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Implementing Global Data Standards for UDI Compliance in Manufacturing: Cook's Journey

Explore how Cook, with 9 manufacturing companies and 10 clinical divisions in 135 countries, achieved UDI compliance by sorting products, forming teams, and implementing changes like labeling and data verification.

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Implementing Global Data Standards for UDI Compliance in Manufacturing: Cook's Journey

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  1. Data Standards Implementation Chuck Franz Vice President & Chief Information Officer IMDMC Annual Conference Indianapolis, November 7, 2013

  2. Cook overview • 9 manufacturing companies • 10 clinical divisions • Coverage in 135 countries • 16,000 SKUs

  3. Cook circa 1999

  4. Implementing a global standard

  5. Cook today

  6. Final steps to UDI compliance • Sort products by classification • Identify gaps • Form cross-functional teams working on operations and systems • Communicate / Educate

  7. Our plan to become compliant • Labeling • Change date format • Label redesign • Alternative AIDC • GUDID • Data collection, verification, validation • Approval / submission process • Quality systems • Conforming amendments • Device history record • Direct part marking • Evaluate technologies • Validate manufacturing processes • Integrate into manufacturing flow and IT

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