Audit Trail Example: What FDA Inspectors Actually Review

An auditor rarely starts with the result. They start with one record, and then they ask what happened to it after it was first written.

That question is answered by the audit trail, not by the notebook entry. The entry shows what the lab says it did. The trail shows the sequence of events behind it, including the parts nobody expected anyone to read: the value that changed at 10:03, the reason field left empty, the permission granted to an account that should not have had it.

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