Information Management Systems (LIMS), and Instrument Operating Software.

3. Responsibilities

• Analyst: Ensures accurate data entry and documents actions during method runs.
• QA Officer: Performs independent audit trail reviews at predefined intervals and prior to critical report sign-offs.
• System Administrator: Maintains audit trail settings and access control to ensure audit trails cannot be disabled or altered.
• Department Head: Ensures audit trail review timelines are adhered to.

4. Accountability

The Head of Bioanalytical Department is accountable for ensuring that audit trail reviews are conducted as per this SOP to uphold compliance with 21 CFR Part 11 and related data integrity requirements.

5. Procedure

5.1 Audit Trail Configuration

1. System Administrators must ensure audit trail features are enabled and validated in all analytical software used.
2. Audit trails must capture:
   • User ID, date/time of action
   • Original value and changed value
   • Reason for change (if applicable)
3. Audit trail records shall be time-stamped and stored securely with no overwrite permission.

5.2 Audit Trail Review Triggers

1. Audit trail reviews must be conducted at the following stages:
   • After completion of each analytical run
   • Before final study report submission
   • During system qualification or method validation
2. Document each review in Annexure-1: Audit Trail Review Log.

5.3 Review Activities

1. Open audit trail viewer and filter log entries based on:
   • Run ID or batch ID
   • Date range
   • Actions such as deletion, reintegration, manual edits
2. Review critical parameters:
   • Manual integrations
   • Changes to sample identifiers
   • System errors or unauthorized access attempts
3. If abnormal or suspicious entries are detected:
   • Raise a deviation form
   • Initiate a root cause analysis and CAPA
   • Escalate to QA and document in Annexure-2: Audit Trail Deviation Report

5.4 Documentation and Archiving

1. Attach audit trail printouts or PDF exports to the batch documentation for traceability.
2. Maintain electronic records in secure archives for a minimum of 5 years.
3. Restrict audit trail access to authorized reviewers only.

5.5 Periodic QA Review

1. QA shall perform periodic (monthly or quarterly) audit trail reviews independent of ongoing study reviews.
2. Summarize observations in Annexure-3: Periodic Audit Trail Summary and share with department head.

6. Abbreviations

• BA/BE: Bioavailability/Bioequivalence
• CDS: Chromatography Data System
• LIMS: Laboratory Information Management System
• CAPA: Corrective and Preventive Action
• QA: Quality Assurance
• SOP: Standard Operating Procedure

7. Documents

1. Audit Trail Review Log – Annexure-1
2. Audit Trail Deviation Report – Annexure-2
3. Periodic Audit Trail Summary – Annexure-3

8. References

• 21 CFR Part 11 – Electronic Records; Electronic Signatures
• MHRA GXP Data Integrity Guidance
• WHO TRS No. 996 – Guidance on Good Data and Record Management
• ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Audit Trail Review Log

Date	System	Run ID	Reviewer	Observations	Status
16/04/2025	Empower 3	BAE-097	Sunita Reddy	No discrepancies	Closed

Annexure-2: Audit Trail Deviation Report

Deviation ID	Observed By	Action Description	Date/Time	CAPA	Status
AT-2025-03	QA Officer	Manual reintegration without reason	15/04/2025 10:12	Training and procedure update	Closed

Annexure-3: Periodic Audit Trail Summary

Review Period	System	Total Entries Reviewed	Observations	Reviewed By	Date
Q1 2025	Waters Empower	125	No critical findings	QA Team	10/04/2025

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Release	New SOP	QA Head
17/04/2025	2.0	Added system configuration and periodic review annexures	Audit Feedback	QA Head