An Audit is a systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which agreed criteria are fulfilled.…
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…
