Definition

Examination of the electronic record of changes to safety database entries to verify data integrity and identify unauthorized modifications.

Example

Audit trail review reveals: all changes are attributable to specific users, timestamps are accurate, original values are preserved, and change reasons are documented.

Regulatory source

21 CFR Part 11, EU GVP

Common mistakes

Only reviewing audit trails when problems are suspected rather than routinely as part of quality monitoring.

Inspector question

How frequently do you review audit trails? What would trigger an intensive review?

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