Glossary
Audit Trail
A secure record that allows the creation, change, and deletion of electronic records, and the reasons for them, to be reconstructed in time order.
Details
An audit trail is the metadata that lets the creation, change, and deletion of GMP relevant data be reconstructed together with when it happened and who did it. Inspections cite the function being switched off, administrator and analyst privileges not being separated, and periodic review either not performed or missing the reason for the change. Check the system configuration, user privileges, the audit trail review procedure and its records, and how data review connects to incident investigation.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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All specific alarm files (.txt) and audit trails (named as `Events`) have been lost.
EMA · EU GMP NCR (EudraGMDP) · 2023-09-07 -
audit trail) or approval of the change of some HPLC sequences, problems with operators’ privileges and lack of computerised systems validation.
EMA · EU GMP NCR (EudraGMDP) · 2025-05-05 -
In addition, the audit trail function was disabled even though…
FDA · FDA Warning Letter · 2022-09-27
