Standard Operating Procedure for Audit Trail Review

Purpose

The purpose of this SOP is to establish procedures for the periodic review and verification of audit trails within the pharmaceutical manufacturing facility. The audit trail review ensures data integrity and compliance with regulatory requirements.

Scope

This SOP applies to all personnel involved in the manufacturing, quality control, and quality assurance of pharmaceutical products, including operators, technicians, and quality assurance personnel.

Responsibilities

• Quality Assurance Personnel: Responsible for conducting periodic reviews of audit trails and ensuring compliance with data integrity principles.
• Operators and Technicians: Responsible for providing access to audit trails and promptly addressing any deviations identified during the review.

Procedure

1. Scheduled Review: Perform a scheduled review of audit trails for all relevant electronic systems, ensuring the frequency aligns with regulatory requirements and the criticality of the system.
2. Audit Trail Accessibility: Ensure that audit trails are accessible to authorized personnel, including Quality Assurance, and that the data is presented in a readable and understandable format.
3. Review Criteria: Establish specific criteria for the audit trail review, including but not limited to:
   • Identification of critical events and changes.
   • Review of user access and permissions.
   • Identification of unauthorized access or changes.
   • Timeliness and completeness of the audit trail.
4. Documentation: Document the audit trail review findings, including any identified deviations or anomalies. Deviations should be classified based on severity and potential impact.
5. Investigation of Deviations: If deviations are identified, initiate a thorough investigation to determine the root cause and assess the impact on data integrity and product quality.
6. Corrective Actions: Develop and implement corrective actions to address the root cause of identified deviations and prevent their recurrence.
7. Effectiveness Check: Conduct an effectiveness check to verify the successful implementation of corrective actions and assess whether the audit trail continues to meet regulatory requirements.
8. Documentation of Corrective Actions: Document all corrective actions taken, including updates to procedures, training records, and any changes made to prevent similar deviations in the future.
9. Archiving: Archive audit trail review records in accordance with established retention policies.

Abbreviations

No abbreviations are used in this SOP.

Documents

• Audit Trail Review Logbook
• Deviation Investigation Report
• Corrective Action Plan
• Effectiveness Check Records

Reference

ICH Q9 – Quality Risk Management

SOP Version

Version 1.0