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.
Source · PIC/S PE 009-17, Annex 11, §9 Audit Trails and Glossary
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 -
Your stand-alone gas chromatogram (GC) computer system lacked appropriate controls, such as an audit trail and individual log-in access to prevent the deletion of data.
FDA · FDA Warning Letter · 2024-06-18
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
PIC/S PE 009-17, Annex 11, §9 Audit Trails and GlossaryGRM Regulatory Glossary
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