UDI Business Process Analysis and Improvement

Several specific business processes will require assessment and modification based on the UDI Final Rule and on the conforming amendments. Specific functions and business processes that are typically effected include:

  • Regulatory Affairs - global UDI Final Rule understanding, training, appropriate guidance and compliant submission
  • Product Development - inclusion of UDI for new or revised products
  • IT – tools to collect, manage, register and produce UDI, GUDID, and possibly GDSN related business functions
  • Quality – planning and adoption of UDI compliant processes for the Final Rule and the conforming amendments, including complaint and adverse event handling.
  • Sales and Marketing – understanding of product identification needs and standard changes to manage, inform and support customer adoption
  • Labeling – assessment of new labeling systems and printers
  • Operations and Supply Chain – both internal business processes and processes integrated with trading partners must be evaluated to determine UDI impact


  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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