Part 11 Compliance Mandates for Interfaces between GxP Application Systems


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This presentation will include:

  • Enterprise System Integration Drivers
  • Interface Development Scenarios
  • Integration Architectures
  • Alternative Integration Solutions
  • Features Required to Meet Part 11 Requirements
  • Integration Design Considerations
  • Summary




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    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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