An audit trail is the system’s own history of a record. For every creation, modification or deletion of GMP data it captures who made the change, when, what the value was before and after, and — under EU expectations — why. It is generated automatically and cannot be switched off or edited by ordinary users.
21 CFR 11.10(e) requires secure, computer-generated, time-stamped audit trails that independently record operator entries and actions, without obscuring previously recorded information. EU GMP Annex 11 asks for audit trails based on a risk assessment, with the reason for a change documented, and for audit trails to be regularly reviewed.
Why it matters in GMP
An audit trail only protects data if someone looks at it. Inspectors increasingly ask to see evidence of audit trail review — routine review of the trails linked to a batch or result before release, and periodic review of the system as a whole for patterns such as deletions or out-of-hours changes.
- Capture the reason for change at the moment of change.
- Keep the audit trail with the record for the full retention period.
- Make it readable and filterable, so review is practical.
How Swat iQua Suite handles it
In Swat iQua Suite every write and its log entry commit together in one database transaction, with a mandatory change reason and the operating site. A read-only audit trail report spans all modules, filters by site, module, user, activity and date, and shows related records up to two levels deep. PDF and Excel exports are themselves logged. Periodic audit trail review freezes its risk signals when it starts, so the review can be reproduced later.