SAP Auto-ID Solutions

Preventing pharmaceutical diversions and counterfeiting Stephen Cloughley, Sr. Director, SAP Labs LLC

2011 SAP AG. All rights reserved.

Traceability
history & credentials

RFID evolution

SAP engagement

Genesis: 1998-2003
First software company to participate in MIT Auto-ID Center, spawning EPCglobal Claus Heinrich, SAP Executive Board, authored the book RFID and Beyond METRO Group Future Store: 2003 Wall Street Journal European Innovations Award

Early years: 2004-2005

Prototype from SAP becomes SAP Auto-ID Infrastructure (SAP AII)
capture of serialized data from devices at local sites provide the business context to turn the data into meaningful business events Visionary adoption: Purdue Pharma, Annin, World Kitchen, Pacific Cycle, Kimberly-Clark

Accelerating innovation: 2006-2007

Wide adoption for pharmaceutical anti-counterfeiting mandates (California and beyond) GS1 EPCIS compliance Broader value proposition: Pratt & Whitney; Airbus; Biomet, Jena, Daimler.

2011 SAP AG. All rights reserved.

RFID evolution

SAP engagement

Today and tomorrow

Food Safety Modernization Act driving adoption in food & beverage Anti-counterfeiting SAP AII platform in China, India, Brazil, Turkey. Alignment with new value proposition in retail
Focus moved from logistics to item tagging for in-store improvement (VICS, WalMart, U Arkansas data)

SAP Future Retailing Center (Regensdorf)

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Pharmaceutical mandate

California ePedigree
Board of Pharmacy
Pedigree: means a record, in electronic form containing information regarding each transaction resulting in a change of ownership of a given dangerous drug, from sale by a manufacturer, through acquisition and sale by one or more wholesalers, manufacturers, or pharmacies, until final sale to a pharmacy or other person furnishing, administering or dispensing the dangerous drugs. The pedigree shall be created and maintained in an interoperable electronic system, ensuring compatibility throughout all stages of distribution. (California Business and Professions Code section 4034(a)).

The electronic pedigree must contain specific information required by statute, and must be made and passed in an interoperable electronic system, an electronic track and trace system based on unique identification numbers (serialization) affixed at the point of manufacture.

2011 SAP AG. All rights reserved.

Pedigree requirement: Prescription drugs/devices; Veterinary drugs; Hospitals; Samples; Injectables; Generics; Biologics; Radiology

SAP solution platform

SAP Solution for Auto-ID and item serialization

Automated Action Situational Insight
Events Tailored Information Content Decision

SAP OER Domain = Corporate lifecycle event management enabled traceability repository for uniquely identified product/ parts/ assets SAP AII Domain = Business Processes Automation with AutoID Data Capture

Things Generated Content

Execution Interaction

AII
Embedded

AII
DM

AII
DM

DM

Item serialized lifecycle traceability: SAP OER (object event repository) is a central, intra- and inter-enterprise repository for serialized item lifecycle information with in-built event management capabilities . SAP OER can record item product/ part related lifecycle data from distributed business, Auto-ID and sensor systems. SAP OER can be configured to report exceptions from business requirements and trigger actions such as workflow or messages. As an EPCIS repository it can be queried by external systems. AutoIDEnabled Process Automation: SAP AII (Auto-ID Infrastructure) verifies and translates auto-ID raw events received from device controllers against business requirements in online shop-floor environments . SAP AII automates ERP backend processes and notifies EPCIS events to SAP OER.
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Country Reporting

SFDA

Process business events Build hierarchical relations Link objects to delivery documents

Traceability to the patient in the hospital

Serialization at packaging line Create unique license plate for each saleable unit.
Data carrier Data content Product Code Serial-number Lot-number Expiry-date

Tracking & Tracing throughout entire Supply Chain Capture each action that is performed against a product items / case / pallet.
Pick / Pack / Ship

Product Verification Ensure product authenticity (at point of dispense or any other supply chain entity)

Goods issue

2011 SAP AG. All rights reserved.

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Solution Landscape
Readers Device management
Partner Device Management Solution

Edge execution

Process integration

Enterprise applications

SAP ERP

Capture interface

SAP OER
Query interfaces

SAP ITS mobile

Legacy

Function
Read, write, and transmit data to systems Manage multiple readers Cleanse data Operator workflow Translate raw data to business execution Enrich core functions with auto-ID data Decision support and execute transactions

Delivery
Physics and device expertise

System integration services: value generation with RFID

2011 SAP AG. All rights reserved.

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Quick Facts: SAP Auto-ID Infrastructure

Functional Domain

SAP business process execution with serialization in warehouse or production/packaging environment Receives business document requirements (e.g. delivery requirements) and translates Auto-ID data capture events into the business context for automated business document update in ERP including business document requirement verification at source of data capture

Integrates with SAP ERP for Business Process Automation, SAP Object Event Repository for item lifecycle & process tracking a and SAP Partner Device
Management Solutions

Core Function

Supports RFID, 2-D and linear barcode Supports iUID (UII), EPC and custom unique identifier schemes Translates Auto-ID raw events into the business context from ERP business process automation Updates SAP OER with Auto-ID events captured Enriches ERP ASN with Unique ID lists

2011 SAP AG. All rights reserved.

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SAP Auto-ID Infrastructure: Translating raw Auto-ID events into business context
Key Features Mapping and rules processing Activities that match business requirements Routing engine Prepackaged, configurable support for business process automation Local data persistence
Auto-ID Raw Events Translation Logic Business Processes Repository
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2011 SAP AG. All rights reserved.

SAP Auto-ID Infrastructure: Translating raw Auto-ID events into business context

Auto-ID Raw Events

Translation Logic

Business Processes Repository

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AII Cockpit Search Functions

By

Document Object Action (Observation)

Search

By By

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AII Cockpit Search Functions

By

Document Object

Search

By

By

Action (Observation)

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AII Cockpit Search Functions

By

Document Object

Search

By

By

Action (Observation)

2011 SAP AG. All rights reserved.

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SAP Object Event Repository

features SAP Event Management as a software component
VISIBILITY CONTROL

SAP OER is the global instance providing visibility on processes, assets as well as performance along your entire supply chain. Extract relevant process information from globally distributed systems & partners into one central repository.

Empowered by the extensive tracking & tracing functionalities of built-in SAP Event Management, SAP OER offers process monitoring, automated exception resolution mechanisms, proactive alerting as well as extensive reporting capabilities in one single solution

monitor

notify

adjust

analyze

Suppliers Retailers Non-SAP system 3 PLs

Subcontractors

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You can view OER data from different perspectives

Supply Chain Views

Lifecycle Current Configuration View

As-Built Configuration View

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In OER you can run concurrently multiple tracking/ visibility scenarios

KEY POINT: Here you can select different views i.e. tracking scenarios affording different views on the repository

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SAP OER Item / UII Lifecycle Tracking High Resolution Traceability & Situational Insight

on tracked items via freely configurable selection profile

to actual status of serialized products all across the globe

SAP OER stores each transaction that is performed for serialized products and serves as the global system of record.
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SAP OER Item / UII lifecycle Tracking High Resolution Traceability & Situational Insight

SAP OER stores hierarchies between objects along their entire lifecycle

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ID Tracking in OER WebUI

Selection and Search Results

EPCs encoded on RFID Tag

Ids encoded on 2-D Barcode

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Extensibility of SAP OER towards item part lifecycle traceability and custom EPCIS clients

Current location of product or asset instances

Cross-system configuration hierarchy tracking

Supply Chain Events

Product Information Services

Leverage of EPCIS query services

*OER = Object Event Repository

Leverage of EPCIS event capture notification

Relevant Doc References Relevant Attributes & updates Links to source systems Doc References Attributes & updates Transaction Links Doc References Attributes & updates Transaction Links

events

events

condition

ERP

ERP

ERP

3rd P

ERP

3rd P

Use Standard Capture Interface

SAP MII or MES

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GPS

SAP AII

Embedded SYS/ sensors

t 25

Regulatory reporting
with SAP OER

Regulatory Reporting with SAP OER

Solution architecture

Receiver 1 (ITS turkey)

Receiver 2 (PTS turkey)

Receiver 3 (SFDA China)

Any receiver

ITS msg

PTS msg

SFDA msg

Any format

SAP PI
Generic Notification

Regulatory Reporting
Flexible configuration engine Automatic creation & transfer of notifications Central UI for visibility & control

SAP OER

EPCIS event

AII

CMO

3rd party DC

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Regulatory reporting with SAP OER

Functional overview

Flexible configuration of notification types

Multiple notification types, configurable. Maintain: Process flow for each notification type (direct transmission / wait for batch release / wait for user approval) Notification characteristics for each notification type (Items only vs. hierarchies)

Automatic creation of notifications

Upon receipt of an EPCIS event, OER creates required notifications automatically Depending on configured process flow, OER directly transmits notifications or wait for further process milestones

Generic & future-proof message dispatching

SAP PI acts as dispatching engine, forwarding notifications to the configured endpoint PI contains country-specific message mappings, transforming generic notifications sent from OER into the target format Flexible framework: easily incorporate new receivers

2011 SAP AG. All rights reserved.

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Regulatory Reporting with SAP OER

Functional overview

Central UI

Full visibility into communication

All process steps are shown via event-based view Access the full message exchange (requests & responses) with the ministries directly from the UI

Process control & exception handling

Control reporting process: Approve notifications, retrigger notifications Automated alerting in case of failing notifications Automatic retriggering of failed notifications

Central source of information for global regulatory reporting Selection screen offers personalized & flexible queries on notification data

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Sample Screen Notification detail view

Event history & message access

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Notification detail view

Event history & Message access

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OER Notification view

Central UI for notification visibility & control

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Notification detail view

Event history & Message access

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Notification detail view

Event history & Message access

2011 SAP AG. All rights reserved.

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New capability
global batch traceability

SAP Global Batch Traceability

Problems solved: Querying of batch/lot data Relationship of lots/batches (bottom up and top down) Quantity accounting (material balance): what product(s) went to what customer(s) at what address(es)? Applies to serialized and non-serialized product

2011 SAP AG. All rights reserved.

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How does batch traceability relates to serialized item tracking?

SAP Global Batch Traceability
How a product came to be
Answers how a product was created Which batches of which materials went into each step of a product creation (product genealogy or batch network) Which instance serialized numbers were created for a finished product

SAP OER/ SAP Auto-ID Infrastructure

Records what happens during a product life
Answers what lifecycle events happened to an instance of a finished from birth to disposal/ consumption Item serialized product event traceability create product item lifecycle event line (track and traceability)

Answers the distribution of the remaining quantities of batches used in the production What other tracked objects can we consider: Handling units Serial Number List Purchase Orders Deliveries

2011 SAP AG. All rights reserved.

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SAP Traceability Strategy

Enable End-to-end Traceability of products, parts and assets - from raw material to point of consumption
Product Genealogy
Product ancestry: How a product item came to be

Product, part & asset lifecycle traceability

Life of a product item: What events happen to a product item

Batch ID Item serialized product instance

New

SAP Global Batch Traceability

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SAP Object Event Repository

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Selection of serialization customers (partial)

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Please visit our dedicated Auto-ID Website at: http://www.sap.com/RFID

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Where to find more functional information

For Solution & Functional Details kindly visit us @ http://help.sap.com/aii

and http://help.sap.com/saphelp_aii710/helpdata/de/48/bdf013bb660611e10000000a42189 b/frameset.htm

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Thank you!
Stephen Cloughley Sr. Director Auto-ID & Supply Network Traceability SAP Labs, LLC 3999 West Chester Pike Newtown Square PA, USA Office +1 610 661-1000 Mobile +1 267 312-0326 Stephen.cloughley@sap.com www.sap.com