Pharma Techexplained
Glossary

Audit trail

A secure, computer-generated, time-stamped record of who did what to a record and when, including what the value was before.

The audit trail is the record's memory. Without it, an electronic value is just the latest opinion; with it, you can reconstruct the history of every change, deletion and reprocessing event, and decide whether the final number deserves trust.

Two expectations travel with it: the trail must be protected from editing, including by administrators, and somebody must actually review it in a way that could detect a problem. Regulators treat the audit trail as part of the record itself, so it inherits the record's retention period.