Audit trails are required by 21 CFR Part 11 for regulated electronic systems (EDC, eTMF, eConsent). They support data integrity (ALCOA+) and are routinely reviewed during inspections.
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Glossary Term
Audit Trail
Data & Safety
Also known as: electronic audit trail, Part 11 audit trail
A secure, computer-generated, time-stamped electronic record that allows reconstruction of the events relating to the creation, modification, or deletion of an electronic record.
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