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Life science track and trace case study

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Life science track and trace case study

  1. 1. AbbVie OER - Serialization
 Mary L. Gimenez – AbbVie Inc. 
 Gagan Bhasin – Krypt Inc. SESSION CODE: HS2034
  2. 2. §  Typical Pharmaceutical Product Serialization Requirements §  Fit/gap analysis with Aii and OER §  Leverage Event Management in OER for Serial Number Management §  Aii can be optional in the Serialization architecture LEARNING POINTS
  3. 3. §  Identify Stakeholders and decision makers upfront during the project §  Utilize ASAP methodology §  Work Shops to walk thru current and future Business Process flows §  Evaluate available standard components §  Use Service Oriented Architecture for Interfaces to OER §  Work as ONE team – from different areas BEST PRACTICES
  4. 4. 
 AbbVie – A Broad and Strong Foundation Medicines available in 170+ countries 19 R&D and manufacturing facilities Portfolio of market-leading medicines Compelling new product pipeline $19.9 billion in 2014 sales 

  5. 5. A niche systems integrator in the Supply Chain space providing unique and high-value solutions using SAP technologies like GTS, WM/EWM, TM, GRC, BI and HANA Corporate §  Founded in 2008 §  Team: 80+ in the US and 25+ in India §  Presence throughout U.S. and in India; HQ in Santa Clara, CA Customers §  Serve companies in 35 countries, mostly Fortune Global 500 §  Over 95% of customers have been repeat customers Financials §  Privately held; 100% (YoY) revenue growth in 2013; annualized rate of 260% revenue growth over past three years Thought Leadership §  Authored 6 books and 65+ white papers published by SAP Press §  Invited to speak at business, industry, and SAP conferences, and expert round-tables §  Continuous investment in R&D; co-innovation with SAP on GRC, SCM and Analytics suite About Krypt Inc.
  6. 6. Discussion Topics AbbVie’s  Product  Serializa4on  Objec4ves   Track  and  Trace’s  old  architecture  and   challenges  faced   Evalua4on  of  Aii  and  OER       Track  and  Trace’s  new  architecture   Func4onali4es  built  in  OER   Q  &  A  
  7. 7. Coding & Serialization Requirements 
 Global & US
  8. 8. Issues & Opportunities 
 Pharmaceutical Supply Chain Lack  of   Supply   Chain   Visibility   Compliance   Issues   High  cost  of   Recalls   Returns,   Shipment   inaccuracy  and   inefficiency   Track   Trace   Report  Assign   Track  &Trace   Needs   Issues   Warehouse/3PL   Distributor   Pharmacy/   Dispenser   Manufacturer /  CMO   Supply  Chain   Par7cipants   Opportuni7es   Value  Apps  
  9. 9. 
 Product Serialization
  10. 10. AbbVie Product Serialization Objectives Achieve  traceability   regulatory  compliance   Assure  supply  of  products  to   markets   Leverage  serializa4on  and   traceability  technology  to   achieve    business  value  
  11. 11. Discussion Topics AbbVie’s  Product  Serializa4on  Objec4ves   Track  and  Trace’s  old  architecture  and   challenges  faced   Evalua4on  of  Aii  and  OER       Track  and  Trace’s  new  architecture   Func4onali4es  built  in  OER   Q  &  A  
  12. 12. Track & Trace’s old Architecture PCE  AP5  (ROCIT)   Packaging Edge Systems Distribution Edge Systems Antares   Internal External TPCM   AbboC   TPM       VeCer   TPM       Aesica   3PL  
  13. 13. Challenges faced Isolated  Solu4ons   • Serial  number  management  and   regulatory  repor4ng  func4onality   cascaded  down  to  produc4on  lines   • No  visibility  as  there  is  no  object   event  capture  at  present   Extensive  Manual  Efforts   • Extensive  manual  work  in  place  for   China,  South  Korea  &  Turkey   • In  2015  need  to  meet  coding  &   serializa4on  requirements  for   Argen4na,  Brazil,  Saudi  Arabia  and   Taiwan   Difficult  to  comply   • DQSA  1/2015  deadline  to  provide   lot  level  traceability  including  TS,  TI,   TH   • Genera4on  of  randomized  serial   numbers  for  market  requirements   Failure to meet regulations impact our ability to sell products in specific markets.
  14. 14. Discussion Topics AbbVie’s  Product  Serializa4on  Objec4ves   Track  and  Trace’s  old  architecture  and  challenges   faced   Evalua4on  of  Aii  and  OER       Track  and  Trace’s  new  architecture   Func4onali4es  built  in  OER   Q  &  A  
  15. 15. Aii and OER Evaluation Aii   •  SN  Range  only   •  Store  serialized  transac4ons   (XML/PML),  not  EPCIS  format   •  Packaging  systems  had  Site   managers,  Aii  is  redundant   •  Packaging  Edge  can  provide   EPCIS  data  format   •  Not  an  Event  repository   OER   •  EPCIS  Cer4fied   •  Aii  Master  Data  in  OER   •  Supports  SN  Range   •  BRF+  (Rule  Engine)   •  Event  Management   •  Stores  and  manages  millions  of   object  id  events  
  16. 16. Requirement Gaps
 Solution Alternatives Alterna7ve   Approach   Enhance   Enhance  OER  Custom  development   Add-­‐on   Implement  SAP  Partner  add-­‐on  to  OER   Integrate   Implement  non-­‐SAP    Solu4ons     Leverage   Leverage  core  base  of  OER  –  Event  Management  –  to  resolve   gaps  
  17. 17. Event  Management   O E R   PI   AII   (Central   Service)   Event   Management   Event  Management   Typical  Implementa4on   • EPCIS  Event  Capture   No4fica4on   • EPCIS  Simple  Event  Query   • Std  Process  &  System   Integra4on   • Central  S/N  Range   Management   • ID  Mapping   • Vocabulary,  Master   Data   • Loca4on  Based  Security   • Object  Hierarchy   Event  Tracking   • Document  Tracking   • Web  UI   • Archiving   Event  Management   AbbVie  Implementa7on   • EPCIS  Event  Capture   No4fica4on   • EPCIS  Simple  Event  Query   • ID  Mapping   • Vocabulary,  Master   Data   • Object  Hierarchy   Event  Tracking   • SN  Get-­‐to-­‐go  (w   BRFplus)   • Archiving   Are  we  ‘Modifying’  OER  by  doing  this?   Let’s  understand  ‘What  is  SAP  EM’  to  answer  this.   Solution Alternatives
 Leverage : SAP OER – Components & their functions
  18. 18. Solution Alternatives
 Leverage : SAP EM Flexibility Are  we  ‘Modifying’   OER  by  using  core   component  of  SAP   OER  –  Event   Management  –  for   Event-­‐based  S/N   Inventory  Tracking  ?       No.  We  are  using  SAP   Event  Management  to   support  Company   Specific  Scenario.  
  19. 19. Object Event Management
 Object Tracking = Managing Reservoir of Object & Event Information
  20. 20. Discussion Topics AbbVie’s  Product  Serializa4on  Objec4ves   Track  and  Trace’s  old  architecture  and   challenges  faced   Evalua4on  of  Aii  and  OER       Track  and  Trace’s  new  architecture   Func4onali4es  built  in  OER   Q  &  A  
  21. 21. Track & Trace’s new Architecture
  22. 22. Discussion Topics AbbVie’s  Product  Serializa4on  Objec4ves   Track  and  Trace’s  old  architecture  and   challenges  faced   Evalua4on  of  Aii  and  OER       Track  and  Trace’s  new  architecture   Func4onali4es  built  in  OER   Q  &  A  
  23. 23. Product Serialization
 Processes Commissioning   (Marriage  of  a   Number  to  a   Product)   SN  Get-­‐to-­‐Go  (G2G)   Produc4on  &  Packaging   Object  Tracking   (Commission  to   Dispense  –  C2D)   In  Scope   GS1 Implementation Guide for Pharma.: “EPCIS  is  a  GS1  Standard  for  capturing  and  communica4ng  data  about  the   movement  and  status  of  objects  in  the  supply  chain  (e.g.,  products;  logis4cs  units;  returnable  assets;  etc.)”  
  24. 24. Discussion Topics AbbVie’s  Product  Serializa4on  Objec4ves   Track  and  Trace’s  old  architecture  and   challenges  faced   Evalua4on  of  Aii  and  OER       Track  and  Trace’s  new  architecture   Func4onali4es  built  in  OER   Q  &  A  
  25. 25. Q & A
  26. 26. STAY INFORMED Follow the ASUGNews team: 
 Tom Wailgum: @twailgum
 Chris Kanaracus: @chriskanaracus
 Craig Powers: @Powers_ASUG
  27. 27. THANK YOU FOR PARTICIPATING Please  provide  feedback  on  this  session  by  comple4ng   a  short  survey  via  the  event  mobile  applica4on.   SESSION  CODE:  HS2034   For  ongoing  educa7on  on  this  area  of  focus,   visit