SOP for Audit Trail Review and Management

1) Purpose

To define procedures for the review and management of audit trails generated by computerized systems within the pharmaceutical manufacturing facility, ensuring compliance with regulatory requirements.

2) Scope

This SOP applies to all computerized systems and personnel involved in the generation, review, and management of audit trails within the pharmaceutical manufacturing facility.

3) Responsibilities

Quality Assurance: Responsible for establishing procedures, reviewing audit trails, and ensuring compliance.
Information Technology (IT): Responsible for configuring and maintaining computerized systems to generate accurate audit trails.
System Users: Responsible for understanding and following procedures related to audit trail generation and review.
Regulatory Affairs: Responsible for ensuring that audit trails meet regulatory requirements and are available for inspection.

4) Procedure

1. Audit Trail Generation:
   1. Configure computerized systems to generate audit trails for critical activities and transactions.
   2. Ensure audit trails capture relevant information, including user actions, timestamps, and system changes.
   3. Verify that audit trail settings comply with regulatory requirements and internal policies.
2. Audit Trail Review:
   1. Regularly review audit trails to detect and investigate anomalies, discrepancies, or unauthorized activities.
   2. Document audit trail reviews and findings, including corrective actions taken.
   3. Ensure audit trail reviews are conducted by authorized personnel with appropriate training.
3. Audit Trail Management:
   1. Archive audit trails securely to ensure integrity, confidentiality, and accessibility for inspection purposes.
   2. Implement procedures for the retention and disposal of audit trails in accordance with regulatory requirements.
   3. Provide access to audit trails during regulatory inspections and audits as needed.
4. Training and Documentation:
   1. Train personnel on audit trail procedures, including generation, review, and management.
   2. Maintain documentation of audit trail configurations, reviews, and management activities.
   3. Update procedures and training materials based on audit trail review outcomes and regulatory changes.

5) Abbreviations, if any

SOP – Standard Operating Procedure

6) Documents, if any

• Audit Trail Configuration Records
• Audit Trail Review Reports
• Training Records
• Regulatory Guidelines on Audit Trails

7) Reference, if any

ICH Q7 Good Manufacturing Practice Guide

8) SOP Version

Version 1.0