Life-Sciences-eQMS 16 Punkte
GxP Audit Trail Review Checklist
Diese Checkliste ist auf Englisch.
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
Kostenlos als PDF oder Word · E-Mail-Adresse eingeben und herunterladen.
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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