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SAP Auto-ID Solutions

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

© 2011 SAP AG. All rights reserved.

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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.

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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)

© 2011 SAP AG. All rights reserved.

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Pharmaceutical mandate .

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The electronic pedigree must contain specific information required by statute. Generics. Radiology 7 . All rights reserved. administering or dispensing the dangerous drugs. Veterinary drugs. through acquisition and sale by one or more wholesalers. Injectables. ensuring compatibility throughout all stages of distribution. and must be made and passed in an “interoperable electronic system. from sale by a manufacturer. © 2011 SAP AG.  Pedigree requirement: Prescription drugs/devices.California ePedigree Board of Pharmacy Pedigree: “means a record.” an electronic track and trace system based on unique identification numbers (serialization) affixed at the point of manufacture.” (California Business and Professions Code section 4034(a)). manufacturers. in electronic form containing information regarding each transaction resulting in a change of ownership of a given dangerous drug. or pharmacies. Samples. Hospitals. The pedigree shall be created and maintained in an interoperable electronic system. Biologics. until final sale to a pharmacy or other person furnishing.

SAP solution platform .

intra. AutoID–Enabled 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 OER can be configured to report exceptions from business requirements and trigger actions such as workflow or messages. 9 . Auto-ID and sensor systems.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. All rights reserved.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. SAP AII automates ERP backend processes and notifies EPCIS events to SAP OER. © 2011 SAP AG. As an EPCIS repository it can be queried by external systems.

Pick / Pack / Ship Product Verification Ensure product authenticity (at point of dispense or any other supply chain entity) Goods issue © 2011 SAP AG. 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. 10 . All rights reserved.Country Reporting 监管码印刷规范 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.

All rights reserved. 11 .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. 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. write.

SAP Object Event Repository for item lifecycle & process tracking a and SAP Partner Device Management Solutions Core Function • • • • • Supports RFID.g. 12 .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. All rights reserved. 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. 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. 2-D and linear barcode Supports iUID (UII).

configurable support for business process automation Local data persistence Auto-ID Raw Events Translation Logic Business Processes Repository 13 © 2011 SAP AG. All rights reserved.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. .

All rights reserved. .SAP Auto-ID Infrastructure: Translating raw Auto-ID events into business context Auto-ID Raw Events Translation Logic Business Processes Repository 14 © 2011 SAP AG.

16 .AII Cockpit Search Functions  By Document Object Action (Observation) Search  By  By © 2011 SAP AG. All rights reserved.

AII Cockpit Search Functions  By Document Object Search  By  By Action (Observation) © 2011 SAP AG. All rights reserved. 17 .

AII Cockpit Search Functions  By Document Object Search  By  By Action (Observation) © 2011 SAP AG. 18 . All rights reserved.

 Extract relevant process information from globally distributed systems & partners into one central repository. SAP OER offers process monitoring. automated exception resolution mechanisms.SAP Object Event Repository features SAP Event Management as a software component VISIBILITY CONTROL  SAP OER is the global instance providing visibility on processes. All rights reserved. assets as well as performance along your entire supply chain. proactive alerting as well as extensive reporting capabilities in one single solution monitor notify adjust analyze Suppliers Retailers Non-SAP system 3 PLs Subcontractors © 2011 SAP AG.  Empowered by the extensive tracking & tracing functionalities of built-in SAP Event Management. 19 .

20 .You can view OER data from different perspectives… Supply Chain Views Lifecycle „Current“ Configuration View As-Built Configuration View © 2011 SAP AG. All rights reserved.

All rights reserved.In OER you can run concurrently multiple tracking/ visibility scenarios KEY POINT: Here you can select different views – i. tracking scenarios affording different views on the repository © 2011 SAP AG.e. 21 .

22 . © 2011 SAP AG. All rights reserved.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.

SAP OER Item / UII lifecycle Tracking High Resolution Traceability & Situational Insight SAP OER stores hierarchies between objects along their entire lifecycle © 2011 SAP AG. 23 . All rights reserved.

24 . All rights reserved.ID Tracking in OER WebUI Selection and Search Results EPCs encoded on RFID Tag Ids encoded on 2-D Barcode © 2011 SAP AG.

GPS SAP AII Embedded SYS/ sensors t 25 . All rights reserved.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 © 2011 SAP AG.

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 © 2011 SAP AG. 27 . All rights reserved.

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. hierarchies) Automatic creation of notifications  Upon receipt of an EPCIS event. OER directly transmits notifications or wait for further process milestones Generic & future-proof message dispatching  SAP PI acts as dispatching engine. 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. configurable.Regulatory reporting with SAP OER Functional overview Flexible configuration of notification types Multiple notification types. All rights reserved. 28 . OER creates required notifications automatically Depending on configured process flow.

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   © 2011 SAP AG. 29 . All rights reserved.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.

All rights reserved.Sample Screen Notification detail view Event history & message access © 2011 SAP AG. 30 .

31 .Notification detail view Event history & Message access © 2011 SAP AG. All rights reserved.

32 .OER Notification view Central UI for notification visibility & control © 2011 SAP AG. All rights reserved.

All rights reserved.Notification detail view Event history & Message access © 2011 SAP AG. 33 .

All rights reserved. 34 .Notification detail view Event history & Message access © 2011 SAP AG.

New capability global batch traceability .

37 . All rights reserved.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.

38 .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.

parts and assets .from raw material to point of consumption Product Genealogy Product ancestry: How a product item came to be Product. SAP Object Event Repository 39 . All rights reserved.SAP Traceability Strategy Enable End-to-end Traceability of products. 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 © 2011 SAP AG.

40 . All rights reserved.Selection of serialization customers (partial) © 2011 SAP AG.

41 . All rights reserved.Please visit our dedicated Auto-ID Website at: http://www.sap.com/RFID © 2011 SAP AG.

com/saphelp_aii710/helpdata/de/48/bdf013bb660611e10000000a42189 b/frameset.sap. 42 .Where to find more functional information For Solution & Functional Details – kindly visit us @ http://help.sap.htm © 2011 SAP AG.com/aii and http://help. All rights reserved.

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