Sample User Requirements Specification (URS) : Global Serialization AND Track and Trace System

Sample User Requirements Specification (URS)
FOR
GLOBAL SERIALIZATION
AND
TRACK AND TRACE SYSTEM
USER REQUIREMENTS SPECIFICATION Page 2 of 43
Global Serialization and Track and Trace URS V3.0
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1.1 Definitions and Abbreviations

Aggregation is the process of recording the serial number of a container with the serial numbers
Aggregation of its contents, often referred to as parent/child relationship or serialized container to content
relationship.
Alphanumeric Character set made up of digits and letters of the alphabet.
The practice of checking a Unique Identifier against a set of captured serialized data to
Authenticate
determine its authenticity
Auto ID Auto ID refers to the methods of automatically capturing data encoded on items and containers
and entering that data directly into computer systems (i.e. without human involvement).
Batch A group of products, usually associated by a manufacturing or packaging operation.
Bundle A group of items held together, usually by shrink-wrap.
Case A container of product cartons which may or may not be bundled
Contract Manufacturing Organization. A company providing manufacturing, and sometimes

CMO packaging, services for one or more companies based on contracts or service agreements. Also
referred to as a Contract Packaging Organization (CPO) or Third Party Manufacturer (TPM)
Process of associating an EPC (Unique identifier) with a particular object (product, shipment,
Commissioned
asset or container).
A counterfeit is an imitation, usually one that is made with the intent of fraudulently passing it
off as genuine. Counterfeit products are often produced with the intent to take advantage of the
established worth of the imitated product. The word counterfeit frequently describes both the
Counterfeiting
forgeries of currency and documents, as well as the imitations of clothing, software,
pharmaceuticals, jeans, watches, electronics, and company logos and brands. In the case of
goods it results in patent infringement or trademark infringement.
Decommissioning is the process of removing the EPC (Unique identifier) from the item so that it
Decommissioned is no longer tracked. Unlike the Destroying business process, the item may still physically exist
after decommissioning even though it no longer carries serialized identification.
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US Federal Legislation passed in November 2013 which requires:

Drug Quality and
• Lot Level Traceability by January 1, 2015
Security Act
• Item Level Serialization- 2017
(DQSA)
• Item Level Traceability- 2023
A character encoding that contains a large number of unique characters or

Double Byte
Character Set
symbols that is used to express languages such as Japanese, Korean, and
Chinese.
EPC Information Services (EPCIS) is a GS1 EPCglobal standard designed to enable EPC-
Electronic Product
related data sharing within and across enterprises. This data sharing is aimed at enabling
Code Information
participants in the EPCglobal Network to obtain a common view of the disposition of EPC-
Services (EPCIS)
bearing objects within a business context. more at www.epcglobalinc.org
Expiry Date of expiration or the last day the item should be used.
Event Repository A computer system designed to store serial number information, events relating to serialized
(ER) products. Also see EPCIS.
A standards-based Product Code, such as GTIN, or a market specific product code which
External Product identifies the product in the external supply chain.
Identifier
This is specifically NOT a manufacturer SKU.
A functional specification (also, functional spec, specs, functional specifications document -

FSD) in systems engineering and software development is the documentation that describes the
Functional
requested behavior of an engineering system. The documentation typically describes what is
Specification (FS)
needed by the system user as well as requested properties of inputs and outputs (e.g. of the
software system).
Global Location Number, a 13-digit number created by a GS1 Company Prefix, a Location
Reference and a Check Digit. A Global Location Number (GLN) is used to identify any location
GLN (physical or legal) that needs to be uniquely identified for use in the supply chain. The GLN
makes possible the unique and unambiguous identification of physical locations and legal
entities used in the supply chain.
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GS1 (www.gs1.com) is a leading global organization dedicated to the design and

implementation of global standards and solutions to improve the efficiency and visibility of
GS1
supply and demand chains globally and across sectors. The GS1 system of standards is the most
widely used supply chain standards system in the world.
A linear barcode, formerly referred to as a Code-128 barcode. Usage granted to organization

GS1-128
members of GS1.
A two-dimensional matrix barcode consisting of black and white "cells" or modules arranged in
GS1-Datamatrix either a square or rectangular pattern. The information to be encoded can be text or raw data.
Usage granted to organization members of GS1.
An identifier for trade items developed by GS1. Such identifiers are used to look up product
GTIN (Global information in a database (often by inputting the number through a barcode scanner pointed at
Trade Item an actual product). The uniqueness and universality of the identifier is useful in establishing
Number) which product in one database corresponds to which product in another database, especially
across organizational boundaries. Usage granted to organization members of GS1.
Header (for Human

Headers comprise the prefixes used in Human Readable Interpretation of variable data.
Readable
Common headers include GS1 Application Identifiers (AIs) or GS1 recommended field labels
Interpretation)
HDMA (Healthcare HDMA is the national association representing primary, full-service healthcare distributors.
Distribution HDMA member companies deliver more than nine million prescription medicines and
Management healthcare products to more than 165,000 settings including chain and community pharmacies,
Association) hospitals, nursing homes, physician offices and clinics in every state and territory.
The technique of assuming the serial numbers of a sealed container based on previous
Inference observation and not directly reading each serial number. Inference is accomplished using data
systems or documents (see pedigree) and is controlled through validated procedures.
Inspection The process of reviewing an item, either manually or using automated systems.
Demonstrates that the process or equipment meets all specifications, is installed correctly, and
Installation
all required components and documentation needed for continued operation are installed and in
Qualification (IQ)
place.
The product secondary package; typically a carton

Item
(Note: also referred to as smallest saleable unit)
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Comprises the data and process of printing labels for use on all containers above the secondary
Logistic Labeling
packaging level. For example, shipper and pallet labels.
Manufacturer Entity or organization responsible for packaging the product
Operational
Demonstrates that all facets of the process or equipment are operating correctly.
qualification (OQ)
Pack Marking Comprises the data and the process for printing on primary and secondary product packaging.
Packaging and Generally the area related to the physical material, artwork and printing used with all levels of
Labeling product and logistics containers
A pallet (sometimes called a skid) is a flat transport structure that supports goods in a stable
fashion while being lifted by a forklift, pallet jack, front loader or other jacking device. A pallet
Pallet is the structural foundation of a unit load which allows handling and storage efficiencies. Goods
or shipping containers are often placed on a pallet secured with strapping, stretch wrap or shrink
wrap and shipped.
The documented evidence that the system, equipment or process is capable of consistently
Performance producing a safe product of high quality. The Performance Qualification protocol describes the
qualification (PQ) procedures that verify the specific capabilities of a process equipment/system through the use of
simulation material and/or actual product.
Primary containment system in which the product is sterilized (excluding shelf cartons and
Primary package shipping containers) that protects the contents to the intended level over a specific period of
time.
RFID (Radio Radio-frequency identification (RFID) is the use of an object (typically referred to as an RFID
Frequency tag) applied to or incorporated into a product, animal, or person for the purpose of identification
Identification) and tracking using radio waves.
Serial Number Typically a portion or component of a Unique Identifier (UID) which provides uniqueness
Serialized Global
The combination of a global trade identification number and serial number which uniquely
Trading Item
identify an item.
Number (sGTIN)
A computer system located in a specific locale responsible for a location specific function. In
Site Server traceability systems, site servers usually refer to local servers which allocate serial numbers to
packaging control systems and/or manage serial number information before it is transmitted to
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an enterprise traceability event repository.
Serialized National Drug Code. The accepted format of UID as defined by the US FDA for
sNDC
serialization of US marketed products. The sNDC is comprised of the NDC + a serial number.
Serial Shipping Container Code, a GS1 standard used in logistic encoding and communications.
SSCC
The SSCC ensures that logistic units are identified with a number that is unique worldwide.
SOR (System of A system of record is an information storage system that is the authoritative data source for a
Record) given data element or piece of information.
3PL (Third Party A contracted company responsible for the distribution of finished goods on behalf of the
Logistics) company.
UID (Unique A string of numbers and characters that is unique within a given system. Example of Unique
Identifier) Identifiers include GS1 SGTIN and GS1 SSCC.
Uniform Product Code, the American standard article number. A form of GTIN data carrier or
UPC
barcode.
User Entity, individual or organization responsible for making use of the product, ,process or systems
Documented procedure for obtaining, recording and interpreting the results required to establish
Validation
that a process will consistently yield product complying with predetermined specifications.
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2 OVERVIEW
2.1 Requirements Matrix
NUMBER Requirement Description RFP Question
Master Data Requirements

Master data is a capability that enables companies to store and maintain master data for their products, their
company and locations, and the companies and locations of their partners.
The Service shall be a “consumer” of master data to be used for identifying attributes of the brand
owner company, its partners and its products. Describe at high level the master
MDM-1
data capabilities of the Service.
The Service shall support all regulatory required master data elements including those that are that
are relevant to the internal and CMO packaging process as there are many master data elements that How does the Service use master
MDM-2 are required in the packaging process. data throughout the serialization
process?
The Service shall have master data look up capabilities so that companies can include fewer data
elements in transactions sent into the Service from packaging sites and lines, passing in key Describe how this is done with at
MDM-3 identifiers for businesses, business locations and products, and the Service will perform the least 3 examples from production
necessary lookups against the master data to populate the additional required data elements for the processes.
transaction before delivering the data outbound.
The Service shall manage Company, Trade Partners and product master data including CMO and
MDM-4 Please confirm capability.
internal site identifiers, product identifiers and pack out configurations for each product packaged.
The service shall provide UI to add/modify/cancel and copy GLN and company prefix. This shall be Please confirm capability.
MDM-3 performed by a designated business/administrative user and not require an IT or vendor resource.
Product master data records should include at minimum the following: SKU ID, description, Please confirm capability.
MDM-4 serialization status (active/ non-active), target market, GLN, GTIN
The Service shall support import of product master data records from an external system via an Please describe how master
MDM-5 automated interface, manual file upload or manual data entry through a UI. data can be populated in the
Service.
The Service shall support both product identifiers: internal SKU, external ID (e.g. GTIN) Please confirm capability.
MDM-6
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The Service shall support defining a location as master data and enable having one or more location Please confirm capability.
MDM-7 identifiers, including GLN and non-GLN identifiers.
Locations can be internal (packaging, warehouse, DC, etc.) or external (CMO’s, 3PL’s, etc.). Please confirm capability and
MDM-8 Management of locations shall be a configurable feature performed by a designated describe how locations are
business/administrative user and not require an IT or vendor resource. managed.
The Service shall support the sharing of Master Data with other systems and partners and provide the Please address how the master
controls, workflows and event triggers to: data capability might be used to
- Push master data to another system or partner send or receive master data to
- Receive master data from another system or trade partner and from another system or trade
partner.
•Leverage Master Data Exchange Service to share Master Data with other systems and trade
partners
-Push Master Data to another system or trade partner
-Receive Master Data from another system or trade partner
•Product Master Data to share with other systems and trade partners
MDM-9 -CMO, Packaging line systems, 3PLs, Customers
-Identification of what parts of master data can be shared and with whom
-Triggers for sharing master data
-Pre-staging of master data with review and approval workflow
•Company and Location Master Data to share with trade partners

-Exchange business information and identifiers
-Opportunity to leverage to automate creation of ServiceLink connections
The Service shall support the pre-staging of master data with review and approval workflow prior to Please confirm capability.
sharing with an external party. This shall be available to designated business users/administrative
MDM-10 users and not require IT support.
The Service shall allow for master data records to be made “active” or “inactive”. This setting shall be Please confirm capability.
MDM-11 performed by a designated business/admin user immediately without IT or vendor support.
Master Data shall be exportable via CSV by a business user with the appropriate permissions Please confirm capability.
MDM-12
MDM-13 The Service shall be capable of managing (where applicable) global identifiers for both Company and Please confirm by providing list of
Partners. currently supported global
AR - CUIT Argentina Tax ID identifiers.
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BR - CNES Brazil National Registry of Health Facilities Number

BR - CNPJ Brazil Tax / Legal Entity ID
BR - CPF Brazil Individual Taxpayer Registration Number
BR - PROF REG Brazil Professional Registration Number
CN - CN NUMBER China identifier (alphanumeric)
COMPANY ID Internal company identifier (alphanumeric) COMPANY SITEID Internal
location / plant / site identifier
DEA US Drug Enforcement Agency Number
DUNS Dunn and Bradstreet Number (9 digit number)
DUNS+4 Dunn and Bradstreet Number with 4 digit extension
GCP (GS1 Global Company Prefix) GS1 Global Company Prefix
GLN Global Location Number
HIN Health Industry Number assigned by HIBCC
IN - IECIndia Importer Exporter Code
IN - PAN India Permanent Account Number
IN - TIN India Taxpayer Identification Number
KR - BUS REG NUM South Korea Corporate Registration Number
SGLN SGLN format representation of Global Location Number
The Service shall be able to accept, manage and share Master Data relative to the specific item Please confirm capability.
codes for the serialized product, for example:
MDM-14
US-NDC542
KR - KFDA Code
IN - Product Code
The Service shall be able to accept, manage and share master data profiles relative to the specific Please confirm by providing
target markets for the serialized project, for example: screenshot of target market
master data profile configuration
PRODUCT TYPE page.
MDM-15 POINT OF DISPENSE VERIFICATION (Y/N?)
TRACEABILITY REQUIRED (Y/N?)
PRODUCT ORIGIN
SCHEDULED DRUG
PRODUCT IMAGE (if applicable)
The Service shall be able to accept, manage and share master data profiles relative to the packaging Please confirm by list of currently
and pack out configuration for each product (where aggregation is applicable) supported packaging and pack
MDM-16 out data elements.
The Service shall log an audit record every time location master data is modified including: Please confirm capability.
A) Date/Time of change
MDM - 17
B) User who made the change
C) Old Value
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The Service shall provide the following functionality as it relates to all master data: Please confirm EACH capability
● Search master data and indicated if this can be
● View master data performed by a business user or
MDM – 18 ● Add master data if IT/Vendor support is required.
● Edit master data
● Print master data
● Import and export company and location master data
When the Service serves as a consumer of product master data, an asynchronous inbound message Confirm capability and provide
interface to enable to enable a company the ability to add, update and disable product master data examples of how customers have
MDM - 19 through an automated transaction shall be available via a standardized XML interface. implemented automated master
data feeds.
When the Service serves as a consumer of product master data via an automated transaction and Confirm capability with examples.
MDM – 20 ongoing updates to existing product master data is provided, either an incremental or a full update
shall be supported.
Partner Management and Connectivity
The Service shall allow a designated company administrator to have the ability to configure external businesses
(partners) and locations of those businesses that the company will connect with for information exchange purposes.
In general, Configured partners are any businesses that a company needs to connect with (e.g., CMO, CMP, 3PL,
wholesale distributor, pharmacy, etc.).
Recognizing that the global life sciences supply chain is highly networked such that many brand Please describe the Network
owners leverage partnerships with the same customers, CMO and 3PL partners, the partner approach. Include an example
connectivity model shall be a “Network” model rather than a point to point approach, reducing the market or program in which the
PART- 1
labor and cost burden on all parties. Network approach has saved
cost and labor for it partners and
the industry.
If a partner is already connected to a Network on behalf of another customer of the Solution Provider, Please confirm this capability by
connectivity to that partner shall be a configurable “point and click” activity that can be performed by a providing screen shots of the
PART - 2 business or administrative user. process by which a business user
can connect with an existing
network partner.
If a partner is not yet connected to the Network on behalf of another customer of the Solution Please verify responsibility and
Provider, connectivity to that partner shall be the responsibility of the Solution Provider. The Solution cost model.
PART - 3
Provider shall assume responsibility for adding each new partner to the network, including assuming
the labor responsibility for establishing, testing and supporting communications and data exchange.
PART - 4 Each partner shall be offered a variety of options for data exchange, ranging from user interface data Please confirm capability and
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entry in a “portal” mode for the “low tech” partner to file upload/download to fully automated data provide two examples of how
exchange. A partner shall have the flexibility to connect to a network according to the level of their IT “low tech” and “high tech”
resources and capabilities. partners are using the Service
today.
The Service shall offer multiple options for a partner to establish communications to the Network Please describe what is
PART - 5 including manual user interface, sFPT, AS2, SOAP. supported in commercial
production.
The Service shall offer functionality that allows the partner to exchange data in their preferred method Please provide examples in
and format. For example, one partner may choose to use EPCIS while others may choose another which variability has been
PART – 6
format. encountered and how it has been
accommodated.
The Service shall have a mapping and data translation layer such that the diversity of file formats and Please describe this capability in
choreography of events from the partner network is transparent to the brand owner. The brand owner general and specifically:
shall have a single connection and a single set of formats in and out of the network and be insulated a) How many maps are
from the variability of the partners’ capabilities. supported today?
b) How is the validation of
maps “defended” against
application changes?
PART - 7
c) Please provide a
screenshot of the
mapping and data
translation dashboard
where partner
transactions are
monitored.
Trade Partner connectivity shall be managed on a “Publish-Subscribe” basis by which the brand Describe partner on boarding and
owner publishes a service and its partners subscribe to the service. This shall be a configurable connectivity process. What are
PART - 8 process that can be performed by a designated business or administrative user and does not require the roles, responsibilities and
IT customization or external consulting support each time a new partner needs to be added. costs of the customer, the partner
and the Service provider?
There shall be no fees assessed to a partner to subscribe to a network connection. Please describe the commercial
relationship with partners that are
PART - 9
not a direct licensee of the
Service.
The Service shall provide the ability for a business or administrator user to search and view partners Please confirm capability.
PART - 10 configured for the company.
The Service shall provide the ability for a business or administrator user to export partners search Please confirm capability.
PART - 11 results fields to CSV format.
PART - 12 The Service shall provide the ability for a business or administrator user to modify and remove Please confirm capability.
partner company and/or location identifiers.
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The Service shall provide the ability for a designated business user administrator to immediately make Please confirm capability and
a partner inactive and prevent any further data from being shared with that partner. indicated if this can be performed
PART - 13
immediately without IT or vendor
support.
Serial Number Generation and Management
Serial Number Generation and Management capabilities are required to create/obtain and manage the allocation of
serial numbers that will be assigned to different products and different internal and external packaging locations. The
Service shall be able to support both scenarios of generating and managing serial numbers within the Service as well
as a variety of use cases in which serial numbers are obtained from external sources.
This capability is required to generate/obtain serial numbers and service requests to provision serial numbers to
requesting locations. To enable this, a template or recipe driven approach should be used to define the parameters
for serial number generation for each product packaging code.
This section describes the core functionality requirements for Serial Number Generation and Management, which
includes:
• Serial number template viewing
• Serial number template configuration
• Serial number generation for sequential (range or list) and random numbers including EFPIA’s 1:10,000
requirement
• Serial number import from external source
• Notifications of remaining imported serial numbers reaching minimum threshold.
The Service shall allow for a template (recipe) driven approach that uses product master data to Confirm capability with
create and maintain serialization profiles for each product SKU. screenshot of serial number
SNM - 1
profiles/template and explain
process.
The Service shall allow for the creation of serial number templates via UI or CSV upload Confirm and describe capability
SNM - 2
In the case of externally provisioned serial numbers from an external sources, the externally obtained Confirm by showing screenshot
SNM - 3 lists and ranges shall be associated with each template of business user setting for
external serial number source
The Service must support both the automated retrieval and manual upload of serial numbers obtained Confirm capability.
SNM - 4 from a regulatory agency (e.g. China or a brand owner packaging customer that manually provides
serial numbers)
The Service shall provide the ability for designated business or admin users to create and edit Please confirm capability for a
SNM - 5 templates for serial number generation for the following product packaging codes without reliance on business user to create
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IT or vendor resources. templates. After creation, what

● GTIN-14 (SGTINs) types of edits can be made to a
● GS1 Company Prefix (SSCCs) template?
● CN-ResCodes (CN EDMC codes)
● Brazil IUM Random codes
Creation of the templates will leverage product master data to minimize data re-entry and ensure data
consistency.
The Service shall provide the ability for designated business or admin users to edit templates for
serial number generation.
The Service shall provide the ability to make templates active or inactive without reliance on IT or Please confirm that this feature is
vendor.. a configurable setting that can be
SNM - 6 ● For inactive templates, the ability to create, import, nor provision serial numbers in response performed by a business or
to a serial number request would be denied. administrative user.
The Service shall provide the ability to configure templates with options appropriate to the packaging Please confirm by showing
code type (e.g., GTIN-14, Company Prefix, CN-ResCode): screenshot of configuration
● Random number generation (GTIN-14, Brazil IUM) options.
● Sequential number range generation (GTIN-14, Company Prefix / SSCC)
● Sequential number list generation (GTIN-14, Company Prefix / SSCC)
● Imported serial number lists (GTIN-14, Company Prefix, CN-ResCode) from external sources
SNM - 7
The Service shall provide the ability to configure GTIN-14 and SSCC sequential number generation
with the following options (configured for each packaging code that will use sequential):
● Maximum request quantity for serial number requests (requests exceeding this value must be
denied)
● Starting serial number to begin the range. This value cannot be changed once serial numbers
are issued
● Ability to set length of GTIN-14 sequential numbers between 10 and 20
The Service must be capable of generating serial numbers using a secure algorithm and should not Please describe randomization
SNM - 8 require a range to be determined beforehand. In other words, randomization within a large range of approach.
SN is an inefficient form of randomization and this practice should be avoided.
The Service shall ensure that no duplicate serial numbers are created or submitted across the full set Please describe how duplicated
SNM - 9 of randomized serial numbers. checks are performed.
Specific to Brazil, the Service shall ensure that no random numbers are duplicated across the entire Please describe how this
SNM - 10
company namespace as required by ANVISA. requirement is met across all
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previously commissioned serial

numbers.
Specifically, if the proposed

solution relies on periodic
archiving of data due to database
size limitations, please describe
how archived serial numbers are
included in duplicate checks. Is
there a performance impact?
The Service shall provide the ability to configure imported serial numbers from an external serial Please confirm configurable
number management system (configured for each packaging code that will use imported serial min/max settings.
numbers).
SNM - 11
This capability is also required when serving as a contract packager to another brand owner.
The Service shall provide the ability to configure at the serial number template level, whether serial Please confirm capability.
numbers for the template shall be provisioned generated within the Service or if the Service shall
accept and commission serial numbers provisioned by an external entity or system for that product
template (e.g. the same product may be made for China and the US market or the same product may
SNM - 12 be packaged on both internal and external lines with varying serial number generation strategies).
The Service shall permit only one option (e.g., only internal provisioning or only external provisioning)
in order to avoid serial number collision.
The Service shall provide the ability to configure GTIN-14 random number generation with the Please confirm capability through
following option (configured for each packaging code that will use randomization): screenshot of randomization
● Maximum request quantity for serial number requests (requests exceeding this value will be settings.
denied)
● Minimum threshold for serial number balance that will trigger the generation of more numbers Please confirm that these
● Maximum threshold to instruct of the high water mark to use when generating additional serial settings are configurable by a
numbers (e.g., maximum balance). designated business or
● Set length of GTIN-14 random numbers between 10 and 20 administrative user without IT or
SNM - 13 ● Ability to specify random numbers to be numeric only (includes numbers 0 to 9) or vendor involvement.
alphanumeric (includes numbers 0 to 9, upper case letters A to Z, and lowercase letters a to z
of the western alphabet)
● Ability to limit letters to only upper case letters, only lower case letters, or both. The default
selection will be to include only upper case letters.
● Ability to exclude any upper and//or lower case letters that can be difficult to interpret. The
default selection will be to exclude the upper case letters I, J, L, O, Q, U and the lower case
letters i, j, l, o, q, u.
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The Service shall allow templates to be set up for product that a brand owner contract packages for Please confirm and describe how
SNM - 14 another brand owner as a contract packager so that there is no likelihood of the wrong company’s this is done. What challenges
serial number being applied to a product. have been encountered?
The Service shall support the configuration of different serial number types to different product and Please confirm by showing a
packaging levels. For example, Product A uses an SGTIN and has a 12-digit sequential serial screenshot of a serial number
SNM - 15
number, and Product B uses China Serial Numbers product configuration with both
options.
The Service shall support the configurable characteristics specific to serial numbers used as part of Please confirm configurable
any serial number type and shall be adjustable by a designated business or administrative user and settings by a business or
flexible to receive each product/packaging level. administrative user without
SNM - 16 vendor or IT support. What
aspects of serial number
construct are configurable?
The Service shall automatically replenish pools of serial numbers once the amount of serial numbers Please describe how automated
for a specific packaging level per product goes below the configured threshold. This is necessary to replenishment is performed.
SNM - 17
ensure that sufficient serial numbers are available when packaging sites request serial numbers. The
objective is to minimize any delays that could impact operational efficiency.
In situations where serial numbers are manually obtained from an external source and the amount of Please confirm the capability for
serial numbers for a specific packaging level per product goes below the configured threshold, the automated alerts for this
SNM – 18
Service shall automatically send an electronic notification to a designated user indicated that numbers scenario.
need to be replenished.
The Service shall provide the ability to view the quantity of serial numbers currently available for each Please confirm capability
SNM - 19 product and location.
The Service shall provide the ability to generate serial numbers in GS1 standard SGTIN AI(01) + Please confirm by showing
AI(21) and SSCC AI(00) formats for logistical units (e.g., item, inner pack / bundle, case / shipper, screenshot of serial number
SNM – 20
pallet). generation settings for multiple
logistical units.
The Service shall provide the ability to generate serial numbers as sequential ranges or as Please confirm capability.
SNM – 21 randomized number lists according to EFPIA (1:10,000) rule.
The Service shall provide the ability to return SGTIN AI(01) + AI(21) and AI(00) serial numbers as Please confirm capability
SNM – 22 sequential lists or sequential ranges.
The Service should check, upon import, that imported numbers are associated with configured GTIN- Please confirm verification check
14 and Company Prefix codes. capability.
SNM - 23
Once imported and confirmed, , the serialization codes should be available for use in responding to
serial number requests for AI(00) and AI(01)+AI(21) serialization codes.
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The Service shall provide support for opt in email notifications to notify when a serial number import Please show user configurable
SNM - 24 has completed. settings for notification opt in.
Serial Number Exchange with Internal and External Lines
The serial number exchange process enables internal and external partner packaging locations to request, exchange
and track the disposition (commission, aggregation, shipment) of serial numbers with an enterprise serialization
management system (see serial number management requirements above). Where applicable, transactions may
include serialized shipment messages and other data fields specific to certain country regulations.
Transactions may also include country-specific event triggers from packaging sites to meet certain regulatory
requirements (pre-lot authorization for Korea, for example).
The Service shall manage and track serial numbers with: Please confirm, through
examples, that all of these
• Internal packaging operations (if applicable) transactions are currently
• External packaging operations (if applicable) supported in commercial
• Both Internal and external packaging operations (if applicable) production.
Regardless of whether packaging is internal, external or both, the Service must enable the following
transactional interactions:
SNX - 1 • Serial Number Request

• Serial Number Response
• Disposition Updated (Encoded, Deactivated, Decommissioned, Destroyed)
• Disposition Assigned (commission/aggregation)
• Serial Number Transfer
• Serial Number Transfer Response
• Serial Number Exchange Request/Response SOAP Interface
• Serial Number Exchange Transaction adapters for unique data exchange requirements (when
packaging for others, for example)
The Service shall support the definition of packaging locations by a designated business or Please confirm capability
administrative users (without vendor or IT support) to enable site-specific systems and user
SNX - 2 administration
The Service shall provide the ability for an application administrator to configure serial number Please confirm capability by
SNX - 3 exchange profiles for each subscribing entity (company or location.) This enables which packaging providing a screenshot of
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codes (e.g., GTINs, Brazil IUM China ResCodes, GS1 Company Prefixes for SSCC numbers) each configuration screen.
location is permitted to request. The assignment of packaging codes will be governed by configured
templates from SNM requirement (above)
The Solution Provider shall be responsible for establishing and maintaining integrations with Line Please provide list of current
SNX - 4 Management Systems (e.g. Systech, Optel, Antares, Laetus, Uhlmann, Mettler-Toledo etc.) production LMS integrations and
“in process” LMS integrations.
In the event of a new LMS vendor to which the Solution Provider has not yet established interfaces, it Please confirm responsibility. If
SNX- 5 shall be the responsibility of the Solution Provider and the LMS vendor to design, test and implement additional cost, please specify
the map between the two systems. cost.
Integration with a new LMS vendor system shall be done at the mapping layer and not require any Please describe architectural
SNX - 6 code changes in the core Service application so as to not impact validation of the core application. approach to meet requirement.
The Solution Provider shall be responsible for maintaining backwards compatible maps, versioned Please confirm and describe how
SNX - 7 separately from the core applications to each line management system. backward compatibility is tested.
The Service shall translate data exchanges from one integrating system or party’s format to another Please describe how this is done
system or party’s format. in the context of exchanging
serial numbers with internal or
SNX - 8
external packaging sites. What
challenges have been faced and
how have they been resolved?
The following requirements (SNX 10– SNX 17) describe the verification and validation checks No response required.
SNX - 9 expected to ensure that products are properly serialized and data being returned from internal and
external packaging lines are correct.
Upon serial number commissioning, the Service should verify that serial number has been Please confirm that this check is
SNX - 10 provisioned for the packaging location (internal or external). performed.
Upon serial number commissioning, the Service should verify that serial number is not a duplicate Please confirm that this check is
SNX - 11 number within the message and within previously commissioned serial numbers (same number, performed.
different commission attributes)
Upon serial number commissioning, the Service should ensure that all verification checks are Please confirm that this check is
SNX - 12 performed on every serial number performed.

The Service should verify that parent serial number is commissioned before aggregated with child Please confirm that this check is
SNX - 13 serial numbers and perform retry when criteria is not met, in the event messages are delivered out of performed.
sequence.
Upon serial number aggregation, the Service should verify that child serial number is not already Please confirm that this check is
SNX - 14 aggregated to another parent serial number. performed.
Revision No.: 3.0
Upon serial number aggregation, the Service should verify integrity of aggregation hierarchy (e.g., not Please confirm that this check is
SNX - 15 aggregating a case into an each). performed.
Upon serial number aggregation, the Service should perform all checks on every serial number in the Please confirm that this check is
SNX - 16 aggregated group of serial numbers. performed.

The Service shall support configuring limits on EPCIS file size (# of EPCs in commissioning events, Please confirm capability and
numbers of events in a file, etc.). include two examples of where
SNX - 17
file size limitations have been
encountered.
The Service shall be capable of identifying and alerting to a designated business or administrative Please confirm both verification
SNX - 18 user when the same serial number is commissioned twice, missing data, or erroneous data check and alerting capability for
this scenario.
The Service shall receive, store and be able to display Decommissioning events from the data Please confirm transactional and
SNX - 19 capturing application (line, site or other edge system.) management capabilities for
decommissioning events.
Upon serial number commissioning, if product code (e.g., GTIN-14) is provided, verify that the product Please confirm that this check is
codes from the data capture application matches configured value associated with serial number in performed.
SNX - 20
the Service. This detects exceptions where a valid serial number may have been associated to the
wrong product during packaging.
Upon serial number request by a packaging location (internal or external,) the Service should verify Please confirm that this check is
requesting party / location is permitted to request serial numbers for the product code (e.g., GTIN- performed. How are controls set
SNX - 21
14,), based on GLN to establish requesting
permissions?
The Service shall support displaying the number of available serial numbers per product and per Please confirm capability.
SNX - 22 packaging level on a per site basis (internal or external).
For the verifications checks specified above, the processing performance processing must be How many serial numbers per
sufficient and scalable to meet the peak capacity requirements of large batches. second (read and write rates)
have been measured in
SNX - 23
performance benchmarking when
performing the verifications noted
above?
The Service shall be available to handle connectivity and management of both internal and external Describe how the same product
packaging lines for the same product if packaged at multiple sites. This shall be managed seamlessly packaged at both an internal and
SNX - 24
and within the same user interface. external is managed and
controlled.
The Service shall provide a business user with the ability to view the details of a serial number Please confirm capability.
SNX - 25 exchange profile for a subscribing entity (internal or external packaging site) including the full list of
packaging codes that the subscribing entity is permitted to request.
Revision No.: 3.0
The Service shall provide reports on messages for all serial number requests / failures and Please confirm capability.
SNX - 26 commissioning and aggregation exceptions. These shall be searchable and sortable by time,
location, product, etc..
The Service shall send an electronic notification (opt in alert) for specified events to assigned users Please conform capability and
SNX - 27 when processing results in an error. It is required that a CMO, for example, be informed of provide at least two examples of
serialization errors so that they can address any issues prior to product shipment. alerts,
Where CMOs are used, data shall be secured and partitioned such that CMO A does not have Please confirm capability and
awareness nor can access or view the data of CMO B. Site level partitioning shall also be possible for describe access control to ensure
SNX - 28 internal lines and sites as well (an internal site may be configured to see only the serialization data that a CMO, for example, can
relative to products which are packaged by that site) only have visibility to products for
which they package.
Where CMOs are used, each CMO shall have its own company instance (at no charge to the CMO). Please conform no cost to CMO
SNX - 29 In other words, providing that a brand owner/MAH is the licensee of the Service provider, the CMO to participate.
does not have to incur licensing any licensing cost to exchange serialized data.
There shall no requirement for a CMO or packaging site to install any software or other local capability Please confirm no installation or
at the site level to establish connectivity between L2/L3 LMS systems and the serial number IT infrastructure required at the
SNX - 30
exchange service. packaging site level for serial
number exchange purposes.
The Service shall provide serial number allocation reporting capabilities. For each packaging location Please confirm by providing
the list of configured serialization packaging codes shall be provided in a business-user friendly screenshot of dashboard and list
dashboard, information for each product at a CMO or internal packaging site. information captured and
SNX - 31 reported relative to each product
The Service should provide ability to drill down into the underlying messages for each number, print at a CMO or internal packaging
out an associated report or export the report in a CSV format. site.
The Service shall provide Exceptions Reporting capabilities. For each packaging location a summary Please confirm and provide three
of exceptions related to serial number provisioning requests and for commissioning/aggregation examples of exception summary
messages, shall be viewable and reportable. reports.
SNX - 32 The intent of these reports is to enable monitoring and analysis of issues occurring at internal and
external packaging locations to help determine patterns and root causes.
The Service should provide ability to drill down into the underlying messages for each number, print
out an associated report or export the report in a CSV format.
The Service shall provide reporting capabilities for a business user on the messages sent and Please confirm capability and
received from CMOs. provide examples of the types of
SNX - 33
The Service should provide ability to drill down into the underlying messages for each number, print messages.
out an associated report or export the report in a CSV format.
SNX - 34 The Service shall provide the ability for a “low tech” site (Internal or External packaging location) to Please confirm through
manually request serial numbers through the user interface. screenshot of UI request
Revision No.: 3.0
capability and describe the

The Service shall allow commission/aggregation/shipment disposition results to be uploaded through process for manual usage.
a user interface. These files shall then be processed identically as those submitted via an automated
connection and shall require no additional steps on the part of the recipient.
The Service shall provide the ability for a site (Internal or External packaging location) to: Please confirm capability and
describe how this requirement is
● update the status of serial numbers to Deactivated through the user interface, file upload or met.
an automated interface using standard APIs
● update the status of serial numbers to Decommissioned, and optionally set attributes of
Damaged, Expired, Recalled, Sampled, through the user interface, file upload or an
automated interface using standard APIs
● update the status of serial numbers to Destroyed, and optionally set attributes of Damaged,
SNX - 35 Expired, Recalled, Sampled, through the user interface , file upload or an automated interface
using standard APIs
The Service shall be configurable to limit an internal or external packaging site to update status of
ONLY those products packaged by that site.
The Service shall support the use case of a brand owner contracting with a 3 rd party label converter Please confirm capability and
(printer) to request serial numbers to create pre-encoded labels. These serial numbers shall be given provide an example of current
SNX -36 a status of encoded (not yet commissioned) and the 3 rd party shall be able to send a message or production usage
manually update the status.
The Service shall support the ability to transfer serial numbers from one entity to another. The Please confirm capability and
primary use case is to support transferring encoded serial numbers (that have been printed on describe how this is
SNX -37 product labels or cartons) from the label or carton printer to the packaging location. This is used in accommodated.
scenarios in which a 3rd party label converter is pre-serializing labels which are then transferred to the
packaging entity with the use case of “encoded”.
In both scenarios above if a CMO is used, neither the CMO nor label converter shall be required to Please confirm.
incur license costs or install software locally to accommodate these requirements.
SNX - 38
If CMOs are used, the Service Provider, under CDA, shall accept a list of CMOs and perform an Please confirm ability to perform
analysis, providing the following: this analysis as part of the
SNX - 39 evaluation process.
● What is the % overlap of CMO’s already connecting to the Service Provider on behalf of other
Revision No.: 3.0
customers of the Service Provider

● How many are live and how many are in process?
● What is the earliest go live date for a CMO from another Brand Owner?
The Service Provider must provide clearly defined roles and responsibilities between the Brand Please provide a matrix (table)
Owner, the Solution Provider and the CMO. which describes roles and
SNX - 40 responsibilities of each party.
The Service Provider shall provide a sample CMO checklist depicting all CMO onboarding steps, Please provide a sample
responsibilities and estimated duration/level of effort for each task. checklist.
SNX - 41
To reduce risk of CMOs not being ready, the Service Provider should be conducting multi-brand Please provide examples of CMO
awareness and educational events and activities to ensure that CMOs understand requirements, outreach initiatives.
SNX - 42 timelines and consequences of not complying with customer and regulatory requirements.
The Service Provider must provide materials and support to the CMO and Brand Owner teams as part Please describe what materials
of a “CMO onboarding toolkit” are provided to CMOs.
SNX - 43
The process of Serialization with CMOs creates a great deal of documentation exchange and dialog Please describe optional
between the Brand Owner and the CMO. The Service Provider, in addition to the serial number capability.
exchange capabilities shall also offer an optional capability to securely capture notes and documents
exchange by the three teams during implementation and production (not visible to other CMOs or
SNX - 44 other customers of the CMO). The notes and documents capability shall serve as the repository of
documentation between the parties and shall be maintained for as long as the system in in operation.
Costs for this feature must be specified.

The Service Provider shall include all labor costs for establishing B2B communications and interfaces Please confirm what costs are
with all CMOs. All initial and ongoing costs must be specified included.
SNX - 45
The Service Provider must establish and support all maps and interfaces with all common packaging Please confirm. If a new LMS
LMS system. All costs must be specified. system is encountered at a CMO
SNX - 46 or internal site, what is the cost
for this integration and which
party incurs the cost?
Revision No.: 3.0
Please address the following scenario. A brand owner has 10 CMO’s and an update in a regulatory Please address scenario. What
requirement two years past the initial implementation requires a change to the interface with each are the costs and who incurs
SNX - 47 CMO. Describe how this change is deployed and how the Service Provider prioritizes this change them?
across its customer base to ensure timely compliance.
If a Partner begins usage of the service as a “low tech” or portal customer and, for example, a year Please specify costs. Who
from now, is ready to transition to a full B2B connection with the Service, what fees will be assessed assumes responsibility and
SNX - 48 for establishing communications and connectivity with that partners (licensing and services)? provides the resources?
The Service Provider shall be able to add additional CMOs or internal sites in the future. Please address the following
scenario: A new product is
being launched in 2018 at a new
CMO. What is the incremental
SNX - 49 cost to add this additional CMO
and complete the B2B connection
and transaction integration? Who
assumes responsibility and
provides the resources?
The Service Provider shall be able to accommodate future changes in Level 2 and 3 systems at Please address the following
internal or CMO sites. scenario: A CMO is in production
with a brand owner for 2 years.
The CMO changes its LMS and it
is necessary to establish a new
SNX - 50
communications and interface
connection with that CMO.
Specify the cost.Who assumes
responsibility and provides the
resources?
Serialization in Support of a CMO Customer
Many Brand Owners, while using a network of CMO’s for their own products, also serve as contract packagers for
other brand owners. While the industry continues to strive towards standards, the reality is that brand owners request
information from CMOs in a variety of ways, and as a CMO, capabilities are necessary to provide the data and
business processes meeting the format and choreography requirements per brand owner that will receive the data.
While some requirements in the above section support this use case, the following requirements are necessary to
specifically support the variability in requirements from other brand owners.
CMO - 1 As Brand Owner integration, format and business processes vary greatly from company to company, Please conform and describe
meeting these requirements must be a configurable option and not require code changes to the core how the variability in brand owner
application with each new brand owner requirement. It is preferable that this be accommodated via requirements has been met in
an adapter or extension layer that is versioned separately from the core application as to not impact production.
Revision No.: 3.0
validation of the core system.
The Service must be able to split and combine messages by content and event type. For example, Please describe how this is
one brand owner may require that commission, aggregation and shipment be in a single file whereas accommodated. To date, how
CMO - 2
another may want three separate files. many variations have been
encountered?
The Service must be able to control ordering of sending serialization events messages by event type Please confirm capability and
or chronological sequence without custom code within the application. describe how various brand
CMO - 3
owner requirements have been
accommodated.
The Service shall have the capability to include a “last file transmission” marker in messages Please conform that if this is a
transmitted in chronological sequence. Some brand owners are requiring this so that they can standard feature.
CMO - 4 confirm that they have received all files related to a particular batch or all files related to a particular
event.
The Service shall be able to accommodate specific file naming convention used to send messages to Describe typical parameters that
CMO - 5 the brand owner with custom data parameters. you have encountered and
implemented.
The Service shall permit Serial number Push instead of Request-Response. Some brand owners Please confirm if you have
have selected external serialization management systems that push serial numbers to an external implemented both
CMO - 6 party with very rigid rules and this use case must be accommodated. request/response and push
capabilities.
The Service shall be able to augment messages with additional data (master data, brand owner Please confirm capability and
subscriber info, serial number states, serial number events, etc.) specified by the brand owner by as provide a few examples of
CMO - 07
part of querying to assemble outbound messages. requirements that have been
encountered and implemented.
In addition to commission/aggregation/shipmen messages, some brand owners require additional Please confirm capability and
linkages to other processes such as production orders. The Service shall provide support for provide examples of supported
CMO - 08
managing serial numbers and reporting against a production order when the brand owners require production scenarios.
this level of tracking.
The Service provider should have proven knowledge and experience with live production Brand Please describe scale and scope
Owner requirements based on published specifications. Solution provider should also demonstrate a of current CMO-Brand Owner
CMO-09 clearly defined strategy and solution to minimize the disruption of Brand Owner specific requirements. implementation program. Provide
examples of live CMO-Brand
Owner implementations.
When serving as a CMO, the packaging entity must have the capability of accepting pre-encoded Please confirm support for this
serial numbers produced by a 3rd party label converter with the status of “encoded”. It is expected that use case assume that the
CMO - 10 the status will change to “commissioned” upon product packaging. Service is being used in the
context of a brand owner
functioning as a CMO.
Post-Packaging and Warehouse Operations (Pick, Pack, Ship)
Revision No.: 3.0
This section provides requirements for the management of serialized product and data from post-packaging through
sales/shipment. Serialization processes must integrate with existing warehouse processes and become a natural
part of operations, not impacting warehouse and distribution efficiency.
● Status Update Functions

- Update status of serial number, release status, product sampling, destruction or decommission
● Movement Into Warehouse Functions
- View Unsubmitted Receipts and Create Return Receipts
● Movement Out of Warehouse Functions
- View Unsubmitted Deliveries and Create Delivery for Sale
● Pack and Repack Functions
- Aggregation and Disaggregation Functions
● Query Functions
- Get serial number or lot status and reconcile containers
● Event Workflow Management
- Configure specific event processes and reporting triggers upon sales and shipment
Note that OPS requirements would not be applicable to a company using external distribution (3PL), but would be
indicative of the types of capabilities that the 3PL would have in place. For requirements pertaining to a using a 3PL,
please refer to ExDist section below.
For small volume operations or exception handling purposes, the Service shall allow status update Please confirm by showing a
OPS - 1 functions to be performed manually through the UI or through the UI with a keyboard wedge scanner sample UI screen for a SN
or other such device. update.
The Service shall provide API (example JAVA, .Net, SOAP) capabilities to interface with existing Please confirm and provide list of
OPS - 2 EDGE and WMS systems to capture serial numbers for status updates. currently supported API
transactions.
The Service shall provide the capability to upload files of serial numbers for status change updates. Please confirm by showing
OPS - 3
screenshot of file upload screen.
Update Serial Number Status: Given one or more serial numbers the Service shall update the status Please confirm and explain how
of the serial number to the new values, and capture the reason code. This will recursively apply to child serial numbers in an
containers and contents (e.g. the parent or child of the serial number being updated). aggregation are updated when
OPS - 4
the parent serial number is
In other words, the Service shall be able to set Serial Number Status to the following: reserved, scanned, uploaded or transmitted
commissioned, decommissioned, destroyed. via an API capability
Revision No.: 3.0
The Service shall be able to set Item Status to the following: available, picked, shipped, returned, Please confirm all tem status
OPS - 5
shipped states are supported.
The Service shall be able to set Reason Code to the following: Product Status Update, Modifying Please confirm all reason codes
OPS - 6
Incorrect Product Status are supported.
The Service shall be able to set Item Attributes to the following: Product Status Update, Modifying Please confirm all item attributes
OPS - 7
Incorrect Product Status are supported.
The Service shall be able to capture a Reason Description for a status change as well as provide free Please confirm through
OPS - 8
form text capabilities.. screenshot.
The Service shall be able to set the product release status across an entire lot: For example, given an Please confirm capability.
item code and lot number set attributes of all associated serial numbers shall be set to quality
OPS - 9 released. This shall update all associated serial numbers at all hierarchies within the lot. This
capability should able to be performed by a business users with appropriate permissions or through
an automated interface (API).
The Service shall be able to set manage Quality Sampling of products and account for and update the Describe the events that are
OPS - 10 serial number status accordingly. Multiple events should occur simultaneously: supported during quality
sampling.
The Service shall be about to capture Destroyed Product and update the serial number status. Describe the events that occur
during the capture of destroyed
OPS - 11 product.
The Service shall be able to capture Decommissioned Product and update the serial number status. Describe the events that occur
during the during the capture of
OPS - 12 decommissioned product.
OPS - 13 The Service shall accept and manage pending or Unsubmitted Receipts for serialized products and Please describe what data is
shall be able to provide a number of different functions to track movements into the warehouse associated with the serial
inbound into the warehouse. numbers in a pending delivery.
Revision No.: 3.0
The Service shall allow serial numbers to be added to the receipt once the receipt information has Please confirm that these
OPS - 14 been entered. Serial numbers can be scanned in using an edge system, typed into the user methods are supported for
interfaces, or uploaded/transmitted through a file (automated transaction) updating receipts.
The Service shall create a Return Receipt, communicate the items and details of a receipt of return Please confirm capability for
goods, and set the status to received. Containers may be specified and will recuse to units. In other updating child serial numbers in a
OPS - 15
words, a parent serial number may be provided and if the hierarchy is still intact from its original return scenario.
shipping form, the child units status shall be set to received.
For tracking movements out of a warehouse, the Service shall accept and manage Unsubmitted Please confirm picked state
Deliveries that are pending as outbound deliveries and have not been submitted for processing. status for this scenario.
OPS - 16
Serial numbers associated with the pending delivery are in the picked state.
Once the return receipt information has been entered the serial numbers will need to be added to the Describe how serial numbers can
OPS - 17
delivery. be added to a pending delivery.
The Service shall be able to create a delivery for sales distribution: Communicate the items and Please confirm capability.
details of a sales shipment of serialized product at ship confirm, and set the status of all serial number Describe how the Service is
to shipped. informed of a sales or shipment
event, either through an
OPS - 18 Containers may be specified and will include the units. ERP/WMS transaction or
manually entering sales/shipment
information in order to create a
delivery.
The Service shall be able to provide a number of different functions to support pack/repack Please confirm both manual and
OPS - 19 Operations that are performed in a warehouse (below), While these can be performed manually at low automated (API) capabilities for
volumes, a set of API capabilities shall be in place for integration with EDGE and WMS systems. pack/repack.
The System shall perform a warehouse function of aggregating items to a container by associating Please confirm that all child serial
OPS - 20 serial numbers with a parent container. If aggregating a case to a pallet, for example, all existing item number aggregations are
to case aggregations are maintained. updated.
The System shall offer the configurable (check box) option to block an aggregation operation if any Please confirm that is capability
child numbers are aggregated to another container. The System shall offer the option such that the is provided.
OPS - 21
child serial numbers will automatically disaggregate from their original parent before being aggregated
to the container.
Revision No.: 3.0
Given a container and set of children serial numbers, the Service shall reset the aggregation to the Please confirm that this capability
OPS - 22
new set and disaggregate any missing children. is supported.
The Service shall be able to replace an item in a container by disassociating a serial number from a Please confirm that this capability
OPS - 23 container and aggregate a new serial number to the container to take its place. Example: replacing an is supported.
item that has been sampled.
The Service shall be able to Disaggregate child serial numbers from their parent containers. Please confirm that this capability
OPS – 24 is supported.
Parent serial numbers do not need to be specified
The Service shall be able to relabel a container by assigning a new serial number to a container, Please confirm that this capability
OPS - 25
preserving the existing aggregation(s) is supported.
The Service shall have the ability for a user to retrieve the following serial number status information Please provide an example list of
by providing a serial number. attributes that are returned from a
OPS - 26
serial number status check.
The Service shall have the ability for user to retrieve the following lot status information by providing Please provide an example list of
OPS - 27 an item code and lot number. attributes that are returned from a
lot status check.
Upon a transfer or shipment, the Service shall be informed of the ship to location and entity. Based on Please confirm that per-country
the country and/or trade partner destination, the Service shall have out-of-the box event triggers and compliance logic is provided “out-
application logic to determine which information (master and serialization data) shall be sent based on of-the-box”.
the global market destination (see “CC” section of URS for additional requirements)
OPS - 28
The Service provider shall maintain current application logic to support all known global regulations.
Custom development to meet global requirements shall not be required.
The event workflow for generating and delivering reports shall be configurable (not based on Please confirm by showing a
customized code). sample screenshot for
establishing event workflow for a
OPS - 29 Further, report creation and delivery must be managed within a single system and shall not require regulatory report and delivery of
separately managed systems for report generation, delivery and exchange of bi-directional data that report to the appropriate
(where required). trade partner or authority.
Revision No.: 3.0
The Service shall automatically trigger reports and transactions pertaining to the market or trade Please confirm that this capability
partner destination which are then managed and delivered through a fully integrated Network exists within the same platform
providing appropriate country compliance (regulatory reporting service). This shall be one unified and does not require the
OPS - 30
system with all data managed within the same platform. purchase or licensing of a
separate system for a Network
capability.
Any interfaces, event triggers or application logic between the operational serialization system and Please confirm that no additional
any regulatory reporting systems shall be pre-integrated and not require customization on behalf of integration or customization by
the manufacturer or the Solution Provider. the MAH, vendor or services
company is required to achieve
delivery and two way
OPS - 31 communication with regulatory
agencies and trade partners.
Please also indicate if integration
is required by systems integrator
or vendor resources, what the
expected costs would be.
The Service shall have roles based permissions for various operations. For example if a warehouse Please confirm roles-based
OPS - 32 operator responsibility is quality sampling, usage of the service shall be able to be limited to the capabilities are configurable by
functions pertaining only to this role. business administrator.
3PL’s and External Distribution
The following sets of requirements are related to the use cases for externally contracted 3 rd party logistics providers
and external warehouse operations. These Trade Partners need to receive information regarding serialized product
being sent to them or need the capability to query the manufacturer’s system to obtain information about serialized
products being handled by them. Upon a sales order event, the 3PL needs to inform the brand owner as to which
specific serial numbers were picked against which order as well as communicate changes in serial number status for
product in their possession.
These requirements are provided from the perspective of the brand owner and not inclusive of “inside the walls” of
the 3PL processes. This assumes that the 3PL has in place systems to receive, manage and send serialized product
information. The 3PL’s need to be able to report back to the Service event information about product shipment,
status and disposition.
ExDist - 1 The Service shall have the capability, as described in PART above, to configure, onboard and Please confirm that the
Revision No.: 3.0
establish connectivity with contracted external logistics providers. responses in the PART URS
section regarding partner
onboarding and connectivity are
generally applicable to 3PLs.
As with Contract Packagers, the Service Solution Provider shall establish and maintain Please confirm that establishing
communications connections and interfaces with each 3PL. and supporting connections with
ExDist - 2 3PLs in included in the
commercial model with no
additional costs for connectivity.
The Service shall support a push model for providing serialized data to 3PLs by providing a 3PL with Please confirm support for this
serial number and aggregation data for products in shipment and enabling the 3PL to reconcile a capability within a single platform
ExDist - 3 serialized receipt. and provide a list of supported
transactions.
The Service shall support a query model for allowing a 3PL to be permitted to to query a manufacturer Please confirm support for this
repository to acquire commission/aggregation data. capability within a single platform
ExDist - 4
and provide a list of supported
transactions.
To support 3PL integration the Service shall support a product receipt capability to confirm receipt of Please confirm support for this
ExDist - 5
serial numbers received by 3PL from transfer of goods (top level container serial numbers) capability within a single platform.
To support 3PL integration, the Service shall support product destruction messages by providing Please confirm support for this
ExDist - 6
serial numbers for products destroyed by a 3PL. capability within a single platform.
ExDist - 7 To support 3Pl integration, the Service shall support aggregation changes when the 3PL makes Please confirm support for this
changes in hierarchies from what was received from the manufacturer or CMO. 3PL processes may capability within a single platform
vary so flexibility as to when the changes are reported shall be supported. and describe which processes
are supported.
To support 3PL integration, the Service shall support either scenario of a 3PL creating an SSCC or Please confirm support for this
ExDist - 8 the brand owner providing a SSCC and the commissioning of new SSCC serial numbers (e.g., case capability within a single platform.
or pallet serial numbers) used in packing aggregations.
ExDist - 9 To support 3PL integration, the Service shall support the 3PL informing the Service on behalf of the Please confirm support for this
brand owner the following: capability within a single platform.
Revision No.: 3.0
● Provide serial numbers shipped with new aggregation hierarchy

● For Shipment Types: Shipment to Customer, 3PL Warehouse Transfer, Shipment back to
Pharma/Bio Company
If a 3PL is handling returns for the brand owner, the Service shall be able to support the confirmation Please confirm support for this
ExDist - 10 of receipt of serial numbers received by 3PL from customer returns. This may or may not include a capability within a single platform.
shipment event from the customer.
US DSCSA Requirements – Lot Level Traceability
The Requirements for US Lot Level Traceability (2015 Requirements) are the subject of a separate URS. The Service
shall be able to provide full lot level electronic communication to all downstream partners including drop shipment
recipients to meet 2017 requirements for full electronic capabilities.
US DSCSA Requirements – 2017 and Beyond Serialization
The following section refers to requirements (trade) pertaining to the exchange of serialized data with downstream
trade partners and the capabilities required by regulation to respond to requests for verification and information.
The Service shall be capable of sending both Lot Traceability messages as well as serialized messages
to support any pilot and production activities with Trade Partners. In other words, the Service shall
be capable of supporting multiple communications and interfaces to the same partner. Per the
US - 1 Please confirm support.
requirements of some US downstream trade partners, this parallel path will allow for the
independent testing of serialized data exchange without interfering with the ongoing exchange of
the Lot Level DSCSA data required by law.
Please confirm support and

US - 2 The Service shall have the capability to link serial numbers for a delivery to associated Transaction
Histories for the NDC and Lot when lot-based picking is performed. describe process.
The Service shall support outbound GS1 US Healthcare EPCIS Shipment transaction using V1.1 GS1
US Healthcare Implementation Guide to communicate commission, aggregation and shipping event Please confirm current support
US - 3
data for serialized items in a shipment using the EPCIS 1.1 standard to those downstream partners for EPCIS 1.1.
requiring information about serialized products.
Revision No.: 3.0
The Service shall also support outbound GS1 US Healthcare EPCIS Shipment transaction using V1.0 of
Please confirm current support
US - 4 the GS1 US Healthcare Implementation Guide for trade partners that have not yet upgraded to EPCIS
for EPCIS 1.0.
1.1.
The Service shall provide a verification portal capability that enables any registered user to verify the Please provide screenshot of
US - 5
status of a product. verification portal capability.
The Service shall provide the capability for a user to verify a product based on the Product Code and
US - 6 Please confirm capability.
Lot number (if the product is not serialized)
The Service shall provide the capability to verify a product based on the Serial Number (if the
US - 7 Please confirm capability.
product is serialized)
Please confirm capability and

The Service shall allow manufacturers the ability to configure which commissioned products can be
US - 8 describe how this is
verified, including product code and lot number for non-serialized products.
administered.
The Service shall allow manufacturers to view and report on which products are configured for Please confirm reporting
US - 9
verification. capability.
In order for an external user to use the verification portal, they must be a registered user with an Please confirm how this is
US - 10 active account, following the standard account registration process of their company and the supported within a single
application. platform
In response to a verification request, the Service shall one of the following verification status: Please provide a list of
US - 11 Verified, Expired, Return Product. data/information that is returned
against a request for verification.
US - 12 If a product is unable to be verified, the Service shall return the following in response to the Please confirm capability.
verification request:
• Verification Status (unrecognized product)

• Product Name: Product Not Found
• Country Drug Code and Type (if provided or associated with Serial Number)
• Lot Number (if provided)
Revision No.: 3.0
• Serial Number (if provided or associated with Serial Number)

The Service shall log verification requests. Please describe what information
US - 13 is captured and logged about the
verification request.
The Service shall support data exchange and verifications at both the item level (non-aggregated) Please confirm what levels are
US - 14
and the aggregated level to meet trade requirements of certain trade partners. supported.
Country Compliance – The following requirements pertain to the capabilities required to meet the regulatory
requirements of the various global mandates, including EU, China, South Korea, India and Brazil. Capabilities are
also required to rapidly adopt new requirements in additional geographies as they are defined and adopted by
regulatory authorities. It is recognized that each mandate has a different set of requirements and different
timelines, with requirements coming in incrementally from each of the governments.
The Solution Provider shall monitor compliance mandates across countries and regularly holds
Please confirm and describe
interactive workshops and discussions with current customers to discuss and inform solution design
CC - 01 regulatory monitoring capability
in a timely manner to meet regulatory deadlines including the development develops
and staffing levels and expertise.
implementation guidelines for the industry
Please provide examples of how

Recognizing that track and trace laws are as new to governments as they are to life sciences
an Authority has “suddenly”
companies, it’s common for governments to iterate on the requirements and evolve their legislation.
CC - 02 changed a requirement and how
The Service Provider must demonstrate a proven track record of rapidly adopting and deploying new
the changed was adopted in the
country compliance capabilities as laws evolve.
Service.
Please confirm that there are no

The Service shall be architected in such a way that the addition of a new country compliance customization or new
CC - 03 requirement is integrated out-of-the-box with the core serialization management system and does development required by the
not require any customization of event triggers or application logic. brand owner to support Country
Compliance.
CC - 04 The Service shall be a single platform that provides both the logic for report generation as well as the Please confirm that the core
delivery of the report to the Authority or trade partner. There shall be no integration or repository and the Network
Revision No.: 3.0
capability are a unified system

customization required nor shall data be processed or stored by two or more separate systems. operating within the same
platform.
Please confirm that the Service is

The Service shall provide support for all aspects of each Authority’s requirements including:
capable of handling two-way
CC - 05 ● Events, data and formats communications, where
● Security and transmission requirements of government applicable, for exchange of data
● Acknowledgement and Responses messages from government connected to original
reported message with Authorities.
Please confirm that the Service

provides complete end-to-end
The Solution Provider shall not only have the capabilities to produce reports, but also automatically
country compliance and not
generate, prepare, sends and records each regulatory report in a pre-configured format for a specific
CC - 06 simply the capability to generate
Authority and, where provided, captures the verification (receipt) of delivery of all regulatory
a report which then must be
authority reports.
passed to another system for
compliance purposes.

CC - 07 The Service shall have the ability to manually regenerate a compliance report to facilitate report
regeneration when needed (e.g not just connected to the “real time” event) describe how report generation
is accommodated.
Due to the complexity and variability of requirements from each country, the Service must provide a separate Describe how requirements are
CC - 08 compliance module for each country. gathered for each new country
regulation.
The Service shall accommodate simplicity of use, management and search of compliance reporting Please confirm by providing
CC- 09 data through user friendly view of submitted reports with link to report record and source data format
(XML, CSV) transmitted to government. A regulatory user shall be able to easily manage and search screenshot of regulatory user
compliance data without involvement from IT or vendor resources.- view of compliance data.
CC - 10 The Service shall provide configurable controls of user access to reporting data. Please confirm capability
CC - 11 Some Authority systems provide confirmation and error reports back to the submitter. In these cases, Please confirm capability and
Revision No.: 3.0
the Government system responses shall be directly linked to the original report record. describe how this is
accommodated.
Some Authority systems provide confirmation and error reports back to the submitter. In these cases, Please confirm alert capabilities
CC - 12 opt in alert capabilities shall be provided upon an error response from a government system
specifically for error messages
from a government system.
EU – The Service shall provide the capabilities to meet EU regulatory reporting requirements by Please confirm capability and
CC - 13 providing the ability to create EU government reports in the European Medicine Verification System that all delivery and regulatory
(EMVS) Hub, deliver the messages to EMVS Hub system to meet regulatory reporting requirements, record keeping are within the
and search, view and print the submitted reports. same system.
EU – The Service shall retain (as a consumer of Master Data) and manage extensive master data Please list master data elements
CC - 14 about products, companies and packaging/identity prior to release for sale. contained in the Service to meet
EU requirements.
EU - The Service shall provide support for the EMVS Hub SOAP Web Services API to communicate Please confirm current support
with the EMVS Hub system per the EMVS SDK for Manufacturers, provided by EFPIA (European and list which interfaces will be
CC - 15
Federation of Pharmaceutical Industries and Associations), Version 3.1 and support the required supported to meet full
interfaces. requirements.
EU – The Service shall provide the ability to search and view all submitted reports. Records of the Confirm capability and show
report submittals and any errors shall be linked directly to the original report. screenshot of business user
CC - 16
(regulatory) level search
capabilities.
CC - 17 EU – The Service shall provide the ability for users to opt in to email notification when error Please confirm capability.
notifications are received for reports submitted to the EMVS Hub
CH – As the CFDA requires use of China defined product and packaging code level relationships that Please confirm capability.
are unique to China reports (e.g. ProductCode, ResCode, CodeLevel, Cascade), the Service shall
CC - 18
provide native support for China specific master data throughout the serialization lifecycle of a China
EDMC code.
Revision No.: 3.0
CC - 19
CH – As the China EDMC codes do not follow the GS1 standards, the Service shall provide native Please confirm capability.
support for China EDMC codes.
CH – As China EDMC codes have proven to not always be unique, the Service shall detect duplicate Please confirm capability and
CC - 20 serial numbers against all previously submitted EDMC codes and automatically filter them from the describe how this is
working set of serial numbers. accommodated.
CH – As China EDMC codes are randomized, the Service shall provide native support for importing Please confirm capability.
CC - 21
and managing randomized China EDMC codes.
CH – As China EDMC codes currently need to be manually obtained from the CFDA, the Service shall Please confirm capability and
CC - 22 provide pro-active consumption tracking and opt-in alerting when serial number stocks reach a pre- describe how serial number
configured minimum threshold for a specific product. balances are maintained.
CH – If the CFDA establishes automated serial number request/response capabilities, the Service Please confirm that the Service
shall have the capabilities to have an automated interface to obtain serial numbers from an external will support an automated
system. interface for China in the future
CC - 23 if available. Provide an example
from another situation in which
serial numbers are obtained
from an external source.
CH – The Solution Provider shall maintain standard integration maps to common Line Management Please describe how the China
Systems (LMS) used at the packaging level. The LMS shall be insulated from having to customize for country compliance solution
CC - 24
China specific requirements and implied line level tracking for serial number consumption. manages China-specific serial
number consumption.
CH – As one approach to meeting CFDA requirements is to use pre-printed carton and label
manufacturers, the Service shall provide a user interface for an internal packaging site or CMO to Please confirm capability is
CC - 25
manually request China EDMC codes that can be downloaded into simple file formats consumable by available for China requirements.
3rd party label/carton printers.
CC - 26 CH – The CFDA reporting requirements require that serialization be integrated into warehouse Please confirm that warehouse
processes to meet inbound and outbound reporting requirements. The Service shall offer both API processes (as described in OPS
Revision No.: 3.0
interfaces and a user interface optimized for warehouse use cases (serial number status updates, section of URS) meet China-
pack/unpack, ship/receipt) specific event requirements.
Please confirm that the Service

can receive ERP and distribution
CH – To meet warehouse inbound and outbound reporting requirements the Service shall have transactions to meet China
CC - 27
integration points based on standard ERP and distribution transactions (i.e. post goods issue) warehouse inbound and
outbound reporting
requirements.
Please confirm that reporting

workflow is configurable rather
CH – The Service shall produce automatic reports based on a workflow that is configurable to than requiring custom
CC - 28
customer business process events (product release, shipments, returns, etc). development. Provide
Screenshot of China workflow
configuration screen.
CH – As CFDA has unique requirements for report submission which vary from report to report (e.g.
file size, file naming, file splitting, etc), the Service shall have the capability to create fully compliant
reports that meet each of the following requirements:
CC - 29 • Not splitting aggregations between files provide examples of how these
• Loose item placement in files have been accommodated.
• File size compliance
• File splitting content boundaries
• Content sequencing within files
• File naming conventions
IN – To support India serialization and DAVA reporting requirements, the Service shall allow the
CC - 30 reporting of all required master data, batch, shipment and production/serialization data for all Please confirm capability.
products packaged and serialized at all required levels to meet all India regulatory requirements.
IN – The Service shall accommodate India-specific company and location identifier types, including
CC - 31 Please confirm capability.
IN-PAN, IN-IEC, IN-TIN, IN-COMPANY ID.
Revision No.: 3.0
CC - 32 IN – The Service shall be able to maintain an item status of “withdrawn”. Please confirm capability.
IN – If the target market/country market code = IN, the Service shall capture a Scheduled Drug
CC - 33 Please confirm capability
designation (Y/N).
IN – If the target market/country market code = IN, the Service shall support a product image (Max Please confirm capability and
CC - 34
size: 2KB; Formats: BMP, GIF, JPG, PNG) provide sample screenshot.
IN – The Service shall maintain (as a consumer of Master Data) the Export Market List/Export Market
Please list master data
CC - 35 Master Data relevant to the India regulations:
maintained for Export Market.
IN – The Service shall maintain Company and Partner Information relevant to the India Regulations. Please list Company and Contact
CC - 36
information maintained.
IN - The Service shall provide the capabilities to manage workflows specific to India Compliance
CC - 37 Please list types of workflows
Reporting Messages.
supported.
IN – The Service shall generate India compliance reporting for required events, using the India DAVA
CC - 38
XML format. Please list supported events.
IN – The Service shall accommodate both:

Please confirm support for both
CC - 39 • The generation of compliance reports and transmittal to a designated user for manual manual and automated
signing and upload into the DAVA portal and
• The automated interface for file transmission (when supported by DAVA portal)
IN – The Service shall support Trade Partner Master Data and Shipment Movement reports when Please confirm that these will be
CC - 40
available in the DAVA portal interface. supported when available.
KR – The Service shall support South Korean track and trace requirements and compliance reporting
to the Korean Pharmaceutical Information Service (KPIS) in support the South Korean Please confirm capability and
CC - 41
Pharmaceutical Affairs Act, Article 45 including Serialization (Unit-level, Manufacturer-issued) and indicate go-live date.
Compliance Reporting (Product master data, packaging/serialization, shipment information).
CC - 42 The Service shall support the required KPIS Transaction/Event Types: .Please list supported
Revision No.: 3.0
Transaction/Event Types.
KR – Upon a product shipment event the South Korea Sales Shipment Master and Serial Number
CC - 43 Please list which supply types are
reports shall be created with designation of the KPIS defined supply types.
supported.
Please describe how response
KR – The Service shall have the ability to create South Korea compliance reports in the KPIS CSV
messages are received and linked
CC - 44 formats, transmit the reports to the KPIS system and receive processing response messages from the
directly to the original report as
KPIS system.
created.
Please confirm capability by

providing a screenshot for a
CC - 45 KR - The Service shall provide the ability to search, view and print the submitted reports.
business user (regulatory) search
and view interface.
KR - The Service shall support generating South Korea compliance messages for events using the
Please list supported KPIS CSV
CC - 46 KPIS CSV formats.
messages.
KR - The Service shall provide search capabilities of previously submitted reports by business user Please provide a list of standard
CC - 47 defined search criteria. search parameters for previously
submitted reports.
BR –The Service shall provide two (2) main capabilities for reporting in Brazil (in addition to the
Serialization requirements covered elsewhere in the URS):
1) Reporting to Trade Partners – Provide capabilities to manage the secure exchange of track
and trace data with supply chain partners (manufacturers, wholesalers/distributors, Please confirm capabilities and
repackagers, dispensers) in accordance with ANVISA regulations.
CC - 48 describe support for both
2) Reporting to and query by ANVISA – Provide capabilities to manage and comply with the
reporting and query requirements of ANVISA. scenarios.
NOTE: This section (Brazil Requirements) shall be updated upon the finalization of an anticipated
new Brazil law in approximately April 2016.
Revision No.: 3.0
Mobility and Verification – While regulatory requirements for mobile, tablet and other device access are emerging,
many companies are deploying programs to leverage the presence of serialized products for field verification and
supply chain purposes. In general, any such Service should be piloting and commercializing opportunities to
leverage the serialized data set within the core repository and present a secure, controlled means of access to the
serialized data.
Please provide a brief description

While not expected yet to be in full commercial production, the Solution Provider shall be able to
of a mobile roadmap as it relates
MOB - 1 demonstrate a comprehensive vision to leverage industry investments in serialized product and
to serialization and track and
serialized data management to gain value through mobile capabilities.
trace.
The Solution Provider shall be able to demonstrate a working system to use mobile devices in
distribution channels to identify diversion and security vulnerabilities. Using a secure application on
MOB - 2 a mobile device, field personnel should be able to “check in” and check out” serialized products,
of this capability if available.
providing visibility of the movement of serialized product as they are transferred between supply
chain hubs (manufacturers, wholesale distributors, dispensers, clinics, etc.)

MOB - 3 The Solution Provider shall be able to demonstrate a mobile application that offers controlled public
(patient) facing capabilities to register and verify the status of serialized medicines. of this capability if available.
The Solution Provider shall be able to demonstrate a mobile application that provide manufactures
to launch and control in-app experiences in areas like:
• Brand awareness / brand protection

MOB - 4
• Patient engagement / notifications of this capability if available.
• Patient communication
• Market research / patient surveys
• Direct-to-patient commerce
MOB - 4 The Solution Provider shall be able to demonstrate a mobile application that utilizes serialization to Please provide a brief description
create secure data relationships between distributed parties that are engaging based on serialized of this capability if available.
drug products:
Revision No.: 3.0
• Clinician (vendor) managed inventory

• Medication adherence programs
• Pharmacy-driven notifications/alerts
• Patient loyalty
Revision No.: 3.0
1.1.2 – Infrastructure and Platform Requirements
Serialization and track & trace solutions are essential supply chain services. If the solution is unavailable for any reason,
or is in any way disrupted or breached, the ability to serve a market is at risk. Therefore, the Service shall be
implemented in accordance with the following capabilities.
Please describe how the

INF - 01 The Service shall be architected to run in an active-active mode across multiple data centers. Service is deployed to
ensure availability.
The Service shall have a Disaster Recovery Time Objective (RTO) and a Recovery Point Objective (RPO) of Please provide statement on
INF - 02
0. most recent DR test.
INF - 03 The Service shall have a minimum uptime of 99.95%. Please confirm uptime SLA
Please confirm if there are

INF - 04 Disaster Recovery and Backup infrastructure should be included as a core capability. additional costs for DR and
backup infrastructure.
The Service shall be capable of provisioning capacity on demand to meet peak loads, scaling capacity up Please explain how peak
INF - 05 (or down) to ensure that the highest volumes of transactions and events can be processes with no volume demands are
disruption or delays to existing operations. managed.
Please describe architecture,

The Service shall be built to scale to meet the demands of large volumes of serialization events and data
INF - 06 database and scalability
management.
approach.
INF - 07 The Service shall not archive regulatory data to storage media as serialization data needs to be kept in an Please describe how
regulatory data retention
Revision No.: 3.0
and availability
requirements are met
readily available state to meet regulatory and trade inquiries for up to six years past expiration.
without requiring separate
storage infrastructure.
If the Service is based on

relational database
technology, please provide
The Service shall use a scalable database architecture designed to handle the large volumes of data and benchmarking figures for
INF - 08
transactional events produced by serialization and track and trace. how large the database can
grow (e.g. how many
serialized events) before
archiving is required.
Using the parameters

provided, please provide a
Given annual serial number volumes of <VOLUME>, average batch sizes of <BATCHSIZE> and annual calculation of transaction
INF - 09 number of shipments of <SHIPMENTS> the solution shall be sized to manage expected scalability scale, transaction volume
requirements. and the size of the database
over a 12 year retention
period.
Please address how this

requirement is met. What
The Service shall be built upon architectural principles such that growth in size of the database shall not costs would be incurred for
INF - 10
cause degradation of performance. additional hardware and
storage infrastructure as the
data set grows?
INF - 11 Serialization with creates a very high number of events and transactions that need to be stored in an Please specify the threshold
active state to facilitate a variety of regulatory and business transactions. upon which initial
infrastructure and storage
capabilities must be
increased to handle the
Revision No.: 3.0
growing data set. Please

specify all costs and indicate
who incurs the costs.
INF
Please specify costs for

keeping several years (up to
12) worth of data in “active”
INF - 12 or live state (as opposed to
Some regulations require that data be available in an active state for several years past expiry.
archiving to storage). Who
incurs this cost?
The Service Provider shall provide benchmark performance data for:
● Importing 100,000 serial numbers

● Provisioning of 100,000 serial numbers Please provide benchmark
INF - 13
● Commissioning of 100,000 serial numbers performance data.
● Aggregation of a 100,000 count batch
● Shipping of 100,000 serialized products
● Generating an EPCIS message for a shipment
Specify all Solution Provider

Changes in requirements, communications, formats, event triggers and regulations are inevitable as costs relative to upgrades
INF - 12 and new releases.
serialization becomes part of operations processes over the next 2-5 years. Upgrades and new releases
will be required to support these changes.

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Sample User Requirements Specification (URS)

1.1 Definitions and Abbreviations

Alphanumeric Character set made up of digits and letters of the alphabet.

Batch A group of products, usually associated by a manufacturing or packaging operation.

Bundle A group of items held together, usually by shrink-wrap.

Case A container of product cartons which may or may not be bundled

Contract Manufacturing Organization. A company providing manufacturing, and sometimes

US Federal Legislation passed in November 2013 which requires:

A character encoding that contains a large number of unique characters or

A functional specification (also, functional spec, specs, functional specifications document -

GS1 (www.gs1.com) is a leading global organization dedicated to the design and

A linear barcode, formerly referred to as a Code-128 barcode. Usage granted to organization

Header (for Human

The product secondary package; typically a carton

Manufacturer Entity or organization responsible for packaging the product

an enterprise traceability event repository.

2.1 Requirements Matrix

NUMBER Requirement Description RFP Question

Master Data Requirements

•Company and Location Master Data to share with trade partners

BR - CNES Brazil National Registry of Health Facilities Number

Partner Management and Connectivity

IT or vendor resources. templates. After creation, what

previously commissioned serial

Specifically, if the proposed

Serial Number Exchange with Internal and External Lines

SNX - 1 • Serial Number Request

capability and describe the

customers of the Service Provider

Costs for this feature must be specified.

validation of the core system.

● Status Update Functions

3PL’s and External Distribution

● Provide serial numbers shipped with new aggregation hierarchy

US DSCSA Requirements – Lot Level Traceability

US DSCSA Requirements – 2017 and Beyond Serialization

Please confirm support and

Please confirm capability and

• Verification Status (unrecognized product)

• Serial Number (if provided or associated with Serial Number)

Please provide examples of how

Please confirm that there are no

capability are a unified system

Please confirm that the Service is

Please confirm that the Service

Please confirm capability and

Please confirm that the Service

Please confirm that reporting

IN – The Service shall accommodate both:

Please confirm capability by

Please provide a brief description

Please provide a brief description

• Brand awareness / brand protection

• Clinician (vendor) managed inventory

1.1.2 – Infrastructure and Platform Requirements

Please describe how the

Please confirm if there are