생명과학 eQMS 16개 항목
GxP Audit Trail Review Checklist
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Verifies that audit trails in GxP computerized systems are enabled, complete, secure, and routinely reviewed as part of data integrity governance. Use for periodic audit trail review and CSV data-integrity assessment.
21 CFR Part 11MHRA Data Integrity Guidance 2018EU GMP Annex 11PIC/S PI 041
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Audit Trail Configuration
- Is the audit trail enabled and cannot be disabled by normal users? *
- Does the audit trail capture creation, modification, and deletion of GxP records with old and new values? *
- Does each entry record the operator identity, date, and time (with reliable time source)? *
- Is a reason for change captured where required? *
Security and Integrity
- Is the audit trail secured against alteration or deletion, including by administrators? *
- Are system clocks controlled and synchronized to prevent time manipulation? *
- Are user access levels segregated so users cannot alter their own audit records? *
- Is the audit trail retained for the full record retention period and readable throughout? *
Routine Review Process
- Is there a procedure defining the scope, frequency, and reviewer of audit trail review? *
- Is the audit trail for critical/GMP-relevant data reviewed as part of record/batch review? *
- Is review risk-based and focused on changes to critical data (e.g., results, integration, reprocessing)? *
- Is the review documented, including reviewer identity and date? *
Findings and Escalation
- Are unexplained changes, deletions, or aborted runs investigated? *
- Are potential data integrity concerns escalated and handled under quality procedures? *
- Describe any anomaly identified during audit trail review.
- Reviewer sign-off on the audit trail review. *
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