Definition

A secure record of who changed data, what changed, when it changed, and often why it changed, supporting traceability.

Example

If a lab value is corrected, the audit trail logs the old value, new value, user, timestamp, and reason for change.

Regulatory source

Computerized system controls consistent with Part 11 principles.

Common mistakes

Allowing free-text reasons that are vague (e.g., 'updated') instead of meaningful change rationale.

Inspector question

How do you ensure audit trail entries are complete and reviewable for critical changes?

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