FDA Part 11 Audit Trail Screener
15 Part 11 exceptions in 21 audit trail entries and 7 accounts: 2 critical, 11 high, 2 medium.
dkowalski was deactivated on 2026-07-31; the 'Approve' entry is dated 2026-08-12, 12 days later. An account may not act on or after its deactivation date.
Method1The trail is ordered by sequence number; skipped or repeated numbers and timestamps earlier than the previous entry break the secure, time-stamped audit trail of 21 CFR 11.10(e).
2Modify and delete entries need a reason for change (11.10(e) with predicate rules such as 21 CFR 58.130(e)); the old value must equal the last recorded value for the same record and field, or the prior value was not preserved or changed outside the trail.
| Seq | Timestamp | User |
|---|---|---|
| 1018 | 2026-08-12 15:20:44 | dkowalski |
| 1022 | 2026-08-14 11:30:00 | lortiz |
| 1006 | 2026-08-04 10:22:48 | mchen |
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Part 11 exception list with the control cited (Exception list (CSV), Review memo, Exceptions (JSON))
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