life science track and trace case study
TRANSCRIPT
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
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
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.
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
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
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