
for spending hours on making this readable for English natives!
Special thanks to elina muratow
for proofreading!
Special thanks to all co-authors
for providing the valuable input!
Special thanks to all i those i may have forgotten!
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11
i
High Level
Introduction
to Track & Trace
12
High Level Introduction to Track & Trace
1 Introduction
why is Track & Trace becoming increasingly important for businesses?
Product piracy is an increasing problem for businesses in the broadest range of industries. A growing number
of companies are forced to confront piracy with measures such as serialization and Tracking & Tracing. Results
from surveys show that nearly every second consumer considers counterfeiting as a serious problem, and
nearly the same amount reported falling victim to counterfeiting.
However, Track & Trace offers businesses far more than assurances against counterfeiting and piracy. The
decision to serialize and track products on item level opens up a whole new range of options and can provide
realvalueaddedforthebusiness.Forexample,thetransparencythatisgainedasaresultcanfacilitatebetter
control of recalls, loss reduction and the optimization of supply chain, marketing and sales strategies.
what does Track & Trace mean?

Tracking means monitoring forward movement of finished goods through the supply chain and ensuring that
all taxes and duties have been paid and volumes verified.
Tracing means working backwards through the supply chain to establish where any genuine product was
diverted out of the legitimate supply chain.
Therefore Tracking & Tracinghasthecapabilitytodeterminethespecificsourceofaparticularproductatthe
lowestpracticallevelofpackaging,andtoprovidevisibilitytospecificinformation(e.g.batch,lot,date,origin,
ingredients, safety, or recall status).
13
why is this useful?

The information can quickly tell the person querying the package or product on: what it is, where it came from,
whether it is subject to a recall or other security issue, when and where it was packed or manufactured and
in some cases, where the product was supposed to be shipped to (and therefore, whether its in the correct
location).1
from serialization over aggregation to Track & Trace

To achieve full Track & Trace the typical approach is to start with serialization. Serialization means to make
eachsingleproductuniquebyplacinganitemidentifieroneverysingleproduct.Typicallytheitemidentifier
is a Datamatrix-Code containing at least the product related GTIN paired with a serial number. This way the
productbecomesthevehicleforcarryingtheinformationneededforTrackandTraceandcanbeidentified
individually. It is also then possible to store further product related information in a database linked to this
unique ID. Serialization takes place directly at the production lines and requires in most cases new printing and
scanning technologies and software.
The next big step after serialization is achieved is typically the aggregation. Aggregation is the process of
building packaging hierarchies and storing this relationship in a database. If, for example single products get
packed in a carton and these cartons get packed on a pallet, this relationship has to be recognized and stored
in a database using scanning processes. Each new packing level, e.g. cartons or pallets, also requires a unique
(serialized)identifier.AggregationisamajorsteptowardsTrack&Traceandthebigadvantageisthat;once
thepackaginghierarchyisbuiltandstoredinadatabase,onlythehighest-levelidentifier(e.g.pallet)hastobe
14
scanned(identified)andallassociatedpackeditemsinthehierarchywillautomaticallybeknown.Thismakes
it much easier to follow the items through the supply chain, as not every single item needs to be scanned at
different intervals in the supply chain. Aggregation can take place directly at production/packaging lines or, for
example, in distribution centers during re-packing. In most instances new or additional scanning technology
and software is required to capture the building of hierarchies and the movement of product through the
supply chain.
Once serialization and aggregation are achieved, everything is in place in order to completely Track & Trace
productsthroughthesupplychain.Thefinalstepistodefinepointsinthesupplychainwheretheproducts
or, the highest packaging level (due to aggregation) has to be scanned. As a result, the state (e.g. produced,
shipped, packed, dispensed, etc.) of all packed items can be changed in the database where the Track & Trace
data is stored (e.g. EPCIS). While serialization and aggregation take place in production and packaging lines or
in distribution centers, Tracking & Tracing mostly takes place in the supply chain.
Thecombinationofhavingauniqueidentifierandcapturingtheinformationrelatingtothemovementofthese aggregated products (when, where, what and why) is the best way to achieve a safe, secure and transparent
supply chain.
In this document, Track & Trace will be addressed and no distinction will be made between Track & Trace
and serialization/aggregation. This is due to the fact that serialization and aggregation are integral parts of an
effective Track & Trace.
1 Traceability: Giving every

product an authentic
identity, Package
Printing, June 1, 2008
15
how do things stand?

Under existing legislation, many pharmaceutical companies are obliged to serialize their products on item
level for certain markets and to pass on the complete tracking data e.g. to authorities. Consequently, the pharmaceutical sector can be credited with a clear, leading role in the development of Track & Trace.
Nonetheless, even without statutory provisions, more and more companies are recognizing the value addition
that can be found in Tracking & Tracing. As such, the perceived high level of investment initially implied by the
introduction of complete tracking is rewarded with huge potential for improvements.
Tobacco companies, manufacturers of explosive products, luxury and high-tech products in particular as well
as manufacturers of licensed software are increasingly opting for Tracking & Tracing. It must be assumed that
other industries will recognize the value added in Tracking & Tracing in the near future or authorities will derive
benefitsforconsumersandthereforeimposelegislations.Theconsumergoodsindustryinparticularshould
expect to be subjected to legislation. Current media reports of contaminated foodstuffs re-emphasize the
significanceofthetopicandtheneedforaction.
Ultimately, all businesses have one thing in common: they may all soon have to deal with Tracking & Tracing
and adapt their IT systems, production and packaging lines and business processes accordingly.
16
how does Track & Trace work?

Track & Trace differs from other brand protection technologies in important ways. Overt and covert technologies such as holograms, intaglio print, micro text, invisible images, and digital watermarks offer excellent
solutions for authentication, but cannot distinguish individual items at a unit level and cannot carry or point
to item-level data, something that is required for tracking & tracing.2
The key to implement Track & Trace is the ability to put variable data on item, case and/or pallet level (depending on the granularity to which items need to be tracked) and to trace these items through the supply
chain. Radio-frequency identification and barcodes are two common technology methods used to deliver
traceability.
TypicallyabarcodeorRFIDtransponderusuallycontainingacombinationofGTINandserialnumberwillbe
applied to items on the production line. In some cases there will be an aggregation of the products, related to
the packaging hierarchy (e.g. item to case and case to pallet). Aggregation makes it easier to trace a bundle
of items through the supply chain as only the ID of the pallet has to be scanned and therefore identifying all
cases and items contained on the pallet.
OncetheIDsareappliedtotheproducts;allproductrelatedeventssuchasproduced,shipped,received,
dispensed will be captured along the supply chain via scanning of these IDs with mobile devices. This captured information will be stored in a database (EPCIS) together with product related information from production such as batch, manufacturing date, expiration date etc.
Authorities, consumers and/or supply chain partners can access this database to trace the origins of products
ortofindthestatusofshipments.Forexample,thiscanbedonebytakingapictureofthe2Dbarcodeusing
asmartphoneorenteringtheproductIDinadedicatedwebsiteorsearchfieldofthedatabase
and querying the related information out of the database.
2 Traceability: Giving every product an authentic

identity, Package Printing,
June 1, 2008
17
18
Fig. 1: High Level Process Flow Track & Trace
19
following these principles of Track & Trace it is possible to know e.g. at any point in the products lifecycle, the following product related information:
Who is the manufacturer of this product

When and where was it produced
When was the product shipped and received by certain parties
Where is the product supposed to be at a certain time
What is the expiration date of a product
Is the Product ID known by the database
How long was the product in the supply chain before reaching the point of consumption
And much more depending of the granularity of stored information in the database
having this information in a database makes it easier for all parties such as manufacturers, authorities
and consumers to:
Separate a counterfeited product from a genuine one

Increase consumers safety
Check whether all taxes and duties have been paid
Discover grey-market products
Optimize the supply chain and logistics
Gaining information about consumers and their behaviors
Offering customer loyalty programs and avoiding abuse of these
And much more depending of the granularity of stored information in the database
20
2 Which industries are affected and why

As described previously, pharmaceutical companies are already obliged by legislations in various countries to
serialize at item level and to pass on the complete tracking data to authorities. This also applies to companies
in the tobacco and explosive goods industry.
Others adopt Track & Trace to address revenue lost due to counterfeiting and those whom recognize the substantialcustomerbenefitsofofferingTrack&Traceinformation.
However, in light of existing and forthcoming legislation requiring unique serialization and submission of electronic records to: authorities, supply chain partners and/or customers, more industries will need to adapt their
IT systems, production- and packaging lines and business processes in time for compliance.
from our experience this currently mainly affects the following industries:
Shipping companies
Returnable Transport Items
Explosives
Food&Beverage
Toys
Pharmaceutical, Medical devices, Hospital supplies, Blood supply
Weapons
Chemicals
Software
Tobacco
21
ii
SAPs vision of
Track Trace
&
introduction from the worlds largest supplier of standard software
saP ag (walldorf),knownastheworldslargestsupplierofstandardsoftware,identified
the need for Track & Trace software solutions at a very early stage and therefore started
to develop a software suite for this very problem over 10 years ago. The majority of wellknown companies that have addressed Track & Trace rely on these SAP products. No other
solution is currently able to manage the huge volume of data arising from serialization at
item level and complete tracking along the entire supply chain.
No other standard software solution offers such a broad range of functionalities and is
currently able to manage the huge volume of data arising from serialization at item level
and complete tracking along the entire supply chain.
22
SAPs vision of Track & Trace
1 Trends Why traceability?

In todays globalized economy, companies not only have global market opportunities but also face global
competition as well as global risks. Global risks can stem from counterfeited products that present a risk to
brands and Return on Investment regarding their Intellectual property (IP) and revenue as well as: from supply
risks or disruptions to raw materials sourced from global suppliers. In the global market place, quality issues
of single products can lead to enormous wide spread cost consequences and risks reverberating throughout
the whole value chain. In order to combat the spread of counterfeiting, some countries have enacted traceability directives in certain value chains that posit a requirement on companies to report traceability data to
government databases.
Traceability can help in providing the visibility and intelligence of both global market opportunity as well as
risk, in an effective and speedy manner. Speed and availability of data is often a necessity to mitigate risk and
to identify and exploit new opportunities.
Companies with a superior command of their global market opportunity, resource network and attendant
goodsandinformationflowhaveaclearcompetitiveedgeinthearenaofglobalopportunityandcompetition.
Combined with global value and supply chain intelligence, traceability provides the core capability to both
effectivelyorchestrategoodstomarketsandtoensureefficient,synchronizedandcoordinatedsupplies.
Furthermore,thereisthenewphenomenonofthepowerofinformationatthefingertipsofconsumersenabled through smart computing devices. News of product quality issues spread fast through social network communities such as Twitter. The immediate spread of this type of consumer communication and broadcasting
requires companies to act faster while facing product issues in order to avoid any damage to brand reputation,
liabilities and sales.
23
Fig. 2: Pressures driving investments in traceability

How about sustainability? If one stays true to the notion that you can only manage what you can measure,
then sustainability management requires high quality data. Why not use traceability as the backbone to record natural resource consumption data throughout a products lifecycle? This can be achieved if a product is
traced from the raw material stage till the point of consumption and its natural resource consumption data is
recorded as attributes throughout the products lifecycle.
Traceability systems today are in most cases expert systems serving a certain domain or line of business such
as supply chain management. These traceability systems serve scenarios for process compliance, logistical
supply chain Track & Trace, license key tracking, asset traceability, item serialized traceability for compliance,
batch traceability for Good manufacturing practice and recall. With few exceptions these systems are typically
deployed On Premise.
Furthertotheintrinsicvalueoftheaforementioned,traceabilitysystemscanalsobeenablers.Whentraceability becomes a core part of the DNA of future corporate information system architecture within companies
(On Premise) and spanning entire value chains (On Demand) traceability can enable complete product provenance across a value chain from raw material to the point of consumption. With the right data model, expert
systems can leverage the traceability DNA for sustainability management, supply risk management, real-time
complex value and supply chain orchestration and provide real-time intelligence.
24
2 Different ways of Traceability

Track&Tracecanbewelldefinedasfollows:Indistributionandlogisticsofmanytypesofproducts,Trackand
Trace or Tracking and Tracing, concerns a process of determining the current and past locations (and other
information) of a unique item or property.
To attain authoritative traceability, which can ultimately add value in a variety of ways, it is useful to take a
deeperlookatthisdefinitionofTraceability.
Firstly,onecandistinguishinternalfromexternaltraceability.Secondly,onecanfurtherdifferentiatedifferent
traceability domains, look at different traceability object types and then look at methods of integration.
2.1 Traceability Types Traceability domain

when looking at traceability one can distinguish different types of traceability
Traceability of a product genealogy

Batch- or serial number component level
Product supply chain traceability
Serialized
Item serialized
Batch level
GTIN or part number level
Product provenance and pedigree
Logistical Track & Trace

Parcel traceability
Sea-freight container traceability
Pallet level traceability
Process traceability
Procure-to-pay or order-to-cash
Traceability for sustainability and product
footprint data recording
25
Inmanycasesdomainexpertsolutionsareavailableforeachtypeoftraceability;insomecasesexpertsolution
canalsoaddressamixtureofthesetypesoftraceability.ForexamplewithtodaysSAPsolutions;SAPEvent
Management and SAP Object Event Repository. In Logistical Track & Trace the concept of handling units can
help to unify the access to different levels of distribution units.
2.2 Unified Traceability

However,ultimately;itmaybenecessarytoarriveatdatamodelsthatunifythesevarioustraceabilitydomains
and combine various traceability trajectories such as genealogy to high resolution downstream supply chain
traceability with sustainability data recording in order to enable full product value chain traceability from
raw material to point of consumption together with their footprint on natural resource consumption.
26
Fig. 3: Concept of unified traceability levels of interrelated traceability trajectories

with an example service layer
27
2.3 Internal Traceability

Internal traceability looks at traceability within the boundaries of a corporation. Here one can differentiate
whether the traceability serves a certain line of business domain, geography or spans traceability across corporate geographies for a functional domain. An important aspect of any traceability solution (even within the
boundariesofacorporation)isawell-definedconceptofdataaccesssecurity.
2.4 External Traceability

External traceability refers to traceability, which is extended beyond the boundaries of corporate traceability.
Here one can differentiate two scenarios:
1.
A scenario whereby traceability extends to the immediate business partner network of customers,
suppliers&partnerssuchasEDIFACTconnectionsandTrack&TraceportalsasprovidedbyThirdparty
logistics providers
2.
Ascenariowherebytraceabilityisextendedtoabusinesspartnernetworkbeyondfirsttieredbusiness
partners and/or an entire value chain community (e.g. a potential network of EPCIS repositories that can
be looked up by a discovery service or a cloud-based value chain traceability community platform.
Inexternaltraceabilityscenarios,awell-definedconceptofdataaccesssecurityrelatedtothedifferentlevels
and different objects, as well as fast response time for external inquiries is of key importance.
28
Fig. 4: Differentiates internal traceability from two external

traceability scenarios
29
2.5 Deployment of internal and external Traceability

Furthermore, one can differentiate the accommodation of internal and external traceability with different
deployment models of their traceability infrastructures.
Fig. 5: Mapping of internal and external traceability example

domains to On Premise and On Demand solutions
30
3 SAPs Track & Trace Solution Portfolio today

SAP Track & Trace solutions enable product, part, component and asset traceability from raw material to the
point of consumption with On Premise solutions. SAP Track & Trace solutions, that can be integrated, support
product batch as well as item product/part serialized traceability, goods and assets in transit as well as traceability for process monitoring and compliance.
Fig. 6: Solution Domains addressed by SAPs Track & Trace

Solution Portfolio
31
Product genealogy links the genealogy of product batches, together with their relation to purchase order, production order and delivery references into a complete corporate batch traceability solution. Traceability into the Product (batch) genealogy can be realized with the saP global batch Traceability solution.
item serialization & product traceability helps to ensure secure distribution of products, prevent and
detect diversion and counterfeiting while complying with regulations and achieving full visibility of endproduct whereabouts and condition over their lifecycle. Item serialized traceability can be achieved with
saP object event repository.
goods and assets in-Transit - improves transparency for goods in transit, including raw material supplies,
goodsmovementsforproductionaswellasthetrackingoffinishedgoods.Thisallowsyoutomanageintransit inventory by exception instead of monitoring processes that are already in control. Furthermore,
allows tracking of assets/returnables as they move along the entire supply chain. Goods and Asset InTransit is accommodated by saP event management and can also be achieved through saP object event
repository.
32
Procurement/Fulfillment Visibility get transparency in your procure-to-pay or order-to-cash cycles by

using real-time status reports, which may span system or even company boundaries. This allows you to monitorprocurementandrespectivelyorderfulfillmentwithgreatergranularitythanwithinyourERPsystem
(e.g. by involving business partner information), and manage by exception instead of monitoring processes
that are already in control. Visibility scenarios can be implemented with saP event management, which
also serves saP object event repository as the core software component.
Combining these solutions offers a wealth of capabilities that support your organization in improving operationalefficiency,reducingsafetystocks,complyingwithregulations,reducingcostlyfire-fightingandimproving
customer service to help you protect your brand. All solutions are offered with interfaces to SAP Business Suite
applications.
33
Corporate Product Batch Genealogy

and tracking of related objects with
SAP Global Batch Traceability
Trace throughout product genealogy, Trace
related objects such as deliveries, production
and purchase order references, One click reporting: delivery distribution, stock overviews, basis for material balances, Report
processing of multiple batches in a single run.
Process, Asset and Transportation

Tracking with SAP Event Management
Management by exception, Visibility for order-to-cash / procure-to-pay cycles, Goods
in-transit visibility, Process compliance.
Item serialized product traceability

with SAP Object Event Repository
Track & Trace throughout downstream distribution, Basis for traceability reporting to authorities. Corporate item serialized product,
asset and component traceability across
distributed business and sensor systems.
Fig. 7: SAP Track & Trace Solutions at a quick glance
34
3.1 SAP Global Batch Traceability

SAP Global Batch Traceability is a new solution that is planned to be available by end of 2012. SAP Global Batch
Traceability allows for comprehensive graphical tracing of batch managed products and components and their
relationships throughout the supply chain network so that understanding the impact and possibly recall of a
flawedbatchisgreatlyenhanced.
SAP Global Batch Traceability provides a corporate stand-alone repository that receives batch data as well
as related tracked objects data, from connected batch record systems.
Fig. 8: SAP Global Batch Traceability (SAP GBT)
35
A powerful search enables the quick understanding of corporate batch

genealogy for example, in the event of product issues:
Fig. 9: SAP GBT Search Batches
With one click, it is possible to launch distribution and stock overview reports. It is also possible to customize
material balance reports with the selection of one or multiple batch IDs in a single run.
Thus, based on the faster insight provided, saP global batch Traceability:
Reduces corporate liability risk associated with product issues

Reduces the costs associated with product issue investigations and outright product recalls
36
It is possible to graphically explore the corporate batch network for

instance during the product investigation phase.
Fig. 10: SAP GBT - Traceability Network Graphic
Increases customer retention rate and service levels by mitigating product issues
Protects the brand by enabling quick reaction time in resolving product issues
Helps comply with regulatory product issue reporting timelines
due to the release date of saP gbT by end of 2012 this booklet will
not focus on saP gbT.
37
3.2 SAP Event Management

SAP Event Management, as part of SAPs Business Suite SCM, provides visibility and the possibility to act on
processes, assets as well as performance along the entire supply chain by monitoring whether events happen
as planned or not.
SAP Event Management provides instance-level Tracking & Tracing for process monitoring, exception resolution, proactive alerting as well as operational & aggregated reporting.
Procurementandfulfillmentvisibilityprocessescanbeimplementedconcurrently,inordertogettransparency in the procure-to-pay or order-to-cash cycles by using real-time status reports, which may span system or
evencompanyboundaries.Thesolutionallowsthemonitoringofprocurementandorderfulfillmentwithgreater granularity than within your ERP systems (e.g. by involving business partner information), and to manage
by exception instead of monitoring processes that are already in control.
Another scenario that can be concurrently implemented is traceability for Goods and Assets In-Transit, improvingtransparencyforgoodsintransitincluding;rawmaterialsupplies,goodsmovementsforproduction
aswellasthetrackingoffinishedgoods.Furthermore,SAPEventmanagementallowsthetrackingofassets/
returnables as they move along the entire supply chain.
as saP event management is from a technical point of view part
of saP object event repository this booklet will not focus on saP
event management.
38
3.3 SAP Object Event Repository

SAP Object Event Repository shares the SAP Event Management engine and database as its core repository.
This is complemented by SAP Auto-ID infrastructure, serving as a service engine component for encoding,
decoding and vocabularies as well as SAP NetWeaver Process Integration content for the EPCIS (Electronic
ProductCodeInformationService)interfaces.SAPObjectEventrepositoryistherefore,configuredbyanamalgamationofthesoftwarecomponents;SAPEventManagement,SAPAuto-IDInfrastructureandSAPProcess
Integration content based on SAP NetWeaver.
With SAP Object Event Repository one can track and trace the event lifecycle of item serialized objects, their
related hierarchies, related batch data as attributes and the related business document context. The standard
content that SAP delivers for this is called product tracking & authentication recently complemented by cold
chain monitoring extensions.
SAP Object Event Repository can serve as a corporate item serialization repository that receives data from
distributedAuto-IDsystemsorothersystemsthatcanmapdatatotheEPCISCapturenotificationmessage.In
Life Sciences, the SAP Object Event Repository may serve as a system of record for item serialized drugs and
beusedasabasisforcompliancereportingtoauthoritiesinthecountry-specificformats.
39
2-D barcoded as well as RFID-encoded serialized product items and their hierarchies can be tracked
together with batch Ids as attribute information for each item serialized product
One can follow the event history of each serialized product item at any hierarchy level
The corporate item serialized data store can be queried from the delivery context
It is possible to capture requests for the status of external authentication requests for item serialized products
SAP Object Event repository can be used for the lifecycle event traceability of item serialized assets, parts
and components especially to track item lifecycle events across distributed systems and changes to
component hierarchies.
The embedded event management capabilities of SAP Object Event repository also allow reaction to
eventsbysendingnotificationstoothersystemsortriggeringworkflows,incaseaneventisoverdueor,
to deal with unexpected events.
WiththerightconfigurationandsomecustomextensionsSAPObjectEventRepositorycanbefurtherleveragedforcountry-specificreporting.Manufacturersofhealthcareproductsinparticulararefacingcountryspecificlegalregulationsonserialization,aimedatcombatingcounterfeiting,reimbursementfraudandillegal
trade. The constantly growing number of regulations imposes serious challenges to concerned parties to
achieve compliance while preserving process control & visibility.
Inresponsetotheserequirements,SAPObjectEventRepository(SAPOER)maybeconfiguredinaprojectfor
regulatory compliance. Within this scope SAP OER may be used for:
40
Handlingthecreation,transferandacknowledgementofnotificationstoauthorities
Managing requirements of multiple authorities within one global solution
Providing one central source of information, offering full visibility into the global process of regulatory
reporting
Processcontrolandexceptionresolutionmechanisms(userapproval,retriggeringofnotifications,alerting)
Flexibleconfigurationofnotificationtypes&characteristicstoadapttochanging&newlyissuedrequirements
This booklet will focus in some of the following chapters on saP
object event repository and saP auto-id infrastructure.
4 Scenarios as to how the Track & Trace domain may develop

In a global market place characterized by global opportunity as well as global competition, visibility of product
flowsacrosstheirlifecycleareofkeyimportanceandmaydeterminecompetitiveness.
Many companies are still working to achieve corporate or internal traceability but this will most likely be complemented by external traceability in the future whereby products can be tracked and traced across a value
chainbusinessnetwork.Exemplaryworkattestingtothisisforexample;theGS1GlobalTraceabilitystandard
thatdefinesdifferentlevelsoftraceability,theirinterconnectionsaswellasinternalandexternaltraceability.
Past efforts were not futile as there has always been a concern about data sharing however, what if one only
sharedelementarydata?Whatwouldbethebenefit/riskequationifoneconsidersthecaptureofemergent
patterns and intelligence derived with traceability from an interacting network of value chain partners?
41
4.1 New technologies

Complete value chain traceability especially at highly granular resolution such as, at serialized level creates
huge data volumes. High-resolution traceability has great value but also poses information system challenges.
High resolution and value chain traceability create a valuable data pool that may be viewed from different
businesscontexts;forexamplefromasales,productlifecycle,audit,supplyrisk,pedigreeandsupplychain
statusperspectivetonamebutafew.However,todothisefficientlyandalsotoallowadhocqueriesonthis
wealth of data, new database technologies are needed. Such a technology may be provided by SAP HANA.
SAP HANA is a game-changing, real-time platform for analytics and applications. While simplifying the IT
stack,itprovidespowerfulfeatureslike:significantprocessingspeed,theabilitytohandlelargedatavolumes,
predictive capabilities and text mining capabilities.
42
4.2 Value Chain traceability

Whilst internal traceability is typically realized through On Premise track and trace platforms there is opportunity to address external traceability i.e. traceability across a network of companies and consumers in a
traceability cloud. Qualities of a traceability cloud may be elastic to data volumes, easy on boarding of network
partners, network connectivity rather than point to point connectivity and emergent value chain insights that
are being created in an emergent manner (i.e. patterns) out of the interactions and data in the cloud. Traceability in such a cloud platform would be the core backbone relating product genealogy to various levels of
supply chain traceability (GTIN level, batch-level, serialized- level products, parts and assets, packing hierarchy
states,andconfigurationstates).However,especiallythevaluechaincommunityservicesthatwouldthenleverage the traceability data, would offer the value by providing insights into supply risks and reliability, alternative sourcing, compliance reporting, supply performance, sales performance, real-time visibility to the supply
chain status, integrate easily the consumer with mobile apps or web based services to gain new insights into
theproduct,forexampleprovideconfidencetousersastotrustedpedigreesofproductsandsoon.
43
iii
GS1 Standards for
Track Trace
&
44
GS1 Standards for Track & Trace
1 Welcome to the world of GS1 Standards Managing complexity and ensuring compliance
GS1publishedtheGS1GlobalTraceabilityStandardforHealthcare(GTSH)inFebruary2009.TheGTSHis
basedontheuseofglobal,voluntaryGS1businessstandards.Itincludesacleardefinitionoftraceability,establishes the minimum business model for traceability and describes the traceability process independent from
the choice of enabling technologies.
Traceability is the ability to track forward the movement through specified stage(s)
of the extended supply chain and trace backward the history, application or location
of that which is under consideration
ForGS1,thetermTraceabilitythereforeincludesthesub-processesofTrackingandTracingaswellas,for
example,enablingauthentication(oftheproductidentifier)anddownstreamreverselogisticsub-processes
such as product returns and recalls.
Thereismorethaneveraneedtoagreeuponandadheretouniversalstandardstomanageproductidentification and supply chain visibility. Standards are the foundation for clear, understandable exchanges between
supply chain partners in an increasingly complex supply chain.
GS1,aninternationalnot-for-profitassociationwithMemberOrganizationsinover100countries,isdedicated
tothedesignandimplementationofglobalstandardsandsolutionstoimprovetheefficiencyandvisibilityof
supply and demand chains globally and across sectors.
GS1hasover30yearsexperienceinglobalstandards.GS1GlobalOfficeenablestheGlobalStandardsManagement Process, managing a neutral forum that brings together hundreds of user-experts from various
sectorsandcountriesanddevelopsglobalstandardstocreateamoreefficientsupplychain.GS1Member
Organizations handle all enquiries related to GS1 Standards and provide related services.
45
2 How the Standards work

The GS1 System of Standards is the most widely used supply chain standards system in the world used in
multiple sectors, including consumer goods, healthcare, high tech, defense and chemicals. More than a million
companies execute more than six billion transactions a day.
GS1 Standards provide interoperable building blocks for an integrated system enabling traceability and visibility
in the supply chain.
The GS1 System of Standards is a flexible architecture built around and upon several elements:
GS1IdentificationKeysarethefoundationoftheGS1Systemandensurethegloballyuniqueidentification
ofproducts,locations,assets,etc.IdentificationKeysincludeforexampleGTIN(GlobalTradeItemNumber)
and GLN (Global Location Number).
GS1 Application Identifiers present a standardized wayto encodeadditionalinformation, such as expiry

date,lotnumberandserialnumber.ASerialNumberisdefinedasbeingavariablelength,upto20characters,alphanumericfieldusingApplicationIdentifier21orAI(21).
GS1 Barcodes provide a portfolio of data carriers, including GS1-128 linear barcodes, GS1 DataMatrix (two
dimensional bar codes) and others. For manufacturers, these meet the various needs including differing
pack sizes, amount of data and packaging/production rates. For users, these carriers can include all the
required data.
GS1EPCglobalusesRadioFrequencyIdentification(RFID)technologytoelectronicallycarryGS1Identification Keys in the Electronic Product Code (EPC).
46
GS1 eCom enables electronic data interchange, providing clear guidelines for creating electronic versions
of all sorts of business documents in the order-to-invoice cycle, such as Purchase Order (PO) and Dispatch
Advice(DESADV),basedonGS1IdentificationKeys.
GS1 Global Data Synchronization Network (GDSN) allows users to obtain, maintain, validate and exchange
master data in a secure and reliable environment via a network of GDSN-certified data pools. The synchronizedinformation(includingGTIN,GLNandadefinedsetofproductattributes(elements)empowers
electronic product catalogues.
GS1 EPC Information Services (EPCIS) provides the ability to track and trace products as they move through
the supply chain, and includes a set of interfaces (capture and query) for obtaining and sharing data about
unique items both within and across organizations.
3 Traceability Models
Atraceabilitysystemtypicallyconsistsofthefollowingbuildingblocks,includinguniqueidentification,data
capture, links management, and data communication.
A number of models for traceability are emerging, for example, one up/one down, pedigree, point of dispense
authentication and distributed network Track & Trace. It is critical to consider regulations that may constrain
or determine which model is selected and implemented.
one up, one down:Inparalleltothephysicalflowoftheproductistheflowofdatarelatedtothatproduct,

this is recorded and sent by one up party (e.g., manufacturer) to the one down party (e.g., Healthcare
provider)whoalsorecordsit.Theoneup,onedownflowmayhappenmultipletimesbeforetheproduct
and data reach the end user/consumer.
47
Fig. 11: One-up, One-down Model
48
Pedigree: A record, paper-based or electronic, containing information regarding each transaction resulting
in a change of ownership, change of custody or both. This may include sale by a manufacturer, acquisition
andsalebyoneormorewholesalers,manufacturers,re-packagers,orpharmacies/Shops,untilfinalsale.A
pedigree should be maintained in an interoperable system, ensuring compatibility throughout all stages of
distribution.
Point of dispense authentication: In general, authentication is the process of determining whether someone or something is, in fact, who or what it is declared to be. The GS1 System Architecture provides the
mechanismforstakeholderstoauthenticatetheGS1ProductIdentifier(e.g.theGlobalTradeItemNumber
(GTIN)inthecarrier(barcodeorRFID)throughcapturingdata,transmittingdataandcommunicatingthe
results.
distributed network Track & Trace: In this model, parties who may have regulated, manufactured, bought,
sold, distributed, sent, received or repackaged product publish key data that is accessible by other parties
authorizedtoviewthedatainorderto,forexample,authenticatetheproductidentifier,establishaproducts
pedigree or locate product for recall.
49
4 GS1 EPCIS
4.1 Introduction to GS1 EPCIS
ePcis makes end-to-end supply chain visibility possible
EPCIS is a GS1 Standard for sharing real-time information about physical events in the supply chain between
trading partners. With the visibility provided by EPCIS, companies can improve their inventory management
by real-time tracking of their products, they can see where their shipments are stuck and if they have been
delivered, they can combat counterfeiting by identifying where products came from, etc.
ePcis enhances business intelligence

EPCIS provides information about physical events concerning products and other assets in the supply chain.
It allows organizations to share data about the location of products or assets within their company and across multiple stakeholders, making it possible to understand what actually happened in the physical world as
products and other assets were handled during operations taking place in factories, warehouses, retail stores,
and other facilities.
ePcis documents real-life events

EPCIS data comprises a series of events. Each event documents at business-level something that happened
in the physical supply chain. Each EPCIS event has four dimensions of information:
WHAT(objectidentifiedbyaGS1Key)
WHERE(eventlocationidentifiedbyanSGLN)
50
WHEN
(date & time of event)
WHY
(business context and object status)
ePcis ensures that event data is understood

TheCoreBusinessVocabulary(CBV)isaGS1StandardthatdefinesspecificdatavaluestopopulatetheEPCIS
data model. This ensures that all parties who exchange EPCIS data have a common and consistent understanding of the semantic meaning of that information. Thanks to this, EPCIS events are designed to be understood
by any business application, without the application needing to know how the process took place or how the
data was captured.
EPCIS defines event-sharing interfaces

Besidesdefiningthestructureandmeaningofphysicalvisibilitydata,theEPCISstandarddefinesinterfacesfor
the secure sharing of EPCIS events between business applications and between trading partners.
The EPCIS Capture Interfacespecifiesastandardwayforbusinessapplicationsthatgeneratevisibilitydatato
communicate that data to applications that wish to consume it.
The EPCIS Query Interface specifies a standard way for internal and external systems to request business
events from repositories and other sources of EPCIS data.
ePcis complements gs1 ecom and gdsn

By documenting supply chain events, EPCIS data complements other types of data exchange in the supply
chain, such as business transaction data (exchanged with GS1 eCOM) and master data (exchanged with GS1
Global Data Synchronization Network or GDSN).
51
ePcis meets multiple industry requirements

The EPCIS standard has been developed to meet the requirements of multiple industries, from Consumer
Goods & Retail, Transport & Logistics or Healthcare. The EPCIS framework is extensible and therefore allows
industry-specificrequirementstoco-existalongsidethecorecomponentsofthestandard.Thisextensibility
allows for experimentation and new requirements development while still safeguarding interoperability.
ePcis provides visibility on a need-to-know basis

A company implementing EPCIS can use the authenticated identity of a trading partner in conjunction with
pre-definedbusinessrulestodeterminewhichinformationismadeavailabletothatpartner.
business applications for ePcis include...
Shipment Tracking
Inventory Management
Product Authentication
Pharmaceutical Pedigree
Electronic Article Surveillance (EAS)
Promotion Tracking
Product and food traceability
4.2 EPCIS - Bridging the physical flow and the information flow
Interfaces and protocols create a single way to capture and share information automatically and allow computers to communicate with each other, so processes can be automated.
Electronic Product Code Information Services (EPCIS) is a set of standardized network interfaces and protocols
for sharing supply chain data between supply chain partners. The What, Where, When, and Why of events
occurring in any supply chain is exchanged, safely and securely, via the EPCIS standard. The EPCIS standard providesinterfacespecificationsbuiltontopofverywidelyusedbusinessandInternetstandards.Andbecausethey
52
are based on common Internet standards, companies can implement the standard in ways that work for them.
TheEPCISstandardprovidesawaytosharehighvolume,veryfinegraininformationaboutmaterialmovement and status among cooperating partners. EPCIS does not address purchasing, forecasts, bidding, billing,
etc. that are typically exchanged via EDI in a business transaction between two parties.
data elements in the ePcis standard include:

WHAT - Product: ItispossibletoincludeanyuniqueidentityintheEPCfield.TheElectronicProductCode
(EPC)isdesignedasauniversalidentifierthatprovidesauniqueidentityforeveryphysicalobjectanywherein
theworld,foralltime.ItsstructureisdefinedintheEPCglobalTagDataStandard,whichisanopenstandard.
ToensurethatanEPCalwaysuniquelyidentifiesanindividualphysicalobject,inthecaseofaGTIN,theEPCis
constructedasaserializedGTIN(sGTIN)bycombiningaGTINproductidentifierwithauniqueserialnumber.
WHERE - location: Read Point indicates the location where an event took place e.g.: Distribution Center
X conveyor belt Y. Business Location describes where the object is immediately after the event occurs e.g.:
Distribution Center X, Shipping Area.
WHEN - Time: Event Time states when an event took place. Record Time indicates when the event was
received through the EPCIS Capture Interface.
WHY - business step and status: Business Step indicates what business operation was taking place at the
time of the event e.g.: Receiving, Picking, Loading, Shipping. Disposition describes the status of the product
immediately after the event occurs e.g.: Sellable, In Progress, Non Sellable, Destroyed.
It is possible for an end-user to build the EPCIS interfaces and data model themselves on top of an existing
enterprise system. But it may be simpler for many organizations to buy an EPCIS repository application from a
solution provider (e.g. SAP Object Event Repository from SAP), or obtain EPCIS-compliant application enhancements from their existing application providers.
53
5 GS1 Standards in the pharmaceutical industry

5.1 GS1 Healthcare - Leveraging global standards to enable
pharma traceability
The Healthcare sector today is facing one of the most serious challenges affecting the integrity of the supply
chain:Introducingtraceabilityandserializationtoincreasevisibilityinthesupplychainandfightcounterfeiting. A multitude of regulatory initiatives worldwide responding to the threat of counterfeit medicines, risks a
significantlyincreasedcomplexityforsupplychainpartners.
GS1 Healthcare, a global and voluntary user group, aims to lead the Healthcare sector to the successful development and implementation of global standards in its supply chain. The user group was established in
2005, and although standards development work continues, it has built a solid foundation of global standards
available to the Healthcare sector. Local user groups in 30 countries have already launched national programs,
pilot projects and other initiatives to drive adoption and implementation in their country.
GS1 Healthcare allows users to interact with regulatory bodies and other stakeholders worldwide and to understand their needs. Those needs can be changed into solutions for the entire Healthcare sector. Hundreds
of expert volunteers participate in GS1 Healthcare work groups and meetings, representing all sides of the
Healthcare supply chain and involving many supply chain leaders. (Twenty-two out of Healthcare Supply Chain
Top 25, a ranking by Gartner, a worlds leading information technology research and advisory company.)
54
5.2 Traceability in Healthcare - Regulatory developments

Government mandates is the main driver for traceability and serialization, for example in Brazil and Turkey.
Morerecently,serializationhasreceivedevenmoreattentionbecauseoftheactivitiesoftheUSFDAandthe
European Commission.
InEurope,themostimportantdevelopmentistheDirective2011/62/EUintroducingobligatorysafetyfeatures
to allow the verification of the authenticity of pharmaceutical products to prevent the entry of counterfeit
products in the legal supply chain. The European Commission is developing delegated acts that will set out
thedetailsofthissystem,includingthecharacteristicsandtechnicalspecificationsoftheuniqueidentifier,the
modalitiesforverificationofthesafetyfeaturesandtherepositorysysteminwhichinformationonthesafety
features is to be stored. The Commission is assessing the cost, benefits and cost-effectiveness that will be
based on the input during public consultation. The adoption of the delegated act is scheduled for 2014. The
directiveneedstobetransposedintonationalregulationinallEuropeancountriesuntil2016.Exemptedfrom
this time line will only be Belgium, Greece and Italy, for them the deadline is 2022.
The european commission is raising fundamental issues in its concept paper for public consultation
(dd. 18/11/2011):
Should individual manufacturers choose the appropriate technical solution for serialization or should the
European Commission regulate this and ensure harmonization?
Should national reimbursement numbers be replaced with the new, harmonized serial numbers or should
they co-exist?
Whatdatacarriershouldbeused:linearbarcodes,2Dbarcodesand/orRFID?
Whenshouldtheserialnumberbeverified?Systematicallyatthepointofdispensing?Randomorsystematic
verificationsbywholesaledistributors?
Who is governing the repository system? Users themselves? An EU-body? National bodies of EU Member
States? There are a lot of questions to be answered but, serialization in Europe is no longer about if, but
when and more importantly how. Many pharmaceutical manufacturers are already considering how to
implement these important changes and have serialization projects underway, or are planning them.
55
TheUSFoodandDrugAdministration(FDA)isalsolookingintopotentialapproachestowardatrackandtrace system for prescription drugs and has been obtaining input from supply chain partners on attributes and
standardsfortheidentification,authenticationandtrackingandtracingofprescriptiondrugpackages.
InMarch2010,theFDApublishedindustryguidanceonstandardsforsecuringthedrugsupplychainthrough
StandardizedNumericalIdentification(SNI)forprescriptiondrugpackages.ItwasthefirstofseveralregulationsandguidancedocumentsthattheFDAwillissuetoimplementsection505DoftheFoodandDrug
AdministrationAmendmentsActof2007(FDAAA),whichrequiresFDAtodevelopstandardsandidentifyand
validate effective technologies for the purpose of securing the drug supply chain against counterfeit, diverted,
sub potent, substandard, adulterated, misbranded or expired drugs. The SNI should be a serialized National Drug Code (sNDC), composed of the National Drug Code (NDC) combined with a unique serial number,
generated by the manufacturer or re-packager for each individual package. In line with GS1 Standards, serial
numbers should be numeric or alphanumeric and should have no more than 20 characters. This alignment was
recommendedinmanyofthecommentssubmittedinresponsetotheFDAsRequestforComments.FDAhas
also further considered compatibility with GS1 Standards. The use of an sNDC is compatible with, and may be
presentedwithin,aGTIN,whichcanbeserializedusinganApplicationIdentifier(AI)(21).
Several other national regulatory bodies have already developed similar requirements or are looking into a
traceabilityinitiative.Forexample,ANVISA,Brazilsregulatorybodyhasissuedguidanceforatraceabilitysystem for medicines in the country. Earlier guidance required the use of a security seal, but this has now been
replaced with the requirement for serialized 2D bar codes printed directly onto secondary packaging, in line
with global developments. ANVISA will manage the national repository of serial numbers. ANMAT, the ArgentinianFood,DrugandTechnologyAdministration,willlaunchanewdrugtraceabilitysystemthatwillallow
pharmacies,healthcentersandpatientstoverifythedruginrealtime.Accordingtothe3683/2011Regulation,
suppliers should place a code on their packaging complying with GS1 Standards.
56
GS1 Healthcare maintains a global, online repository of regional and country regulations, directives and guidelinesrelatingtorequirementsforHealthcareproductidentification,productcataloguesandtraceability.Information introduced in the database is compiled on the basis of information received by staff of the worldwide
network of 108 GS1 Member Organizations (MOs) and members of the global GS1 Healthcare community, or
information received directly from governmental bodies and regulators issuing the requirements, guidelines
and regulations.
6 Advancing a unified approach

There is momentum in the Healthcare sector to implement serialization, not only to comply with existing and
developing regulations, but also to drive value. There is also momentum to adopt global, user-driven standards to effectively and efficiently implement traceability solutions. The GS1 System of Standards provides
a foundational framework to meet this challenge and manage inconsistencies in legislation, regulation and
resources existing from country to country.
for more information about gs1 healthcare, visit
www.gs1.org/healthcare
57
iv
Drivers of
Track Trace
&
58
Drivers of Track & Trace
1 Legislations
As implied several times in this booklet Track & Trace
These are primarily the pharmaceutical industry,
is still a very legislation driven topic. Investments are
followed by the tobacco and explosives industry.
highandoffsettingthisonlywithbusinessbenefits,
Beside these industries, there are certainly other
which are gained due to the better transparency
regulatory requirements and it is highly likely that
in the supply chain is hard to achieve. Therefore, it
there will be much more in future. Due to the rapidly
is worth mentioning the most common industries
changing nature of legislation, the focus of this
with legislations/regulations in place.
chapter will be the three key industries stated.
59
1.1 Pharmaceutical Industry
Fig. 12: Pharma Serialization Deadlines3
60
61
3 Quelle: PharmaIQ - http://www.pharma-iq.com
iv
Questions asked
A) deadline date
(If applicable. If country already serialized,
simply state current)
B) method of serialization
(E.g.2DDatamatrix,RFID,linearbarcodes,
e-pedigree, etc.)
C) any additional restrictions or requirements?
(E.g. special labels? Where from? Etc.)
D) level of serialization required
(E.g. country, lot, package, etc.)
62
Argentina
A) 15.12.2011
B) 2D,TheHealthAuthoritydoesnotgiveanyspecificrecommendation.Thelaboratories
couldchoosebetweenopticaltechnologies(Datamatrix&GS1-128)orRFIDEPC,Not
fixed.GS1standard.(Barcode,DatamatrixorRFID)Preferred:Datamatrix
C) Security labels are required. The labels used must leave marks when removed. Visual
code in the label.
D) GTIN + SERIAL
Belgium
A) Current
B) 2D - Sequential Barcode, 1D barcode Code-128C, linear barcode
C) Special Labels - IPEX, Labels applied by Vignette labeller
D) Package number lot info, GTIN, lot, exp., Serial nr, Package, reimbursed medicines
Brazil
A) January 2012 (Please note: this is being contended and may change - TBC)
B) 2D as per GS1
C) Additional tamper evident label to seal carton, auto-adhesive labels with the 2D code
D) Package, secondary and tertiary packages
California
A) 50%ofproductbyJan2015and50%byJan2016
B) E-Pedigree,2DDatamatrix,RFID,Linear
C) X
D) Item, smallest saleable unit, every level of packaging, Saleable unit point of sale,
e-pedigree, full track and trace
63
China
A) 2015, although some started April 2010
B) 128 Barcode
C) Need to obtain barcode from Government
D) X
Germany
A) AsperEUDirective;NationallegislationbyJan2013,enforcedbyQ42016
B) 2D Datamatrix
C) Pilot project to be run in 2013 to decide widespread implementation strategy
D) Likely to be package level
France
A) As per EU Directive possible extension to 2022 pending
B) 2D Datamatrix, 2D required for CIP code
C) GTIN, lot, exp., Serial nr
D) X
Greece
A) Ongoing
B) Bollini Label 1D barcode: Code-39, linear barcode
C) Labels applied by Vignette labeller
D) GTIN, lot, exp., Serial nr, Package, reimbursed medicines
64
India
A) Not applicable, only Expiry Date required, Primary level Packaging: 1/07/2012, Secondary Level Packaging 1/01/12, Tertiary Level Packaging 1/10/11
B) MethodofRFID,2DBarcodes.ChangeonlyonetagFDA(Green/Approval).2Dor1D
barcode as per GS1. Primary level Packaging: GS1 2D DataMatrix, Secondary Level
Packaging: GS1-128 i.e. 1D or GS1 DataMatrix i.e. 2D or GS1 Databar, Tertiary Level
Packaging: 1D Barcode (GS1-128). 2D Datamatrix
C) No more Tag/Details: of prescription drug packages. Unique serial number, product
identificationcode,batchnumberandexpirydate
D) FDCA:ForDomesticsnotforExport:chainofapprovalfromalldealers,doctorsand
pharmaauthorization.Everypackaginglevel.AsperDGFTnotification.
Italy
A) Ongoing
B) Bollini Label 1D barcode: Code-39 (2D under discussion)
C) Labels applied by Vignette labeller purchase of Bollini from Italian MoH
D) GTIN, lot, exp. Serial nr, Package related to Batch Id
Nordic Countries
A) As per EU Directive
B) X
C) X
D) GTIN, lot, exp., Serial nr
65
Russia
A) 2015, current
B) Linear, 1D barcode Code-128C
C) Serials provided by Government (not GS1-compliant)
D) Serial nr, every packaging level
Scandinavia
B) 2D Datamatrix
C) X
Spain
A) 2016,Pilotprojectfinished
B) Datamatrix (pending Delegated Acts in EU Directive &
their transposition into Spanish laws)
C) All reimbursed medicines
D) Unit/package level
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UK
B) 2D Datamatrix
C) X
USA
A) 2015-16onsomepharma
B) E-pedigree,2DasperGS1,e-ped(RFIDorbarcode)
C) Possibly(ifRFthenencodingimportant)
D) Sales pack, Lot Potency, Expiration - NDC -eProduct Code - Manu
- DC/Pharmacy UID
67
1.2 Tobacco Industry

The WHO Framework Convention on Tobacco Control (WHO FCTC) is the first treaty negotiated under the
auspicesoftheWorldHealthOrganization.TheWHOFCTCisanevidence-basedtreatythatreaffirmstheright
ofallpeopletothehigheststandardofhealth.TheWHOFCTCrepresentsaparadigmshiftindevelopinga
regulatorystrategytoaddressaddictivesubstances;incontrasttopreviousdrugcontroltreaties,theWHO
FCTCassertstheimportanceofdemandreductionstrategiesaswellassupplyissues.
TheWHOFCTCwasdevelopedinresponsetotheglobalizationofthetobaccoepidemic.Thespreadofthe
tobacco epidemic is facilitated through a variety of complex factors with cross-border effects, including trade
liberalization and direct foreign investment. Other factors such as global marketing, transnational tobacco
advertising, promotion and sponsorship, and the international movement of contraband and counterfeit cigarettes have also contributed to the explosive increase in tobacco use.4
The who fcTc also regulates the illicit trade in tobacco products
in Part iv, article 15 in the who frame work convenTion on
Tobacco conTrol. following is an abstract of article 15:
1.1.
The Parties recognize that the elimination of all forms of illicit trade in tobacco Products, including smuggling, illicit manufacturing and counterfeiting, and the development and implementation of related national
law, in addition to sub-regional, regional and global agreements, are essential components of tobacco
control.
2.
2.
Each Party shall adopt and implement effective legislative, executive, administrative or other measures to
ensure that all unit packets and packages of tobacco products and any outside packaging of such products
are marked to assist Parties in determining the origin of tobacco products, and in accordance with national
law and relevant bilateral or multilateral agreements, assist Parties in determining the point of diversion and
monitor, document and control the movement of tobacco products and their legal status. In addition, each
Party shall:
68
(a) Require that unit packets and packages of tobacco products for retail and wholesale use that are sold
on its domestic market carry the statement: Sales only allowed in (insert name of the country, sub
national,regionalorfederalunit)orcarryanyothereffectivemarkingindicatingthefinaldestination
or which would assist authorities in determining whether the product is legally for sale on the domestic
market;and
(b) Consider, as appropriate, developing a practical tracking and tracing regime that would further secure
the distribution system and assist in the investigation of illicit trade.
3.
3.
EachPartyshallrequirethatthepackaginginformationormarkingspecifiedinparagraph2ofthisArticle
shall be presented in legible form and/or appear in its principal language or languages.
4.
4.
With a view to eliminating illicit trade in tobacco products, each Party shall:
(a) Monitor and collect data on cross-border trade in tobacco products, including illicit trade, and exchange information among customs, tax and other authorities, as appropriate, and in accordance with
nationallawandrelevantapplicablebilateralormultilateralagreements;
(b) Enact or strengthen legislation, with appropriate penalties and remedies, against illicit trade in tobacco
products,includingcounterfeitandcontrabandcigarettes;
(c)Takeappropriatestepstoensurethatallconfiscatedmanufacturingequipment,counterfeitandcontraband cigarettes and other tobacco products are destroyed, using environmentally friendly methods
wherefeasible,ordisposedofinaccordancewithnationallaw;
(d) Adopt and implement measures to monitor, document and control the storage and distribution of
tobaccoproductsheldormovingundersuspensionoftaxesordutieswithinitsjurisdiction;and
(e)Adoptmeasuresasappropriatetoenabletheconfiscationofproceedsderivedfromtheillicittradein
tobacco products.
4 WHO Framework
Convention on Tobacco
Control
69
5.
5.
Information collected pursuant to subparagraphs 4(a) and 4(d) of this Article shall, as appropriate, be provided in aggregate form by the Parties in their periodic reports to the Conference of the Parties, in accordance
with Article 21.
6.
6.The
Parties shall, as appropriate and in accordance with national law, promote cooperation between nati-
onal agencies, as well as relevant regional and international intergovernmental organizations as it relates
to investigations, prosecutions and proceedings, with a view to eliminating illicit trade in tobacco products.
Special emphasis shall be placed on cooperation at regional and sub-regional levels to combat illicit trade
of tobacco products.
7.
7.
Each Party shall endeavor to adopt and implement further measures including licensing, where appropriate,
to control or regulate the production and distribution of tobacco products in order to prevent illicit trade.5
5 WHO Framework
Convention on Tobacco
Control - http://whqlibdoc.who.int/publications/2003/9241591013.pdf
6 FEEM European Explosives

Code Structure - http://
www.tt-e.de/download/
Guidance%20Note%20
on%20the%20FEEM%20
European%20Explosives%20
Code%20Structure.pdf
70
1.3 Explosives
Regulatory requirements in the explosives industry are regulated in the European Directive 2008/43/EC on
Identification&TraceabilityofExplosivesforciviluses.
in the following an abstract of the feem european explosives code structure:

ThisFEEM(FederationofEuropeanExplosivesManufacturers)GuidancedocumenthasbeenpreparedtooutlinethemethodadoptedbyFEEMMemberstoachieveaharmonizedsystemforthepurposeofimplementing
theEuropeanCommissionsDirective2008/43/ECtoestablishasystemfortheidentificationandtraceability
of explosives for civil uses, and the associated national legislation. The system being recommended is not bindingonanyFEEMMembers,buttheadoptionandadherencetoitshallminimizelogisticalproblemsthroughout civil explosives supply chains in Europe. It is also available for others to adopt should such as system be
seenasbeneficial.
TheEuropeanDirectiveonIdentification&Traceabilityofexplosivescameintoeffectonthe4thofApril2008.
Thisdirectiveisintendedtoestablishaharmonizedsystemfortheuniqueidentificationandtraceabilityofall
packaged explosives, detonators, reels of detonating cord, primers and other explosives used in civil applications across the European Union. The directive was adopted into the national legislation of each European
Union member state on 5th of April 2009 with compliance achieved throughout Europe by the 5th of April
2012. The requirements of the Directive apply to all explosives manufactured, used and imported into the European Union from 5th April 2012.
The European legislation states that all packaged explosives for civil uses must be uniquely identified and
tracked at every stage throughout its life cycle. This requires every explosives cartridge, detonator, detonating
cord (every 5 meters), reel of detonating cord, and primer to have a visibly readable unique number on a label,
withabarcodeorRFIDtag,andanassociateddatacapture/recording/reportingsystem.Itisalsoarequirementfortherecordsofeveryuniquelyidentifiedarticletobemaintainedandtobeavailableforinspection
for a period of 10 years.6
71
72
Fig. 13: Big Picture: Potential benefits of Track & Trace
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2 Beyond compliance: potential benefits of Track & Trace

Setting up an item serialization infrastructure from scratch is always very cost intensive and disruptive and
most companies would only do it if they have very good reasons to do it (patient safety, compliance etc.)
However, putting a Track & Trace infrastructure in place in addition to pure item serialization is even more
disruptive and requires not only technology on the packaging lines, but lots of change management within
the entire supply chain.
Forthisreason,theMillionDollarquestionisalways:howcanweleverageourTrack&Traceinvestment?
SeeFig.13on
page 72-73
As the reader can derive from the diagram above, there is no simple answer to the question. There are many
opportunitiestogainbenefitsoutofTrack&Trace,howeverwhichofthosebecomerealtangiblegainsstrongly depends on the following factors:
1.
2.
Whataretheprocessrequirementsinordertoachievethebenefit?
What are the data requirements?
Subsequent sections of this chapter are aimed at providing some guidance to the reader. The insights and
inputs are the results of many workshops, discussions and analysis conducted mainly with multinational corporations from predominantly pharmaceutical industries, tobacco, agrochemicals or chemical industries.
74
2.1 Improved operations

The opportunity to improve operations mainly results from the following:
2.1.1 Process standardization and harmonization

Running a Track & Trace project always means going back to the manufacturing plant and warehouses or
distribution centers and introducing new processes in order to scan IDs on goods receipt, good dispatch, destructions and any changes in the aggregation (Pallet-case-bundle-item). Those processes are in most cases
(even though the particular country legislations might differ significantly) very standard and homogenous
across all warehouses and plants. Thus, if embedded in current processes, they represent a clear opportunity
of standardizing operational procedures and harmonizing processes.
TheglobalITandSupplyChainteamsarethemainbeneficiariesofstandardizedprocessesandoperations,
asitmakesitsignificantlyeasierforthemtosupportdifferentcountriesanddeploynewpracticesandtechnologies.
Theprocesspre-requisitetorealizethispotentialbenefit,istobuildinTrack&Traceprocesseswithinsupply
chain processes. Although this is not always practical due to timelines pressure (e.g. legal compliance driven by
a given market could make it impossible to run an exhaustive change management program), it should always
be the long-term vision of any global corporation to put Track & Trace in place. In many instances corporations
put Track & Trace on top of current processes and design a long-term roadmap to move from on top to
built-in.Thiskindoftransitionroadmaphasbeenobservedtobethemostefficientandriskfreeapproach
to implement Track & Trace across the supply chain. The alternative, to place integrated processes everywhere
from day one, tends to have very high failure rates, running into escalations and high impact operations problems (e.g. deliveries could not go out because Track & Trace process or technical failure).
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2.1.2 Gain production performance KPIs

Even with pure item serialization (comprehensive Track & Trace not required) it is possible to gain more insights into the production performance as individual items are produced, read and recorded on each of the
packaging lines. In this way it is possible to have a 100% accurate rate of packaging line performance, rejections etc. Obviously the gain derives not so much from the KPI itself but from the actions taken as a result of
the KPI analysis.
ThefactorymanageristhemainbeneficiaryofgainingKPIdatafromthepackaginglines.Basedonthisdata;
maintenance, purchase and other strategic decisions can be taken.
Therearenoprocessrequirementsinordertoconvertthispotentialintoabenefit.Therequirednumbersfor
theKPIcalculationareusuallyrecordedautomatically;therearehoweverdatarequirementsasaKPIreporting
system needs to be linked to the Track & Trace system in order to obtain the desired KPIs.
2.1.3 Gain warehouse performance KPIs

An obvious potential in cases of comprehensive Track & Trace deployments, in which the operators need to
scan nearly everything as a part of daily operations, is gaining transparency in warehouse performance as a
whole and taking it further, and also gaining insights into the individual operator performance. This kind of
transparency however is not always desired, and very frequently, especially in European countries with strong
tradeunionsandlargesocialconsiderations,thisisoftenanunacceptablepractice,andalmosttaboo;asa
result scanning mobile solutions treat users as anonymous (without any personal logins etc.) in order to avoid
the corporation from deriving operator performance KPIs through the scanning activities in warehouses or
manufacturing plants.
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The warehouse manager and on a higher level, the head of logistics in the country or region is the main beneficiaryofgainingKPIperformancedatafromthewarehouses.
As was the case for the production performance KPIs, there are no process requirements in order to convert
thispotentialintoabenefit.TherequirednumbersfortheKPIcalculationareusuallyrecordedautomatically;
there are however data requirements as evidently a KPI reporting system needs to be linked to the Track &
Trace system in order to obtain the desired KPIs.
2.2 Competitive advantage

WhenwefirststartedworkingintheTrack&Tracespace,backin2006,weweresurprisedbythehighdegree
of collaboration between directly competing corporations when it came to Track & Trace implementation.
We have even observed how industry wide working groups were formed across verticals in order to share
knowledge, establish best practices and even reuse IP and software solutions (good examples are the tobacco
industry working group or the CRISTAL working group from the agrochemicals industry). The only reason for
thiswasthatTrack&Tracewasperceivedasanon-valueaddingmusthave;somethingthatmustbedone
for compliance, costing large amount of money and not bringing any competitive advantage.
In recent years however, we have noticed a paradigm shift in this perception. Although the collaboration
around technicalities is still on going, companies are starting to leverage the existing investments to go beyond compliance. In industries like pharmaceutical or agrochemicals (less in tobacco due to legal restrictions in
terms of consumer facing marketing activities) we see great interest in areas that create customer value added
services. Examples are:
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2.2.1 Customer consumption, alerts, monitoring

The most common example is mobile apps for the end customer that assists medicine or product consumption. In pharmaceutical mobile apps, corporations are starting to link Track & Trace data with consumption
profiles,alertingconsumeraboutmedication,andmonitoringdosageconsumptionetc.(assumingthepatient
scans every medicines pack bought before consumption).
In the agrochemical industry the materialization of those customer added services also come in the form of
mobileapps,suchthatoncedeployed,theconsumersareabletoadviseonquantitiestoputinfields,calculate
bend formulas based on expected weather forecasts for a given location (based on device coordinates) etc.
2.2.2 E-Leaflets and targeted illness or product info

Driven by Track & Trace, but not necessarily linked to this (as Track & Trace is not really required to provide those services), are those mentioned customer friendly apps usually containing more additional functions which
allowthepatientstoscanthemedicineID(notnecessarilytheuniqueID)anddisplaytheelectronicleaflet
(whatwecalltheeleaflet)orreceivesomeadditionalinformationabouttheillnessforwhichthemedicineis
beingtaken(asortofelectronicflyer,whichwouldnormallybeacquiredinthepharmacyorfromthedoctor,
explaining the illness and ways of combating it etc.).
2.2.3 Increased customer loyalty

Forlifestyledrugs(lessprescriptiondrugs),theluxurygoodsindustryorforotherindustrieswhereproducts
are more commoditized (like agrochemicals, electronics, beverages etc.) we participated in several projects
with the mission of linking Track & Trace to loyalty programs.
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AgoodexampleofthisistheBonuslandprogramlaunchedbySyngentafortheGermanmarketin2010;a
program that allows farmers who bought Syngenta products (all products containing random serial numbers)
to collect unique ID labels (the 2D data matrix could be extracted from the bottle) and exchange the collected
labels for rewards. The publicly accessible documentation for this project is available on YouTube (search for
Syngenta Bonusland).
The reason for integrating Track & Trace with loyalty programs is normally to ensure that any unique ID receives points only once (as the numbers are unique), and that only real IDs are awarded (hence, the unique
numbers have to be randomized and cannot be sequential).
2.2.4 Establishing a direct dialog with consumers

Thisisallaboutcrossingthebridgetotheconsumers;thankstothepreviouslymentionedservices,manufacturers from any industry are in the position to establish a direct dialog with consumers and patients. Even in
industries where the consumer might have to stay anonymous for legal reasons (e.g. patient protection laws
in some countries) this direct dialog has a great marketing value for producing companies. In the past the
only channel to the consumers was via wholesalers/retailers. This new channel brings a whole range of new
opportunities.
Fromallthementionedvalueaddedservices,Marketingmanagersaretypicallythemainbeneficiariesofgaining this new channel to the end consumers.
Requisites in order to exploit these opportunities by gaining the required data are: building the consumer mobile app and linking it in with the Track & Trace system, with the loyalty/CRM systems or with whatever other
systems required (e.g. weather forecast databases).
79
However, the real benefit is not in collecting the data, but in acting on this data (cross selling, up selling,
profilingetc.).Therefore,thereareprocessrequirementsinordertoensurethatthemarketingdepartmentis
capitalizingonthebenefitofgatheringallthisadditionaldata.Thoseprocessesarealwaysbytheirnaturevery
customerspecificandnormallysubjecttoconfidentiality(asthisiseffectivelywhatcreatesthecompetitive
advantage).
2.3 Better Waste Management

Scanning scrapped/decommissioned products whenever single items are taken out of the supply chain is
normally compulsory for a company that puts Track & Trace in place (even in simple item serialization scenarios this is a must). This small process change has the potential to add additional gains to any corporation
in terms of:
2.3.1 Waste statistics (Intelligence)

Knowing exactly which items, when and for what reason were decommissioned (e.g. quality sampling or product expired) and having this information in a global centralized database can be of great value especially for
supply chain managers (allowing central monitoring of warehouse waste) or to quality managers (documenting the entire size of samplings etc.).
The data requirement means that the central Track & Trace repository is able to provide a report of decommissioned items per location.
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2.3.2 Avoid waste to revert to Supply Chain

Thegreatestbenefitisforthepatientorconsumer,andofcourseforthequalitymanagerwithinthecorporation,becauseflaggingeverydecommissionedproductintheTrack&Tracedatabaseandofferingthecorrespondinglookup/verificationservicestoconsumerscanavoidwasteproductfrombeingre-introducedinto
the supply chain and be consumed.
Inordertogainthisbenefitthedatarequirementisthatacorrespondingverificationserviceisaccessibleto
the end consumer via a mobile app, internet website or pharmacy Point of Sale (PoS) integration during dispensing etc.
2.4 Visibility in parallel trading

Parallel trading is very frequently an illegal practice in many industries, especially in those in which additional
import/export taxes are added to the product price (e.g. tobacco or alcohol). In the tobacco industry for example parallel trading (thus, avoiding tax evasion) is the main driver for governments to enforce Track & Trace.
In other industries such as pharmaceuticals, parallel trading however is partially legal, like in the EU, where free
trading of goods allows many re-packagers to run very lucrative businesses by purchasing drugs in Greece
and re-packaging them for the UK market. Parallel trading is however not legal outside of the EU (e.g. drugs
purchased in EU cannot be legally imported into the US).
Even though it is not widely acknowledged, especially in the pharmaceutical industry (despite parallel trading
being encouraged by governments based on the free trade of goods principle) Track & Trace is without question a very useful instrument to gain insights in parallel trading activities from wholesalers.
Againthesupplychainmanageristhemainbeneficiary.Themainrequirementtorealizethisbenefitistobe
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able to gather feedback from the market on a given ID. Thus, whenever an ID is dispensed, this ID needs to
be validated against the Track & Trace repository. With the corresponding alert mechanism in place, it is then
possibletoidentifythefirstpurchaserofthisitemandthecountryinwhichtheitemwasintendedtobesold.
2.5 Avoid brand damage

Foranymarketingresponsibilitytheworstpossiblenightmareiswhenaconsumerdiesorisinjuredduetothe
consumption of expired, defective or counterfeit product. But even in less extreme cases (e.g. in the luxury
goodsindustry)theimageofyourproductscanbeseriouslydamagedbyfalsifiedcopiessoldasthegenuine
one but obviously qualitatively inferior as the original product. In other industry, like in the cars or machinery
sparepartsindustry,theproblemisnoteventhequalityofthefalsifiedproducts,butthefactthatthisresults
inrevenuelosses.Themostcommonbenefitsinmostindustriescanbesummarizedas:
2.5.1 Avoid consumption of recalled batches

Providedthatitemsbelongingtodefectivebatches(andthereforerecalled)areflaggedintheTrack&Trace
database as recalled and provided that the corporation offers its customers some means for verifying the
product before its consumption, the usage/consumption of items belonging to re-called batches can be easily
avoided.
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2.5.2 Avoid anti-counterfeits

Provided that the end consumer is able to verify a given product ID, (and that this product ID contains authentication features in addition to plain unique printed randomized numbers) any consumer will be able to verify
the authenticity of a given item before its consumption.
2.5.3 Avoid consumption of expired product

Provided that the expiration date is an attribute of each unique item in the Track & Trace database, and assuming that the corporation offers to its customers a means of verifying the product before its consumption,
(e.g. during product dispensing at pharmacies, via mobile apps or internet etc.) the usage/consumption of
expireditemscanbeavoided;although,inmostcases,expirationdateisprintedinhumanreadableformaton
the item packaging thereby adding an additional alert for the end consumer.
2.6 Improved recall Management

Batches can be recalled for different reasons but the most common is the detection of faulty ingredients within
a given batch. In this case, neither item serialization nor Track & Trace help to identify which batches are affected;thisrequirestrackingofrawmaterialsandproductandcompleteproductgenealogytracing(tracingall
materials purchased, consumed, manufactured, and then distributed in the supply network).
However,oncetheaffectedbatchisidentified,Track&Tracehelpstofindoutinwhichstoragelocations,wholesalers and retailers stocks the affected batch exists.
In the event of a batch recall, the quality manager and supply chain director in charge of the recall campaign
arethemainstakeholders.Themostcommonderivedbenefitsresultingfromtheimprovedbatchrecallcapabilities are:
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2.6.1 Faster and partial batch recalls

Having a global Track & Trace system that contains serialized item information (in which typically each unique
itemhasthebatchNr.attributepopulated)andprovidesreportingcapabilitiesusingBatchNr.asafilter(and
groups the resulting items by location) would allow the execution of a batch recall much faster than usual,
since normally such a central system does not exist. In reality, most companies today require lock ups in several
systems in order to be able to consolidate all required information to initiate the recall campaign. Also, partial
batch recall might be something useful in given circumstances.
2.6.2 Faster version replacement

In particular, the pharmaceutical industry has regulations around product instructions, packaging, information
andartworkandrelatedupdates(medicineleaflets)thatareveryprescriptive.Inmanycases,eventhougha
givenbatchmightnothaveanyqualityrelatedissue,ifitcontainsanolderversionofaleafletoroftheartwork, the given batch supplied to a given market needs to be retired from the market. Thanks to Track & Trace,
in future, it would be possible to improve the management of versions and its stocks.
2.6.3 Theft stocks recalls

With non-serialized products, in the event that genuine product is stolen, it becomes quite impossible to
identify during trading exchanges in the supply chain or during its later consumption. Thanks to Track & Trace,
anystolenproductIDs(giventhateachproductIDisauniquenumber)canbeflaggedasstolenandlaterbe
identifiedbyinspectors,qualitymanagersortradingpartners.
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2.7 Shipment visibility and alerting

Whenever Track & Trace is implemented (not the case if only item serialization is in place), any warehouse
operator needs to scan individual items (or hierarchies of items) during receiving, shipping, aggregation or deaggregation operations. Two side effects of these scanning activities are potential opportunities to generate
benefitsforanywarehousemanagerorsupplychainmanager.
2.7.1 3 PL performance measurements

If Track & Trace is required, scanning operations are also required in outsourced operations. Due to this fact
it is relatively simple to compare work performance between different 3PL partners, and so review existing
contractsoragreeonmeasurestoboostproductivityandefficiency.
2.7.2 Error-free pick & pack

ProbablythemostapparentbenefitofintegratingTrack&Traceinthecurrentlogisticsoperationsistoavoid
errorsduringpickingandpackingandultimatelywrongshipments.Usually,warehouseoperatorsonlyconfirm
quantitiesduringdeliveryprocesses(wheneveranSKUispackedtofulfilladelivery,theoperatormanually
confirmsthequantitiesofthedeliverylineitemsafteravisualcountingprocedure).WithTrack&Trace,an
automaticconfirmationofquantitiestakesplaceinsteadofamanualone.Asaresult,deliveriescontaining
Track & Trace relevant products can only be completed if all the correct items with the correct SKU and batch
combinations were scanned in the exact quantity as expected in the delivery. Clearly a very low error quote
increases customer satisfaction and decreases error handling related costs.
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2.8 Optimized Inventory

Optimized Inventory is one of the key principles of the lean enterprise (very widely considered a best practice
in manufacturing companies). To the greatest possible extent, the following will be maximized: just in time,
firstinfirstout,producetoorderandpossiblyworkingcapitalandoutofstockscanbeminimized.Optimizing inventory is usually a project in itself, frequently not related to Track & Trace. With Track & Trace however,
because a central repository for individual items is usually created, it is possible to build on top of this, the
dream tool of any supply chain manager: a real time global inventory monitor. In order to achieve a strong
reportingtool,aconnectiontotheitemsrepositoryisrequired.Furthermore,therawdataexist,itisglobal
and it is extremely granular (on item level). The following points below are just some of the examples that this
global inventory monitoring could offer in terms of functionality:
Updated planning process with actual lead times

In-transit inventory
Reduce & stabilize lead time
Multi-stage inventory (Safety stock)
Inanycase,achievingthesebenefitsrequiresthatthecorrespondingreportsarebuilt.Thishowever,doesnot
imply changes to processes, as the data is available and collected as part of Track & Trace operations. It is only
a question of providing different views and perspectives of the existing Track & Trace data.
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2.9 Additional aspects to consider

There are additional advantages that can be gained from full item traceability, which are not shown on the
graphic at the beginning of this chapter. An interesting aspect for example is sustainability.
Traceability is one key pillar for sustainability
Much of todays sustainability data recording is a somewhat fuzzy exercise, apportioning through statistics or
averages of for example energy consumption of products.
With the right traceability system as backbone, the product genealogy, downstream traceability and product
provenance data could be attributed with product footprint data such as energy and/or water consumption
actually used in each production step. Actual natural resource consumption data across a products lifecycle
can be recorded from raw material till the point of sale. Emission calculations or measurements could be integrated as well.
Traceability to support sustainability strategies and its associated data recording will increase in importance
to support the maintenance and building of brand image, especially as resources become scarcer. In that
sense, traceability not only serves supply chain management or distributed manufacturing or the compliance
to traceability directives but also helps support corporate sustainability strategies. And ideally, a corporation
and their value chain partners have a single harmonized traceability data set that provides a single traceability
DNA supporting the different Supply Chain Management (SCM), Manufacturing, Quality Management (QM)
and sustainability context views.
87
v
Software components for
Track Trace
and their features
&
88
Software components for Track & Trace and their features
1 Requirements for Track & Trace Software Components

1.1 Introduction
In recent years, an entire industry providing Track
The principal software components are described in
& Trace solutions to businesses has arisen. Track &
more detail in subsequent chapters. In order to get
Trace systems include both hardware and software
a better understanding of the features, which will be
components. In this booklet the primary focus will
described later, the requirements for Track & Trace
be on the software components required to set up
software components will be addressed first. The
a Track & Trace solution.
best way to do this is to start with a simple example,

describing the single process steps and the requirements they generate for the software components.
89
90
Fig. 14: Overview Track & Trace process steps
91
1.2 Process example to explain the software requirements

1.
1.
Track & Trace in the production
Process step 1: Production

Physical: The products are produced
System: This process is not yet managed by Track & Trace software components. In general, the production
and packaging lines are connected to a Manufacturing Execution System (MES) in order to guarantee better
transparency and control.
Process step 2: application of the storage medium
Physical:Thestoragemedium(RFIDtransponder,1D-,2Dbarcode)isinscribedwiththeuniqueserialnumber
(e.g. EPC) and further data may be applied to the products and packaging containers (e.g. boxes, shippers,
pallets, etc.). This normally happens during production/packaging process. In general, the medium is checked
before it is applied to the product.
System: At this stage 4 necessary Track & Trace components are apparent. There has to be a global Track &
Trace repository (in regards to GS1 standards = EPCIS System), which at this stage contains all replicated products from the backend system and the associated GTINs (Global Trading Item Number). A so-called consolidation system (which can have different functions, at least if it comes to the SAP product which is described
later in this booklet and which in regards to GS1 standards is called edge server) manages the local number
ranges (e.g. per production plant). The software system on the production line (e.g. Systech, PCE, Werum,
Seidenader,etc.)thatgeneratestheRFIDorbarcodelabelscallsupawebserviceandautomaticallyrequests
new number ranges from the site manager/consolidation system. It is therefore ensured that labels can be
created without interruption, although the serial numbers are managed on the global software level (EPCIS
System).Andfinallytheprinting software/technology at the production lines, to print the storage medium
in cases where on-line printing is used.
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Process step 3: creation of Packaging hierarchies

Physical: In this process stage, outer packaging is applied to the individual products. By allocating individual
productstoanouterpackaging,apackaginghierarchyiscreated.Infurtherprocessstages,itisthensufficient
to read only one label from this container in order to identify all of the corresponding products.
System: The software system on the production line notes the relationship between the individual products
and the outer packaging. As soon as the complete packaging hierarchy has been generated (e.g. after the
outer packagings have been palletized), this information is passed through the edge server (if there is one)
to the global Track & Trace repository (e.g. EPCIS System). Multi-level hierarchies are of course possible,
e.g. items in folding boxes, folding boxes into shipping boxes, shipping boxes on pallets. Some important
attributes of the individual products, e.g. batch, expiry date, lot size, etc. are also carried over and can now be
retrieved at any time for each individual product.
Process step 4: loading the goods for Transport

Physical: The pallets are loaded e.g. onto a truck for transporting to the next station in the supply chain.
System:Eachpallethasitsownlabel,bymeansofwhichitisclearlyidentifiable,e.g.withaSSCC(SerialShippingContainerCode).Fromthepalletlabel,thecompletehierarchyofthepalletandtheattributesofeach
individual item can be queried in the global Track & Trace system. While loading the truck the individualized
pallets are scanned by a mobile scanning solution.Duetothescanningprocesstwothingswillhappen;the
automation of the goods issue posting will be triggered in the backend system using a system providing the
necessary logic and rules framework (e.g. the edge server) and a shipping event will be stored for each
individual item on the pallet with a time stamp and related location in the global Track & Trace system for
tracking and tracing purposes.
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2. Track & Trace in the Distribution Centre

2.
Process step 1: unloading the Transport

Physical: The pallets are unloaded in the distribution facility. If the production and distribution facility are locatedinthesameplace,thepalletsenterafinishedgoodsstore.
System: By scanning the pallets while unloading with the mobile scanning solution again two things will
happen: the automation of the goods receipt posting will be triggered in the backend system using a system
providing the necessary logic and rules framework (e.g. the edge server) and a receiving event will be stored
for each individual item on the pallet with a time stamp and related location in the global Track & Trace system for tracking and tracing purposes.
Process step 2: Picking
Physical: In reference to a consignment, the ordered products are picked. It may be necessary to create entirely
new packaging hierarchies for this, e.g. if items from various outer packagings have to be placed together in
one new consignment.
System: In the backend system, based on the customer order, a consignment is generated and sent to the
edge server. Picking is now carried out from this consignment. If e.g. individual products are removed from
an existing packaging unit at this stage, this is registered in the global Track & Trace repository by scanning
(RFIDorbarcode)theunitswiththemobile scanning solution. The same applies if new hierarchies are formed. In this case, new serial numbers are also assigned. As a result, a current hierarchy is always available in
the global Track & Trace repository and it is possible to track at any time where which product is now or has
been at a given time in each packaging hierarchy.
Process step 3: generating the dispatch unit
Physical: When picking is completed, a new dispatch unit (pallet) is packed / generated.
System: The generation of the dispatch unit (pallet) is also based on the consignment received by the edge
serverfromthebackendsystem.Inthefirststage,thepickermustthereforeassigntheconsignmentfrom
the edge servertoamobileterminal(barcodescannerorRFIDreader),whichisconnectedtothemobile
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scanning solution. When loading the pallet, the employee scans the packages and thus aligns them with the
consignment received. If the scanned products or corresponding quantities, batches etc. do not match the
details from the assigned document, a warningnotification is issued. As soon as the pallet is fully packed,
the employee closes the packing process and thereby activates the automatic generation of the pallet label
including a new serial number. As soon as all pallets in the consignment have been packed, the data is sent
from the edge server to the backend system and potential goods movements are posted. The global Track
& Trace repository holds all of the current data about the products, attributes, hierarchies and new states
(event messages, e.g. packed).
Process step 4: loading the dispatch units
Physical:Thefinisheddispatchunitsareloadedontothetransport.Here,variousconsignmentscanbecombined in one transport.
System:Foreachdispatchunitloadedontothetransport,themobile scanning solution scans the units in
relation to the shipping document. The global Track & Trace system receives the information of the scanned
units/pallets, the related shipping document and a new shipping event with time stamp and location, which
will be added to each individual item on the scanned units/pallets. As soon as the dispatch units have left the
distribution facility, the goods issue must be entered in the backend system. This can again automatically be
triggered with the scanning process and using business logic in a consolidation system.
Process step 5: during Transport
Physical: The transport is on the way to the next stage in the supply chain.
System:Withfleetmanagementsolutionsandintegratedcoldchainmonitoring,itwouldbepossibletointegratee.g.GPSdataandtemperatureprofilesintotheglobal Track & Trace system. This information can
be saved at individual item level and accessed later for use by integrated alert management in such a global
Track & Trace system.
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3. Sending Track & Trace Data to Authorities or supply chain partners

3.
The following process steps are explained with an example of e-pedigree.7 E-pedigree only concerns companies in the pharmaceutical industry, however, it can (to understand the process) be adapted by all companies
obliged to operate Track & Trace due to legal provisions.
Process step 1: loading the dispatch units
Physical: The distribution facility sends the dispatch units to a wholesaler.
System: As soon as the dispatch units have left the warehouse and the goods outwards have been entered
inthebackendsystem,anAdvancedShippingNotification(ASN)isautomaticallygeneratedandsenttothe
global Track & Trace system. The ASN generally contains information about the recipient, such as contact
detailsandaddress,butnoserialnumbersfromwhichproductswouldbeclearlyidentifiable.
Process step 2: enriching the asn and sending
Physical: The manufacturer sends the wholesaler all of the information about the pallet, packagings and individual products (attributes and serial numbers).
System: The global Track & Trace solution receives the ASN from the backend system and enriches it with
the corresponding serial numbers of the pallets, packaging and products it contains. The global Track & Trace
repository then converts this data into the format required by the external receiver. An external program now
receivestheASNenrichedwiththeserialnumbers,fromwhichitgeneratestheofficialE-Pedigreedocument.
Process step 3: receipt of the e-Pedigree document by the wholesaler
Physical: The wholesaler receives the E-Pedigree document even before the pallets physically arrive.
System: The E-Pedigree document is received by the wholesalers Track & Trace system, where it is checked
(senders authorization etc.).
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Process step 4: unloading the dispatch unit at the wholesalers

Physical: The dispatch unit is unloaded at the wholesaler.
System: The wholesaler enters the goods inwards in their backend system. The goods physically received are
validated for correctness against the information from the enriched ASN by the Track & Trace system.
4.
4.
Authentication
Process step 1: authentication and Track & Trace

Physical:Therecipienttakesdeliveryoftheorderedproducts.Byscanningthebarcode/RFIDtransponderon
the product, the authenticity of the products can be checked and Track & Trace data can be shown.
System: As explained above the global Track & Trace system contains all the product-related information
(serial numbers, attributes, supply chain information etc.) right from manufacturing, through the parties in
the supply chain and till it reaches the recipient. In addition, the global Track & Trace solution can hold
authentication features, such as unique characteristics of the product. By scanning the serial number with a
mobile scanning solution, every partner in the supply chain who has access to this data is now able to view
thenecessaryinformation,inordertoconcludewhethertheproductisgenuineorcounterfeit.Furthermore,
all product-related data such as the date of manufacture, batch, expiry date, temperature data etc. can be
displayed for any desired point in the supply chain.
1.3 Summary of the necessary components and requirements
7 An epedigree
(sometimes referred to as
e-pedigree or electronic
The simple example above, has illustrated that the following software components are
neededtofulfilltheabovementionedrequirements.Thereareadditionalfunctionsavailable for each component, which will be described in subsequent chapters.
pedigree) is an electronic
document , which provides data on the history
of a particular batch of
a drug. It satisfies the
requirement for a drug
pedigree while using a
convenient electronic
form (http://en.wikipedia.
org/wiki/E-Pedigree)
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Printing software/Technology
Printing and applying the storage medium
Etc.
Please refer to chapter V, 3.1.
line system
Managing local serial number ranges
Checking Labels
Building Hierarchies
Etc.
This booklet will focus on Serialized Product Tracking (SPT) from Systech as a Line system.
edge server/consolidation system

Business Logic for automation of business processes
Checking the physical goods against e.g. shipping documents and consignments
Consolidation of data
Etc.
This booklet will focus on SAP Auto-ID Infrastructure as a consolidation system/Edge Server.
global Track & Trace system (ePcis)

Storing all Track & Trace relevant data such as events, attributes and hierarchies
Access/Query of all these data
Transferring data to authorities and supply chain partners
Etc.
This booklet will focus on SAP Object Event Repository as a global Track & Trace system/EPCIS.
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mobile scanning solution

Scanning of different process steps along the supply chain to capture the data for the global Track & Trace
solution and to trigger business processes/goods postings
Authentication features for e.g. consumers

Etc.
This booklet will focus on Movilizer for Track & Trace as a mobile scanning solution.
why is this booklet focused on a line system from systech?

WiththefriendlysupportfromSystech,significantdetailsandspecializedknowledgehasbeengatheredfor
the chapter on line systems than what the author would have been able to provide. It is for this reason that
Systechs solution has been addressed in this chapter.
why is this booklet focused on the edge server and ePcis system from saP?
SAP,knownastheworldslargestsupplierofstandardsoftware,identifiedtheneedforTrack&Tracesolutions
at a very early stage and developed a software solution for this very problem over 10 years ago. All well-known
companies that have dealt with Track & Trace rely on these SAP products. No other solution is currently able
to manage the huge volume of data arising from serialization at item level and complete tracking along the
entiresupplychain.Theearlystartofdevelopmentandtheearlyconfidenceofleadingcompaniesthatrely
on these solutions have given SAP an unsurpassable edge in terms of maturity level, stability and the standard
rangeofTrack&Tracefunctionsofthissolution.Thereforeitisjustifiedtocallthemthedefactostandard.
why is this booklet focused on the mobile enterprise application Platform from movilitas?
Besides the fact that Movilitas as a company has extensive experience in this software, it is also the only software in the market for mobile data capturing known to the author which offers many out of the box and
easy to implement Track & Trace features. Therefore, Movilizer for Track & Trace is regarded as the de facto
standard for mobile data capturing in Track & Trace processes.
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1.4 Short Description of necessary de facto standard components

In subsequent sections a brief description of the above mentioned software components will be covered to
provide a better understanding of the architecture overview in the next chapter.
a) Printing Technologies for Track & Trace related marking activities

Tracking and Tracing applications require products and/or handling or packaging units to be uniquely identifiable.Theidentificationifcapturedatthepointofmanufacture,isusuallydoneautomaticallybyafixed
reading unit, installed within or directly after the production line.
The most common and most effective way to mark these units is to label them directly at the production line.
b) systech serialized Product Tracking - software at production lines

Systech Serialized Product Tracking (SPT) application enables track and trace, ePedigree and authentication.
SPT leverages Systech Advisor and Systech Guardian to obtain Electronic Product Code (EPC) serial numbers
and assigns them to items, cases and pallets, establishing parent-child relationships for each. It also addresses
pharmaceutical manufacturers needs for elegant solutions that are alternatives to customized software to
configureandadministerline-andmachine-leveloperations.
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Fig. 15: High Level Software Architecture SAP AIE
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c) saP auto-id enterprise (saP aie) edge server & ePcis

SAP AIE combines SAP Auto-ID Infrastructure (SAP AII) and SAP Object Event Repository (SAP OER) in one
software package and therefore offers the possibility to use serialized information in different software applicationssuchasforexample;SupplyChainManagement,production,andservice-andassetmanagement.
saP auto-id infrastructure (saP aii) edge server

SAP AII acts as a factory consolidation server. This means that all packaging lines are sending serialized information to the SAP Auto-ID Infrastructure, which then consolidates it and sends only event
relevant information to the centralized SAP Object Event Repository. Furthermore SAP AII can be
usedfortheautomationoflogisticprocesses,(e.g.deliveriesareconfirmedinSAPAIIassoonasIDs
are scanned and automatically updated in SAP ERP, including the materials movements and necessary postings). If you refer to the GS1/EPC Global terminology SAP AII is called the Edge Server.
saP object event repository (saP oer) - ePcis

The Fig. 15 demonstrates that Track & Trace always requires a global component. A component,
which acts as a central repository for serial numbers and product related information. On the one
hand this data storage repository has to hold all product related serial numbers and information (Tracking) and on the other hand it is the basis for every product related reporting (Tracing). SAP Object
EventRepositoryfulfillsexactlytheserequirementsandis100%EPCIScompliant.FollowingtheGS1/
EPC Global terminology, SAP OER is called the EPCIS-System (Electronic Product Code Information
System). In addition SAP OER takes care of the coordination of any local SAP AII system.
saP Process integration (saP Pi)

SAP PI is an integration broker that allows the asynchronous processing of EPCIS messages. The
integration between SAP AII, SAP OER and SAP ERP is done through SAP PI. This ensures message
processing regardless of peaks within the different manufacturing locations and warehouses. With
SAP PI a Track & Trace landscape will be able to cope with incoming messages containing serialized
data. Additionally, SAP PI allows data buffering, data reprocessing and audit trail.
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d) movilizer for Track & Trace mobile scanning solution

The Movilizer is standard software developed and supported by Movilitas. This software is an on demand
mobile enterprise applications platform. It supports most of the available mobile devices in the market (Android, iOS, Blackberry, Symbian, etc. as well as any industrial PDA/Handheld). It allows a secured connection via
end-to-end encryption with any SAP or non-SAP System. Additionally, it includes some interesting features
like usage of mobile phone cameras as barcode scanners, geo location, etc. Movilizer for Track & Trace is
anoutoftheboxSAPcertifiedplugInforSAPAIEtosupportallTrack&Tracerelevantmobileprocesssteps
onlineandoffline.
2 Architecture examples of implemented

Track & Trace software landscapes
InthefollowingfiguresyouwillseesomesampleTrack&Tracesoftwarelandscapesthatwehavealready
implemented at different companies.
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Fig. 16: Architecture example 1 SAPs standard proposition

figure 16 shows SAPs standard proposition. In short this means 1 global SAP OER, 1-n local SAP AIIs, 1-n
SAP ERP systems and integration of those via SAP PI. The line systems report serialized information and aggregation information directly into SAP AII. The mobile scanning solution can be integrated in different ways,
depending on the related process step it is used for within the supply chain.
The diagrams below show different variations of SAPs standard proposition.
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Fig. 17: Architecture example 2 No Edge Server (SAP AII)

As can be seen in figure 17, some companies dont use SAP AII or a consolidation system/Edge Server. Simply
speaking these are usually customers who dont want to use the consolidation functions and features to automate logistic processes or those that only need to serialize products and store the serialized information in a
global Track & Trace repository without integration of logistic operations.
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Fig. 18: Architecture example 3 Global Edge Server (SAP AII)

It is not always necessary to use SAP AII as a local system with different instances. Generally it depends on the
datavolumesandperformance,specifictoeachcompany.Thereforefigure 18 shows an architecture example
where only one global SAP AII system is used. These companies can still use the checks against e.g. shipping
documents at the point of scanning and automation of logistic processes but abstain from the local consolidation functionalities and therefore accept a certain level of potential performance issues.
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3 Detailed description of the software components

3.1 Printing Technologies for T&T related marking activities
3.1.1 Introduction
Tracking and Tracing applications require products and/or handling- or packaging units to be uniquely identifiable.Theidentification,ifcapturedatthepointofmanufacture,isusuallydoneautomaticallybyafixed
reading unit, installed within or directly after the production line.
The most common and most effective way to mark these units is to label or mark these units directly on the
production line.
Marking Technology regardless of its nature impacts the production Equipments efficiency (OEE). OEE
impactsofupto5%couldbeobservedindifficultenvironments.Therefore,specialattentionneedstobepaid
to the requirements for printing technology, when introduced into an operational environment as part of a
Track and Trace project.
TheBasicRequirementsforprintingcanbedistinguishedasGeneralRequirementsandApplicationspecific
(Track and Trace) Requirements.
general requirements:
Lowest possible performance impact (OEE)
Acceptable TCO for equipment
Long maintenance cycles
RequiredcertificatesforrespectiveProductionenvironments
Possibility to integrate with existing Production IT Systems i.e. SCADA or MES Systems
Printing and Application speed must to be greater (or minimum equal to) production
speed of the Line / machine
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Track and Trace Specific Requirements

Capability of the printing equipment to reliably generate a globally unique Code (according to the desired
Standards)inthedesiredCodeFormat(i.e.Barcode,2DMatrixCodeetc.)
Sufficientresolutionforsubsequentcodereadingapplications
3.1.2 Available printing Technologies

3.1.2.1 Continuous Inkjet
The continuous inkjet technology is often used for markings onto existing wrapping materials in high-speed
applications, where a cost-effective and reliable marking technology is required. The downside however is a
degraded reading capability for automated readers compared to traditional label printing and application.
This is due to the fact that only a single line of ink is used to print the code.
In Continuous Inkjet applications, a single string of ink is adjusted up and down by piezo-electric diodes to
form in accordance with the objects speed.
SpecialkindsofInkjetprintersarethetypessoldbyWolkethatuseastandardOffice-gradeprintercartridge.
Almost the same speed is possible with this technology and the print image is more stable in terms of optical
accordance. However the printing height is limited by the Cartridges used (typically around 10mm).
advantages:
Requiresjustonesteptofinish
Available for very high speeds
Relatively Robust in operation
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limitations:
Limitedprintingheight,whichmayresultinsmallcodesthataremoredifficulttoreadbyautomaticreading
devices
Needs regular maintenance and supervision during operation (ink-supply)

Material use is restricted due to possible bleeding on certain materials (e.g. dark surfaces cannot be used)
Printing on dark backgrounds, such as corrugated cardboard, results in low contrast
3.1.2.2 Direct Laser marking

In-Line Laser marking uses an approach similar to continuous inkjet technology, however a Laser is used to
physically alter (burn) the base material, to add the information onto it. Laser applications are not suitable
for all applications, as it may have unwanted side-effects such as undesired heating of the content (i.e. in
pharmaceutical applications) and may increase the risk in heat sensitive environments. Also, depending on the
base-material, the actual contrast is typically lower compared to printed markings.
advantages:
Requiresjustonesteptofinish
Available for very high speeds
Very Robust in operation
No Supply materials required (e.g. Ink)
limitations:
Printing Contrast is low -> may impose problems during reading

Axial conformity of 2D Codes critical to achieve
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3.1.2.3 In-Line Label printing and application

(Thermal Transfer/Thermo Direct)
A very typical application for package markings is the in-line Label Print and application technology.
A printer with an attached application device is present on the production line and labels the goods that are
transported by a conveyor. The information is printed onto a self-adhesive label on demand and is applied
usingapackagingspecificapplicationdevice(stamp,bloworanyspecialcombinationsofthese)connected
to the printer. Label printers require a certain effort in regular preventive maintenance to maintain the desired
print quality as well as to ensure proper operation and low performance impact. This maintenance usually
consists of cleaning and changing of print heads as well as maintenance of mechanical components such
as rollers, motors and transmissions. Compared to Inkjet printing or laser marking, the costs for Labels and
consumables are higher but the amount of information as well as the printing quality is best. This printing
technology is very well suited for Code-applications, such as Barcodes or 2D Codes.
Forin-linelabelapplicationtherearetwomajorprintingtechnologiesavailable.Thermaltransferandthermal
direct printing.
A) A thermal transfer printer prints onto the carrier material by melting a coating of ribbon so that it
stays glued to the material on which the information is applied.
B) A direct thermal printer produces a printed image by selectively heating coated thermo chromic
paper. The coating turns black in the areas where it is heated, producing an image.
Both printing technologies have comparable results in terms of image quality, however not all technology is suitable for all kinds of applications, as environmental factors may mandate a certain technology. If for example the product is exposed to high temperatures after the printing process, direct
thermal printing must not be used, as the thermo chromic paper may degrade (turn black) and the ID
will become unreadable.
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A) Thermo transfer Label Printing and application
B) Thermo direct Label Printing and application
advantages:
advantages:
High readability of the code
High readability of the code
Flexibilitytoincludeotherinformationonthe
Flexibilitytoincludeotherinformationonthe
label
More robust labels than direct thermo printed

labels
label
Lower complexity compared to thermo transfer

printing
Lower abrasion of print heads as with Thermo

direct printers
limitations:
limitations:
Labels sensitive to temperature, light and other
Labels sensitive to temperature, light and other
environmental factors
Relatively complex systems requiring supplies

(e.g. compressed air)
Requires regular maintenance and constant

supervision during operation
Considerable running costs (Labels, Ink Ribbon,

Printing heads)
environmental factors
Relatively complex systems requiring supplies

(e.g. compressed air)
Requires regular maintenance and constant

supervision during operation
Considerable running costs (Labels, Printing

heads)
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3.1.3 Conclusion
Therearemultiplefactorsthatinfluencethechoiceofthebestmarkingtechnologysuchaswrappingmaterial,
form factor, means of transport, speed of the line, surface of packing material and others.
Ingeneral,agoodcompromisebetweenprintingquality,price,reliabilityandflexibilityisavailablewhenusing
Label print & applied technologies.
in-line printing vs. pre-printed codes

In general, printing the unique code for Track and Trace purposes in-line has multiple advantages over the
usage of pre-printed codes:
GreaterFlexibility
Depending on the technology used, it is easily possible to add information delivered by the printer to the
product, also in later stages.
Reliable Code-Generation
With modern printing technology it is possible that the required globally unique code used for Track and Trace,
is generated by the printer autonomously. This can guarantee uniqueness of the code by the self-checking
mechanism between the printer and a subsequent reading system that captures the code shortly after its
generation.Thisallowsquickreactiononmalfunction(e.g.duplicateprinting).Furthermore,theautonomous
code generation guarantees independence of the printing system from any surrounding systems such as MES,
ERP, SCADA etc.
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Nevertheless most Printing/Print & Apply Systems can be integrated into existing environments if desired to
maintainprocesscontrolandtostreamlinethedatahandlingontheshopfloor.
There are multiple options, to print the required T&T Code in line, the two basic concepts are via self-adhesive
label or directly onto the surface of the packaging object. It is important however, that the code is printed with
highcontrastandaccordingtothespecificationse.g.axialconformity(especiallyimportantwhen2DCodes
are used).
3.2 Processes, Considerations and Software at production/packaging lines

3.2.1 Quick Overview of the Systech Software Components
sentri machine level
SentrioffersanextensivesetofvisiontoolsincludingOpticalCharacterVerification(OCV),OpticalCharacter
Recognition(OCR),BarCodeVerification(BCV)andPrintQualityVerification(PQV),whichcomplementgeneral quality inspection functions such as gauging, object presence, shape, defect, count and color.
The Sentri product comes complete with audit logs to provide assurance for procedural control, quality and
regulatorycompliance.Italsoconductsdevicesetup,recipe-drivenworkflow,rejectstationmanagement,and
control of intelligent online devices (printers, bar code scanners, and weight checking) to ensure integrated
quality control.
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advisor line level

Systech Advisor is a packaging line automation product that seamlessly integrates with Systech Sentri for realtime production monitoring, control, data collection and reporting. Advisor connects and manages intelligent
devices on the packaging line, provides data reporting and archiving, line security and procedural controls
through one central source. Advisor conducts the line management activity and data functions necessary to
support performance metrics, serialization and advanced business intelligence applications.
guardian Plant level

Systech Guardian enables enterprise-wide visibility of packaging line data, empowering management to make
better-informed business decisions. Systech Guardian, integrated with Systech Sentri machine vision inspection and Systech Advisor line management and control solutions, represents a comprehensive Packaging
Execution System (PES) for pharmaceutical manufacturers. Guardian is capable of supporting multiple Advisor
line solutions.
Systech Guardian also provides the foundation of unique item-level serialization and aggregation of serial
numbers to packaging units. Systechs software manages the writing, reading, and printing of serial numbers
at the line level and controls the provisioning of serial numbers within the packaging environment.
serialized Product Tracking (sPT)

Systech Serialized Product Tracking (SPT) application enables track and trace, ePedigree and authentication.
SPT leverages Systech Advisor and Systech Guardian to obtain Electronic Product Code (EPC) serial numbers
and assigns them to items, cases and pallets, establishing parent-child relationships for each.
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3.2.2 Serialization walkthrough old view, new view

For the purpose of this document the term unit refers to the smallest packaging level
and the term packaged item or item refers to any package level (unit, bundle, case,
or pallet).
The traditional packaging paradigm has been to produce large numbers of identical items to an exacting standard. Thus packaging lines (manual and automated) and SOPs for those lines have focused on making sure
everyitemisidentical;uniquenessconstitutesadeviationfromthenorm,whichthereforemakesitareject.
Theseworkflowsdonotspecifytheneedtotrackthestatusandlocationofindividualpackageitems.Rework,
samples, line stops, and machine jams resulting in the manual movement of product have no impact on the
end results. It does not matter if the same bottle was inspected twice or was packed into one case, removed
andpackedintoadifferentcase.Eachpackageditemisassociatedwithlotorbatchdata;thereisnoneedto
maintain individual data about each item. Inventory records must be created for the original lot and updated
toreflectsamples,damagedgoodsandshipments.Thefocusisonquantitynottracking.
Traditional Packaging Paradigm Produce large numbers of identical items to exacting standards.
Fig. 19: Traditional Packaging Paradigm

The serialization packaging paradigm is to produce large numbers of uniquely identified units containing
common information and associated with lot data and packed into multiple sterilized package levels. This is a
radicalchangeinthinkingatthepackaginglinelevel.Packagingworkflowsmustnowconsidereachpackaged
item individually, track it, update its status, and reference the physical package to an individual data set. Sud-
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denly operators are forced to change their way of thinking about each item. No longer can they stack cases
onthefloortokeepthecasepackerrunningwhenthecaselabelerisdown.Nolongercantheytakeitems
from a reject bin and place them back for a re-inspection. No longer can samples be pulled from one case to
be manually replaced at the end of the lot. All of these common practices now jeopardize the data integrity
of each physical serialized item and its representative serialized data set.
serialization Packaging Paradigmproducelargenumbersofuniquelyidentifiedunitscontainingcommon
information and associated with lot data and packed into multiple sterilized package levels.
Fig. 20: Serialization Packaging Paradigm
It is a dangerous world outside of the packaging line for serialized items. Every step of the way, there are traditional processes aimed at breaking the integrity of the items data from the physical item. Sampling, reworking
damagedgoods,reconfiguringpalletsandmanualqualityinspections:allthreatenthedataintegrityofthe
serialized package.
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3.2.3 Serialization Requirements/Considerations

Serializationrequiresnewworkflowsnotonlyonthepackinglinebutalsothroughoutthesiteupuntilthe
time of shipment. The key element in all of this is the human factor. Serialization requirements place a great
deal of burden on operators and supervisors. The automated and IT solutions, once installed, will operate as
designedoverandoveragain.Thehumanfactorchangesdaybydayandifnotconsideredintheworkflow,it
willresultinanunstableandunreliableserializationdeployment.Fromtheoperatorspointofview,theideal
workflowwouldbethesameforserializedandnon-serializedproducts.Therealityisthatnewworkflowswill
berequiredandwillforcechangesinstandardoperatingprocedures.Thekeytosuccessistocreateworkflows
that reduce the impact on human processes while maintaining data integrity.
Serialization starts with the provision of serialized numbers (involves obtaining unique unused serial number).
This can be a manual or automated process and can be performed ahead of time or on-demand. Once a serialized number is available, it needs to be formatted in order to comply with label formats, country regulations
and data carriers. At this point, the serialized number has been issued and cannot be issued for another item.
The formatted numbers, multiple formats may have to be created from the same original number, can now be
senttotheprinterorRFIDreader.Oncetheitempassesallinspectionsitcanbecommissioned.
3.2.4 How it works/How it should work

In a commissioned item, the child, is available for packing into a higher-level package, the parent. At this point
the child is considered as an orphan- a commissioned child that has not been packed into a parent. Aggregationistheprocessofassigning(packaging)childrentoaparent.Theaggregationrulesaredefinedbythe
packaginghierarchy,whichspecifieswhatpackagetypescanbepackedintootherpackagetypes(e.g.bottles
into case, case into pallet). The aggregation operation checks the childs type, state and maintains a child count
against the required count or pack factor. If the child type does not match, or a child is not an orphan, or the
expected count is not reached, the aggregation will fail. In order to commission the parent three things must
happen:
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The parent must be issued a serialized number

The aggregation has to be completed
The required inspections must pass
The commissioned parent may now become a child for higher-level packages (e.g. case is the parent of a bottle
but the child of a pallet).
On line level, any serialized number assigned to an item will in general have one of three states, issued, commissioned or decommissioned. Decommissioning is the result of a failed inspection or a manual operation.
Once a serial number is decommissioned, its state cannot be changed. Decommissioned children cannot be
packed (aggregated) into parents.
At some point, the product will reach the highest-level package or top-level parent. The top-level parent will
varydependingontherequiredserializationhierarchy.Forsinglelevelhierarchythetop-levelparentwouldbe
the bottle, for two levels it could be the case and for three levels it could be the pallet. Before ending the lot,
reconciliation of all the used serial numbers is required.
dealing with abnormalities

Now that the packaging lot is over, something has to be done with the physical product and the data for this lot.
Lets assume that we are not going to ship each pallet immediately after it is wrapped and commissioned. We
will move all pallets for the lot into a holding area until quality assurance formally releases the lot into inventory.
During this holding period, quality assurance decides they have to pull additional samples from cases of each
pallet. The removed samples will be replaced, so that all case will have a full count again. The physical aspect of
this process is straight forward but how does one allow this and maintain the integrity of the serialized data?
Manufacturers need to consider a solution that will ensure data integrity and has the ability to meet the demands of existing and emerging regulations around the world (see also chapter V, 3.6 Mobile Scanning Solution).
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3.2.5 Protect data/packaging integrity and ensuring data accuracy

data integrity for serialized products is the ability to ensure that the physical world matches the data representation. There is a large manual component to maintaining the integrity between the stored data and the
physical product. Even on automated packaging lines there exist exception use cases where product may
deviatefromtheexpectedworkflow.Onthepackaginglinequalityassurancesampling,machinejams,power failures, reject bins, manual rework and quality challenges all cause multiple products to deviate from the
data representation. After packaging is complete, quality assurance sampling/inspection, damaged packages,
shippingconfigurationsandmanualreworkallhaveanimpactontheabilitytomaintainthematchbetween
the data and physical world.
Maintaining Data Integrity is not just an aggregation issue but also applies to single item level serialization.
The level of reliance on the operators to maintain the data integrity is always present. It is recommended that
asolutionisimplementedthatcanreducethedependenceontrainedoperatorsasmuchaspossible.Features
such as auto-decommissioning products that have not made it to the end of the packaging line reduce the
need for operators to manually decommission products.
virtual packaging functions support aggregations where no parent serial number is assigned. This allows a
single child serial number to be used to obtain all siblings utilizing inference to facilitate higher levels of aggregation. Virtual packaging may also be used to provide some level of auto-decommissioning when dealing
with item level serialization.
end of lot reconciliation is the ability to verify that the physical world matches the data storage. A solution
is recommended that can provide reconciliation reports prior to ending the packaging lot and gives operators visibility to the commissioned, decommissioned, packed and orphaned products. This allows operators
to verify the physical product against the recorded data ensuring what was produced was not inadvertently
modifiedthroughmanualintervention.
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manual overrides must be in place to:
Allow packaging to continue, if an automated piece of equipment is down

Maintain data integrity with minimal impact on the operator
Any time an operator has to manually pack and label a case there is an increased risk of error. It is recommended to have a solution that provides checks and balances to assist the operator during the manual process
and will not allow an operation to be completed if there is a discrepancy. Additional support for authorized
exception to the rules allowing the creation of partial pack quantities when approved is also suggested.
It is important to support centralized operations such as manually palletizing to match the movement of the
physicalproductandtheassociateddata.Forexample,whencasesarecompletedonapackaginglineand
then moved to a central area for palletizing, it is important to keep this data consistent with the case data and
all its children at the time the case is commissioned. Being able to access that data to verify that the case is
commissioned and not packed on another pallet is vitally important.
Functionalitytomaintainthedata integrity for offlineusecasesisimportant.Forbothaggregationandunit
level there has to be functionality to address physical changes in the packaged product. Removing additional
samples,removingorreplacingdamagedpackaging,replacingdamagedlabelsorchangingshippingconfiguration all require an update of the data to match the physical world.
3.2.6 Protect packaging line efficiency and throughput

There are two fundamental principles that must be maintained for serialization to be successful in the package
environment.Thefirstistokeepthepackaginglinesrunning.Thisconceptgoesbeyondtheactualpackaging
line and needs to take into account the relationship with corporate networks and enterprise level systems. Having
a solution that provides a gateway between the corporate enterprise systems and the packaging line will help
(e.g.SystechGuardianorSAPAuto-IDInfrastructureoracombinationofboth).Forserializedproductsthis
includes provisioning, notification, number formats, packaging hierarchies and package quantities that are
required regardless of what packaging line a product is packed on.
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Asolidsolutionwillallownumberrangestobeobtainedfromenterprisesystemsinsufficientquantitiesto
allowpackingtorunpriortothestartofapackaginglot.Asolutionthatprovidessufficientnumberranges
to run several days of any single product, breaks the dependency of IT schedules and availability for corporate
enterprise systems on packaging operations.
The second principle is to not negatively affect throughput of the packaging line. It is important that the solutionpre-verifiesallprovisionnumberrangesandperformsanypre-formattingofthesenumbers.
Maintaining processing data rates that exceed packaging line throughput requirements is recommended. In
this way, software is not the gating factor on line performance.
3.2.7 Serialization Considerations

Total cost of ownership Total cost of ownership extends for years beyond the initial equipment purchase,
non-recurringengineeringandinstallationcosts.Changecontrol,support,training,flexibility,scalability
and lower downtime are all factors that go into total cost of ownership.
reduced deployment risks Serialization is a reality in todays world. The days of small pilots for learning
are over and companies have to deal with multi-line and multi-site deployments. The deployment risks include technology, varied line equipment, network connectivity, internal engineering resources, IT resources
and corporate and site sponsorship.
flexibleFlexibilityistheabilitytoeasilyadapttochangingdemandswhileintroducingminimalimpact.
Each packaging site and each line within a site has its unique set of requirements and challenges. Each site
willhavepreferencesforspecificdevicesandpackagingequipmentaswellhasdifferentmarketregulations
thathavetobefollowed.Packaginglineworkflowscanrangefromfullyautomatictofullymanualandanywhereinbetween.Multiplelinesmayrunthesameproductsorindividuallinesmaybededicatedtospecific
productsormarkets.Inthetraditionalpackagingparadigm,flexibilitywasnotdependentonhigher-level
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systems. With the serialization paradigm, data integrity must be maintained regardless of the packaging
lineconfiguration.Withtheconsolidationofpackaginglinesduetomergersandplantclosures,unique
site-specificsolutionswillbehardtomanage.
scalable Scalability is the ability to start with a base system and at a later date, add functionality without
replacing the base system. In todays economy companies are merging, consolidating and cutting expenses.
To reduce their total cost of ownership they are looking for solutions that offer them an entry level that can
be scaled to meet future demands. Scalability is only truly achieved if pervious equipment and engineeringcostscanbeleveraged.Payingtwiceforthesamefunctionalityisnotscalable;payingfortheadded
functionality is.
3.2.8 Benefits of Systech Serialized Product Tracking (SPT)

Systech SPTs value resides in the ability to address a manufacturers business concerns while supporting their
packaging needs without custom development. Since 2005, Systech has been working with customers to definepackaging,usecasesanduncoverriskareasrelatedtopackagingserialization.Thisexperienceisrolled
intoastandardslibraryofprovenworkproductsbasedonactualdeployments.Fromthesestandardsemerge
the requirements that allow the creation of composites. Composites are packaged solution standards that not
only include the functionality, but design and validation documentation as well. Standard packages and composites reduce deployment risks by reducing the design time assumptions and unknown deployment effects.
Companies can create a corporate standard deployment package that can be proven on pilot lines and then
deployedglobally.Sitescanbenefitfrompreviouseffortsindesign,configurationandvalidation.Repeatable
deployments are possible because all sites are based on common solution architecture. In the section that
follows there is asynopsis ofsome Systech specific considerationsmatched tothepoints of:TotalCost of
Ownership,ReducedDeploymentRisk,ProductizedSolutions,FlexibilityandScalability.
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3.2.8.1 Total Cost of Ownership

Reducing the total cost of ownership by addressing the packaging serialization issue as a whole, instead of
a disconnected sub system is the ultimate objective. Unfortunately, the hidden costs and unanticipated use
cases are not obvious to manufacturers at this point. Serialization is a new concept to many companies, and
those with experience typically have a narrow perspective due to a single project executed within one department or manufacturing site. The following is a short list of things to consider when discussing total cost of
ownership.
ConfigurableSoftwarevs.CustomCode
Change management and the development
lifecycle
Dealing with evolving standards

SeeFlexibilityandScalability (chapter V, 3.2.7,
V, 3.2.8.4, V, 3.2.8.5)
No standards for communication as applies

to serialization between L3-L2 and L2-L1
systems
XMLandOPCarenotsufficientforrealtime processing and communications speed

(serialization) Passing data to a printer at
600partsperminutedeterministically.OPC
is not deterministic and is better suited for
batch type processes not individual items.
Consistent architecture with a core solution

across multiple sites
Traditional systems designed around the
Customer Support for packaging serialization

software
What types of global support programs are

available for systems?
Line re-validation efforts due to software upgrades at the IT level
Isolate changes at the plant-level from the

packaging level
Separate packaging and IT

isolation between packaging and IT
Who has the ownership of bi-directional communication between disparate systems?
Ability to scale across multiple sites

See Scalability (chapter V, 3.2.7, V, 3.2.8.5)
Abilitytogainfinancialandproductivitybenefits
from repeatable deployments
See Reduced Deployment Risks

(chapter V, 3.2.7, V, 3.2.8.2)
ISA95 stack were focused on batch processes

and not individual items.
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manufacturers need to be aware of the

following:
Additional costs that will be incurred to support

new functionality
Systems Integrator Management costs with
Lost opportunity costs if only one vendor completes the new functionality on time
Who is paying for the communication interfaces
regard to managing requirements, design, im-
that tie it all together? Is the customer paying
plementation,unittesting,debuggingorfinally
once/twice for each side to implement a com-
deployment.
mon interface?
3.2.8.2 Reduced Deployment Risks

As packaged software, a productized serialization solution such as Systech Serialized Product Tracking (SPT) is
readytobequicklyinstalledwhenitisbought,therebyincreasingefficiencyandspeedoflineset-up.Inaddition to speedy installation, productized solutions are replicable, making each packaging line consistent. As more
countriesgloballyimplementserializationrequirements,manufacturersbenefitfrominvestinginaserializationsolutionthatisquicklyinstalledandreplicableline-to-lineorplant-to-plant.Forinstance,amanufacturer
whoinstallsaproductizedserializationsolutiontoaddressregulationsinFrancecanusethesamesolutionat
their plant in Turkey to meet regulations there. This repeatability reduces design, deployment, maintenance,
and associated training costs. Moreover, since it does not require new code to be written, productized software is easily upgraded and can be deployed more easily than custom software. On the other hand, custom
solutions are built line-by-line increasing the cost and time of installations. Lines of code need to be developed
for changes and maintenance, which often require more steps and more resources and results in additional
downtime for software developments. As a result, there is a greater loss of opportunity cost and additional
risks that are involved from line to line and from plant to plant.
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3.2.8.3 Comprehensive Productized Solutions

Serialization extends risk mitigation beyond the comfort zone of most packaging engineers. Touch points that
did not exist in the traditional packaging paradigm extend beyond the packaging line and cross over to other
areas. Packaging Engineers may not be aware of the added risks or may assume that it is someone elses
problem. IT and network groups most likely dont realize the impact they are going to have when imposing
IT policies and requirement down to the packaging line. Corporate engineering and IT groups need to be
confidentthatsitescandeployquicklyandwithminimaldisruption.Siteengineersandmanagersneedtobe
confidentthattheycanupgrademultiplelineswithoutimpactingproductionquotas.Siteoperationsneedto
beconfidentthatnewworkflowswillhaveminimalimpactonotherareasofthebusiness.
To address corporate and site concerns it is important to combine productized software, proven standards and
a repeatable methodology to reduce deployment times and risk. By utilizing a productized software solution,
manufacturers do not have to go through the software development lifecycle for design, implementation, unit
testing, formal testing and deployment packaging. Systech takes on the responsibility of this development
lifecycle. Their development, QA and implementation procedures have been developed based upon meeting the cGMP needs of their customers. They are frequently audited by their customers and maintain the
industrys most comprehensive development and QA procedures.
3.2.8.4 Flexibility
Flexibilityistheabilitytoeasilyadapttochangingdemandswhileintroducingminimalimpact.Serialization
isacorporateinitiativethatismandatedtoindividualsites.Corporatehasspecificgoalsandobjectivesthat
mustbemetwhileallowingsitestheautonomytomanagesite-specificrequirements.Addressingthecorporateneedswithacommonarchitecturebutallowingsitestheflexibilitytomanagetheiruniquerequirements
isofmajorimportance.Refinementofworkflowsanddeviceselectionallowsitestoachievetheirobjectives
while supporting the corporate goals. Sites can leverage design and validation documentation from other
sites while maintaining the ability to modify where needed.
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Theintroductionofserializationintoanyexistingpackagingworkflowwillresultinnewworkflowsandprocesses. Some processes will have to change others will have to be eliminated or added. Software and tools that
recognizethisandprovidefunctionalitytohelptominimizetheimpacttothepackagingworkflowswillhelp.
Forexample,ifaproductisrunonamanuallineandonanautomatedlineonlytheworkflowandtheconfiguration change. The solution architecture, software and deployment strategy remain the same. Systech SPT
alsoprovidestheflexibilitytoextendbeyondthepackaginglinetoaddressofflineoperationssuchasrework,
sampling and pallet building.
The following timeline shows the changes that have taken place in regards to EPC Global and GS1 standards.
In the past years the numbering format standard has changed four times. Solutions that are tightly tied to a
singlenumberstandardarenotinapositiontomanagechangewithoutdevelopment.SPThastheflexibility
to handle evolving standards and regional regulations because the products are data carrier and number formationagnostic.Theformattingisintheconfigurationandnothardcodedinthesoftware.
Fig. 21: Timeline of changes in regards to EPC Global and GS1 standards
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Thesameconfigurationflexibilityappliestopackaginghierarchiesandnumberassociation.Theimageon
theleft(Fig.22)showsthemostcommonpackaginglevels.Thisprovidesconsistencyacrossallpackaging
linesandSPTworkareaswhileallowingflexibilitytohandlechangesthroughconfiguration.Theimageonthe
right(Fig.22)illustratestheflexibilitytoassociatemultipleserialnumberswithasinglepackageditem.This
abilityismanagedattheAdvisorSPTlevelandprovidesthesupportformultipleproductclassworkflowson
the same packaging line. Similar products packaged for different geographical regions may include or exclude
data carriers. Because Systech SPT is not rigid in its numbering support data-name value pairs can be added
as needed to meet changing requirements.
Fig. 22: Configuration flexibility of packaging hierarchies and number association
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3.2.8.5 Scalability
In measuring the scalability of a product family, it is not necessary to know where the start and end points are.
Aproductthatcanscalebyadding16additionaloutputsmaybevaluabletoanOEMbutarenotapplicable
to the overall customer solution. In the context of serialization scalability needs to be assessed based on the
products ability to solve new application demands through the reuse of existing products. The diagram below
shows how Sentri, Advisor and Guardian scale to address different standards and regulatory requirements.
Customers with immediate initiatives for CIP13 can start with Sentri and then add Advisor and Guardian in
the future.
Fig. 23: Scalability of Sentri, Advisor and Guardian (pharmaceutical view)
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3.2.9 The Bottom Line

A holistic solution ends up providing lower cost of ownership, reduced deployment risks, handle site requirements(flexibility)andtheabilitytoscalethesolutionstomeetfutureneeds.Thefewerthemovingpartsinvolved,thelowertheoverallcostofownershipwillbe;thisincludesmaintainingahighlevelofindependence
betweenPackagingOperationsandIT.Aproductizedsolutionthatisconfigurableinsteadofcustomizable,reduces the engineering cost for the contract dollars and internal resource investment. Internal resources attend
meetingsthatarefocusedondefiningworkflowsandbusinessusecasesinsteadoflow-levelinteroperability,
compatibility and software testing efforts.
Deploying a Holistic Solution will ultimately result in less time and money expended for planning, design integration and validation of disparate system interfaces. A productized solution that supports site variations
throughconfigurationwhilemaintainingcorporateglobalobjectivesforglobalrolloutscanleveragepervious
designs to reduce startup, deployment and validation efforts.
By leveraging the capabilities of such a solution, the overall individual site resource investment can be reduced. Sites can leverage design, deployment, validation and training deliverables from other sites and adapt
themtomeettheirspecificworkflows.Sitesmaybelessapprehensiveofnewtechnologyandbusinessrequirements if they all share a common approach. Greater acceptance leads to shorter deployment times by not
having to revisit every requirement and issue. If sites can see for themselves a working solution they may gain
confidenceinwhatothershavedoneinsteadofstartingfromablankpageeachtime.
Another consideration in todays reality is the global consolidation of line equipment from various sites. If
each site has its own unique solutions, moving a packing line to another site introduces additional design and
risk into an already complex and expensive endeavor. A global solution must isolate the line variations at the
packaging level while maintaining a common IT architecture. By utilizing a common approach a line can be
moved from one location to another without requiring new integration with existing enterprise systems. The
greater the isolation between IT technology and packaging technology the easier the move will be.
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A solution must be able to scale and adapt as the industry regulations evolve and internal business requirementschange.Aproductizedsolutionallowscustomerstoconfigureratherthandesignandimplement.
Havingasolutionthatis:evolved,maintained,testedandreleasedfollowingadefinedandauditableproduct
life cycle makes things easier in many ways.
ISA 95 was created years before serialization was even a concept and was targeted for process automation
morethanpackaging.TherealityisthatPESsolutions,specificallyserializationsolutions,donotfitperfectly
into the traditional ISA95 stack. There is a gray zone created that not only bridges the Level 3 and a Level 2
layers but plays a little in each space.
Fig. 24.: Bi-directional Data Flow
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There is no single accepted standard interface between Server Solutions (Level 3 MES) and Line Management
Solutions (Level 2 SCADA) or between Line Management Systems (Level 2 SCADA) and Line Devices (Level
1PLC)tomeettheserializationdemands.Eventheavailablestandardsaretypicallyvendorspecificorcustomized by the systems integrator. There is no single accepted standard for high performance bidirectional
communication between these layers.
It is also an accepted conclusion that all of these elements (server, line management, devices) are required to
provideacompleteserializationsolutionforpackaging;inmanycasesaforthelementisrequiredtohandle
offlinepostlotoperations.Theseelementsarenowmissioncriticaltokeepingpackagingrunningwhilenot
impacting line throughput.
in summary you should consider the following questions:
Who owns the lines of communication between systems?

Who is responsible to keep up with software version and backward compatibility?
What additional validation testing is required to exercise all of the communications between these systems?
Can all of the above be accomplished integrating disparate systems?
Anything can be accomplished with enough time and money but is that the best approach?
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3.3 SAP AII - Consolidation software/Edge Server

SAP Auto-ID Infrastructure (SAP AII) is a flexible and adaptable infrastructure, which creates a connection
between Auto-ID technologies and existing systems. On delivery, SAP AII offers various logistical processes,
whicharepre-set.Furthermore,theuserhastheoptionofadaptingthiscontentandimplementingcompletely
individualprocessesinasimpleway.ThefollowingdiagramclarifiesthemainelementsofSAPAIIandthe
integration options:
In the context of Track & Trace, SAP AII is generally used as a local solution for the issues of data consolidation,
control and automation of logistic processes.
3.3.1 Functions and Features of SAP AII

3.3.1.1 Integration Scenarios
The following integration scenarios are available for saP auto-id infrastructure:
Standalone Installation
Integration with the ERP system
Integration with the SAP Object Event Repository
Integration with the SAP Object Event Repository and the ERP system
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3.3.1.2 Master Data

The basic master data in SAP AII are products, locations and devices. A location may be e.g. a storage location.
Thisstoragelocationgenerallyhasvariousdevices(e.g.barcodeandRFIDscanners).
3.3.1.3 Number Range Administration

Numberrangeadministrationisrequiredinordertoachieveclearidentificationofindividualproductsthrough
serialization. The tasks of number range administration are mainly the generation, distribution and monitoring
of the individual number ranges. If several local SAP AII instances are in use, SAP OER takes on the administration of the entire global number range, whilst the local SAP AII instances order and administer the respective
local number ranges.
3.3.1.4 Rules and Activities

SAPAIIoffersanextensivecontrolprocessor.Thisiswhereconfigurationtakesplaceofwhatshouldhappen
e.g.whenanRFIDtransponderorabarcodeisregistered.ThestandardSAPAIIpackagealreadyincludesa
largesetofpredefinedrulesandtheassociatedactivities.Withthehighlyflexibleruleframework,userswith
SAP knowledge are able to adapt and add to these rules with no programming effort. New, customized rules
can,ofcourse,bedefinedatanytime.
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134
Fig. 25: High Level Overview SAP AII
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Fig. 26: Rules & Activities Framework in SAP AII

A breakdown of the main processes already supported by the corresponding rules and activities with delivery
of SAP AII out-of-the-box are listed below. Most supported processes are listed, despite not all being relevant
for Track & Trace. However, this does give the reader an idea of what SAP AII is able to support besides Track
& Trace processes.
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3.3.1.4.1 Goods Issue

SAP AII supports the following processes in the goods outwards process, in order to be able to successfully
dispatch serialized products:
Generation of serial numbers (e.g. EPC, DoD UII or individual formats)

CreationofRFIDtranspondersand/orprintingofbarcodelabels
Allocation of transponders and/or barcodes to packages, cartons, pallets etc.
Automatic generation of hierarchies, e.g. with several levels for boxes outer packagings and pallets
Communication of this information e.g. to SAP ERP/SAP OER
Scanning and tracking of products or containers in relation to shipping
Linking of serial numbers with shipping documents
Completeness check at the point of shipping
Automatic entry of the goods issue in the SAP ERP system
Automatic dispatch of a delivery notice (ASN) to the customers
3.3.1.4.2 Goods Receipt

SAP AII supports the following processes in the goods receipt process, in order to be able to successfully receive serialized products:
Receipt and processing of the delivery notice (ASN)

Logging of the serialized information in the goods receipt control
Reconciliation of serial numbers with the delivery notice (ASN)
Association of serial numbers with the goods receipt documents
Entry of the goods receipt in SAP ERP
Automaticcreationofthedeliveryconfirmation
Updating of SAP OER
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3.3.1.4.3 Returnable Transport Items (RTI)

The RTI process involves tracking reusable items in a closed cycle (e.g. reusable containers). SAP AII supports
the following:
Tracking the current and historic locations of RTIs on their way through the closed cycle. Here, the place
time and condition (full, empty, defective etc.) are recorded for each item.
CreationofRFIDtranspondersorbarcodelabelsusingallcurrentformatssuchassGTIN,GRAI,SSCCetc.
Automaticmonitoringofeventsandconditionsandintegratednotificationfunctions(alertmanagement)
3.3.1.4.4 Kanban
In the Kanban scenario, the serialization of containers in the production processes and the automatic initiation
of Kanban-typical replenishment strategies are supported. The following functions form the main standard
delivery package for the Kanban scenario:
Automatic emptying of the containers and automatic set-up of the replenishment element (e.g. order, productionorder,stocktransfer)byscanningoneorseveralRFIDtranspondersorbarcodelabels.
Automatic change of the container status to full and automatic stock increase in the relevant area as well
asclosureofthereplenishmentelementbyscanningoneorseveralRFIDtranspondersorbarcodelabels.
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3.3.1.4.5 Product Tracking and Authentication

The core functions of product tracking and authentication include the following:
Recording of IDs/serial numbers, hierarchies, locations and events

Linking of IDs/serial numbers with business objects, e.g. batches, lots, orders, consignments etc.
Data exchange with trading partners
Queries about IDs, status, place, events, order or other business characteristics
Notification(alertmanagement)inpredefinedexceptionalsituations
Authentication using Track & Trace information (secure supply chain)
Authentication with extended features, e.g. such as transponder ID, hologram tags, images with clear
product features
Logging of authentication attempts and the responses
3.3.1.5 CCMS Monitoring and Alert Management

AllerrornotificationsandwarningscomingfromSAPAIIareaccessiblethroughthestandardCCMS(Computer
Centre Management System) monitoring.
3.3.1.6 Technical Reporting and Application Log

All events and movements in SAP AII are recorded in the application log. This memory constitutes the basis
for the technical reporting.
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Fig. 27: Screenshot: Application Log
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3.3.1.7 Interface with SAP ERP through SAP PI

saP auto-id infrastructure can be used with an erP system to:
Provide SAP Auto-ID Infrastructure with documents

Provide SAP Auto-ID Infrastructure with GTIN serial number ranges
Provide SAP Auto-ID Infrastructure with material master data
Have SAP Auto-ID Infrastructure create and update handling unit information in SAP ERP
3.3.1.8 Other Functions

The Generic Document Interface allows the simple integration of documents into SAP AII and the processing
of these documents with Auto-ID data.
Auto-ID integration with SAP Extended Warehouse Management (SAP EWM) covers the following processes:
Inbound, inclusive ASN handling, unloading, goods delivery (inwards) and warehousing
Outbound, comprising picking, container processing, packing, provision, loading, goods outwards and delivery
Return goods deliveries

Resources,includingtheset-upofawarehouseorder,openingandconfirmingonthebasisofRFIDscanning procedures
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3.4 SAP OER - Global Track & Trace Repository (EPCIS)

3.4.1 Classification of SAP OER in a global Track & Trace environment
SAP Object Event Repository (SAP OER) together with SAP Auto-ID Infrastructure (SAP AII) forms the SAP product SAP Solutions for Auto-ID and item serialization or the so-called SAP Auto-ID Enterprise.
While SAP AII can be used in manufacturing plants and distribution centers as a consolidation system for
SAP OER relevant events or for business process automation during logistics operations, SAP OER is a global
centralized system of record. It supports inter- and intra-company tracking of serialized objects and collects
andadministratesallviaauto-idtechnology(1D-,2DBarcode,RFID,etc.)capturedinformationinaccordwith
thecentralrequirementsspecifiedbyEPCglobalforanEPCIS(ElectronicProductCodeInformationSystem).
SAP Object Event Repository is built on top of the very reliable and mature SAP solution called Supply Chain
Event Management. With SAP OER you will have a scalable and high performing repository for managing your
global serial numbers.
SAP OER has the mission to store all Product IDs in a global database (Tracking). Any site (Manufacturing site,
DistributionCenters,etc.)hastobeabletoreportscannedProductIDstothecentraldatabase.Forthispurpose, the Global Repository needs to have a standard Capture Interface (EPCIS Compliant if interoperability
with trade partners is or maybe will be required in the future). But on the other hand, this repository is the
basisforanyProductIDrelatedreporting(Tracing).ForthispurposetheGlobalRepositoryforproductIDs
has to have a standardized reporting interface to extract the required data. This interface is called in the EPCIS
standard Query Interface.
SAP OER is the key component of a SAP Track & Trace scenario. Due to the very large data volumes handled
in a common Track & Trace scenario, this central repository is a separated database and is not part of the ERP
System.
As you see in the picture below, SAP OER has different functions and features, which will be described in the
chapters that follow.
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Fig. 28: Main Features of SAP OER
143
advantages of saP oer:

Preconfiguredout-of-the-boxprocessesavailableincludingoperationalmonitoringandaggregated
reporting
Easyimplementationofindividualprocessesduetoahighflexibleinfrastructure
Support of established data format standards
Active participation of SAP in all relevant standardization committees and research projects
Continuous enhancement of supported standards according to new developments across industries
SAP Object Event Repository is based on SAP NetWeaver Technology to provide a scalable and robust
platform
Seamless integration into the existing SAP solution landscape

EnsuringdatasecuritybyfulfillingSAPssecurityguidelines
Proved and enhanced due to many high volume productive Track & Trace projects
3.4.2 Functions and Features of SAP OER

3.4.2.1 The EPCIS compliant Capture Interface
This Interface allows your Manufacturing Plants and
Distribution Centers to send Product ID information to SAP OER in a standardized format (In form of
EPCIS Events).
InthestandardEPCISspecification,therearetypically four different Event Types:
Object Event
Aggregation Event
Transaction Event
Quantity Event
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SAPOERsupportsallfourevent-types.Formoreinformationabouteventformats,parametersetc.pleaserefer
totheGS1/EPCGlobalEPCISstandardspecification.
SAP OER is 100% EPCIS compliant, which means that the capture interface as well as the query interface
(which is described later) is delivered as a part of the standard software. Both interfaces are accessible in the
development workbench via the transaction sproxy (Transaction displayed in the screenshot below). The
capture interface and its processing and monitoring capabilities in particular are crucial strengths of the SAP
OER solution.
Fig. 29: Transaction SPROXY
Beside the above mentioned event types the capture interface supports, via EPCIS vocabularies, any kind of
bizSteps,whichcanbedefinedviaconfiguration(e.g.commissioning,decommissioning,shipping,dispensed,
returns, recalled).
Thecaptureinterfaceduringtheprocessinglogicisabletoexecuteanyrulesdefinedwithintherulesframework.
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Therefore, it is possible to trigger any consequent action as a result of an event processing. An example here
would be to change the status of a given ID (e.g. to shipped) according to the bizStep (e.g. shipping) contained within the incoming event.
Aggregation events are supported and so SAP OER is capable of creating (packing with Action = ADD) or
delete (unpacking with Action = DELETE) a hierarchy of IDs at any point of time. Multilevel hierarchies are
supported as well (e.g. an item-case-pallet is a three level hierarchy).
The capture interface supports EPCIS messages of large size containing multiple EPCIS events. It is however
recommended, for performance optimization reasons, that the sending applications limit the size of the EPCIS
messages. However, the capture interface supports parallel processing of multiple messages.
Additionally,itispossibletoimplementanycustomerspecificlogicinthecaptureinterfaceviaBADIimplementation(customerenhancementratherthanimplementation).Thisallowsforexample;toeasilyimplement
any authorization check before event processing (e.g., check if incoming request belongs to authenticated
users with registered addresses IP/MAC Address). It also allows checking of commissioned IDs for a registered
companyprefixfromthesender(incasethetargetcountryusesGS1GTINstandard).
Non real time processing of EPCIS message is supported in SAP OER as well.
saP oer handles two timestamps as standard:
Event Timestamp (recorded by the actor and part of the EPCIS message)
Record timestamp (recorded by SAP OER and documenting the arrival of the EPCIS event in SAP OER)
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The relevant timestamp for processing steps is always the event timestamp.
SAP OER also offers a track changes functionality for any status change. Timestamp, user, old value and new
value can be logged for any ID status change. However, in large volume scenarios it should be considered that
switching on the track changes functionality generates a considerable amount of additional data that needs
to be handled additionally.
Fig. 30: View of the Integration Engine (Part of SAP PI stack integrated in SAP OER)
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3.4.2.2 The EPCIS compliant Query Interface

This interface allows internal and external users (e.g.
legal authorities) to report on the Product ID information in a standardized format (In the form of EPCIS queries).
Thanks to this interface, any business user is able
to retrieve data based on any parameter out of SAP
OER (e.g. product IDs in a given timeframe reported
by a given business location).
In EPCIS specification, there is one generic query,
which is called Simple Event Query. With this event
query it will be possible to retrieve the data correspondingtotheEPCISeventsspecifiedbytheparameters in the query. Additionally this query can be consumed by Interrogation or by Transmission, for which
SAPOERaswellastheEPCISSpecificationhasdefinedtheconceptofSubscriptions.Formoreinformation
abouttheQueryInterfacepleaserefertotheGS1/EPCGlobalEPCISstandardspecification.
additional reporting functionalities (standard saP oer)

Additionally, SAP OER provides a standard reporting interface (not EPCIS compliant), which is available via the
web. In general it is possible to authenticate the user based on user and password in order to allow a report
to be run.
The report interface in SAP OER supports role based assignment of reports. Each web report in SAP OER terminologyiscalledWebInterfaceTransaction,andcanbehighlyconfigured.
Modifying exiting reports or creating new reports based on existing reports can be done mainly via customizing(noprogrammingrequiredtohideordisplayfields).BADIscanalsobepopulatedtofillcertainreport
fieldsifrequiredwithspecificlogicetc.
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Fig. 31: SPRO transaction to configure fields for display and selection.
Fig. 32: Sample of standard web report (Web Transaction)
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3.4.2.3 The Event Handlers, Event Messages and Hierarchies

In SAP OER, Event Handlers are IDs. This means
that any ID/serial number that needs to be tracked
(e.g. Item IDs, Cases IDs, Pallets IDs or even Delivery
Document IDs) becomes an Event Handler in SAP
OER. Event Handlers can then have:
A current ID hierarchy (e.g. Pallets have cases and

cases have product items)
One or more event messages
The reason why IDs are called Event Handlers in SAP OER terminology is that Event Handlers are able to handle events (in our particular case EPCIS events like Object Events, Aggregation Events and Transaction Events).
ForexampleapalletIDcouldhaveoneormoreeventmessagessuchasPacked,Shipped,Received,etc.
This means that in SAP OER, each single Product ID becomes an Event Handler. But this also means that any
Document ID becomes an Event Handler in SAP OER as well. (E.g. every Outbound Delivery, Inbound Delivery,
Stock Transfer Order etc. becomes an Event Handler of a different type)
Event Handlers are the most important entities created in SAP OER and can handle Rule Sets, expected or
unexpectedeventmessages,StatusProfilesandAdditionalParameters.
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Fig. 33: Event Handler

Itispossibleforexample,todefinedifferenttypesofEventHandlersinthesystem,havingdifferentattributes,
different status and different associated behaviors.
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Fig. 34: Standard Event Handler in SAP OER - Header data
AlthoughthestandardEventHandlerentitiesallowlotsofconfigurationandparameterizationinSAPOER(as
depicted in the picture above) the leanest possible implementation of the Event Handler entity is recommended considering the expected volumes of data.
Event Handlers in standard SAP OER can receive one or more EPCIS events (Event Messages). The description
oftheEventmessagesistakenfromthebizStep.BizStepsarecustomervocabulariesandcanbeconfigured
specificallyviastandardSAPCustomizing
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Fig. 35: One Event Handler can handle multiple events
Additionally, Event Handlers are able to have one or more hierarchies in SAP OER standard at different points
of time. Hierarchies are always updated in SAP OER by the EPCIS Aggregation Events (representing packing
or unpacking).
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Fig. 36: One Event Handler handling multiple hierarchies at different points in time
Forexample,inSAPOERitispossibletodisplaythehierarchycontentsofapallet.
but there are two different types of hierarchies:
Current Hierarchy
Hierarchy valid for a given event (Event Hierarchy)
Forexample,agivenCaseIDmayhavebeenpackedintotallydifferentpalletsafterthepackaginginthemanufacturing plant and after the shipping from the Distribution Centre. SAP OER supports the management of
these different hierarchies during the Product ID lifecycle.
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event handlers attributes

InSAPOERitispossibletodefineandpopulateviathecaptureinterfaceanyspecificattributesthatmaybe
requiredfortheProductIDwithoutanycodeofprogramming(viaconfiguration).Sometypicalattributesare
for example Product ID, Batch Number, Expiration Date, Unit of Measure, etc.
3.4.2.4 SAP OER: Tracking Services and Rule Processing

Whenever an event message arrives in SAP OER, the
ruleprocessingstartstheexecutionlogic.Foreach
of the Event Handler types contained in an EPCIS
Message SAP OER can execute different rules. It is
here that custom logic can be added during messageprocessing.ForthispurposeSAPOERoffersa
veryflexibleconfigurationworkbenchwhichallows
consultants and IT staff with ABAP knowledge to
create rules, conditions etc. without programming
efforts. The rules engine is already a standard component in SAP OER. The Rules Engine allows adding,
deleting or modifying any rules via the SPRO transaction in the SAP customizing workbench. SAP OER predeliversrulesforallrelevantEPCISevents.PredefinedrulesforObjectEvents,AggregationEvents,Transaction
EventsandVerificationEventsalsoexist.AdditionallyviaSPROitispossibletodefinenewrulesviaasystem
assistant (Not exactly a rules wizard, but a kind of graphical tool delivered in SAP OER standard). Adding new
rules to the rule engine does not require any system downtime, and any of the rules built within the framework
is able to access any of the inbound parameters passed through by the interface (including potentially newly
definedparameters).Rulescanbedefinedataverylowgranularityandwithintherulesprocessingframe-
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work it is possible to call any type of remote function, which is able to trigger the connection to any external
system. Of course the rules engine supports parallel processing and asynchronous communication, so that no
messages can be lost unprocessed (messages are stored in the SAP OER integration engine before and after
processing with the current status).
Fig. 37: Graphical tool (wizard) for rule definition in the SAP OER configuration workbench (Transaction SPRO)
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3.4.2.5 ID Types
In SAP AII (in the stack of SAP Auto-ID Enterprise),
ID types are used to specify the formats of the IDs
passed to SAP OER via the EPCIS message. This is
only relevant to guarantee interoperability with trading partners in the future.
3.4.2.6 Authentication
SAP OER supports technical authentication features. This authentication means that via a Web
User Interface, an OER user is able to authenticate
a given Product ID based on the ID and based on
additional attributes if required (any authentication
featurecanbedefinedinSAPOER).
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3.4.2.7 Alert Framework

It is possible to use this feature as an alert system to
notify the SAP OER system administrator about any
irregularities or potential bottlenecks, inconsistencies etc. in the Track & Trace scenario.
E.g. an ID was marked as destroyed but then, in a
later stage the same ID was scanned during a shippingprocess;thiscouldtriggeranalert.
ForthispurposeSAPOERoffersintegrationwiththe
standard SAP monitoring system so called CCMS
(Computer Center Management System).
SAP OER offers a full-blown alert framework, which
allowsanyagenttobenotifiedaboutanyirregularities or potential bottlenecks, inconsistencies etc. in
the Track & Trace system.
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Fig. 38: Multichannel alerting
Via configuration in the alert framework it possible to define:

A) When an alert is triggered (embedded within the SAP OER rules engine)
B) Whatshouldhappen:theABAPprogramtobeexecutedcanbedefinedviaconfiguration
C) To whom it should be sent: alert recipient can be determined
D) What should be sent: text and content of the alert
E) How it should be sent: via email, fax, text message etc.
ForthispurposethereisaspecificcustomizingnodeinthetransactionSPROwhereanyalertscanbeconfiguredandcustombuiltwithminimumornodevelopment.Generatedandnotifiedalertsarealwaysregistered
in the SAP OER system for audit trail purposes and can be accessed via the standard transactions ALRTDISP
and ALRTINBOX.
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3.4.2.8 Central number range management

SAP OER is able to control the creation and distribution of number ranges in a system landscape with
one or more instances of SAP AII. SAP OER has a
number range administration user interface: it offers an upload report for integration of external
number ranges, Web Services to allow the request
of additional serial numbers (e.g. for Third Party
Manufacturers integration), is able to block and allocate number ranges and keeps a historical log of
distributed number ranges etc.
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Fig. 39: Central Number Range Management
However, the standard SAP OER functionality for number range management does not support randomized
numbers. In order to support randomized numbers an external tool/algorithm for serial number randomization has to be used (see chapter V, 3.4.2.9). This tool will receive an index from SAP OER, based on the index,
parameter and the number of IDs to be generated, it will generate a block of randomized serial numbers. The
generated block is then uploaded to SAP OER.
3.4.2.9 Excursion: Serialization vs. Randomization

Serializationisthetechniquetomarkitemsorobjectswithauniquenumericoralphanumericidentifier.This
techniqueisappliedwhereveruniqueidentificationofsingleobjectsisrequired.Examplesincludetheshipment tracking provided by parcel services, the tracking of components in the assembly of e.g. cars or electronic devices, and the registration of end-consumer products on a manufacturer website as part of the warranty
processing. What these examples have in common: The information related to a single object unveils its value
in particular if one can get access to the physical object too.
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However,asecondtypeofsituationsexistswherejusttheknowledgeofaserialnumberprovidesabenefit.
Activating the copy of software through the internet using the software license code or earning bonus points
in a customer loyalty program by entering promotional codes on a website, are examples, where, whether the
requesterhastheactualobjectornotcannotbecontrolledorverified.Toavoidanymisuse,itisofutmost
importance that the serial number cannot be guessed or predicted, not even with the knowledge of other valid
serial numbers. The method of choice for this second scenario is: randomization i.e. usage of random numbers
as serials.
Unfortunately, standard random number generators lack the uniqueness of the generated serials. This leads
to a trial-and-error type of implementation that is similar to dicing: A number is generated and checked for
previous occurrence. If the number is already known it is thrown away. If not, it is accepted. A major disadvantage of this type of method is the time required to calculate the next serial and thus, the effort to exploit the
fullpre-definednumberrangegrowsexponentially.
Fig. 40: Effort for dicing-type

methods in relation to number
range exploitation
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As we have seen, generating randomized serials using a random number generator is not the best option for
a Track & Trace scenario. A direct formula that has a sequential index as an input and calculates the random
numbers out of this index is much more suitable. But how can it be assured that the calculated numbers are reallyrandom?TheEuropeanFederationofPharmaceuticalIndustriesandAssociations(EFPIA),hasformulated
minimum requirements on the quality of randomization for their case of application. They postulate that the
probability to guess a valid serial number should be less than 1:10.000, that the serials are independent and
distributed across the entire number range, and that they must not be built using an algorithm that is easy to
decipher when a given set of serials is known or a subset thereof.
To summarize, the requirements for randomized serialization are as follows:
The serial numbers must be unique

A prescribed number range should be fully exhausted
Therandomizationshouldfulfillappropriatequalitycriteria
The generation of serials should be with high performance
AnalgorithmthatfulfillsthesecriteriaistheBayCoderthathasbeendevelopedbyBayerTechnologyServices GmbH. This algorithm is in use in different industries and comes with additional features that are importantforitscustomers.Firstofall,thecustomeritselfparameterizesit,sothatnothirdpartyisabletogenerate
identicalserialnumbers.Furthermore,itcalculateseachserialinlessthan1mseci.e.theproductionoutput
isnotnegativelyimpacted.Duetotheleanimplementation,noadditionalhardwareisrequired.Andfinally,
it has proven to be quick and easy to integrate into existing serialization solutions (e.g. SAP OER) due to its
standardized interface.
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3.4.2.10 Master Data Management

In SAP OER it is usually possible to replicate the following master data (not mandatory) from the SAP
ERP system:
MATERIALS (Material IDs and Description, Unit of

Measure and Conversions, EAN numbers, Number
Ranges (only required for repacking purposes)
In addition to the materials, in SAP OER the followingmasterdataisdefined(thiscanalsobe

definedinSAPOERdirectly):
locaTions (Location IDs, GLNs, Location ID

Mapping Readers etc.) Location ID Mapping
Readers are optional. Only if detailed information is required
oTher Master Data required for delivery Information (e.g. Sold-to-party, Ship-to-party), &
Business Description of Events (EPCIS bizSteps)
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3.4.2.11 Locations & reading points

In SAP AII (in the stack of SAP Auto-ID Enterprise)
it is possible to maintain Locations and Reading
Points. Locations are the sites reporting Product ID
information to SAP OER (E.g. Manufacturing Plants).
Reading Points are areas within those locations.
(E.g. Packaging Line 1 at the Manufacturing Plant)
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3.4.2.12 Archiving
SAP OER contains archiving tools to save SAP Event data on external mediums and then deletes data from the
database.
The following objects can be archived in the object event repository:
Event Handler Tables (e.g. All item, cases and pallet IDs)
Event Messages Tables (e.g. All event messages to item, cases and pallet IDs)
Theapproachisbasedontheassumptionthatforeachobject/EventHandleraneventcanbedefinedthatis
the last event expected to occur for the said object. When tracking an item from production to goods issue
forinstance,thelasteventtobemonitoredisthegoodsissueevent.Thisgoodsissueeventcanbeidentified
by a number of parameters, e.g. event type, business step, action and location. When this last event happens,
therepresentationoftheobjectandtherelatingeventsshallstillberetainedinthedatabaseforapre-defined
residence time. Within this residence period all selection criteria supported by the database can be used and
(ifconfiguredaccordingly)furtherevents,whichwerenotexpectedtohappencanstillbereceived.Assoon
as the residence time has passed, the object will be archived. If those event messages need to be displayed
completely, the standard SAP OER user interface (Web UI) is able to display archived and non-archived data
within the same screen.
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3.4.2.13 EPCIS Vocabularies

EPCIS Vocabularies are nothing other than the
descriptions of the EPCIS Events (e.g. Shipping,
Packing, Receiving, Decommissioning, etc.)
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3.5 SAP Process Integration (SAP PI)

SAP Process Integration (SAP PI) is the interface from which the SAP OER system can be reached. Any inbound
and outbound message will always go through SAP PI.
The main functions of saP Pi are:
a) monitoring:
It allows the monitoring of the inbound and outbound queues, provides the ability of displaying the EPCIS
Message processing status and also offers reprocessing capabilities (in case of EPCIS message failure).
b) buffering:
AnyEPCISmessageisbufferedintheSAPPIintegrationengine.Thesizeofthebufferisconfigurable,but
typical customer implementation allows a 4-week buffering period, so that any incoming or outgoing EPCIS
message is accessible via the integration engine. This provides audit trail functionality for a 4-week timeframe
in which the buffering occurs.
c) routing:
The SAP PI integration engine allows message routing in both directions (in and outgoing messages). Additionally SAP OER has an integration engine (accessible via the transaction SXMB_MONI), which effectively
allows SAP PI message monitoring directly in SAP OER.
3.6 Mobile Scanning Solution

Mobile scanning is the only way to guarantee that product IDs are scanned as they move across the supply
chain. Therefore a Track & Trace solution will sooner or later require mobile access to at least the global repository.Accesswillprimarilyberequiredfor:verificationpurposes,specialexceptionalsituations(e.g.decommissioning IDs) and operations with aggregations for example (e.g. packing, unpacking, shipping, rework).
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3.6.1 Movilizer for Track & Trace Architecture
Fig. 41: Movilizer for Track & Trace - Architecture
169
1. The movilizer client is a very small software (some few Kilobytes) written in different native languages
5.
(depending on the target device) capable of running on most mobile phones, smart phones, PDAs, Tablet
PCs, industrial devices, etc.
2.
6.The
movilizer cloud is a secured multitenant and hosted middleware with 99,5% guaranteed availability
that can connect any backend system with any mobile device by sending and receiving business data in
both directions. Because it is multitenant, it allows economies of scale (single infrastructure is leveraged by
many tenants). The Movilizer cloud follows the classic principles of Software as a Service (SaaS).
3. The movilizer connectorisaSAPcertifiedoutoftheboxConnectoravailableforSAPOER,SAPEMand
7.
SAP PI, which once installed on the system, accelerates the integration of the system with the Movilizer
Cloud and provides all features described in the following chapters.
3.6.2 Technical Features of Movilizer for Track & Trace

Online&Offlinecapability
Optimized for sites with poor infrastructure (maximum data compression)
100% EPCIS compliant
Background integration with existing DSD, PoD mobile applications
Background integration with exiting mobile Warehouse Management applications
Barcode/RFIDScanning
Supports Printing (for Re-Packing and other reports)
Offlinefieldvalidationsofanytypeandcentrallymanaged
Capturing of GPS geo-coordinates
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3.6.3 Supported Processes

Movilizer for Track & Trace supports all Track & Trace relevant processes, which are required by a mobile scanning solution for supporting Track & Trace at a glance. In the picture below you can see an overview of the
supported processes. In this section the key processes will be described in more detail.
Fig. 42: Overview supported Processes
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3.6.3.1 Capturing packing events

In order to be able to pack, the parent ID is normally entered followed by all the children IDs that are packed
into the parent. With this function it is possible to pack any hierarchy level (e.g. packing items into cases,
packing cases on pallets). In SAP OER the packing events and the corresponding Hierarchy can be seen.
Fig. 43: Sample Hierarchy in SAP OER
3.6.3.2 Capturing unpacking events

In order to be able to unpack, the parent ID is normally entered followed by all the children IDs that are being
unpacked. With this function it is possible to unpack any hierarchy level (e.g. unpacking items from cases, or
unpacking cases from pallets). The changed hierarchy is then automatically updated in SAP OER.
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3.6.3.3 Capturing shipping/receiving events

In order to be able to capture a shipping or receiving event, normally, the reference document number must
be entered or selected, against which the shipping (outbound delivery ID) or receiving (inbound delivery ID) is
being done. Once the Delivery ID is entered, the user can then proceed to enter the Pallet IDs (or cases, items
IDs) shipped or received with the delivery.
As soon as the delivery is completely shipped, the synchronization is started and SAP OER will be updated.
AlternativelyitispossibletogetaconfirmationscreenwiththedetailsoftheshippedIds.InSAPOERthe
Product IDs (including Pallets and cases can be displayed) as well as the details of the corresponding delivery.
3.6.3.4 Decommission Capturing decommissioning events

In order to be able to document the destruction of Product IDs, the user would use decommissioning function.
Via this function, it is possible to decommission a single ID (provided the hierarchy was unpacked before) or
the entire hierarchy (e.g. a full case with its corresponding items can be fully decommissioned). In SAP OER the
new event decommissioning will be visible not only for the observed ID (e.g. the case ID in case a full case
was decommissioned), but also for all Product IDs contained in the hierarchy.
3.6.3.5 Verify/Authenticate Product IDs

ThisfeatureallowsanyProductIDtobeverifiedagainsttheglobalrepository.Forthis,theuserentersthe
ProductIDtobeverifiedandthesynchronizationstartsautomatically.SAPOERthensendstherelevantinformation with regards to the Product ID (Event handler attributes and overall status known or unknown) to
themobiledevice.Foreachverificationtransaction,aneventtypeauthenticatediscreatedandbookedinthe
systemcontainingtherequestoroftheverificationeventaswellasthetimestampforwhentheverification
event was created. Thanks to this feature audit trail is guaranteed.
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3.6.3.6 Design and print Track & Trace labels

For re-labeling or re-packaging processes it is important to take label-printing options into consideration.
Therefore the Movilizer for Track & Trace offers label-printing functionalities out of the Movilizer Cloud (using
third party NiceLabel software).
Enables any label to be printed out of the Cloud without requiring any additional new infrastructure in the
IT landscape
Requires no footprint to be deployed locally other than a local printer connected to any standard PC with
periodic connection to the internet
Forthepurposesofbusinesscontinuity,thereisofflinefunctionalitywithinthePrintingportal.Thepurpose
of this functionality is to enable users to continue printing in the event of losing network connectivity
Over 2000 printer types supported, with out of the box drivers
Flexiblelabelandformsdesignerallowsprintinglayoutstobeeasilydefinedcentrally
3.6.3.7 Device management

Dispersing several devices around the world, often in areas with no IT experts in place, results in the need for
central control of the devices. Therefore, a Device Management tool will be necessary.
a mobile device management tool is mainly
The major features provided in that area are:
required for:
Remote Device Control
Device Status
Remote control for helpdesk (troubleshooting)
Lock Device
System Manager
Preventive control of hardware resources (sto-
Wipe Device
Call Log
rage capacity, timestamps etc.)
Security: killing the device in the event of losing

etc.
Send Message
Warm/Cold reset
GPS Tracking
Screen Capture
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3.6.3.8 Create Marketing/Change Management and

Communication mobile Apps for e.g. Smartphones
The Movilizer can improve change management and communications by providing the following features:
a) dynamic contents which are always available
c) mashing up Track & Trace communication with
(offline support):
Track & Trace functionality:
Today, commonly used platforms for change and
It is possible to embed communications and
communications management are still Power Point,
change management within the application itself.
PDF files, flyers and some more advanced portal
E.g. white-collar users of the mobile App could
based solutions. Most of them have the disadvan-
run ID authentication out of the App and blue-
tage of being static, so the contents and key mes-
collar users of the App could see an additional
sages cannot be changed without considerable ef-
menu item on their handheld, where they are able
fort. Via a mobile App, organizations will be able to
tofindusermanualsandFAQs.
update the contents without programming efforts

and without end user involvement (changing the
content of the app does not require any new deployment of the App).
b) role based approach:
d) Two way communication channel:

With using a mobile App for communications and
change management the communications manager can also receive end user feedback in the form
of surveys or questionnaires, which can be embed-
ThecontentsoftheAppcanbedefinedatverylow
dedwithintheAppcontents.Itispossibletodefi-
granularity,sothatitispossibletodefineuserroles,
ne the structure and contents of the questionnaires
which have a different view and access to different
without any programming skills and the answered
functionality within the application. Roles and users
questionnaires will be available in digital format
can be managed centrally out of the Movilizer
automatically.
cloud. (E.g. country manager sees T&T project details like timelines, but an operator is not able to see
them).FurthermoreanAppcanincreasethelevel
of engagement and involvement from the stakeholders involved compared to a document.
e) usage statistics and usage patterns:

Via the app it is possible to monitor the usage of
the mobile application and recognize behavior patterns etc. User synchronization and navigation can
be protocolled and in this way centrally monitored.
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Fig. 44: Sample screenshots of a Marketing/Change Management and communications app
176
177
Fig. 45: Sample screenshots of a Marketing/Change Management and communications app
178
179
3.6.4 Security of Movilizer

Security is always a major problem in Track & Trace projects. In particular in a scenario where another user/
system is accessing the global database where serialized information is stored. Therefore, security is a very
important topic for the mobile application platform.
The security of the Movilizer has already been proofed and accepted by several customer audits and because
the Movilizer is a cloud based mobile application platform its security standards will be discussed as a kind
ofbenchmarkofsecurityfeatureswhichhavetobefulfilledbyamobileenterpriseapplicationplatform,in
particular when considering cloud based solutions.
3.6.4.1 Security of the Cloud Servers

The servers are hosted in a secure computing center on a multi-tenant server landscape, which obeys the
following standards:
security
fire protection
BuildingsafeguardedthroughaVdScertifiedguard service
24x7 responsible Security Manager according to

BDSG
VESDA early warning system

VdScertifiedextinctionsystem
Supplementary measures for fire extinction ac-
Electronic access control for respective security

levels
cording to BGR 133
FiresafetyengineeraccordingtoVFDB12-09/01-
VdScertifiedalarmsystem
Closed circuit surveillance for both interior and
exterior areas
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VdScertifiedfireprotection
2009-03
Architectural measures with T30-RS doors, and

F90wallsaccordingtoDIN4102
failover concept
24/7 staff availability in the datacenter
Power Grid Ring Structure, n+1 Emergency Power Concept, n+1 redundancy for Air Conditioning
Systems, Network and Power Grid Uplinks
3 Emergency Power Aggregates (5.540 KVA and
Certifications
Certifiedhighavailabilityandsecurity:LevelTier
3 (TV Saarland)
Certifiedhighavailabilityandsecuritystandards
according to ISO 27001
Eco Datacenter Star Audit Level 4
51.000 liter oil reserve)
Redundant entrances for suppliers
3.6.4.2 Data Management

Enterprise information will be stored inside the Movilizer Cloud only while it is required to execute the corresponding business processes on a mobile device. The Movilizer does not represent, and cannot be compared
with, a database for storing company data in terms of database outsourcing.
Process related information is kept on the Movilizer server as long as the corresponding process step is still
located on a mobile device. Reply information for a process will be stored on the Movilizer server until it has
been transmitted to the source system, e.g. SAP OER (acknowledgement mechanism). Additionally, data will
bestoredformonitoringpurposesforadefinedperiodoftime.
The process related information is stored in the Movilizer database in an unstructured format (text representation).Thebusiness datais filedtogetherwithformattinginformationandtechnicalcharacteristics, which
complicates an automated analysis. In addition, only fragments of information will typically be part of a mobile
process therefore, no complete business information units (business object instances) will be transferred to the
Movilizer Server as a whole.
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3.6.4.3 Data Transfer

Data transfer among the system components will be executed securely, by applying high grade SSL encryption
The following communication paths exist:
Source system customer - Movilizer Cloud

Movilizer client - Movilizer Cloud
Data transmission between the backend system (e.g. SAP OER) and the Movilizer Server will happen via a SSL
encrypted http connection. The connection can additionally be routed via a regular web proxy.
The authentication information for the Movilizer web service is part of the payload data. It will therefore also
be subject to SSL encryption.
Fig. 46: Source system customer - Movilizer Cloud
The initiator of data exchange is always the customer system (e.g. SAP OER). Therefore a customer network is
notrequiredtoacceptincomingcalls.Fortheencryption,aThawteSSLcertificateisused.
The data exchange between a mobile device and the Movilizer Cloud is also accomplished via an SSL- secured
httpconnection(https).ForencryptionaThawteSSLCertificateisused.
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Fig. 47: Movilizer client - Movilizer Cloud
3.6.4.4 User authentication on a mobile device

In the standard deployment, the mobile client becomes personalized during installation, and does not need
any further user authentication at start-up.
If required, user authentication can be activated. In such a case the user must enter a password phrase before
the Movilizer can be used. Some users also prefer authentication cards for user authentication.
The password for this purpose will be transmitted to the mobile device in the form of a MD5 hash code. The
input of the user will be translated into a hash value as well. If both hash code values are identical, access to
the functions of the Movilizer client is granted.
The password of the mobile user is not saved on the mobile device, neither in plain text nor encrypted. The
password cannot be reconstructed out of the hash value either (one way transformation).
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3.6.5 Sample Screenshots of the mobile Application

Typically these transactions run on industrial mobile devices such as Intermec or Motorola barcode scanners.
However, it is also possible to use the same transactions on smartphones.
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Fig. 48: Sample Screenshots of the mobile application for Track & Trace
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vi
Best Practices How to start a global
Track & Trace project
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Best Practices - How to start a global Track & Trace project
1 Disconnection of serialization and Track & Trace

To ensure that products are serialized and traced in a consistent manner, many companies develop separate
user requirements for both serialization and for centralized business systems (e.g. SAP OER) used for Track
& Trace. (In this chapter serialization mean all activities, which have to take place to get the production lines
ready to serialize products)
Serialization requirements provide in general, guidance for how products will be encoded at packaging sites,
while the Track & Trace requirements focus on the systems that will manage information about serialized
items. Separating requirements for serialization from Track & Trace allows local packaging sites to implement
serialization technologies that meet their regional requirements the most, while allowing centralized traceabilitysystemstobedefinedbyacentralITdepartmentandsupplychainresponsiblepersons.
a serialization requirements document covers in general (high level only):
Serial number and data carrier formats
Software used at a packaging site to store serial
Handling of pre-encoded serial numbers
numbers before transmission to a central Track
Recording of serial numbers
& Trace system
Communication of packaging batch serialization

information to Track & Trace systems
Serial number allocation

Packaging control and inspection software
Hardware used for encoding or reading serialized items
Etc.
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Fig. 49: Serial Number Lifecycle
2 Business Blueprint of a global Track & Trace System

In the previous chapter we learned why some companies disconnect serialization and Track & Trace systems
from a requirements and project setup point of view. As Movilitas is an expert in setting up Track & Trace
systems, the focus in the following chapters will be on the work packages that are necessary for setting up a
global Track & Trace system and the necessary documentations to start implementing such a system.
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2.1 Business Blueprint & Functional Specifications & Technical Mapping

as already mentioned, Track & Trace Projects are, from experience, always global projects. There are
various reasons and could be as follows:
ForexampleitmakesnosensetohavemorethanoneglobalEPCISSystemtomanageandstoretheserial
numbers of a company. This means that all plants, factories, warehouses, etc. have to report the serialized
data and supply chain information to this single global repository.
Also the underlying software components such as EDGE Servers are affected by the way data is received
and managed.
Considering the synergies of all line systems and printing technologies on a global level can be an interesting prospect. The reason is that in most cases many of the production and packaging lines are not yet
equipped with the necessary technology to serialize products during the production and packaging process.
DuetothetypicallyglobalnatureofTrack&Traceprojects;stakeholdersfromvariouscountries,businessareas and divisions are inevitably involved (IT, Logistics, Supply Chain, Plant Managers, Packaging, Commercials,
Marketing, Managers). Therefore, it is crucial to commence Track & Trace projects with a detailed Business
BlueprintandwritingofFunctionalSpecification.Ifthisisnotdone,itcanleadtoexpensivechangemanagement activities in later stages.
The following are typical topics, which should be touched on during the blueprint phase of setting up the
software systems and processes. Some of them require more attention than others, but these are the key
considerations.
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2.1.1 Business Blueprint & Functional Specifications

During Business Blueprint workshops the following topics should be covered in order to create a comprehensivebusinessblueprintandappropriatefunctionalspecificationdocuments:
business Process summary: Summarizing the overall business processes, which will be affected due to the
implementation of Track & Trace on a high level.
serial number management: This topic is about where the serial numbers are generated, where are they
managed, which formats will they have, are there national codes which have to be included, is the government or authority providing serial numbers, are randomized serial numbers required, are there external
serial numbers which have to be transferred into the global repository, should the number ranges be given
to 3rd party manufacturers, etc.
managing labels: This topic relates to the serialization at packaging lines

manufacturing Processes: Capturing in detail on a global level all manufacturing processes and what happens at each stage with the serial numbers, e.g. when should there be an interaction between line systems
and EDGE/EPCIS System, etc.
site logistics & warehouse processes: Capture all Track & Trace relevant logistic and warehouse processes, how to collate Track & Trace relevant data in the different steps in the software systems and what should
be done with it, are there any processes or postings that should be triggered automatically, etc.
special scenarios in supply chain: Are there any special scenarios?

Maybe only relevant in dedicated countries?
exception processes within supply chain: Are there any exceptions from standard processes?
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integration of supply chain stakeholders in the Track & Trace repository: Who has to interact with the
global EPCIS System, what are the interaction patterns, how are they integrated, etc.
main features:WhatarethemainfeaturesoftheTrack&Tracesystems,e.g.productverification,exception
handling, product history, product re-packing, entering of new product details, product recalls, administrative features, etc.
2.1.2 Technical mapping of the requirements

while mapping the requirements gathered during business blueprint workshops, for the technical features more in-depth topics must be considered, such as:
Overall System Architecture

Master Data Management
Serial Number Range Management
Alignment with current standards (e.g. GS1)
Indirect Use of coding structures versus direct
use Data carriers
The use of a GTIN or pseudo GTINs as part of

product code.
The use of a serial number, which combined

with SKU is unique
Support of randomized or non-randomized

serial numbers
Inclusion of the product batch code and product expiry date.
Supporteddatacarriers(2Dand/orRFID)and
minimum sizes
Alignment with current standards (e.g. EPCIS

GS1)
Types of required communication messages

(e.g. manufacturing, import, decommissioning etc.)
Required message parameters

Standardized identification of location and
supply chain actors (e.g. GLNs)
Communication security and privacy

Event Handlers
Capture Interface
Query Interface
Misc. Interfaces
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Alert & Exception Handling
Reliability
Archiving
Availability
Role & Authorization concept
Administration
Security Requirements
Response time
Connection authentication
Manufacturer access
Coding standards
Constraints
Pharmacy access
Health and safety requirements
Firewall/Intrusionprevention
Procedural constraints
Monitoring
Design constraints
System Requirements
Handling high data volumes
Compatibility
Maintenance
3 Movilitas Add-Ons for SAP Track & Trace

All the Track & Trace Add-Ons described below were conceived during one of the more than 30 implementation projects (status in 2012) in which Movilitas has implemented item serialization and Track & Trace processes
and systems with customers running SAP.
The value of using those Add-Ons for our customers and partners can be summarized in three points:
1) do not reinvent the wheel

There is no need to re-develop what has already been developed and is in operation at several customers.
Re-using out of the box Add-Ons save project time and mitigates the risks, as the Add-On has already been
implemented, tested and gone live successfully.
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2) supported coding
The problems of customer developments almost always arise in support later down the line (e.g. in future
upgrades they need to be updated to ensure they continue to work with newer versions of other components
andinterfaces;incaseofproblemsduringoperationsexpertadviceisrequiredtosolveproblems).Allofthe
Movilitas Add-Ons presented below are supported Add-Ons.
3) no need to engage any movilitas consultants

As a partner, when future requirements dictate, one or more of those Add-Ons can be used without having
toinvolveanyMovilitasconsultantsintheTrack&Traceprojects.Forcustomer,thisallowsthefreedomof
working with local partners of choice and still leveraging the in-depth Track & Trace knowledge accumulated
by Movilitas.
3.1 Randomization Add-On

brief overview:
The Randomization Add-On allows SAP OER to integrate with an external library to produce randomized serial
numbers according to a number of variable parameters.
who should use it?

Any company using SAP OER and needing randomized serial numbers, as randomization is not supported
in standard SAP OER/AII (Version 7.1 or lower). Via the randomizer Add-On, SAP OER can connect to a randomization service and receive back-randomized unique serial numbers, which can then be used for later
processing.
detailed architecture:
The Randomization Add-On is comprised of two components:
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1.1.
The randomizer ABAP classes which allow for the integration of the external randomizer service out of the
box (no additional ABAP development required). Those classes are delivered as ABAP transports. Depending
on the customer landscape, the Add-On can be installed on the SAP OER system or on the SAP AII system.
2.
2.
The randomizer algorithm (an algorithm called BayCoder (see also chapter V, 3.4.2.9), written by Bayer
Technology Services). The algorithm is a piece of software written in Java that can be installed on any server
supporting Java.
detailed functional description:

The following are the key highlights of the product:
01) Each single number generated only once
02) Probability of guessing a valid serial number in any case is more than 1:10.000
03) Serials are equally distributed across the number range
04)Thealgorithmisnoteasytofindoutevenwhenathegivensetofserialsora
subset thereof is known
05) Numeric or alphanumeric codes
06)Lengthofserialnumbercustomizable(max.30)
07)Javacoding,flexibleinallsystemlandscapes
08) Initialized by customer using self-chosen parameter values
09)Pre-definednumberrangeisfullyexhausted
10)Customerspecificparameterization:Thirdpartiesnotabletogenerateidentical
serialnumbersbyusingBayCoder
11) High performance: Unique serial numbers generated in less than 1 msec per
number. No impact on production output!
12)Nospecifichardwarerequired
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3.2 Data Reconciliation cockpit Add-On

brief overview:
The data reconciliation cockpit Add-On allows the reconciliation of captured Track & Trace data.
who should use it?

Any corporation that needs to rollout Track & Trace in a number of markets, in a limited timeframe, or any
organization deploying Track & Trace in manufacturing plants and warehouses with heterogeneous processes
and system landscapes. In those cases, the only feasible solution is to put Track & Trace on top rather than
integrating it with existing processes. The advantage of this approach is the speed of deployment, (as existing
processes or systems already in operation are not touched) but the clear downside of it is that, scanning Track
& Trace data is an addition to normal operations and therefore, technically optional (an outbound delivery can
leave the warehouse without the operator scanning the serial numbers of the delivery).
Any customer putting Track & Trace on top requires some level of reconciliation in order to monitor the accuracy of the Track & Trace data collected and in order to measure the scanning performance in the different
locations capturing Track & Trace data.
The Reconciliation Cockpit Add-On is comprised of two components:
1.3.
The Reconciliation ABAP classes which are delivered as ABAP transports and are to be imported into the
SAP OER system.
4.
2.
SAP PI business content (SAP PI Interfaces) that provide the data channels in order to feed the reconciliation
cockpit in SAP OER with reconciliation data.
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The data reconciliation cockpit Add-On provides the following functions. In any of the four main functions
described below, the user can always select by timeframe and location:
a) manufacturing reconciliation
Via the manufacturing reconciliation it is possible to monitor the printing and reading accuracy of a given
manufacturing plant. In cases where numbers were printed and scanned on the packaging lines but, never
arrived in SAP OER, these will be highlighted and the missing numbers will be displayed in the SAP OER
reconciliation cockpit. In the scenario where full cases were produced in the packaging lines, but the cases
arrived incomplete (less items than expected in SAP OER) or even empty in SAP OER (e.g. the items to cases
relationship was not created), those incomplete or empty cases are highlighted.
b) logistics reconciliation
Via the logistics reconciliation it is possible to monitor the accuracy of the Track & Trace scanning during
deliveryprocessing.Forexample,ifadeliverynumberwasprocessedinthewarehouses,butisnotvisiblein
SAPOER,thiswillbehighlightedinthereconciliationcockpit;oriffeweritemswerescannedagainstadeliverythanwhatwasexpectedandconfirmedbasedonthedeliverylineitems,thiswillbehighlightedinthe
reconciliation cockpit as well.
c) Timestamp reconciliation
The event timestamp is one of the most critical parameters in EPCIS messages. Since the capturing applications (packaging lines or mobile scanning devices) are generating messages, it needs to be ensured that none
of those devices has the wrong timestamp during operations. Also, every device needs to be registered in the
righttimezoneandusethecorrecttimestampterminologytoexpressthetimestampinUTForlocaltime.
Thetimestampreconciliationenablesthecentralmonitoringofanyofthecapturingdevicesandtodefine
timestamp deviation thresholds in order to trigger automated alarms should a capturing device go out of
sequence.
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d) logical random checks reconciliation

For any Track & Trace scenario, there is the so-called expected logical sequence. (E.g. an item normally is
firstpackedinacase,thatcaseonapalletandthatpalletisthenshipped).Thisfunctionalitycatersfordaily
random checks to be run and to highlight and/or trigger alerts in case a given ID does not follow the logical
sequence of expected event messages (number of randomly checked numbers as well as expected logical
checkconfigurablebylocation).
3.3 Authorities Reporting Add-On

brief overview:
The authorities reporting Add-On allows leveraging on experiences of other companies when connecting their
SAPOER/AIIwithexternalauthorities.ThisAdd-Onisspecificallybuiltforthepharmaceuticalindustry.The
Add-On includes among other things, standard coding to interact with the Ministry of Health (MoH) in Turkey,
withthesFDAinChina,andalsoallowsthecreationofapharmaASNbasedonSAPOERserialnumberinformation (which can then be used to generate an e-Pedigree document or any other type of electronic Track &
Trace documentation).
who should use it?

Any pharmaceutical company using SAP OER as the EPCIS repository is confronted with the same problem:
reporting to the authorities is compulsory and a key driver for the serialization of SKUs for the country. This
functionality is however not standard in SAP OER (Version 7.1 or earlier versions) and means custom coding
and new complex interfaces in SAP PI.
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The authorities reporting add-on is comprised of two components:
1.5.
SAPOERpre-configuredsetting(BCSets)andABAPClasseswhicharedeliveredasWorkbenchorCustomizingtransportsandaretobeimportedintotheSAPOERsystem;whichallows:
Map Global codes local codes:

National codes such as the National Chinese Medicine Code or the PZN (Pharmazentralnummer) in Germany
need to be mapped in the central system.
Adapt your number range management to the country requirements:
This Add-On supports various ways of doing number range management (and not only sequential numbers
based on sGTIN). It supports:
a) number ranges import (e.g. china)
b) alphanumeric serial numbers
c) random serial numbers
Extract data from SAP OER:
The data pool is used to extract data for authorities reporting, taking the date from SAP OER.
2.
6.SAP
PI business content (SAP PI Interfaces) that allows:
Data formatting, mapping and conversions in SAP PI

Data formatting, mappings and conversions are required to adapt generic reporting to local format requirement (e.g. adding Chinese texts for product codes)
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Audit trail, monitoring and error handling interfaces

Any incoming or outgoing interactions need to be handled as an event handler, so that
a detailed protocol can be created (including re-processing capabilities etc.)

The following functionalities are provided today out of the box with the delivery of the
Authorities Reporting Add-On:
a) authorities reporting for china - sfda:
Serial Number request, import and export to the lines

Master data mapping (GTIN National Chinese Medicine Code)
OutputformattingfortherequiredmessagestothesFDA
Errorhandling,audittrailandmonitoringofthesFDAInterface
b) authorities reporting for Turkey:
Output formatting and for the required messages to the Turkey MoH
Web service integration with the Turkey MoH for message submission
Error handling, audit trail and monitoring of the Interface
c) Pharma asn:
Output of enriched ASN with SAP OER serial numbers (triggered by ERP)
Used as basis for other outputs like e-Pedigree
Errorhandling,audittrailandmonitoringofthesFDAInterface
d) Pdf report generation for requested Product id:
Generation of a full Track & Trace record for a given requested ID

IntegrationwithSAPconnectsothate-mailwithPDFreportiscreated
User registration, report versions and white/black lists
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3.4 The special events Add-On

brief overview:
The Special Events Add-On provides transactions that will allow product Ids to be marked
as stolen, missing, contraband, counterfeit or seized.
This add-on comprises in total three abaP transactions:
Mark Product IDs as stolen

Mark Product IDs as missing
Upload Product IDs scanned during a seizure
who should use it?
AnycompanyrunningTrack&Tracewithaneedtoflagproductsasstolen,missing,counterfeitorcontraband
under special circumstances. This functionality is mainly used in exception events (e.g. full shipment stolen).
This functionality is not standard in SAP OER.
The special events Add-On is comprised of a single component:
1.7.
ABAP transaction and classes which are delivered as ABAP transports and are to be imported into the SAP
OER system. All three special transactions mentioned are delivered as new transaction codes to be used
within the SAP OER system (ABAP transactions executed from the SAP GUI).
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The following three transactions are added as a part of this Add-On:
a) stolen goods transaction

Whenever goods are stolen, typically the only information available is a reference delivery number (or the
shipmentnumberandfromthereitispossibletofindouttheaffecteddeliveriesinyourERPsystem).This
transactionallowsuserstoenteradeliverynumber;thetransactionthendisplaysallpallets,casesanditems
contained in that delivery with the corresponding hierarchies. It is then possible to select one or more of the
pallets, cases or items contained in the delivery and create a special event called stolen. When this event is
posted against the Event Handler, the status then changes to Stolen.
b) missing goods transaction

Sometimes the received quantities do not matched the shipped quantities. In those scenarios, the only solution is to flag those disappeared product IDs as missing. This transaction allows entry of two reference
documentnumbers(e.g.andoutbounddeliverandtheinbounddelivery);thetransactionthendisplaysthe
differences only (e.g. all pallets, cases and items contained in the outbound delivery but not scanned during
the inbound delivery processing. It is then possible to select one or more of the pallets, cases or items and
create a special event called Missing. When this event is posted against the Event Handler, the status then
changes to Missing.
c) Product seizures transaction

During project seizures, inspectors collect serial numbers, inspect them and come to conclusions. This transactionallowsthedocumentationofanyseizureactivity;byallowingtheimportofanExcelfilewiththecollected numbers (any formats etc. are checked), highlighting ID numbers if the numbers uploaded exists in the
SAPOERrepositoryorarenewandthenpostingeventmessagesagainsttheaffectedIDsflaggingthemas
seized, contraband or counterfeit in the SAP OER database (new event created in addition to the change of
the Event Handler attribute accordingly).
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3.5 The Performance Test Add-On

brief overview:
The performance test Add-On provides all the transactions required to run stress and performance testing in
a landscape, simulating future expected data volumes. Two types:
A) SAP OER performance and stress test
B) End to End performance and stress test
who should use it?

Any corporation implementing SAP OER and expecting large amounts of future data should ensure that the
implementationoftheSAPOERrepositoryfulfillstheperformancerequirements.Thisexerciseisamustmilestone on any SAP OER implementation. The risk of not performing this test during the initial implementation
is that, further down the line, the SAP OER repository may not cope with the serialized items sent by the packaging lines and the entire landscape might have to be redesigned (normally, the ramp-up phase for any customer to achieve high data volumes is 1 to 2 years depending on the implementation of the packaging lines,
softwareandhardware).Aperformancetestiskeyforcustomerswithenhancementsorspecificconfigurations
of SAP OER (e.g. long tracking IDs or many event handler attributes). In general any ABAP enhancement in
SAP OER that has not been performance tested (due to the high volumes expected on any SAP OER system)
has a probability of 90% to fail (e.g. timeout) as soon as the repository starts receiving larger volumes of data.
The Performance Test Add-On is delivered in two packages:
1.8.
ABAP package (as ABAP workbench transports) contains the ABAP classes and transactions that are neededinordertogenerateIDs(configurable)andinordertomeasuredatabaseperformanceduringthetest
execution.
9.
2.
.Netexecutable:whichcontainsaprogramusedforIDgeneration(configurable)usedduringEndtotest.
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Normallyperformanceisfirsttestedendtoendintherepositoryitself(toensurethattheexpectedvolumes
can be handled), in order to ensure that the SAP PI landscape or WAN network can handle the expected volumes. Both tests are fundamental and for both tests tools are required for execution as well as for performance
measurement. Therefore, the following functions are delivered:
a) Performance test execution

SAP OER ABAP program to generate high volumes of different IDs and event message types within SAP OER
(not end to end). EPCIS Messages are sent to SAP OER within the ABAP proxy. The attributes, types of IDs
andtypesofmessagestobegeneratedandsentareconfigurableviathecustomizingtool.
.Net program to generate high volumes of different IDs and event message types outside of SAP OER. Generated EPCIS messages are then sent via the SAP PI web service interface to SAP OER (End to End). The
attributes,typesofIDsandtypesofmessagestobegeneratedandsentareconfigurableviathecustomizing tool.
b) Performance test measurements

SAP OER ABAP set of reports that measure the database performance when writing data in SAP OER and
generated various ratios and statistics (e.g. Number of Event Handlers created per minute).
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3.6 The Archiving Add-On

brief overview:
The SAP OER data archiving Add-On is a holistic package to implement SAP OER archiving. (OpenText is part
of the prepackaged standard offering).
who should use it?

Any corporation using SAP OER and handling high data volumes should have an archiving strategy. The main
reason is that in most industries, data retention policies are around 10 years. However, there is no real need
tokeepIDsintheactivedatabaseoncenofurtherEPCISmessagesareexpectedforthoseIDs.Forthisreason
most customers archive data after one or two years. This data can still be retrieved at any time, however it does
not reside in the active database (archived data is deleted from the SAP OER active database once archived).
The archiving Add-On is delivered in two packages:
1. SAPOERConfigurationtransports,whichconfigurethearchivingobjectsintheSAPOERsystemandprepa10.
res the system to support archiving (standard business content in SAP OER).
2. Underlying archiving system (extra archiving server normally required), which builds the platform for the
11.
physical data archiving and is connected to SAP OER via the standard ArchiveLink interface.
Most of this functionality is standard in SAP OER. Thus, the Add-On needs to be understood as an accelerator
toconfigureandimplementarchivingtwiceasfastandriskfree(leveragingpreviousexperiencesarounddata
archiving with SAP OER.
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There are four main functionalities provided by this add-on:

Dataflaggingandselectionforarchiving(EventHandlersandEventMessages)
Datawritingonthearchivefileandfurtherpostinginthearchivesystem
Data deleting from the SAP OER active database
Dataretrievaltest(customerspecificasthisalwaysdependsonthetypeofdataconsumption)
3.7 ECPIS Repository migration Add-On

brief overview:
The EPCIS Repository Add-On allows the extraction of an entire database from SAP OER into EPCIS format, so
that this data can be seamlessly migrated to a different EPCIS directory.
who should use it?

Any customer migrating from SAP OER7.0 to SAP OER7.1 or any customer migrating from SAP OER7.0 or SAP
OER7.1 to another non SAP EPCIS repository.
This Add-On is delivered as an ABAP transport that contains the required ABAP classes and transactions, not
only to extract data from SAP OER structures back into EPCIS messages but also to monitor the migration run
(this functionality is only available for SAP to SAP migration and not for SAP to non-SAP migrations).

The add-on contains functionality to:
A) Extract data from SAP OER structures back into EPCIS messages
B) Monitor the data extraction process (e.g. Statistics)
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3.8 The Industrial mobile scanning Add-On

brief overview:
The industrial mobile scanning Add-On allows the use of industrial scanners (e.g. Motorola or Intermec devices) to capture events and to send them in EPCIS format directly to SAP OER. The Add-On provides over 20
different mobile transactions (goods receipts, goods dispatch, aggregate, disaggregate, decommission, etc.)
anditworksoffline/online(sonotevenaWi-Fiinfrastructureisrequiredinthelocationswhereitisdeployed).
All that is required to send data is a connection to the Internet (no special VPN required etc.).
who should use it?

Any company with the need to deploy Track & Trace to many locations with heterogeneous infrastructure and
possiblyevenwithdifferentsystemlandscapes,aswellasanycorporationhavingtofulfillaggressivetimelines
in deploying Track & Trace in those sites. It is also a must have for those companies deploying Track & Trace
to external agents. In all cases, investing in process harmonization (in order to integrate Track & Trace within
current logistic processes) and investing in the required infrastructure in the sites is normally not practicable.
Deploying this industrial mobile scanning solution capable of capturing and sending any kind of EPCIS events
without any changes in the current processes or infrastructure (Track & Trace on top) is the most appropriate
approach in all the scenarios considered.
The Movilizer for Track & Trace (see also chapter V, 3.6) isanSAPcertifiedAdd-OnthatisdeliveredasanABAP
Add-On which can be imported in to the ABAP stack of SAP PI or SAP OER. The Movilizer Connector (delivered
as a part of the Movilizer for Track & Trace ABAP package) connects the corporate system with the mobile device via the Movilizer Cloud, which allows mobile customers to send EPCIS messages from any device running
the Movilizer client with the right credentials (and send messages via a simple internet connection)
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The following functions are delivered out of the box as part of this Add-On:
on the mobile device:
on the movilizer connector:
Goodsreceipt
Configureuserrolesperlocation
Goodsreceiptandpalletize
Configurescannerfunctionalitiesand
Goodsdispatch
behavior per location
Pack(items,bundles,cases,palletsetc.)
ConfigureEPCISmessagepackaging
Unpack(items,bundles,cases,palletsetc.)
ConfigureEPCISconversionrules
Decommission
Configureuserlogonanddevicedetails
Mergepallets
per location
Unloadanddispatch
Configurelocationdependenthelpdesk
Breakbundles,cases,pallets,etc.
Configurehandheldsandtimedependent
Printlabels
settings
PrintKPIs
ConfigureMovelets(sequenceofscreens)
Viewdeliveries/transferorders
Configurescenarios
Editscannedtransactions
Displayscannedtransactions
Helpdeskinfo
Changelanguage
Logon/LogOff
Synchronize
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3.9 The mobile app for event capturing, ID verification and more
brief overview:
AnappforeventcapturingandIDverificationthatallowssmartphonestobeused.
who should use it?

Any company willing to use smartphones in order to capture EPCIS events and verify IDs against any type of
EPCIS repository (and of course against SAP OER). In particular, those companies willing to connect external
agents to the EPCIS repository will require this Add-On, as it would allow them to provide a mobile app supporting any major smartphone or tablet (iPhone, iPad, Android, etc.) capable of using the smartphone camera
as a barcode scanner and able to send data via the internet (no VPN or additional software required).
Please refer to chapter VI, 3.8

The following functions are delivered out of the box as part of this add-on:
On the mobile device (ID verification):
VerifyID(Synchronously)
on the mobile device (ePcis event capturing):

VerifyID(Asynchronously)
GetIDdetails(header,eventmessages
and hierarchy)
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on the movilizer connector:

3.10 The logistics label printing Add-On

brief overview:
The logistics label printing add-on allows:
A) Advanced label printing as well as the design of labels and input forms. This Add-On would normally
beusedinconnectionwithfixedprintersandespeciallyusefulinlogisticoperations,whereoperators
need to be able to print new labels during rework operations. The advantage of this approach is that
it does not require any footprint at all.
B) Basic label printing triggered directly from the mobile device and printed via a Bluetooth printer.
who should use it?

Any companies completing re-work in warehouses or distribution centers (re-work meaning: having to create
new aggregations and therefore having to print new IDs) will need this functionality. Also companies running
re-labeling operations across the supply chain (it does not matter where) may use this Add-On to generate
and print out unique IDs from a mobile scanner. Several customers have also used this solution in order to
avoid implementing serialization on a whole packaging line, if only a small amount of SKUs with low volumes
havetobeserializedforagivenmarket.ForasmallamountofIDsperyear,amanualrelabelingofcasescan
savesignificantcosts.
The label printing Add-On does not require any local footprint.
The advanced label-printing suite (based on a third party underlying label printing technology) is running on
the Movilizer Cloud and can be accessed via the Internet (provided the required credentials: user/password/
token, are known). It supports over 2,000 printer models and does not require any other software than an
Internet Explorer browser and Silverlight in order to work.
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The basic label printing capability, only requires a mobile device connected to a mobile printer via Bluetooth.
Handheldsareabletoprintlabelseveninofflineoperation.

The basic label-printing capability provides the
The advanced label-printing suite provides the
following functions:
following functions:
GenerationofIDsofflineoronline
GenerationofIDsofflineoronline
Printnewlabelsforitems
CertifiedconnectorforSAPformasterdata
Printnewlabelsforbundles
Abletoworkinpureofflineenvironments
Printnewlabelsforcases
Supportof2,000+printers
Printnewlabelsforpallets
Installationviainternetbrowser
Multi-languagesupport
PrintingonmobileprintersviaBluetooth
printers (limited printer models supported)
(no local footprint)

Printnewlabelsforitems
Printnewlabelsforbundles
Limitedlayoutcapabilities
Printnewlabelsforcases
Flexibilitywhendesigninginputformsfor
Printnewlabelsforpallets
label generation
Labelreprintforitems,bundles,casesor
pallet labels
Multi-languagesupport
Labelrepositoryandconfigurationperlocation
Centralrepositoryforlabellayoutsandinputforms
LocationdependentinputformsforID
generation
Labelreprintforitems,bundles,casesor
pallet labels
Etc.
210
3.11 The lean Track & Trace Add-On

brief overview:
The lean Track & Trace Add-On allows companies with low volume serialization requirements (e.g. most logistic providers without manufacturing operations) to enable their existing SAP ERP systems to act as an EPCIS
repository for low volume Track & Trace data.
who should use it?

Mainly suitable for logistic providers under pressure to provide Track & Trace services for their customers
(mainly manufacturers). Often, logistic providers mainly handle cases and pallets and bundles and only in exceptionalcasesatitemlevel.Forthoserequirements,settingupafullscaleSAPOERsystem(includingSAPPI
etc.)mightnotbepracticable.Thus,thisAdd-OnallowsanycustomerusinganSAPERP(ECC6.0orhigher)to
have a Track & Trace enabled SAP ERP (including EPCIS interface in order to receive messages).
This Add-On contains two parts:
1. ABAP transports to be imported in to the existing SAP ERP environment, containing the logic to act as an
12.
EPCIS repository.
2. Mobile scanning transactions capable of capturing EPCIS event and sent onto SAP ERP.
13.
211

a) on saP erP:
EPCISinterfaceforSAPERP
Eventhandlerandeventmessages
b) mobile scanning transactions:

Onthemobiledevice(EPCISeventcapturing):
data structures
Basicreportingfunctionality
OntheMovilizerConnector:
(ABAP reports and statistics)
SerializedASNprocessinginterface
(for integration with manufacturer ASN)
212
3.12 The 2cd level support package Add-On

brief overview:
The Movilitas 2cd level support package Add-On ensures worry-free operations for SAP Track & Trace systems.
This package allows you to access the 24*7 support helpdesk in order to identify and solve any problems that
might occur in the Track & Trace landscape. With the exception of packaging lines, this package covers any
other components: SAP OER, SAP PI, SAP AII and of course any of the other Movilitas Add-Ons.
who should use it?

Any company running SAP Track & Trace that do not have a dedicated support team with deep knowledge on
SAP OER, SAP AII, SAP PI, Label Printing or Mobile scanning solutions.

Support package provides modular support for any of the following components:
SAPOER
SAPPI
SAPAII
Movilizerscanningsolution
Movilizerprintingsolution
AnyoftheMovilitasAdd-Ons.
Thelevelofsupportcanbeconfiguredbythecustomerondemand.
213
Authors
Stefan Hockenberger,
Director Business Unit Track & Trace and Marketing, Movilitas Consulting AG
Master of Business Administration stefan hockenberger studied business administration in the BerufsakademieMannheim,UniversityofCooperativeEducation.From2002to2009StefanworkedasSolutionSales
Executive at SAP Germany AG & Co. KG and had the overall Pre-Sales responsibility for the SAP Solutions for
item Serialization (SAP AII/OER) within all industries in Germany, Austria and Switzerland. Since 2009 Stefan
has been responsible for Marketing and the business unit Track & Trace at Movilitas Consulting AG.
Karl Christian Roediger,

SCM Solution Management, SAP AG (Chapter II SAPs vision of Track & Trace an introduction from the
worlds largest supplier of standard software)
karl christian roediger who joined SAP in 2001, is a Solution Manager in the SAP Supply Chain Management
SolutionsArea.SincejoiningSAP,ChrishasworkedchieflyintheSAPSupplyChainExecutionandSAPAuto-ID
solution areas and helped in shaping products such as SAP Auto-ID Infrastructure, SAP Object Event repository
and the forthcoming new SAP Global Batch Traceability. Chris was awarded an MBA by Henley Management
College, UK (now Henley Business School as part of the University of Reading) in 2000.
Prior to joining SAP, Chris can look back on a 17 year long career in international logistics operation and management with multi-year assignments to international location such as Germany, UK, Hong Kong and China.
214
Authors
gs1 healthcare (chapter iii - gs1 standards for Track & Trace)
GS1 Healthcare is a global, voluntary user community bringing together all Healthcare supply chain stakeholders, including manufacturers, distributors, Healthcare providers, solution providers, regulatory bodies
and industry associations. The mission of GS1 Healthcare is to lead the Healthcare sector to the successful
development and implementation of global standards by bringing together experts in Healthcare to enhance
patientsafetyandsupplychainefficiencies.
GS1Healthcaremembersincludeover60leadingHealthcareorganizationsworldwide.Formoreinformation
about GS1 Healthcare, please visit www.gs1.org/healthcare.
Alberto Zamora Pueyo,

Member of the Board, Movilitas Consulting AG (Chapter IV, 2 - Beyond compliance: potential benefits of
Track & Trace & Chapter VI, 3 Movilitas Add-Ons for SAP Track & Trace)
alberto Zamora Pueyo,bornin1976inHuesca(Spain)holdsadegreeincommunicationsciences(UniversidadPontificiadeSalamanca,Spain),adegreeineconomics(UniversidadaDistancia,Spain)andadegree
in informatics engineering (Hochschule Heidelberg, Germany). Prior to co-founding Movilitas in Mannheim
(Germany)in2006,Albertoworkedfora5yearperiodinGermanyatSAPSIandSAPAGandforoneandahalf
years at SAP UK, always in positions related to mobility in the supply chain and SAP Track & Trace. Working in
theareaofTrack&Tracesince2006,Albertohasbeenplayingkeyrolesin25Track&Traceprojects.Among
others he has worked with 10 out of the worldwide top 25 pharmaceutical companies, with 2 out of the 4
worldwide tobacco manufacturers. Today Alberto is a Principal Track & Trace consultant at Movilitas as well as
a board member and is based in London.
215
Pharma iQ (chapter iv, 1.1 - Pharmaceutical industry)

Pharma IQ, a division of IQPC, is an international online community focusing on providing pharmaceutical
professionals with knowledge, information and articles. They are dedicated to creating a learning environment
for sharing ideas, best practices and solutions within the pharmaceutical community - www.pharma-iq.com.
Yannick Hofmann,
ChiefExecutiveOfficer,XavoSystemsAG(Chapter V, 3.1 Printing Technologies for T&T
related marking activities)
yannick hofmann, born in 1983, studied Economy at University of Bayreuth, Germany. He subsequently specializedinITandhasworkedatXavosince2005,firstasQualityManagerandsubsequentlyasBusinessConsultant and Project Manager. Since 2008 Yannick has worked as Manufacturing Test Lead within a Pilot Project
for a globally re-usable Tracking and Tracing Solution in the Tobacco Industry. Today, Yannick is a Business
Consultant responsible for global System Roll-out, including Development and Pre-Test of manufacturing ITSystems.Since2009YannickHofmannisChiefExecutiveOfficerentrustedinthemanagementandSalesfor
Xavo Systems AG, Switzerland.
216
Authors
Frederic Menardo,
General Manager Europe, Systech (Chapter V, 3.2 - Processes, Considerations and Software at production/packaging lines)
frederic menardo has been the General Manager Europe for Systech International for the past 4 years, holdingresponsibilityforthecompanysEuropeanoperations.FredericisanexecutivememberoftheSystech
serializationdeploymentsteeringcommitteeforglobalcustomers.PriortojoiningSystech,Fredericservedin
various management functions at European level with Johnson & Johnson, Esko-Graphics and Kodak.
Dr.-Ing. Stefan Artlich,

Director Supply Chain Optimization, Bayer Technology Services GmbH (Chapter V, 3.4.2.9 Serialization vs.
Randomization)
stefan holds a diploma in mathematics from University of Bonn and a Ph.D. in chemical engineering from the
TechnicalUniversityofHamburg-Harburg.StefanjoinedBayerin1996andnowholdsapositionasDirector
Product Tracking and Authentication. Since 2008, he has been involved in the Coding and Serialization activitiesofbothBayerHealthCareAGandtheEuropeanFederationofPharmaceuticalIndustriesandAssociations(EFPIA).StefaninitiatedthedevelopmentofBayCoder(R)atBTS.CurrentlyhesupportsEFPIAsactivities
towardsdesignandimplementationofapan-Europeanmedicinesverificationsystem.
217
Definitions, Acronyms and Abbreviations

anvisa| Agncia Nacional de Vigilncia Sanitria (National Health Surveillance Agency Brazil)
anmaT| Administratin Nacional de Medicamentos, Alimentos y Tecnologia Mdica (National Health
Organization Argentina)
ai (application GS1-128usesaseriesofApplicationIdentifierstoincludeadditionaldatasuchasbestbefore
Identifier)| dates, batch numbers, quantities, weights and many other attributes.
asn|AnAdvanceShipNoticeorAdvanceShippingNotice(ASN)isanotificationofpendingdeliveries, similar to a packing list. It is usually sent in an electronic format and is a common EDI
document.
badi| Business Add Ins are enhancements to the standard version of the code of SAP. They can be
insertedintotheSAPsystemtoaccommodateuserrequirementstoospecifictobeincluded
in the standard delivery.
cgmP| (current) Good Manufacturing Practice regulations (GMPs) are used by pharmaceutical, medical device, and food manufacturers as they produce and test products that people use. Drug
GMPs also apply to the veterinary drugs.
ciP (club inter FrenchClubInterPharmaceutique,whichcomprises ofmanufacturers,distributors,agents,
Pharmaceutique)| organizations representing pharmacies, biological systems as well as hospital pharmacists
andperformsthefunctionofatechnicalexpertfortheFrenchHealthsector.
data matrix code| A two-dimensional barcode such as e.g. Datamatrix.
218
Definitions,AcronymsandAbbreviations
datamatrix| A two-dimensional matrix barcode consisting of black and white cells or modules arranged
in either a square or rectangular pattern. The information to be encoded can be text or raw
data.
desadv| Dispatch Advice Message
din| Deutsches Institut fr Normung e.V. (in English, the German Institute for Standardization)
is the German national organization for standardization and is that countrys ISO (see ISO)
member body. DIN is a Registered German Association (e.V.) headquartered in Berlin. There
arecurrentlyaroundthirtythousandDINStandards,coveringnearlyeveryfieldoftechnology.
ean| An EAN-13 barcode (originally European Article Number, but now renamed International
Article Number even though the abbreviation EAN has been retained) is a 13 digit (12 data
and 1 check) barcoding standard which is a superset of the original 12-digit Universal Product
Code(UPC)systemdevelopedintheUnitedStates.TheEAN-13barcodeisdefinedbythe
standards organization GS1.
ecom| eCom is a GS1 term used for the Electronic Data Interchange. GS1 eCom provides global standards for electronic business messaging that allow rapid, efficient and accurate automatic
electronic transmission of agreed business data between trading partners.
ePc| TheElectronicProductCodeisdesignedasauniversalidentifierthatprovidesauniqueidentityforeveryphysicalobjectanywhereintheworld,foralltime.Itsstructureisdefinedinthe
EPCglobal Tag Data Standard, which is an open standard freely available for download from
the website of EPCglobal, Inc.
219
ePcis| EPC Information Services (EPCIS) is an EPCglobal standard designed to enable EPC-related
data sharing within and across enterprises. This data sharing is aimed at enabling participants
in the EPCglobal Network to obtain a common view of the disposition of EPC-bearing objects
within a business context.
ePcglobal| EPCglobal is leading the development of industry-driven standards for the Electronic Product
Code(EPC)tosupporttheuseofRadioFrequencyIdentification(RFID)intodaysfast-moving, information rich, trading networks.
e-Pedigree| An electronic document, typically in XML format, containing the history of custody.
efPia| European Federation of Pharmaceutical Industries and Associations (EFPIA) is a Brusselsbased trade union founded in 1978 representing the research-based pharmaceutical industry operating in Europe. Through its direct membership of 31 national associations and 44
leadingpharmaceuticalcompanies,EFPIAisthevoiceontheEUsceneof2,200companies
committed to researching, developing and bringing new medical treatments.
fcTc|TheWHOFrameworkConventiononTobaccoControl(WHOFCTC)isthefirsttreatynegotiatedundertheauspicesoftheWorldHealthOrganization.TheWHOFCTCisanevidencebasedtreatythatreaffirmstherightofallpeopletothehigheststandardofhealth.
fda| TheFoodandDrugAdministration(FDA)isanagencywithintheU.S.DepartmentofHealth
and Human Services.
fdaaa|OnSeptember27,2007,PresidentGeorgeW.BushsignedtheFoodandDrugAdministration
AmendmentsAct(FDAAA)of2007intolaw.ThisnewlawisanimportantstepfortheFood
andDrugAdministration(FDA).Itreviewed,expanded,andreaffirmedseveralexistingpieces
oflegislationregulatingtheFDA.ThesechangeswillallowtheFDAaccesstomuch-needed
220
resources that will enable the agency to better protect American consumers by allowing more
comprehensive reviews of potential new drugs and devices.
feem| TheFederationofEuropeanExplosivesManufacturersisanon-governmentalorganization
createdin1976byEuropeanindustrialexplosivesmanufacturers.Themainobjectiveofthe
Federationistoencouragebestpracticeintheindustry,particularlyintheareasofsafety,
quality and security, and to make the public aware of the importance of different uses of industrial explosives in creating its infrastructure and environment.
gamP| Good Automated Manufacturing Practice (GAMP) is both a technical subcommittee of the
International Society for Pharmaceutical Engineering (ISPE) and a set of guidelines for manufacturers and users of automated systems in the pharmaceutical industry.
gdsn| The Global Data Synchronization Network (GDSN) is built around the GS1 Global Registry,
GDSN-certifieddatapools,theGS1DataQualityFrameworkandGS1GlobalProductClassification,whichwhencombinedprovideapowerfulenvironmentforsecureandcontinuous
synchronization of accurate data.
gln| The Global Location Number (GLN) is part of the GS1 systems of standards. It is a simple tool
used to identify a location and can identify locations uniquely where required.
grai| TheGlobalReturnableAssetIdentifier(GRAI)ispartofthesystemofGS1standards.Itisa
simple tool to identify assets by type and can uniquely identify assets where required.
gs1| GS1 (www.gs1.com) is a leading global organization dedicated to the design and implementationofglobalstandardsandsolutionstoimprovetheefficiencyandvisibilityofsupplyand
demand chains globally and across sectors. The GS1 system of standards is the most widely
used supply chain standards system in the world.
221
gTin| Global Trade Item Number (GTIN) is an identifier for trade items developed by GS1. Such
identifiers are used to look up product information in a database (often by inputting the
number through a bar code scanner pointed at an actual product), which may belong to a
retailer, manufacturer, collector, researcher, or other entity.
isa-95| ANSI/ISA-95, or ISA-95 as it is more commonly referred, is an international standard for developing an automated interface between enterprise and control systems. This standard has
been developed for global manufacturers. It was developed to be applied in all industries,
and in all sorts of processes, like batch processes, continuous and repetitive processes.
iso| The International Organization for Standardization, widely known as ISO, is an international
standard-setting body composed of representatives from various national standards organizations.FoundedonFebruary23,1947,theorganizationpromulgatesworldwideproprietary,
industrial, and commercial standards. It has its headquarters in Geneva, Switzerland.
iso 9001| ISO 9001:2008 Quality management systems Requirements is a document of approximately 30 pages, which is available from the national standards organization in each country. It
is supplemented by two other standards, ISO 9000:2005 Quality management systems
FundamentalsandvocabularyandISO9004:2009Managingforthesustainedsuccessofan
organization.
mes| Manufacturing Execution Systems are information technology systems that manage manufacturing operations in factories. Over the years, international standards and models have
refinedthescopeofsuchsystemsintermsofactivities.
moh| Ministry of Health
ndc|TheNationalDrugCode(NDC)isauniqueproductidentifierusedintheUnitedStatesfor
222
drugs intended for human use. The Drug Listing Act of 1972 requires registered drug establishmentstoprovidetheFoodandDrugAdministration(FDA)withacurrentlistofalldrugs
manufactured, prepared, propagated, compounded, or processed by it for commercial distribution.DrugproductsareidentifiedandreportedusingtheNDC.
oee| Overall equipment effectiveness (OEE) is a hierarchy of metrics developed by Seiichi Nakajima
in1960s(basedonHarringtonEmersonwayofthinkingregardingtolaborefficiency),which
evaluates and indicates how effectively a manufacturing operation is utilized
oPc| The Open Packaging Conventions (OPC) is a container-file technology initially created by
MicrosofttostoreacombinationofXMLandnon-XMLfilesthattogetherformasingleentity
suchasanOpenXMLPaperSpecification(OpenXPS)document.
Pes| Packaging Execution System
Plc| A programmable logic controller or programmable controller is a digital computer used for
automation of electromechanical processes, such as control of machinery on factory assemblylines,amusementrides,orlightfixtures.
Qa| Quality assurance refers to the planned and systematic activities implemented in a quality
systemsothatqualityrequirementsforaproductorservicewillbefulfilled.
rfid| Radio-frequencyidentification(RFID)istheuseofanobject(typicallyreferredtoasanRFID
tag)appliedtoorincorporatedintoaproduct,animal,orpersonforthepurposeofidentification and tracking using radio waves.
scada| Supervisory Control And Data Acquisition generally refers to industrial control systems (ICS):
computer systems that monitor and control industrial, infrastructure, or facility-based processes.
223
sfda|StateFoodandDrugAdministration,P.R.China
sgTin| Serialized Global Trading Item Number (sGTIN) a global trade item number combined with a
serial number.
sni|StandardizedNumericalIdentification
soP| A Standard Operating Procedure is a written document or instruction detailing all steps and
activities of a process or procedure. ISO 9001 essentially requires the documentation of all
procedures used in any manufacturing process that could affect the quality of the product.
sscc| TheSerialShippingContainerCode(SSCC)istheGS1IdentificationKeyforanitemofany
composition established for transport and/or storage, which needs to be managed through
the supply chain. The SSCC is assigned for the life time of the transport item and is a mandatoryelementontheGS1LogisticLabelusingApplicationIdentifier(00)
vds| VdSisanindependentinstitutionwhichhasbeenensuringsafetyandtrustinthefieldsoffire
protectionandsecurityformanydecadesanddevelopsadvancedsafetyconceptsforsignificant industrial and commercial enterprises, leading manufacturers and system businesses as
wellasspecialistfirmsandindependentspecialists.
who| The World Health Organization (WHO) is a specialized agency of the United Nations (UN) that
acts as a coordinating authority on international public health.
xml|ExtensibleMarkupLanguageisamarkuplanguagethatdefinesasetofrulesforencoding
documentsinaformatthatisbothhuman-readableandmachine-readable.Itisdefinedin
theXML1.0SpecificationproducedbytheW3C,andseveralotherrelatedspecifications,all
gratis open standards.
224
Appendix
1 Track & Trace Survey - Overview
The survey was designed to be answered by a variety of industries. All in all, it contains 39 questions on the
following areas:
CompanyandPerson
Itemserialization/Track&Traceingeneral
UseofTrack&Tracedata
Standards
Software&Serviceprovider
Budget
Software
Project
Thesurveywassentto367recipientsand29answerswerereceived,whichisareturnrateof7,9%.Forthe
results of the survey (static and dynamic) please refer to Appendix 3. and 4.
Appendix
225
2 Overview Survey Questions

company and Person
Whatisyourrole/jobtitle?
Whatisyourdepartment?
Whatwasapproximatelyyourorganizations2010revenue?
Howmanyemployeesdoesyourcompanyapproximatelyhave?
Pleaseselecttheindustrythatdescribesyourorganization
item serialization/Track & Trace in general
HowlonghasyourcompanyhadaTrack&Traceinitiativeinplace?
Whatis/areforyourcompanythemaindriver(s)forTrack&Trace?
Inwhichofthefollowingareasdoyou(orwillyou)useitemserialization?
Pleasegiveusaroughestimationofyournumberoffacilities/plantsandinhowmanyof
them you already use or plan to use item serialization and Track & Trace.
Ifyouarealreadydealingwithserialization/Track&Trace,onwhichlevelareyoutracking?
Onwhichleveldoyouplantotrackinfuture?
Isyourorganizationaffectedbycounterfeitsandifyeshowhigharethelosses?
Howisyourorganizationsboardlevelawareofitemserialization/Track&Traceand
the related meanings and outcome?
use of Track & Trace data
TheserializedinformationstoredinyourEPCISrepository,isitforinternalpurposesonlyor
do you have to share these information?
AreyourTrack&Tracedataintegratedinexistingsoftwareapplications,e.g.SAPERP?
Howlongdoyouhavetostoreserializedinformationinaglobalrepository?
(Please also indicate a time frame if not yet required, but will in future)
Whatareyoudoingwiththeserializedinformationafterstoringinarepository?
226
Appendix
Howmanyserializeditemsdoyoualreadystoreinarepositoryeachyear?
Whatsyourforecastofserializeditemstostoreinarepositoryonceyoureachglobalcoverage?
Howmanyeventmessagesaregeneratedoveranitemslifecycleinaveragebytoday?
(E.g. produced, shipped, stored, etc.)
Howmanyeventmessageswillbegeneratedoveranitemslifecycleinaverageinfuture?
(E.g. produced, shipped, stored, etc.)
standards
HowfamiliarareyouwithEPCGlobalandstandardslikeEPC&EPCIS?
HowimportantisitforyourorganizationtofollowEPCGlobalstandardsintheareaofTrack&Trace?
IfyouhaveindustryspecificstandardsdifferingfromEPCGlobalstandardscanyoupleaseshortly
summarize?
software & service Provider
Pleaseselectthetopcriteriaforyourorganizationtoselectasoftwareproviderforaglobal
Track & Trace repository
Pleaseselectthetopcriteriaforyourorganizationtoselectaserviceprovidertohelpyouin
implementingaglobalrepositoryanddefiningrelatedbusinessprocesses
budget
Whatisyourorganizationsapproximate2011budgetforitemserialization/Track&Trace?
Howhasyourorganizations2011Track&Tracebudgetchangedfromthe2010budget?
Howwillyourorganizations2012Track&Tracebudgetchangefromthe2011budget?
BywhendoyouthinkyouwillreachROIonyourinvestmentsforserialization/Track&Trace?
227
software
IfyoualreadyhaveTrack&Traceinplaceorplantohavedidyouordoyouplantoseparatethetopic
of serialization at production lines from the tracking and tracing of the items in the supply chain?
Doyouhavealreadyserializationtechnologyatyourproductionlines?
DoyoualreadyhaveanEPCISrepositoryinplace(e.g.SAPOER)?
Doyouhaveorplantohavelocal/regionalconsolidationsoftwareforserializedinformation
(e.g. SAP AII)?
Doyouhaveorplantohaveamobileapplicationforcapturingeventinformationalongthe
supply chain?
Howimportantisitforyourorganizationtointegrateeventinformationfromtheexternalsupply
chain in your repository?
Howimportantisitforyourorganizationtohaveaneasytouseandeasytointegratemobileapplication
for event capturing along the supply chain?
Howimportantisitforyourorganizationthatthemobileapplicationoffersoutoftheboxfeatures
for Track & Trace?
Project
PleaseidentifythethreemostimportanttopicsinaTrack&Traceprojecttohandlewith
WhatdoyouthinkisthemostimportanttosucceedwithaglobalTrack&Traceproject?
228
Appendix
3 Track & Trace survey - static results

1.
company and Person
roles/job Titles:
departments:
Projectmanager
Corporate
SolutionArchitect
StandardTechnologies
ComplianceManager
SCMIT
GeneralManager
BrandProtection
RegulatoryIntelligenceManager
RegulatoryAffairs
DivisionalController
EngineeringSystems
PrincipalScientistPackaging
ExecutiveBoard
GlobalCoordinationAuto-IDAffairs
PharmaceuticalsTrack&Trace
ResearchAssistant
Export
DistributionManager
TechnicalOperations
ITLeadSerialization&ProductTracking
TechnologyManagement
ProgramManagerSerialization
PharmaceuticalsLogistics
Track&TraceManager
CustomerService
NonConformanceManager
IT
MaterialsManagement
ProductionExecution
BusinessAnalyst
SupplyChainStrategy&DesignManager
revenue of organizations
Max:60Billion
employees of organizations
Max:137.000
Min:10Million
Average:8.821Billion
Min:10
Average:36.161
229
Please select the industry that describes your organization.

Number of Answers
Answers
Automotive
Chemicals
Food/Beverage
Health/medical
Military
Oil & Gas
11
Pharmaceutical
Retail
12
Others (please explain): Service Providers, Office Equipment, Aviation, Transportation, 3rd Party integrated solutions, Logistics & Distribution, Tobacco, Agriculture Business
2.
how long has your company had a Track & Trace initiative in place?
Number of Answers
230
Answers
More than 5 years
3 to 5 years
2 years
1 year
Less than 1 year
We are about to start right now
We plan to start in future
No plans to start with Track & Trace
Dont know
Appendix
what is/are for your company the main driver(s) for Track & Trace?
Number of Answers
(multiple answers
were possible)
Answers
19
Comply with government mandates/legislations
Comply with requirements given by supply chain partners and/or customers
15
Businessbenefitssuchastransparency/visibility
11
Customer service such as patient safety or others
Reduce cost
Better security
14
Anti counterfeiting
Others
Dont know
in which of the following areas do you (or will you) use item serialization?
Number of Answers
(multiple answers
were possible)
Answers
21
Manufacturing/Production
15
Warehouse
13
Shipping
10
Receiving
15
Distribution Centers
14
Internal Supply Chain
13
External Supply Chain
Others
Dont know
231
Please give us a rough estimation of your number of facilities/plants and in how many
of them you already use or plan to use item serialization and Track & Trace.
Answers
Answers
Max:
500
Min:
Average:
81,3 NumberofFacilities/Plantsofyourorganization
Not representive
In how many do you already use item serialization/Track & Trace
Not representive
In how many do you plan to use item serialization/Track & Trace
Not representive
Dont know
if you are already dealing with serialization/Track & Trace, on which level are you tracking?
Number of Answers
Answers
Item level
Case level
Pallet level
Container Level
Dont know
on which level do you plan to track in future?

Number of Answers
232
Answers
22
Item level
Case level
Pallet level
Container Level
Dont know
Appendix
is your organization affected by counterfeits and if yes how high are the losses?
Number of Answers
Answers
We are not affected by counterfeits
Weareaffected,buthavenofigure
Less 1% of revenue
1-2% of revenue
2-5% of revenue
5-10% of revenue
10-20% of revenue
More than 20% of revenue
Dont know
how is your organizations board level aware of item serialization/Track & Trace and the related
meanings and outcome?
Number of Answers
Answers
They never heard of it
Not aware
They are aware, but dont know about meanings and outcome
14
The are aware and know about meanings and outcome
I dont know about awareness, but they support Track & Trace
Others
I dont know
233
3.
The serialized information stored in your ePcis repository, is it for internal purposes only
or do you have to share these information?
Number of Answers
(multiple answers
Answers
were possible)
6
We only use the data internal
We will use this data only internal also in future
We have to share these data with external resources such as authorizations due
to legislations
10
We plan to share these data with external resources such as authorizations due
to legislations
We already share these data with external resources such as partners for optimization
We will share these data in future with external resources such as partners for
optimization
234
Others
I dont know
Appendix
are your Track & Trace data integrated in existing software applications, e.g. saP erP?
Number of Answers
(multiple answers
Answers
were possible)
7
No, we just store serialized information in a standalone repository
10
Yes, we use event information to trigger logistic transactions such as goods

issue posting, or others in internal systems
Yes, we use event information to sending information in external software systems, e.g. proof of delivery
Others
Dont know
how long do you have to store serialized information in a global repository?

(Please also indicate a time frame if not yet required, but will in future)
Number of Answers
Answers
Less than one year
2-5 years
5-10 years
More than 10 years
We are not forced to store serialized information for a certain time, but plan to
storedataforindefiniteyears
Others
Dont know
235
what are you doing with the serialized information after storing in a repository?
Number of Answers
Answers
14
Archived
Archived for a certain time then deleted
Deleted
Others
Dont know
how many serialized items do you already store in a repository each year?
Number of Answers
Answers
Up to one million
1-5 million
5-10 million
10-50 million
More than 50 million
17
Dont know
whats your forecast of serialized items to store in a repository once you reach
global coverage?
Number of Answers
236
Answers
Up to one million
1-5 million
5-10 million
10-50 million
More than 50 million
16
Dont know
Appendix
how many event messages are generated over an items lifecycle in average by today?
(e.g. produced, shipped, stored, etc.)
Number of Answers
Answers
Only one
1-3
3-5
5-10
More than 10
19
Dont know
how many event messages will be generated over an items lifecycle in average in future?
(e.g. produced, shipped, stored, etc.)
Number of Answers
Answers
Only one
1-3
3-5
5-10
More than 10
18
Dont know
237
4.
standards
how familiar are you with ePc global/gs1 and standards like ePc & ePcis?
Number of Answers
Answers
Never heard of it
Heard of it, but dont know what it means
11
I know what it is all about
We actively use these standards
I/we are actively engaged in EPC Global working groups
how important is it for your organization to follow ePc global/gs1 standards in the
area of Track & Trace?
Number of Answers
Answers
Not important
Preferred but not necessary
Must have requirement
In general we follow EPC Global standards, but will have slightly changes due
to industry requirements
Wehavetofollowindustryspecificstandards
Dont know
If you have industry specific standards differing from EPC Global/GS1 standards can you
please shortly summarize?
3 x own standard, based on GS1
238
Appendix
5.
Please select the top criteria for your organization to select a software provider for a global
Track & Trace repository.
Number of Answers
(multiple answers
Answers
were possible)
24
Industry experience
14
Standard solution
25
Track & Trace expertize
11
References
Recommendation by peers
Maturity of solution
15
Scalability of solution
18
Compatible with standards, e.g. EPC Global/GS1
Partner ecosystem
Length of time in business
Size/Capital of company
Offering of consulting services
Others (please explain): 2 x SAP, 1 x Cost
Please select the top criteria for your organization to select a service provider to help you in
implementing a global repository and defining related business processes.
Number of Answers
(multiple answers
Answers
were possible)
24
Industry experience
25
Track & Trace expertize
15
References
239
6.
Recommendation by peers
Length of time in business
Size/Capital of company
Offering of training services
Offering of complementary products for Track & Trace
Others (please explain): SAP Knowledge, Cost, Vista, MDS Logistics PLC
budget
what is your organizations approximate 2011 budget for item serialization/Track & Trace?
Number of Answers
Answers
Lowerthan100.000
100.000200.000
200.000500.000
500.0001.000.000
1-3million
Morethan3million
We have not budget for serialization/Track & Trace
16
Dont know
how has your organizations 2011 Track & Trace budget changed from the 2010 budget?
Number of Answers
240
Answers
Same budget
Decreased
Increased
13
Dont know
Appendix
how will your organizations 2012 Track & Trace budget change from the 2011 budget?
Number of Answers
Answers
Same budget
Decreased
Increased
14
Dont know
by when do you think you will reach roi on your investments for serialization/Track & Trace?
Number of Answers
Answers
Less than one year
1-2 years
3-5 years
5-7 years
8-10 years
More than 10 years
Never
14
Dont know
241
7.
software
if you already have Track & Trace in place or plan to have did you or do you plan to separate
the topic of serialization at production lines from the tracking and tracing of the items in
the supply chain?
Number of Answers
Answers
10
No, we handle this as one topic
Yes, we see this as separate topics, but the same team will handle it
Yes, we see this as separate topics and will have different teams handle these
10
Dont know
topics,e.g.differentRFPsandprojects
do you have already serialization technology at your production lines?

Number of Answers
242
Answers
No we havent and dont plan to have
No we havent but plan this for the future
Yes we are already fully equipped
So far less than 10% of all production lines
11
Dont know
Appendix
do you already have an ePcis repository in place (e.g. saP oer)?

Number of Answers
Answers
We currently evaluate a global repository
Yes we are already have one
13
Dont know
do you have or plan to have local/regional consolidation software for serialized

information (e.g. saP aii)?
Number of Answers
Answers
We currently evaluate a consolidation system
15
Dont know
do you have or plan to have a mobile application for capturing event information along
the supply chain?
Number of Answers
Answers
We currently evaluate a mobile application
We will use the provided SAP tools for this
11
Dont know
243
how important is it for your organization to integrate event information from the external
supply chain in your repository?
Number of Answers
Answers
No need for this
Nice to have, but not necessary
IsorwillbearequirementinaRFP
Must have
10
Dont know
how important is it for your organization to have an easy to use and easy to integrate mobile
application for event capturing along the supply chain?
Number of Answers
Answers
No need for this
Was,isorwillbearequirementinaRFP
Must have
11
Dont know
how important is it for your organization that the mobile application offers out of the box
features for Track & Trace?
Number of Answers
244
Answers
No need for this
IsorwillbearequirementinaRFP
Must have
14
Dont know
Appendix
8.
Project
Please identify the three most important topics in a Track & Trace project to handle with.
Number of Answers
(multiple answers
Answers
were possible)
10
Managing labels
11
Data volumes and archiving
10
Process design
Serial number range management
System architecture
10
Master data management
Attributes of serialized items
12
Interfaces
Alerting
Role & authorization concepts
Dont know
Others
what do you think is the most important to succeed with a global Track & Trace project?
Number of Answers
(multiple answers
Answers
were possible)
11
Starting with a detailed/global blueprint (assumed involvement of all stakeholders is given)
17
Having necessary involvement by all stakeholders during build phase
14
That implementation is done by someone with experience in the area of

Track & Trace
Dont know
Others
245
4 Track & Trace survey - dynamic results

This chapter will give an interpretation of the results. Individual answers will not be commented on. Please
refer to Appendix 3. to get a complete overview of all answers. 100% is always based on the complete answers
received (29). If the sum of percentages for some questions dont reach 100%, the rest are minorities or dont
know answers.
company and Person

The insight gained from the survey is that the majority of the companies, which answered the survey, are global players. This is an assumption based on the revenues and number of employees. While the lowest annual
revenueisjust10Millionandthesmallestcompanyhasjust10employeesand/or1plantthebiggestnumbersare60Billionannualrevenue,137.000employeesand/or500plants.Takinganaverageofallanswers,
thesamplecompanyhasarevenueof8.821Billionwith36.161employeesand81.3plants.
As expected, most of the companies (48%) answering the survey are from the pharmaceutical/health/medical
sector.Thisfitsperfectlywiththehighnumberofcompanies(65%)statingthatcompliancewithgovernment
mandates and legislations is the main driver for the implementation of Track & Trace.

Anotherindicationthatlegislationisthedriveristhat;17%answeredthattheyhavebeeninvolvedinTrack
and Trace for 3-5 years and 31% answered that they had been involved in Track & Trace for more than 5 years.
As Track & Trace as a concept is quite new most of the corporations taking care of it do it because they are
forced to do so.
The most important area within a company to start Track & Trace implementation is the production/manufacturing according to 72% positive answers. This is somewhat predictable, as this is where products have to
246
Appendix
beserialized.Thisalsoexplainsthefactthat76%ofthecompaniesalreadydoorplantoserializeonitem
level. The next most important area where the companies aim to implement serialization or already have, are
warehouses and/or distribution centers, which were both chosen by 51% of those who responded.
50% of participants stated that they are affected by counterfeiters and 50% arent. This is an indicator that
anti-counterfeiting measures are not the strongest argument for implementing Track & Trace.
A very positive outcome of the survey is that the importance of Track & Trace has already reached the board
levelat72%ofthecompaniesparticipating.Furthermore,theboardisawareoftheimportance,meaningsand
outcome or at least supports the Track & Trace initiatives and projects within their companies.

While 24% stated that they are already obliged to share their serialized information with authorities and 34%
stated that they will share due to legislations, 21% use the serialized information for internal purposes only.
17%alreadysharecaptureddatawithsupplychainpartnersand28%plantodoso.Whilethefirstpartisdriven by legislations, the sharing data with supply chain partners seems to be more for optimization reasons in
the supply chain and shorter ROI. It is also for this reason that most of the answers (34%) to the next question
were that the Track & Trace data is integrated in existing software applications due to automatic triggering of
logistic transactions such as e.g. goods issue posting.
Regarding the duration of data storage in the active database and what will happen with the data after a certaintime,thefollowinganswerswerereceived;themajority(24%)holdtheserializedinformationfor2-5years
in the active database. 21% 5-10 years and 10% even more than 10 years. After the data is removed from the
activedatabase69%willarchiveit.21%deleteitfromthearchiveafteracertaintimeand3%willdeletethe
data directly from the active database.
247
For the next block of questions mostly dont know answers were received. So perhaps less value can be
placed on the answers received.
When addressing the present status 14% of the companies currently store up to one million IDs in their repository. This is the majority bearing in mind that 58% answered, dont know. 10% already have between 1050 million IDs per year and 7% even more than 50 million IDs per year. The average of event messages (e.g.
produced,shipped,received,etc.)perIDisbetween3-5but,66%gaveadontknowanswer.
Fromtheresponsetothequestiononfutureforecastswelearnthatthemajorityofcompanies(28%)willhave
more than 50 million IDs per year. Only 10% 10-50 million IDs per year and 55% again dont know. The rest
are minorities. Response to the question on forecasts for event messages per ID does not necessarily shows
an increase in line with the increase in the number of IDs. This can lead to the conclusion that processes and
event messages are mostly in place, but not all production lines are included or equipped with the technology
needed to serialize on an item level.
standards
Only 10% of companies that responded had never heard of EPC Global and the related standards such as EPC
and EPCIS. 27% had heard of it, but did not know the background or origins.
The remainder knew all about it and already uses the standards or is even involved in working groups of EPC
Global/GS1. The reason for the majority knowing about the standards is answered by the next question, which
shows that 24% are required to have them. Only 7% said that the EPC Global standards are not important and
14%saidthattheyhavetofollowindustryspecificstandards.TherestofthecompanieseitheruseEPCGlobal
standards or follow them with slight changes.
248
Appendix

The organizations were also asked for their top criteria to select a software and service provider for the
Track & Trace software and the implementation project.
Top 3 criteria for the selection of Track & Trace Software
86% - Track & Trace Experience
83% - Industry Experience
62% - Compatible with standards, e.g. EPC Global
Top 3 criteria for the selection of a service provider
86% - Track & Trace Experience
83% - Industry Experience
52% - References
It is interesting that in both categories Track & Trace experience is the most important criteria directly followed
by industry experience. Experience in the implementation of projects also shows that it is very important to
know what the essential topics are for a Track & Trace project to save valuable time during the business blueprint and design phase of such a project. Track & Trace projects are in nearly all cases global projects hence,
getting involvement of all necessary stakeholders from the beginning is crucial and therefore, taking up as
little of their time as possible too.
249
budget
Analyzing the answers to the questions around the budget for Track & Trace projects, again a high number of
dont know answers were received. Taking the positive answers into consideration, in 2011 14% of all companieshadabudgetofbetween1-3million.13%hadlessthan1millionand10%morethan3million
for 2011. It is interesting to see that from 2010 to 2011 the budget stayed the same for all companies (24%)
or increased (31%). None of the companies had a decreasing budget from 2010 to 2011. The same trait can
be seen for 2011 to 2012. 17% will have the same budget, while 31% will have a budget increase. Only one
company gave the answer that the 2011 to 2012 budget will decrease. This leads to the conclusion that for
those in the Track & Trace business the market is only just beginning.
It is also clear for all, that Track & Trace is a very legislation driven topic. Investments are very high and therefore ROI times are longer than in regular IT projects. Therefore, it is a surprise to see that the majority of
companies (28%) answered that they will reach ROI within 3-5 years (48% dont know). 14% even said ROI
would be reached in less than 2 years. Only 1 company gave the answer that they never will reach a ROI. With
the majority stating that ROI will be reached in less than 5 years, this has to lead to the conclusion that the
serialized information and the transparency gained will be used extensively for supply chain optimization and
not only to comply with legislations.
software
Thefirstpointtoaddressinthesoftwarerelatedquestionswaswhethertheorganizationsseparatethemore
technical related topic of serialization from the more process related topic of tracking and tracing of items. The
spread of answers were quite equal. 34% will handle both topics in one and 31% will handle them as different
topics. However, 31% of those who stated they would handle the two topics separately will do so with the same
team of people, except for one company.
250
Appendix
As indicated by the questions around number of IDs stored in the active database, only a small number of
production lines are already equipped with the serialization technologies. 31% have less than 10% of all production lines equipped so far. 10% said that they are already fully equipped on all lines. The remainder responded that they dont know or dont plan to equip any lines. The last ones are surely the service providers
answering the survey.
Concerning the existence of the most important software applications, the following answers were received.
consolidation software/edge
mobile application
server
(event capturing)
17% - already have consolidation
14% - already have a mobile
software in place
14% - currently evaluate
consolidation software
10% - plan to implement
consolidation software
in future
7% - dont plan to have one
52% - dont know
application in place
24% - currently evaluate a mobile
application
10% - will use the provided
SAP tools
14% - plan to implement a
mobile application in
ePcis/global repository
21% - already have an EPCIS
repository in place
14% - currently evaluating an
EPCIS repository
17% - plan to implement an
EPCIS repository in future
3% - dont plan to have one
45% - dont know
future
38% - dont know
251
Project
Thelastchapterincludes2questionsontypicalTrack&Traceproject.Firstwasthequestionofthethreemost
important topics in a Track & Trace project.
The most widely chosen answer was interfaces with 41%, closely followed by data volumes and archiving
(38%).Inthirdplacetherewere3topicswith34%each.Thesetopicsare;managinglabels,processdesignand
master data management.
Thelastquestionofthesurveywas;whatismostimportantforsuccessinaglobalTrack&Traceproject.The
answer was the involvement of all stakeholders during the build phase, which is an opinion wholly endorsed
by the author. There are a number of examples of projects stagnating due to the lack of involvement of key
stakeholders. It is essential that companies get all necessary people involved and of course, that all of these
people have shared opinions on processes and how implementation should proceed.
Printed and bounded in Germany 2012

ISBN 978-3-00-039041-8
252
Appendix

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Track Trace with SAP Solutions

Which industries are affected and why

ii saPs vision of Track & Trace

Trends Why traceability?

Different ways of Traceability

Traceability Types Traceability domain

Deployment of internal and external Traceability

SAPs Track & Trace Solution Portfolio today

SAP Global Batch Traceability

SAP Event Management

SAP Object Event Repository

Scenarios as to how the Track & Trace domain may develop

Value Chain traceability

iii gs1 sTandards for Track & Trace

Welcome to the world of GS1 Standards - Managing complexity

Introduction to GS1 EPCIS

GS1 Standards in the pharmaceutical industry

GS1 Healthcare - Leveraging global standards to enable

Traceability in Healthcare - Regulatory developments

iv drivers of Track & Trace

Process standardization and harmonization

Customer consumption, alerts, monitoring

Increased customer loyalty

Establishing a direct dialog with consumers

Better Waste Management

Waste statistics (Intelligence)

Avoid waste to revert to Supply Chain

Visibility in parallel trading

Avoid brand damage

Avoid consumption of recalled batches

Avoid consumption of expired product

Shipment visibility and alerting

Error-free pick & pack

Additional aspects to consider

v sofTware comPonenTs for Track & Trace and Their feaTures

Requirements for Track & Trace Software Components

Process example to explain the software requirements

Summary of the necessary components and requirements

Short Description of necessary de facto standard components

Architecture examples of implemented Track & Trace

Detailed description of the software components

Printing Technologies for T&T related marking activities

Available printing Technologies

Processes, Considerations and Software at production/packaging lines 113

Quick Overview of the Systech Software Components

Serialization walkthrough old view, new view

How it works/How it should work

Protect data/packaging integrity and ensuring data accuracy

The Bottom Line

SAP AII - Consolidation software/Edge Server

SAP OER - Global Track & Trace Repository (EPCIS)

vi besT PracTices - how To sTarT a global Track & Trace ProjecT

Disconnection of serialization and Track & Trace

Business Blueprint of a global Track & Trace System

Technical mapping of the requirements

Movilitas Add-Ons for SAP Track & Trace

Data Reconciliation cockpit Add-On

Authorities Reporting Add-On

The special events Add-On

The Performance Test Add-On

ECPIS Repository migration Add-On

The logistics label printing Add-On

The lean Track & Trace Add-On

The 2cd level support package Add-On