SAP Auto-ID Solutions Preventing pharmaceutical diversions and counterfeiting

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2 Traceability history & credentials

3 RFID evolution SAP engagement Genesis: 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: 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: Wide adoption for pharmaceutical anti-counterfeiting mandates (California and beyond) GS1 EPCIS compliance Broader value proposition: Pratt & Whitney; Airbus; Biomet, Jena, Daimler SAP AG. All rights reserved. 3

4 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. 4

5 Pharmaceutical mandate

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7 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. Pedigree requirement: Prescription drugs/devices; Veterinary drugs; Hospitals; Samples; Injectables; Generics; Biologics; Radiology 2011 SAP AG. All rights reserved. 7

8 SAP solution platform

9 SAP Solution for Auto-ID and item serialization Events Tailored Information Content Decision Situational Insight Automated Action SAP OER Domain = Corporate lifecycle event management enabled traceability repository for uniquely identified product/ parts/ assets Things Generated Content Execution Interaction Embedded AII AII AII DM DM DM SAP AII Domain = Business Processes Automation with Auto- ID Data Capture 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. 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 AII automates ERP backend processes and notifies EPCIS events to SAP OER SAP AG. All rights reserved. 9

10 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. 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 Goods issue Product Verification Ensure product authenticity (at point of dispense or any other supply chain entity) 2011 SAP AG. All rights reserved. 10

11 Partner Device Management Solution Solution Landscape Readers Device management 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 Delivery Manage multiple readers Cleanse data Operator workflow Physics and device expertise Translate raw data to business execution Enrich core functions with auto-id data System integration services: value generation with RFID Decision support and execute transactions 2011 SAP AG. All rights reserved. 11

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.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. 12

13 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 2011 SAP AG. All rights reserved. 13

18 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 Non-SAP system Retailers Subcontractors 3 PLs 2011 SAP AG. All rights reserved. 19

20 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 2011 SAP AG. All rights reserved. 21

21 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 AG. All rights reserved. 22

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

24 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 events Doc References Attributes & updates events Doc References Attributes & updates condition Links to source systems Transaction Links Transaction Links ERP ERP ERP 3rd P ERP 3rd P Use Standard Capture Interface SAP MII or MES GPS SAP AII Embedded SYS/ sensors 2011 SAP AG. All rights reserved. 25 t

25 Regulatory reporting with SAP OER

26 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 SAP OER Regulatory Reporting Flexible configuration engine Automatic creation & transfer of notifications Central UI for visibility & control EPCIS event AII CMO 3rd party DC 2011 SAP AG. All rights reserved. 27

27 Regulatory reporting with SAP OER Functional overview Flexible configuration of notification types Automatic creation of notifications Generic & future-proof message dispatching 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) 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 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. 28

28 Regulatory Reporting with SAP OER Functional overview Central UI Full visibility into communication Process control & exception handling Central source of information for global regulatory reporting Selection screen offers personalized & flexible queries on notification data All process steps are shown via event-based view Access the full message exchange (requests & responses) with the ministries directly from the UI Control reporting process: Approve notifications, retrigger notifications Automated alerting in case of failing notifications Automatic retriggering of failed notifications 2011 SAP AG. All rights reserved. 29

34 New capability global batch traceability

35 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. 37

36 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. 38

37 SAP Traceability Strategy Enable End-to-end Traceability of products, parts and assets - from raw material to point of consumption Product Genealogy Product, part & asset lifecycle traceability Product ancestry: How a product item came to be Life of a product item: What events happen to a product item Batch ID Item serialized product instance SAP Global Batch Traceability New SAP Object Event Repository 2011 SAP AG. All rights reserved. 39

41 Thank you! Stephen Cloughley Sr. Director Auto-ID & Supply Network Traceability SAP Labs, LLC 3999 West Chester Pike Newtown Square PA, USA Office Mobile