Best Practices for Part 11 Audit Trails

Do you understand FDA’s expectations for Part 11 audit trails?

EduQuest’s staff experts have conducted literally thousands of site inspections around the globe. Here’s a quick self-check from our Compliance Toolkit to ensure you’re using the best practices for your audit trails.

Are your audit trails:

  • Independently computer generated?
  • Date and time stamped?
  • Capable of tracking all changes that create, modify or delete data?
  • Identifying the person making the change?
  • Preventing someone from obscuring previous data?
  • Retained for the full retention period as defined by the appropriate predicate rules?
  • Available for inspection, copying and review?

For more information on meeting FDA’s expectations for Part 11 compliance, attend EduQuest’s FDA Auditing of Computerized Systems and Part 11/Annex 11 Compliance training class.

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