SAP Advanced Track and Trace for Pharmaceuticals

Solution Overview
Dr. Oliver Nürnberg
Product Owner SAP Life Sciences
September 24, 2015 Customer
Agenda

Market Requirements
Co-Innovation & Why SAP Advanced Track and Trace for Pharmaceuticals?
Overview of SAP Advanced Track and Trace for Pharmaceuticals

“The red pill and its opposite, the blue pill, are popular culture symbols representing the choice between embracing the sometimes painful truth of reality
(red pill) and the blissful ignorance of illusion (blue pill). Redpills are people who have chosen to face reality, while bluepills remain living in ignorance of
the truth, whether by choice or because they have not had a choice.“
Source: WIKIPEDIA (https://en.wikipedia.org/wiki/Red_pill_and_blue_pill)

“This is your last chance. After this, there is no turning back. You take the blue pill - the story ends, you wake up in your bed and believe whatever you
want to believe. You take the red pill - you stay in Wonderland and I show you how deep the rabbit-hole goes.”
Source: Morpheus, The Matrix, Part 1 (1999)

© 2015 SAP SE or an SAP affiliate company. All rights reserved. Customer 2

Market Requirements
International legislation fighting the counterfeiting/ falsification of
medicinal drugs requiring serialization

In response to and with the aim to counter the large scale counterfeiting/ falsification of medicinal
1 drugs, international governments have implemented, enacted or are planning to draft legislation calling
for the serialization and reporting of medicinal drugs to improve patient safety.

© 2015 SAP SE or an SAP affiliate company. All rights reserved. Customer 4

Why will it become BIG DATA?
Scale of international legislation calling for serialization of drugs

USA EU CHINA
• Serialization by Nov. 2017 • Serialization Q1/2019 • Serialization in effect
• Full value chain track & trace by 2023 • Point of dispense verification • Reporting S/N to China FDA DB
• ~31% of global sales affected • ~25% of global sales affected • ~15% of global sales affected

Significant increase in volume of serialized items

Different reporting needs for compliance

Compliance to serialization directives is a MUST to retain the license to sell in these regulated target markets.
Customers should start implementing now because of the massive scale of required process re-engineering.

© 2015 SAP SE or an SAP affiliate company. All rights reserved. Customer 5

The implementation of these legislations require serial numbers be
encoded in 2-D barcodes

The implementation of these

2 legislations require serial numbers be
encoded in 2-D barcodes

 Serialized trade item information is contained in a

2-D barcode (GS1 Data Matrix) which is applied to
medicinal sales unit packages, in some cases also
GTIN (Global Trade Item Identification Number)
to their aggregations to bundles, cases and then Expiration Date (YYMMDD)
pallets - either for compliance or logistical reasons. Batch or Lot Number
Serial Number
 The 2-D barcode typically contains the following
elements:
 Global Trade Identification Number
 Expiration date
 Batch/ lot Number
 Serial number

Source: 2-D Matrix barcode courtesy of GS1 Germany

© 2015 SAP SE or an SAP affiliate company. All rights reserved. Customer 6

Overview of legislation and reporting

Presently there are 3 types of compliance requirements

3

Serialization with reporting to an

Serialization with reporting to a institutional database for Serialization with reporting along to
governmental database mandatory verification at the the supply chain
point-of-dispense

in effect enacted enacted & partially in force

expected expected

© 2015 SAP SE or an SAP affiliate company. All rights reserved. Customer 7

Requirements imposed on Pharma Manufacturers and the Pharma
Value Chain

1. Global Serial Number Management

2. Serialization and aggregation at packaging lines
3. Efficient process integration as this becomes part of “normal business”
4. Scalable repository to deal with expected volumes of serialized product
5. Efficient reporting to different country reporting requirement regimes

© 2015 SAP SE or an SAP affiliate company. All rights reserved. Customer 8

Resulting key business challenges

How do I efficiently comply with many country-specific compliance

1
and reporting requirements on drug trade item serialization?

2 How do I efficiently manage my global serial number pool?

3 How do I efficiently integrate serialization with my business

processes and systems?

4 How do I efficiently message serialization data to my business

partners?
5 How do I scale with the expected data volume arising from
serialization?

© 2015 SAP SE or an SAP affiliate company. All rights reserved. Customer 9

Why SAP Advanced Track and Trace for
Pharmaceuticals?
SAP took the decision to create a new pharma-specific solution
based on market changes and customer feedback

SAP Advanced Track and Trace for Pharmaceuticals is available to the market since
September 15, 2015

SAP Adv. T&T is developed in response to the requirements raised by SAP’s Customer Consortium (“Serialization
Round Table”) which includes 40+ pharma-companies running SAPs existing serialization Solution (OER/Aii)

The solution is developed via “Co-Innovation” Significant investment from Co-Innovation customers
with 13 companies  more than 400 people-days spent in workshops with SAP
 9 of top 20 pharma companies development (plus homework)
 1 top 3 US Wholesaler  Spec, design and UI reviews with co-innovation customers
 Regular customer reviews after Sprints finished including demos
 Co-innovation customer testing executed in July 2015

© 2015 SAP SE or an SAP affiliate company. All rights reserved. Customer 11

Quick Overview of SAP Advanced Track
and Trace for Pharmaceuticals
Solution overview

government
lot
SAP Advanced Track and Available country version reporting

Trace for Pharmaceuticals

provides a corporate serialization
repository and serial number
SAP Advanced
management solution tightly Track and Trace for 3PLs, CMOs
ERP/
integrated into supply chain and WM
Pharmaceuticals wholesalers
warehouse management
processes with regulatory reporting
interfaces and content supporting
compliance to international
legislation to fight falsified Predefined message content

medicines! pack line/ SAP application interface framework

device any middleware

© 2015 SAP SE or an SAP affiliate company. All rights reserved. Customer 13

SAP Advanced Track and Trace for Pharmaceuticals
provides a corporate serialization repository and serial number management solution for regulatory reporting that
supports compliance with international legislation to fight falsified medicines.

It allows you to
 Report serial number events to authorities and business
partners, enabling compliance to international legislation
 Integrate with ERP systems, warehouse management
systems, and packaging lines
 Capture serial numbers from packaging lines and
warehouse systems, and store serial number events
centrally
 Track and trace serial numbers of medicinal sales units and
their aggregations
 Track batches and their related serial numbers
 Globally manage number ranges and randomized or
sequential serial number lists
 Browse and affect internal reporting on usage and
distribution of serial numbers globally

© 2015 SAP SE or an SAP affiliate company. All rights reserved. Customer 14

Functional overview
SAP Advanced Track and Trace for Pharmaceuticals

INTEGRATION REPOSITORY MESSAGING

ERP system integration WMS integration toolkit
 Capture and store objects, events
 Material, business partner, location  Real-time verification with data in and business transactions Regulatory reporting /
master data repository rules engine
 Ad-hoc reporting with repository
 ERP transactions (deliveries,  Integration with receiving, internal browser  Rule framework for regulatory
production / process order) movement and goods issues, and reporting and business rules
cycle counting  Deployable on SAP HANA or
 Batch / Lot classic databases  Message mapping and handling
 Number import for China
 Country packages included in first
Serial number management Packaging line integration release: Turkey, China, and
 Define number format and ranges  Serial number interface (request Argentina, U.S. DQSA for lot
 Randomization list and range, status update) traceability

 Assign ranges and S/N lists to  PML or EPCIS capture interface

SAP Application Interface Framework (integral solution
consumers
software component)
 Receive lists and ranges
 Integration to business partners, packaging line, SAP ERP, LES WMS and
 CN: import China product master regulatory reporting, EPCIS capture interface
and serial numbers from files
 Business and technical monitoring of all messages with restart option in case
of transmission failure

© 2015 SAP SE or an SAP affiliate company. All rights reserved. Customer 15

© 2015 SAP SE or an SAP affiliate company. All rights reserved. Customer 16
High level process scope delivered by the solution

Request and receive

serial numbers (lists & Send regulatory
ranges) from MAH reporting messages to
Contract Authorities
manufacturers Pharma authorities
MAH Send messages to
3PL business partner Wholesaler
Send serial usage data

Packaging line Warehouse Audits and internal Compliant

CMO collaboration
integration operations reporting messaging

Web services EPCIS + PML Warehouse toolkit Repository Browser Interfaces & country
versions
SAP Advanced Track and Trace for Pharmaceutical
delivers compliant reporting and integrates with your internal business operations and with your supply
chain network.
Legend
MAH: market authorization holder (brand owner/ OEM) | CMO: contract manufacturing organization | 3PL: third-party logistics provider | PML: Product Markup language

© 2015 SAP SE or an SAP affiliate company. All rights reserved. Customer 17

Main characteristics of SAP Advanced Track and Trace for
Pharmaceuticals

Designed as one component Built for the Pharmaceutical Minimum Footprint

Industry  Lean data model
Used GS1 global standards for  Designed to work for MAHs,  Designed for volume and speed
implementation* CMOs and US wholesalers  Optimized for SAP HANA while also
 EPCIS 1.1  Co-Innovation with 10+ leading deployable on classical
 CBV 1.1 (core business vocabulary) pharmaceutical customers data bases
 TDS 1.9 (tag data standard)
 GS1 general specification
Capable to handle any upcoming Optimized TCO
(version 14, Jan 2014) legislation  Minimized footprint
 Roadmap for future legal requirements  Deployment and commercial model
that works for the entire industry: 1m
items -> 10b items / year

* EPCIS 1.1 is a powerful, comprehensive, generic and global standard. Not everything defined in EPCIS 1.1 is relevant to support the business
processes of the pharmaceutical industry.

© 2015 SAP SE or an SAP affiliate company. All rights reserved. Customer 18

Product details
Regulatory reporting: availability of country version content

Available for country reporting compliance Outlook / road map*

Regulatory reporting to MoH Supply chain partner Further country version content is
databases notification for US DQSA lot planned subject to the availability to
reliable and sufficient quality
Country version packages are traceability
specifications.
available for SAP Advanced Track SAP Advanced Track and Trace for
and Trace for Pharmaceuticals, Pharmaceuticals, version 1.0 further
version 1.0: supports EPCIS notification
*Legal Disclaimer: SAP has no obligation to pursue any course of business
• China messages from supply chain partners outlined in this document or any related presentation, or to develop or release any
functionality mentioned therein. This document, or any related presentation and
to support U.S. DQSA lot traceability SAP's strategy and possible future developments, products and or platforms
• Turkey directions and functionality are all subject to change and may be changed by SAP
compliance requirements at any time for any reason without notice. The information on this document is not
a commitment, promise or legal obligation to deliver any material, code or
• Argentina functionality. This document is provided without a warranty of any kind, either
express or implied, including but not limited to, the implied warranties of
merchantability, fitness for a particular purpose, or non-infringement. This
document is for informational purposes and may not be incorporated into a
contract. SAP assumes no responsibility for errors or omissions in this document,
except if such damages were caused by SAP intentionally or grossly negligent.

All forward-looking statements are subject to various risks and uncertainties that
could cause actual results to differ materially from expectations. Readers are
cautioned not to place undue reliance on these forward-looking statements, which
speak only as of their dates, and they should not be relied upon in making
purchasing decisions.

© 2015 SAP SE or an SAP affiliate company. All rights reserved. Customer 19

SAP Advanced Track and Trace for Pharmaceuticals
Technical solutions components

SAP ECC add-on SAP Advanced Track and Trace

SAP ECC add-on for SAP Advanced Track SAP Advanced Track and Trace for
and Trace for Pharmaceuticals 1.0 Pharmaceuticals 1.0

SAP ECC 6.0 (EhP 6) SAP Application Interface Framework 3.0

SAP NetWeaver 7.31 SAP NetWeaver 7.40 SP7

Database options
Any database as
supported by SAP or SAP HANA
NetWeaver 7.40

Supported languages:
English, German, French, Spanish, Portuguese, Russian,
Turkish, Danish, Chinese

© 2015 SAP SE or an SAP affiliate company. All rights reserved. Customer 20

SAP is making a difference

Simplify regulatory Integrate serialization into Manage the expected

reporting compliant with your business processes steep increase in
different international with SAP ERP, packaging serialization data volume
directives with country- line, and warehouse due to global serialization
specific content. integration. directives

SAP Advanced Track and Trace for Pharmaceutical

integrates with your internal business operations and with your supply chain network

© 2015 SAP SE or an SAP affiliate company. All rights reserved. Customer 21

Benefits: SAP Advanced Track and Trace for Pharmaceuticals

Comply Cost Scale

Effectively comply with Benefit from efficient Efficiently scale with a

global serialization integration of a corporate- pharmaceutical solution
requirements, including level pharmaceutical capable of handling large
different formats and serialization solution with your serialization data volumes.
country-specific reporting business processes and
from a single corporate supply chain network, while
serialization repository. reducing TCO and
compliance cost.

© 2015 SAP SE or an SAP affiliate company. All rights reserved. Customer 22

Thank you

© 2015 SAP SE or an SAP affiliate company. All rights reserved. Customer 23

© 2015 SAP SE or an SAP affiliate company. All rights reserved.

No part of this publication may be reproduced or transmitted in any form or for any purpose without the express permission of SAP SE or an
SAP affiliate company.

SAP and other SAP products and services mentioned herein as well as their respective logos are trademarks or registered trademarks of SAP SE
(or an SAP affiliate company) in Germany and other countries. Please see http://global12.sap.com/corporate-en/legal/copyright/index.epx for additional trademark
information and notices.

Some software products marketed by SAP SE and its distributors contain proprietary software components of other software vendors.

National product specifications may vary.

These materials are provided by SAP SE or an SAP affiliate company for informational purposes only, without representation or warranty of any kind, and SAP SE or its
affiliated companies shall not be liable for errors or omissions with respect to the materials. The only warranties for SAP SE or
SAP affiliate company products and services are those that are set forth in the express warranty statements accompanying such products and services, if any. Nothing
herein should be construed as constituting an additional warranty.

In particular, SAP SE or its affiliated companies have no obligation to pursue any course of business outlined in this document or any related presentation, or to develop or
release any functionality mentioned therein. This document, or any related presentation, and SAP SE’s or its affiliated companies’ strategy and possible future
developments, products, and/or platform directions and functionality are all subject to change and may be changed by SAP SE or its affiliated companies at any time for
any reason without notice. The information in this document is not a commitment, promise, or legal obligation to deliver any material, code, or functionality. All forward-
looking statements are subject to various risks and uncertainties that could cause actual results to differ materially from expectations. Readers are cautioned not to place
undue reliance on these forward-looking statements, which speak only as of their dates, and they should not be relied upon in making purchasing decisions.

© 2015 SAP SE or an SAP affiliate company. All rights reserved. Customer 24