Drug Supply Chain Security Act Compliance Serialization epedigree Challenges and Potential Benefits to Manufacturers

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1 Drug Supply Chain Security Act Compliance Serialization epedigree Challenges and Potential Benefits to Manufacturers Joe Whyte Rockwell Automation Global Serialization Lead Ph: Presenter Joe Whyte joined Rockwell Automation in 2006 and is currently the company s Global Serialization Lead. His background at Rockwell Automation includes Strategic LifeSciences OEM Sales and Corporate Global LifeSciences Account Management. Given the challenges that manufacturers face with global deployments, since 2009 Whyte has focused on the development, launch and delivery of a holistic serialization solution that encompasses all five layers of the serialization epedigree data model. Rockwell Automation has developed a holistic serialization solution that offers customers an opportunity to realize a return on their regulatory compliance investment by leveraging serialization data and the real time visibility to customers and products that it provides. Rockwell Automation empowers its customers by using commercial off the shelf PLC hardware, non proprietary code and Ethernet/IP to deliver packaging line serialization solutions that are modular, reusable and scalable. As a global leader of Manufacturing Execution Systems, Rockwell Automation has leveraged its core capabilities to create an interoperable holistic serialization solution that connects operations and the supply chain to the business enterprise, while hosting a customer s serialization and supply chain event data in its strategic partner, Microsoft s Azure Cloud Computing Platform. 2 1

2 Agenda Serialization, Aggregation, Track & Trace Serialization Track & Trace Implementation Challenges Benefits of Serialization epedigree Track & Trace 3 What is Serialization? Serialization is the Application of Unique Serial Numbers to Packages Aggregation is the association of all primary package serial numbers to their lower level sub package serial numbers in parent/child relationships. Pallet to Cases (Parent/Children) Cases to Bundles (Parent/Children) Bundles to Units (Parent/Children) Unit Bundle Case Pallet

3 Holistic Serialization Solution 5 Holistic Serialization Solution 6 3

4 Why Serialize? 7 Why Serialize? 8 4

5 GS1, EPCIS & Global Interoperability GSI An International not for profit association with over 100 country organizations Design and implement global standards and solutions that improve efficiency and visibility of supply and demand chains globally across sectors. Most widely used supply chain standards system in the world. GS1 Standards Barcode Standards Data Accuracy Standards ecom Standards EPC Standards GDSN Standards Global Data Dictionary GPC Standards XML Standards EPCIS: Electronic Product Code Information Services Enables disparate applications to leverage EPC data via EPC-related data sharing, both within and across enterprises. 9 Agenda Serialization, Aggregation, Track & Trace Serialization Track & Trace Implementation Challenges Benefits of Serialization epedigree Track & Trace 10 5

6 Level 0 and Level 1 Challenges - Serialized Packaging Lines With Aggregation 11 Level 2 Level 4 Challenges - Data Integration & Data Management EPCIS ERP Site Serial Serial range number EPC data EPC event Wholesaler Pharmacist External Supply Chain Level 4 GTIN SSCC Batch number Internal Order Supply number (Enterprise) Order Order endchain status Order start Produced quantity Expiry Prod. date date AlarmsPlant A Plant B Contractor OEE data Level 3 Serialization-relevant Shop data Floor is A1widely distributed A2 over B1 different B2Automation C1 and Information Systems at different ISA-95 levels! Line A1-1 Order number Order status GTIN SSCC SSCC Batch number Order end Level 2 Alarms Order start Produced quantity Serial number OEE data Shop Expiry date EPC data EPC event Prod. date Line configuration Unit configuration Floor Print data DM data Label Layout Level 0,1 Packaging size Cartoner Bundler Case Packer Palletizer Verification data 12 6

7 Level 2 Level 4 Data Management Challenges 13 Level 3 - Site Server Database Challenges 14 7

8 Level 5 Supply Chain Challenges - Data Accessibility, Management & Security 15 Level 5 - Forward / Reverse Logistic Challenges 16 8

9 Mission Critical Asset Support - Enhanced Multiple Security Levels 17 Agenda Serialization, Aggregation, Track & Trace Serialization Track & Trace Implementation Challenges Benefits of Serialization epedigree Track & Trace 18 9

10 Benefits of Serialization epedigree 19 Benefits of Serialization Connecting the Enterprise 20 10

11 Prediction - All manufacturers in all industries will serialize their products within 10 years Business benefits - A common data source for: Real time product consumption & demographic data Customer buying behavior information Brand protection, brand loyalty, compliance. Big Data from manufactured products will optimize businesses by serving as a common thread across their connected enterprise Various departments will use the common data for their specific needs In the Internet of Everything world, a company s serialization data, when used to optimize the way a business operates, will become one of its most valuable assets 21 Questions? 21 11

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