Life sciences and healthcare

Our solutions for life sciences and healthcare help bring life-saving medications to market faster and improve patient outcomes.
Streamlining complex life sciences and healthcare supply processes Life sciences and healthcare industry solutions from SAP
help you optimize clinical operations and bring drugs and therapies to market faster and more sustainably.

Our life sciences and healthcare industry solutions can help you:

 Build a resilient supply chain in a secure and trusted data ecosystem

 Support effective clinical trials
 Orchestrate cell and gene therapy treatments to reduce cycle time
 Empower life sciences and healthcare staff to work more effectively
 Drive a sustainable and profitable business
View the product road maps for life sciences

View the product road maps for healthcare

Find out how our customers are using life sciences and healthcare industry software from SAP

Life sciences and healthcare software solutions from SAP and our partners
Solutions addressing life sciences and healthcare business needs enable operational efficiencies, supply chain resilience, and
sustainable growth.
Cloud ERP
Clinical operations
Supply chain management
Artificial intelligence
Spend management
Human capital management

What is SAP ATTP in a nutshell?

SAP Advanced Track and Trace for Pharmaceuticals (SAP ATTP) is a serial number management solution built for
pharmaceutical companies to label and track products with drug serialization numbers.

What are the key benefits that SAP ATTP provides?

SAP ATTP minimizes the costs of maintaining compliance and a secure supply chain. It includes regulatory reporting
interfaces and content, to help clients stay 21CFR Part 11 / EU Annex 11 compliant.

In which scenarios do companies utilize SAP ATTP?

Manufacturers of prescription drugs utilize SAP ATTP to ensure that each package they produce can be uniquely identified to
enable traceability, prevent counterfeiting and secure patient safety. This also supports the serialization processes of other
parties in the supply chain, including wholesalers, distributors and third-party logistics suppliers.

The extension of serialization requirements into other markets, such as animal health and food, has expanded the need for
comprehensive solutions in these industries, and NTT DATA Business Solutions has experience here too.
What makes an SAP product ideal as a track and trace solution
What challenges does SAP ATTP help pharmaceutical companies overcome?

 Drug serialization compliance

 Efficient serial number management
 Integrating serialization processes with logistics and warehouse systems
 Exchanging serialization data with business partners

Why Choose an SAP Product for Track and Trace?

SAP proactively monitors global serialization requirements and is in contact with regulatory bodies to ensure that the solution is adapted
in time to meet future deadlines. These SAP ATTP feature packs contain product improvements and new regulatory updates.

In addition to the native integration with the SAP ERP system, SAP also provides a framework to integrate complex operational
warehouse processes for drug manufacturers. NTT DATA Business Solutions has developed an accelerator to incorporate serialization
processes into logistical processes.

With NTT DATA Business Solutions’ SAP ATTP integration, customers create robust serialization systems which ensure compliance with
regulatory requirements and enhance patient safety.

SAP ATTP can work as a standalone or as an extension to SAP ERP. Whether it concerns the exchange of master or transactional data,
SAP ATTP makes it possible. Special country packs simplify communication with government agencies. This means you do not have to
worry about ever-changing legislation and regulations.

SAP ATTP Main Features

 Supporting serialization strategy

 Reporting events
 Integration with ERP, warehouse management systems, and packaging lines
 Tracking and tracing serial numbers
 Tracing batches
 Consulting reports
 Communicating with external partners and regulatory bodies

Serialization Made Easy - With NTT DATA Business Solutions

We have vast experience with SAP software and fully understand the complexities of pharmaceutical compliance. Serialization is a topic
that holds no mysteries for us. SAP ATTP customers acquire a robust serialization system which helps to comply with both current and
future regulatory requirements and enhances patient safety.

Djerry Tervoort, Serialization Lead & SAP Expert, Life Sciences & Chemicals
Why Use NTT DATA Business Solutions for SAP ATTP Integration?
Our consultants have over 25 years of experience in the pharmaceutical sector. They are familiar with all aspects of serialization, both
with the legislation and regulations and with the processes and systems that are required for compliance.

We don’t just implement SAP ATTP, we help our customers with a full serialization strategy to optimize and extend their existing
workflow, enabling them to focus on their core business whilst ensuring their serialization solutions are ready for whatever the future
holds.

We specialize in the following areas of SAP ATTP:

 ERP & Warehouse integration

 Manufacturing Integration
 Business Partner Integration
 Regulatory Reporting

By assisting you in building a secure supply chain, we help you to ensure patient safety. Reach out to us via our contact form for more
information or to arrange a dedicated SAP ATTP workshop.

How Our SAP ATTP Integration Stands Out

 Lower cost for compliance: With SAP ATTP, your business is prepared for both current and future serialization
requirements such as the obligation to report by country.
 Optimal integration: Easily integrate master and transactional data in existing processes for Enterprise Resource Planning
(ERP) and warehousing.
 Large storage capacity: Secure large data volumes consisting of objects, events, and transactions for further analysis.
 More efficient supply chain: Provide insight into movements in the supply chain, down to the level of a single package.
 Scalability: Process large quantities of serialization data and always be prepared for new legislation and regulations.
 Communication: Share data with Market Authorization Holders and Contract Manufacturing Organizations via the SAP
Information Collaboration Hub for Life Sciences (SAP ICH).

We specialize in the following areas of SAP ATTP:

 ERP & Warehouse integration

 Manufacturing Integration
 Business Partner Integration
 Regulatory Reporting

By assisting you in building a secure supply chain, we help you to ensure patient safety. Reach out to us via our contact form
for more information or to arrange a dedicated SAP ATTP workshop.

 Companies in Life Sciences, and in the pharmaceutical industry in particular, are put under great pressure to provide
regulators and the public with an immense amount of transparency in their end-to-end supply chain. That comes as
no surprise, considering that compliance rules and regulations become stricter on both local and international level to
battle all sorts of excesses in the industry. One of those challenges is counterfeit drugs that pose a serious threat to
global health. Serialization is a sound way to supply regulators with transparency, and to monitor and control the
safety and quality of your drug products. However, it’s also complex and bound to become more difficult in the
future. In this blog series, we delve into the topic of serialization. In this first blog, we’ll outline the status quo
of the international industry regarding the tracking of products with sGTIN numbers. And we explain
why it is vital to implement serialization in your entire internal supply chain.

 In the other blogs of this series, we’ll provide you with practical business cases and solutions that show how you can
leverage this growing complexity in your pharmaceutical supply chain, while ensuring the safety and a high-quality
standard of your medicines. We’ll also explain how to maintain flexibility concerning changes in rules, regulations,
and in the global market.

 The Global Problem of Counterfeit Medicines

 Counterfeit medicines form a huge threat to patient safety. In the Western world, approximately 1% of the products
are substandard or falsified. In developing countries this number is even higher, much higher. On average 10% of
 the medical products that are sold in developing countries are counterfeit. In some countries this percentage is even
as high as 40% for some medicines. The consequences of these practices are immense. A falsified medicine might
contain no active ingredient, a different active ingredient or a different amount of active ingredient. Taking such a
medicine might result in no effect, but it can also result in a deviating effect or an overdose. In countries with the
highest amounts of falsified medicines, in addition to the health issues, this also leads to societal issues. Citizens lose
their trust in the healthcare providers and health systems and look for alternative (non-scientific) solutions.

 What You Need to Know about Serialization: The Basics

 sGTIN explained
 Luckily the world is very aware of the issues with counterfeit medicines. Thanks to digitalization we are now
serializing the drugs that are produced for an increasing number of countries. Manufacturers of the medicines
provide every sellable unit that they produce with a unique serial number. The combination of this unique serial
number and the number that belongs to the produced product, the Global Trade Item Number (GTIN), forms a
Serialized Global Trade Item Number (sGTIN). The product provided by SAP which is used to enable traceability is
SAP Advanced Track and Trace for Pharmaceuticals (ATTP).

 How pharmacists in Europe use sGTIN

 In Europe, all prescription medicines that are produced are registered by the marketing authorization holder to a
database that is regulated by the government. At the moment that the product is sold at a pharmacist, this
pharmacy is obliged to scan the sGTIN number that is printed on the pack that is being sold. This scan action checks
whether or not the sGTIN number can be found in the regulatory database, and if the number is found it checks if
the status is correct. When that is the case, the pharmacist can sell the pack. This will trigger an update in the
database for the serial number which is then marked as being dispensed. If the number was not found in the
database or if the status is incorrect, it means that the medicine might be falsified. The pharmacist is not allowed to
dispense this pack and the producer is automatically alerted that an unknown sGTIN number was verified.

 Here’s Where it Gets Complicated: International Requirements

 In Europe, all EU countries are governed by the same serialization organization; the EMVO (European Medicines
Verification Organization). When manufacturers are producing solely for the European market, the serialization rules
are uniform. Things get more complicated when products are sold to countries outside Europe.

 Not only are other countries governed by other Medicine Verification systems, but they can also have other
serialization requirements. The European market requires the serialization process as mentioned above, where
manufacturers are obliged to report serial numbers to the institutional database. This requirement is also referred to
as ‘reporting’.

 Some markets, such as Russia, China and Saudi Arabia, even require a complete track & trace process. This is
because these countries also use serialization to detect cases of corruption, stolen drugs and illegally imported drugs.
Instead of only reporting serial numbers in the production process these markets also require reports about which
serial numbers are shipped to which customers. In other words, these markets require more serialization related
handling throughout the supply chain.

 Serialization Aggregation in Pharmaceuticals

 In order to enable these track and trace processes, it is required that serial numbers are aggregated. This means
that the serialization software knows which serial numbers are included in a box and which boxes are stacked on a
pallet. Whenever an order is picked for a customer that requires track and trace; instead of scanning thousands of
serial numbers the warehouse operator only needs to scan the pallet identification label (SSCC). This scan action is
then sufficient to report all included serial numbers that are shipped to the governmental database.

 Different Pick Processes for Different Markets

 Since most medicine manufacturers produce for multiple countries, these serialization requirements result in diverse
pick processes for the markets that have those ‘track & trace’ requirements. At this moment, only a limited number
of countries are requiring these activities. Therefore, manufacturers can still separate the pick processes for these
‘special’ markets from the pick processes for the ‘normal’ markets.

 Transparent Supply Chains Become The Norm; opt for Integrated Serialization
 However, more and more markets are requiring a more transparent supply chain. As a consequence of this the
internal supply chain processes become more complex. When the ‘special’ markets are no longer a small amount of
the total markets they become part of the ‘normal’ business. As a consequence, the ‘normal’ process includes
multiple scenarios. It is impossible for a warehouse operator to know exactly when which serialization activity is
required. To help operators, serialization processes must be integrated in the warehouse solution that is used. For
our customers this is often an SAP EWM solution.
 Serialization Integration: Relevant for All Warehouse Processes
 Another result of the increasing need for supply chain transparency, is that more and more pallets in a warehouse
need to become aggregated. This means that when pallets in the warehouse are repacked or consolidated not only
the warehouse system needs to be updated, but also the object hierarchy in the serialization system needs to be
updated. If these systems are not aligned, it will result in incorrect shipping of serial numbers to customers. So,
integration of serialization processes is not only relevant for the picking process, but also other warehouse processes
must be taken into account.

 Your Supply Chain is Becoming More Complex, Be Ready

 That the internal supply chain for producers of prescription drugs is becoming more complex due to serialization
requirements is more than evident by now. In our next blog, we will share insights from our day-to-day experiences
in the Life Sciences industry. And tell you more about how we optimize serialization-related warehouse processes.
Most of the customers we help, are struggling with complying to these strict serialization demands in their
warehouse. As adhering to it often comes with tedious – and error prone – manual labor. It is a challenge that can
be overcome with an integrated end-to-end solution in which serialization forms an integral part.

 Serialization offers both opportunities and challenges for companies in Life Sciences. As you have discovered in my
previous blog, the use of sGTIN and SSCC numbers is a sound method to battle counterfeit drugs and keep the
supply chain for pharmaceuticals safe and free of corruption. But serialization – and the increasing pressure from
regulators to become more transparent in your end-to-end supply chain – adds a growing complexity. In every
aspect of your manufacturing, warehousing, and logistic processes. The good news? The stand-alone ATTP solution
you are using for serialization can be integrated in your supply chain, more specifically in your existing or in a new
(E)WM solution, optimizing your operation efficiency and simplifying your processes.

 In this blog, I will outline several challenges in the outbound, internal, and inbound processes, that you can run into
as a pharmaceutical company with regards to serialization. However, I will also show you how you can leverage this
growing complexity and compliancy in your facility, and use it to do the work smarter, safer, and more efficient. All it
takes is an end-to-end solution of which you make your serialization solution an integral part.

 Ready to read how you can get rid of manual error-prone labor and up the flexibility of your
organization regarding rules, regulations, and market trends? Here we go!

 The Impact of Serialization on Outbound Processes

 Up Your Customer Service by Simplifying Loading
 One of the most complicating serialization factors in outbound processes is loading (interlinking serial numbers to
delivery numbers) of items for markets that require serialize and trace activities (e.g., Russia, China, Saudi Arabia).
This is the process in which all parties in the supply chain need to be informed about the exact objects that are being
shipped from location to location. Quite the work. As explained in the previous blog aggregation minimizes the
amount of objects that need to be scanned. However, when you do not integrate loading into your outbound process
it can be easily forgotten by a user. Moreover, when this process is not integrated and not enhanced with repack
functionality it will only be possible to ship full boxes or pallets to the customer. Integrate this ATTP process into
your warehousing solution, and you can even offer better customer service to your clients.

 Aggregation
 First things first. The starting point – if you want to simplify the loading process – is aggregation. It accelerates the
outbound supply chain process (certainly when goods are shipped between several countries), because only SSCC
numbers of boxes and pallets need to be scanned, instead of all the serial numbers.

 Repacking
 Aggregation gets complex when a customer orders partial boxes or partial pallets. With wholesalers, this is rarely the
case, but for pharmacies this is a bottleneck. Now, most manufacturers limit the flexibility of the order quantity, so
that the customer can only order full boxes or pallets. Which is, obviously, not very customer friendly. Some
medication can be very expensive, and the obligation to order an entire box could deter or postpone a sales order.
Instead of limiting orders, go for an integrated repack solution in your picking process, with which you can offer your
customers the option of ordering partial boxes. This solution prompts the operator to scan the serial numbers that
are picked and automatically repacks these numbers to the relevant box and/or pallet. Making it possible to pick
partial boxes or pallets.

 The repack solution will, again, also eliminate human errors like forgetting to scan items and has an automated
calculation tool that alerts the picker when the requested pick quantity was reached. And although developing and
integrating such a solution takes time and money, it also drives great value in the long run. Currently, we are
 working on such an integration, so we recommend you keep an eye on our NTT DATA Business Solutions social
channels and blog section.

 The Impact of Serialization on Internal Processes

 Win over Customers with a Smart Repacking Integration
 If a customer can order partial pallets, it comes with consequences for your internal processes. Pallets might need to
be consolidated at some point, because we all know it’s not efficient to store a pallet with just one box on it.
Repacking this, however, has an impact on the ATTP hierarchy of a pallet, since the serial numbers it contains, need
to be assigned to a different pallet. If you offer this partial-pallet-service to your customers and you do your
repacking activities manually, it costs you a lot of time and money, plus, you’ll risk that the two systems are no
longer in sync. It’s one of the main reason manufacturers do not offer this service. However, integrate ATTP and this
functionality in your warehousing system architecture and you’ll get an inventory-space-saving, timesaving, and
money-saving solution that ups your level of service at the same time. Sounds like a win-win to me!

 Integration Makes Decommissioning Easier

 The process of decommissioning items – meant for the European market – for export to external markets or article
23 customers (such as universities, veterinary surgeons, and government bodies) is complicated. Mainly because it
contains a lot of manually triggered actions. You must dispense the items in the European Database in a separate
transaction. Integrate this ATTP activity in your (E)WM pick process, and you can achieve this semi-automatically
with less hassle or errors. You still must scan products manually, but warehouse pickers will get an automated pop-
up to dispense items through the same transaction. A big plus, because you won’t have to settle in or instruct new
employees, different shift workers, or temps anymore. And anyone who works with the scanner is less likely to make
mistakes.

 How to Never Forget to Scrap an Item

 Another outbound activity that could be optimized with the integration of ATTP in your warehousing system, is the
scrapping process. It is mandatory to report which serial numbers are being scrapped, to prevent that the serial
numbers of these packs remain active. By integrating the process, a pop-up message is shown on the scanner in
case serial numbers need to be scanned. The system detects serialization objects that need to be scanned, making it
easy for users to recognize the scenario. Again, with this integration, there is little room for human errors.

 The impact of serialization on inbound processes

 Prevent the Scrapping of Sellable Medication
 When customers return items that are serialized, these products cannot just be resold. It is mandatory that a check
is executed against the European Database for each returned item to see if its status is still correct. Without the right
tool this costs a lot of time (and money), and often, manufacturers opt for scrapping. However, if an item is not
already marked as dispensed it could be resold. To me this sounds like the most desirable outcome, considering the
scarcity of medication these days. In case of water damage, scrapping is the obvious choice. But what if a customer
ordered too many boxes and sends back good quality products?

 SAP ATTP doesn’t provide an efficient solution for this issue. With our integrated return verification tool, it is possible
to scan returned boxes or items (with an audit-trail) and automatically send a request to the European Database to
verify their real-time status. You can now re-sell the items and adhere to all rules and regulations that come with this
action. Easy, efficient, and sustainable!

 Integration Makes Internal Logistics Efficient

 When CMO’s or other plants internally transfer serialized and traced items, these items must be received in ATTP in
the related location. If the external plants are in the same SAP landscape, the captured serial numbers from the
issuing plant can be used to trace back which items need to be received. We came up with an integrated solution
that makes sure this happens automatically in the back end, so that an extra scanning action doesn’t need to
happen. Another example of how you can simplify the complexity of serialization in your processes and work more
efficiently.

 The Future of Serialization in Supply Chain: Stay Tuned!

 Of course, this is not where the story of challenges in serialization ends. I’ve got more insights to share. In my next
blog, I will share our vision on the future of serialization. Where is the Life Sciences industry headed in respect to
serialization? What are new developments we can expect? Are there any innovative technologies we will undoubtedly
see emerge in Life Sciences soon? Spoiler alert: there are! In the next blog, we will also dive into the potential of
blockchain technology for the optimization of supply chain processes that deal with serialized products.
Clinical trials are an essential means to ensure patients’ safety and drug efficacy. One of the most critical steps of a successful
clinical trial is how the trial is designed, planned, and executed. The smooth management of clinical supplies is crucial to avoid
any delay in medication delivery to patients or supply shortages while at the same time not producing costly overages and
wastage.

For these reasons, SAP Intelligent Clinical Supply Management has been developed as a frontrunner for the Industry Cloud for
Life Sciences providing support for end-to-end clinical process operations, and visibility to plan, source, manufacture, distribute
and reconcile supplies for clinical R&D.

To cover customer needs best, SAP Intelligent Clinical Supply Management has been designed as a cloud solution integrating
with an SAP S/4HANA add-on:

o Two modules of SAP Intelligent Clinical Supply Management are cloud modules based on SAP BTP
covering study management, planning and demand forecasting.

o Two modules of SAP Intelligent Clinical Supply Management are part of an SAP S/4HANA Life Sciences
add-on covering the specific blinding and randomization needs for clinical trials to facilitate manufacturing,
packaging, labelling, and shipments of clinical supplies.

Release Schedule

o Every year, releases are planned for Q2 and Q4.

o Every release will support two SAP S/4HANA back-end releases at a time, which will be the SAP S/4HANA
release where it was originally implemented AND the succeeding SAP S/4HANA release.

o There will be only one cloud release live in production at any point in time which is always the most recent
generally available cloud release. In case customers do not upgrade to the latest compatible SAP
S/4HANA version, an interoperability of new cloud releases towards older supported SAP S/4HANA
releases will be provided but there will be of course a limitation to the functional scope as supported by
their installed SAP S/4HANA release.

SAP Intelligent Clinical Supply Management provides two customer environments, STAGING and PRODUCTION. During
customer and business partner onboarding, the staging environment is connected to the customers' and their business
partners’ test systems. Upon go live the connections are applied into the production environment for productive
use accordingly.

Each cloud release follows a standardized sequence of events:

o Day x: Staging Deployment

 o Day x+2 months: Production Deployment

SAP S/4HANA Life Science add-on releases are available for download at the RTC date.

The list below shows past release dates and the upcoming release schedule (DISCLAIMER: This is the current state of
planning and may be changed by SAP at any time without notice)
Dates for
SAP S/4HANA SAP S/4HANA Staging Dates for
Release Status /
Cloud Life Science add- version (Cloud) / Production
Year Comments
on compatibility RTC (Add- (Cloud)
on)

SAP S/4HANA 2021

2022 2210 2210 October 31 COMPLETED
FP01

SAP S/4HANA 2021

2023 2306 2306 June 30 August 31 COMPLETED
FP02

SAP S/4HANA
COMPLETED
2310 2021 FP02 October 16

SAP S/4HANA
2022 FP02

SAP S/4HANA 2021

2024 2406 2406 FP02 June August PLANNED

SAP S/4HANA 2022

FP02

SAP S/4HANA
2021 FP02
24xx 24xx Q4 tbd PLANNED
SAP S/4HANA
2022 FP02

SAP S/4HANA
2023 FP01