AbbVie OER - SerializationMary L. Gimenez – AbbVie Inc. Gagan Bhasin – Krypt Inc.SESSION CODE: HS2034

§  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

§  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

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

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 HANACorporate§  Founded in 2008§  Team: 80+ in the US and 25+ in India§  Presence throughout U.S. and in India; HQ in Santa Clara, CACustomers§  Serve companies in 35 countries, mostly Fortune Global 500§  Over 95% of customers have been repeat customersFinancials§  Privately held; 100% (YoY) revenue growth in 2013; annualized rate of 260% revenue

growth over past three yearsThought 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.

Discussion TopicsAbbVie’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  

Coding & Serialization Requirements Global & US

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  

Product Serialization

AbbVie Product Serialization Objectives

Achieve  traceability  regulatory  compliance  

Assure  supply  of  products  to  markets  

Leverage  serializa4on  and  traceability  technology  to  achieve    business  value  

Discussion TopicsAbbVie’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  

Track & Trace’s old Architecture

PCE  AP5  (ROCIT)  

Packaging Edge Systems

Distribution Edge Systems

Antares  

Internal External

TPCM  AbboC  

TPM      VeCer  

TPM      Aesica  

3PL  

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.

Discussion TopicsAbbVie’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  

Aii and OER EvaluationAii  •  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  

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  

Even

t  Man

agem

ent  

O E R  

PI  

AII  (Central  Service)  

Event  Management  

Even

t  Man

agem

ent  

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  

Even

t  Man

agem

ent  

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

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.  

Object Event Management Object Tracking = Managing Reservoir of Object & Event Information

Discussion TopicsAbbVie’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  

Track & Trace’s new Architecture

Discussion TopicsAbbVie’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  

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.)”  

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  

Q & A

STAY INFORMED

Follow the ASUGNews team: Tom Wailgum: @twailgum Chris Kanaracus: @chriskanaracus Craig Powers: @Powers_ASUG

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