Audit Trail
An audit trail is the secure, computer-generated, time-stamped record of relevant creations, changes, and deletions of GxP-relevant data – who, what, when, and why; which events it captures is defined on a risk basis (EU GMP Annex 11 §9; 21 CFR 11.10(e)). It makes changes reconstructable (Traceable) and is a regular focus of inspections.
