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.