SAP Advanced Track and Trace

SAP Advanced Track and Trace for PharmaceuticalsSolution 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)

https://en.wikipedia.org/wiki/Red_pill_and_blue_pill

Market Requirements


International legislation fighting the counterfeiting/ falsification of

medicinal drugs requiring serialization

1In 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


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


INTEGRATION

Functional overview

SAP Advanced Track and Trace for Pharmaceuticals

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 collaborationPackaging line

integration

Warehouse

operations

Audits and internal

reporting

Compliant

messaging

LegendMAH: 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.


SAP Advanced Track and Trace for PharmaceuticalsTechnical 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 7.40SAP 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 volumedue 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

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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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