Standard Operating Procedure for Management of Regulatory Electronic Records and Audit Trails

Department	Regulatory Affairs
SOP No.	RA/2026/771
Supersedes	NA
Page No.	1 of X
Issue Date	17/04/2026
Effective Date	17/04/2026
Review Date	17/04/2028

Purpose

This Standard Operating Procedure (SOP) describes the systematic approach for the management, control, and maintenance of regulatory electronic records and associated audit trails within the organization. It aims to ensure the integrity, confidentiality, availability, and compliance of electronic regulatory documents with applicable regulatory requirements, internal policies, and quality standards. The SOP supports the control objectives of data accuracy, traceability, and audit readiness for regulatory submissions and inspections.

Scope

This SOP applies to all electronic regulatory records and audit trails generated, received, maintained, or archived across all functional areas including Regulatory Affairs, Quality Assurance, Quality Control, Manufacturing, Laboratory, Engineering, and Compliance departments. It covers all systems, software applications, and electronic tools used in the creation, review, approval, storage, retrieval, and archival of regulatory documents related to submissions, filings, regulatory correspondence, certificates, and related controlled records. This SOP excludes non-regulatory electronic records and paper-based documentation management controlled under separate procedures.

Responsibilities

The following functional roles are involved in the management of regulatory electronic records and audit trails:

• Regulatory Affairs Personnel – Responsible for creation, review, approval, and submission of electronic regulatory documents.
• Quality Assurance – Oversight of compliance with SOP requirements for electronic records and audit trails; periodic review and audit support.
• IT Support Team – Maintenance and backup of electronic record management systems; ensuring system access control and data security.
• System Owners – Ensure validation and compliance of electronic document management systems (EDMS).
• Document Control/Records Management – Proper archival, retention, retrieval, and destruction of electronic records as per document retention policy.

Accountability

The Head of Regulatory Affairs is accountable for the overall implementation, adherence, monitoring, and periodic effectiveness review of this SOP. They ensure escalations of non-compliance issues and drive continuous improvement related to management of regulatory electronic records and audit trails.

Procedure

1. Preparation and Prerequisites:

• Ensure the electronic record management system is validated and has audit trail functionality enabled as per regulatory requirements.
• Confirm user access rights are assigned based on roles and responsibilities following the principle of least privilege.
• Review relevant training records to verify personnel are trained on SOP requirements and system usage.

2. Creation and Capture of Electronic Records:

• Generate electronic regulatory documents using approved templates and within the designated EDMS or validated software.
• Ensure all documents have version control and unique identifiers as per internal documentation policies.
• Record metadata and necessary document attributes during creation for traceability.

3. Review and Approval:

• Use electronic workflows routed through the system to capture review and approval actions.
• Verify that electronic signatures or equivalent authentication conform to regulatory expectations for electronic records.
• Ensure audit trails capture every action related to document creation, modification, approval, and archiving with date/time stamps and user identification.

4. Storage and Security:

• Store electronic records in secure, backed-up repositories with controlled access to prevent unauthorized changes or deletions.
• Implement encryption or other security measures as required to protect sensitive regulatory information.
• Maintain system logs and conduct periodic monitoring to detect unusual activity or potential breaches.

5. Retrieval and Use:

• Ensure authorized personnel can easily retrieve electronic records for queries, inspections, and submissions without compromising document integrity.
• Prevent any alteration of finalized records unless through controlled amendment processes documented in audit trails.

6. Archival and Retention:

• Archive electronic regulatory records according to retention schedules mandated by regulatory authorities and company policies.
• Ensure continued readability and accessibility of archived records throughout the retention period.

7. Deviations and Non-Compliance:

• Document any deviations or incidents related to electronic record management immediately.
• Investigate root causes and implement corrective and preventive actions.
• Report significant deviations to the Head of Regulatory Affairs for escalation.

8. Periodic Review and Audit:

• Conduct regular internal audits and reviews of the electronic records system and audit trail logs to confirm compliance with this SOP.
• Update SOP and systems based on audit findings, technological changes, or regulatory updates.

9. Documentation and Record Keeping:

• Retain all associated records such as audit trail reports, system validation documents, training records, deviation reports, and internal audits related to electronic records.
• Ensure all activities are properly documented and signed off electronically where permitted.

By following these procedures, the organization ensures effective control, traceability, and compliance of regulatory electronic records and their audit trails, supporting integrity and readiness for regulatory inspections and submissions.

Abbreviations

EDMS: Electronic Document Management System

GMP: Good Manufacturing Practice

SOP: Standard Operating Procedure

IT: Information Technology

QA: Quality Assurance

RA: Regulatory Affairs

Documents

Only essential documents related directly to this SOP topic are listed below:

1. Electronic Record Creation and Approval Log (Annexure-1)
2. Audit Trail Review Checklist (Annexure-2)
3. Electronic Records Retention and Archival Register (Annexure-3)

References

1. FDA 21 CFR Part 11 – Electronic Records; Electronic Signatures

2. EMA Annex 11 – Computerised Systems

3. ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

4. PIC/S GMP Guide Chapter on Documentation

5. Internal Document Control and Data Integrity Policies

6. Company Validation Master Plan (VMP)

Version

1.0

Approval

Prepared By
Checked By
Approved By

Annexures

Annexure-1: Electronic Record Creation and Approval Log

Purpose: To systematically record details of electronic regulatory records created and their approval status to ensure traceability and control.

Record ID	Document Title	Version	Created On	Created By (User ID)	Approved On	Approved By (User ID)	Status
REC-2026-001	Regulatory Submission Dossier	1.0	05/03/2026	RAUser01	10/03/2026	RAVerifier02	Approved
REC-2026-002	Certificate of Analysis	2.1	12/03/2026	QCLab03	15/03/2026	QAManager05	Approved

Annexure-2: Audit Trail Review Checklist

Purpose: To provide a structured checklist for periodic review of electronic audit trails ensuring compliance, completeness, and detection of anomalies.

Checklist Item	Yes	No	Comments
Audit trail captures all user actions including create, modify, delete	✔
Time stamps and user IDs are accurate and consistent	✔
No unauthorized deletions or tampering detected	✔
Audit trail reports are archived as per retention policy	✔		Next review due 18/04/2026
Any anomalies investigated and documented	✔		No anomalies found

Reviewed By: ______________________ Date: 15/04/2026

Annexure-3: Electronic Records Retention and Archival Register

Purpose: To document and track retention and archival status of electronic regulatory records ensuring compliance with regulatory and internal requirements.

Record ID	Document Title	Date Created	Retention Period	Archival Date	Location/Repository	Status
REC-2025-054	Regulatory Correspondence Record	01/10/2025	5 years	01/11/2025	EDMS Archive Folder G1	Archived
REC-2026-010	Product Registration File	20/01/2026	10 years	Not yet archived	RA Network Drive – Regulatory	Active

Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
17/04/2026	1.0	Initial issue	New SOP creation