Glossary
Audit Trail Review
Reviewing the history of creation, change, and deletion of GMP relevant data on a risk basis and investigating anomalous activity.
Source · PIC/S PI 041-1 (2021), §9.6 Audit trails; MHRA GxP Data Integrity Guidance §6.13
Details
Audit trail review looks beyond the approved results for deletions, reprocessing, configuration changes, and failed attempts, and so assesses the possibility that data was selected. Inspections cite scope, frequency, and responsibility that were never defined, or review carried out as a formality after batch release. Check the risk assessment, the per system review procedure, the evidence of review, exception reports, and how review connects to raw data review and OOS investigation.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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The (b)(4) and (b)(4) audit trail reviews will help CAPS ensure that (b)(4) .” However, you did not provide documentation of the SOP revision, employee training, or audit trail reviews.
FDA · FDA Warning Letter · 2024-08-13 -
Audit trail review procedures for production software are general and do not contain instructions soecific to the different softwares to ensure a thorough review ofraw data.
FDA · FDA 483 · 2024-09-06
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
PIC/S PI 041-1 (2021), §9.6 Audit trails; MHRA GxP Data Integrity Guidance §6.13GRM Regulatory Glossary
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