Standard Operating Procedure for Audit Readiness of Regulatory Archives
| Department | Regulatory Affairs |
| SOP No. | RA/2026/782 |
| 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) establishes the systematic approach to ensure audit readiness of regulatory archives by maintaining accurate, complete, and compliant records in accordance with applicable regulatory requirements and internal quality standards. It supports the control objective of ensuring that all archived regulatory documentation is readily available, well organized, and safeguarded to withstand audits and inspections effectively across all relevant functional areas.
Scope
This SOP applies to all regulatory archives including electronic and physical documentation related to regulatory submissions, approvals, correspondence, and audit trails maintained within Regulatory Affairs. It covers document management, archival processes, data integrity controls, and audit preparedness activities. Documents outside of regulatory affairs archives, such as manufacturing batch records or lab data archives, are excluded unless they intersect with regulatory archive requirements.
Responsibilities
- Regulatory Affairs Executives: Execute archival and retrieval activities following this SOP.
- Regulatory Affairs Supervisors: Review and supervise adherence to archival processes and audit readiness.
- Quality Assurance (QA): Verify compliance and perform periodic audits of the regulatory archives.
- Compliance Officers: Monitor overall compliance to regulatory archive practices and oversee corrective actions.
- Document Control Personnel: Manage version control, documentation identification, and archiving logistics.
Accountability
The Head of Regulatory Affairs is accountable for the implementation, compliance, periodic review, and escalation of issues related to this SOP, ensuring audit readiness and effective maintenance of regulatory archives.
Procedure
1. Preparation and Prerequisites:
Ensure all regulatory documents are finalized, approved, and formatted per internal guidelines before archiving. Verify that all metadata, including document titles, version numbers, dates, and authorship, are accurately recorded in the Document Control System (DCS).
2. Archival Process:
a. For physical documents, organize files in clearly labeled folders following the regulatory indexing format.
b. For electronic archives, save documents in secured, access-controlled repositories with backup provisions.
c. Register all stored documents into the archive master log with location, responsible person, and retention timelines.
3. Data Integrity and Controls:
Implement checks to confirm that archived data is complete, legible, and unaltered. Perform periodic reviews to validate the integrity of both physical and electronic archive materials.
4. Audit Readiness Checks:
a. Conduct scheduled mock audits and verification exercises on regulatory archives to simulate inspection conditions.
b. Review archive accessibility and retrieval timelines for documentary evidence during audits.
c. Ensure corrective and preventive actions from prior audits are addressed and documented.
5. Documentation and Record Keeping:
Maintain detailed records of archival activities including archive register updates, audit findings, corrective actions, and access logs. All records shall be stored securely and retained according to applicable regulatory and company retention policies.
6. Handling Deviations and Approvals:
Report any discrepancies or damage to regulatory archives immediately to QA and Compliance. Deviations must be documented, investigated, and approved corrective actions implemented and recorded.
7. Closure:
Confirm that audit readiness activities and archival maintenance are complete and reviewed by supervisory personnel. The archive status report shall be compiled and submitted to Regulatory Affairs leadership for periodic review.
This procedure ensures continuous compliance and preparedness for regulatory inspections by establishing robust archival practices and ongoing verification mechanisms applicable to all regulatory archive documentation.
Abbreviations
- SOP – Standard Operating Procedure
- QA – Quality Assurance
- DCS – Document Control System
- GMP – Good Manufacturing Practices
Documents
The following documents are mandatory to support audit readiness of regulatory archives:
- Regulatory Archive Master Log (Annexure-1)
- Audit Readiness Checklist for Regulatory Archives (Annexure-2)
- Archive Deviation Report Form (Annexure-3)
References
- EU GMP Annex 11 – Computerised Systems
- FDA 21 CFR Part 11 – Electronic Records; Electronic Signatures
- ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
- Company Quality Management System Documentation Control Procedures
Version
1.0
Approval
| Prepared By | |
| Checked By | |
| Approved By |
Annexures
Annexure-1: Regulatory Archive Master Log
Purpose: To maintain a comprehensive record of all regulatory documents archived, including their location, retention period, and responsible personnel to facilitate retrieval and audit readiness.
| Document ID | Document Title | Version | Archive Location | Date Archived | Retention Period | Responsible Staff |
|---|---|---|---|---|---|---|
| RA-2026-001 | Regulatory Submission Dossier | 3.1 | Physical Archive Room A, Shelf 5 | 10/02/2026 | 10 years | Regulatory Affairs Executive |
| RA-2026-002 | Change Control Correspondence | 2.0 | Digital Archive – Server Folder RA_Submissions/CCI | 15/03/2026 | 5 years | Regulatory Affairs Executive |
Annexure-2: Audit Readiness Checklist for Regulatory Archives
Purpose: To provide a systematic checklist for evaluating the state of regulatory archives prior to internal or external audits ensuring completeness, compliance, and accessibility.
| Audit Item | Yes | No | Comments |
|---|---|---|---|
| All regulatory documents indexed and logged | ✔ | No missing files observed | |
| Archive location clearly labeled | ✔ | Labels up to date | |
| Data integrity confirmed (no damage or alterations) | ✔ | Electronic backups verified | |
| Retention timelines adhered to | ✔ | No documents past retention period | |
| Access logs complete and up to date | ✔ | No unauthorized access detected |
Annexure-3: Archive Deviation Report Form
Purpose: To document, investigate, and track deviations or discrepancies identified within the regulatory archives, ensuring corrective and preventive actions are implemented.
| Deviation Report No. : | DEV-RA-2026-0042 |
| Date of Deviation : | 12/03/2026 |
| Description of Deviation : | Missing pages identified in regulatory submission dossier RA-2026-001 during routine archive check. |
| Immediate Actions Taken : | Searched entire archive; notified Quality Assurance; secured the incomplete dossier from further use. |
| Root Cause Analysis : | Improper document handling during archiving detected due to inadequate staff training. |
| Corrective Action : | Conduct refresher training for all archive staff; implement checklist for page count verification before archiving. |
| Preventive Action : | Introduce electronic page-count verification system and weekly audit of archive completeness. |
| Verified By (QA) : | [Signature] |
| Approved By (Head Regulatory Affairs) : | [Signature] |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
| 17/04/2026 | 1.0 | Initial issue | New SOP creation |