SAP Advanced Track and Trace

SAP Advanced Track and Trace for Pharmaceuticals
Solution Overview
Dr. Oliver Nürnberg
Product Owner SAP Life Sciences
September 24, 2015 Customer

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

International legislation fighting the counterfeiting/ falsification of
medicinal drugs requiring serialization
1
In response to and with the aim to counter the large scale counterfeiting/ falsification of medicinal
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.

Why will it become BIG DATA?
Scale of international legislation calling for serialization of drugs
USA
• Serialization by Nov. 2017
• Full value chain track & trace by 2023
• ~31% of global sales affected
EU
• Serialization Q1/2019
• Point of dispense verification
CHINA
• Serialization in effect
• Reporting S/N to China FDA DB
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.
Significant increase in volume of serialized items
Different reporting needs for compliance

The implementation of these legislations require serial numbers be
encoded in 2-D barcodes
2
GTIN (Global Trade Item Identification Number)
Expiration Date (YYMMDD)
Batch or Lot Number
Serial Number
Source: 2-D Matrix barcode courtesy of GS1 Germany
 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
to their aggregations to bundles, cases and then
pallets - either for compliance or logistical reasons.
 The 2-D barcode typically contains the following
elements:
 Global Trade Identification Number
 Expiration date
 Batch/ lot Number
 Serial number
The implementation of these
legislations require serial numbers be
encoded in 2-D barcodes

Overview of legislation and reporting
3
Serialization with reporting to a
governmental database
Serialization with reporting to an
institutional database for
mandatory verification at the
point-of-dispense
Serialization with reporting along to
the supply chain
in effect
expected
enacted enacted & partially in force
Presently there are 3 types of compliance requirements
expected

Requirements imposed on Pharma Manufacturers and the Pharma
Value Chain
4
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

Resulting key business challenges
4
3
How do I efficiently manage my global serial number pool?2
How do I efficiently comply with many country-specific compliance
and reporting requirements on drug trade item serialization?
1
5
How do I efficiently integrate serialization with my business
processes and systems?
How do I efficiently message serialization data to my business
partners?
How do I scale with the expected data volume arising from
serialization?

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 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”
with 13 companies
 9 of top 20 pharma companies
 1 top 3 US Wholesaler
Significant investment from Co-Innovation customers
 more than 400 people-days spent in workshops with SAP
development (plus homework)
 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
SAP Advanced Track and Trace for Pharmaceuticals is available to the market since
September 15, 2015

Quick Overview of SAP Advanced Track
and Trace for Pharmaceuticals

Solution overview
any middleware
SAP application interface framework
Predefined message content
pack line/
device
ERP/
WM
government
3PLs, CMOs
wholesalers
SAP Advanced
Track and Trace for
Pharmaceuticals
SAP Advanced Track and
Trace for Pharmaceuticals
provides a corporate serialization
repository and serial number
management solution tightly
integrated into supply chain and
warehouse management
processes with regulatory reporting
interfaces and content supporting
compliance to international
legislation to fight falsified
medicines!
Available country version reporting
lot

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

INTEGRATION
Functional overview
REPOSITORY
 Capture and store objects, events
and business transactions
 Ad-hoc reporting with repository
browser
 Deployable on SAP HANA or
classic databases
SAP Application Interface Framework (integral solution
software component)
 Integration to business partners, packaging line, SAP ERP, LES WMS and
regulatory reporting, EPCIS capture interface
 Business and technical monitoring of all messages with restart option in case
of transmission failure
MESSAGING
Regulatory reporting /
rules engine
 Rule framework for regulatory
reporting and business rules
 Message mapping and handling
 Number import for China
 Country packages included in first
release: Turkey, China, and
Argentina, U.S. DQSA for lot
traceability
ERP system integration
 Material, business partner, location
master data
 ERP transactions (deliveries,
production / process order)
 Batch / Lot
WMS integration toolkit
 Real-time verification with data in
repository
 Integration with receiving, internal
movement and goods issues, and
cycle counting
Serial number management
 Define number format and ranges
 Randomization
 Assign ranges and S/N lists to
consumers
 Receive lists and ranges
 CN: import China product master
and serial numbers from files
Packaging line integration
 Serial number interface (request
list and range, status update)
 PML or EPCIS capture interface

High level process scope delivered by the solution
Pharma
MAH
Contract
manufacturers
3PL
Authorities
Wholesaler
Request and receive
serial numbers (lists &
ranges) from MAH
Send serial usage data
Send regulatory
reporting messages to
authorities
Send messages to
business partner
SAP Advanced Track and Trace for Pharmaceutical
delivers compliant reporting and integrates with your internal business operations and with your supply
chain network.
CMO collaboration
Packaging line
integration
Warehouse
operations
Audits and internal
reporting
Compliant
messaging
Legend
MAH: market authorization holder (brand owner/ OEM) | CMO: contract manufacturing organization | 3PL: third-party logistics provider | PML: Product Markup language
Web services EPCIS + PML Warehouse toolkit Repository Browser Interfaces & country
versions

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

Product details
Regulatory reporting: availability of country version content
Regulatory reporting to MoH
databases
Country version packages are
available for SAP Advanced Track
and Trace for Pharmaceuticals,
version 1.0:
• China
• Turkey
• Argentina
Further country version content is
planned subject to the availability to
reliable and sufficient quality
specifications.
Supply chain partner
notification for US DQSA lot
traceability
SAP Advanced Track and Trace for
Pharmaceuticals, version 1.0 further
supports EPCIS notification
messages from supply chain partners
to support U.S. DQSA lot traceability
compliance requirements
Available for country reporting compliance Outlook / road map*
*Legal Disclaimer: SAP has 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's strategy and possible future developments, products and or platforms
directions and functionality are all subject to change and may be changed by SAP
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
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.

Technical solutions components
SAP NetWeaver 7.31
SAP ECC 6.0 (EhP 6)
SAP ECC add-on for SAP Advanced Track
and Trace for Pharmaceuticals 1.0
SAP ECC add-on
SAP NetWeaver 7.40 SP7
SAP Application Interface Framework 3.0
SAP Advanced Track and Trace for
Pharmaceuticals 1.0
Supported languages:
English, German, French, Spanish, Portuguese, Russian,
Turkish, Danish, Chinese
Any database as
supported by SAP
NetWeaver 7.40
SAP HANAor
Database options
SAP Advanced Track and Trace

SAP is making a difference
Integrate serialization into
your business processes
with SAP ERP, packaging
line, and warehouse
integration.
Manage the expected
steep increase in
serialization data volume
due to global serialization
directives
Simplify regulatory
reporting compliant with
different international
directives with country-
specific content.
SAP Advanced Track and Trace for Pharmaceutical
integrates with your internal business operations and with your supply chain network

Benefits: SAP Advanced Track and Trace for Pharmaceuticals
Effectively comply with
global serialization
requirements, including
different formats and
country-specific reporting
from a single corporate
serialization repository.
Benefit from efficient
integration of a corporate-
level pharmaceutical
serialization solution with your
business processes and
supply chain network, while
reducing TCO and
compliance cost.
Efficiently scale with a
pharmaceutical solution
capable of handling large
serialization data volumes.
Comply Cost Scale

Thank you

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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.

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