Compliance
Audit trail
Tamper-evident log of who changed what, when, and why — required by Part 11.
An audit trail is a chronological, computer-generated record showing every create / change / delete of a regulated record, including the user, timestamp, old value, new value, and reason for change. Part 11 requires the audit trail to be secure, time-stamped, and not modifiable by the user.
In V5 the audit trail is at the database row level, so it's impossible for an operator (or an admin) to silently rewrite history.
Regulatory anchors
- 21 CFR 11.10(e)
- EU Annex 11 §9
Related terms
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