Standard Operating Procedure for Backup and Recovery of Regulatory Records
| Department | Regulatory Affairs |
| SOP No. | RA/2026/777 |
| 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 defines the controlled process for the systematic backup and recovery of regulatory records to ensure data integrity, availability, and regulatory compliance. The SOP aims to safeguard critical regulatory documents from loss, corruption, or damage, thereby supporting uninterrupted regulatory operations and compliance with applicable quality and data management standards.
Scope
This SOP applies to all regulatory records generated, received, or maintained within the Regulatory Affairs department, including electronic and physical regulatory documents. It covers backup procedures for electronic data repositories, physical archival records, storage media management, and recovery processes applicable to all regulated submission documents, correspondence, certificates, and related regulatory files. Other departments’ records or non-regulatory data are excluded unless specifically referenced under cross-departmental regulatory data management.
Responsibilities
- Regulatory Affairs Executives – Execute backup tasks and maintain records as per schedule.
- Quality Assurance – Review and audit backup and recovery processes for compliance and effectiveness.
- IT Support – Provide technical support for electronic backup systems, data storage, and restoration activities.
- Regulatory Affairs Manager – Supervise backup procedures, authorize recovery actions, and ensure SOP adherence.
- Document Control – Manage archival of physical regulatory records and ensure retrievability.
Accountability
The Regulatory Affairs Head is accountable for the overall implementation, compliance monitoring, periodic review, escalation of issues, and effectiveness evaluation of this SOP to ensure the integrity and security of regulatory records.
Procedure
1. Preparation and Prerequisites
Identify the critical regulatory records requiring backup based on their regulatory importance and frequency of use. Maintain an up-to-date backup schedule approved by Regulatory Affairs management. Ensure all backup media and storage locations comply with environmental control and security policies.
2. Backup Execution
For electronic records, initiate backups using validated systems or software approved by IT and Regulatory Affairs. Backup frequency shall be at least daily for high-priority electronic records and weekly for less frequently updated files. Backup data shall be encrypted and stored in secure, access-controlled locations, preferably offsite or cloud-based for disaster recovery. For physical records, create duplicate copies or scan documents as per document retention policy. Physical backups must be stored in fireproof, humidity-controlled archival facilities.
3. Verification and Validation
Post-backup, perform verification by checking checksums, file counts, or automated reports to confirm successful backups without errors or omissions. Document verification activities and report discrepancies immediately to Regulatory Affairs Manager and IT support.
4. Incident and Deviation Handling
Any backup failure, data corruption, or unauthorized access incidents shall be recorded in a deviation report and escalated per the deviation handling procedure. Root cause analysis will be performed, and corrective and preventive actions (CAPA) implemented.
5. Recovery Process
In case of loss, corruption, or damage to regulatory records, initiate recovery as per documented recovery plan. Obtain approval from Regulatory Affairs Head before restoration. Recovery shall be from verified backup copies only. Validate the integrity and completeness after restoration and document the recovery process thoroughly.
6. Documentation and Record Keeping
Maintain backup logs, verification reports, deviation records, and recovery documentation in accordance with applicable regulatory record retention periods. Ensure these documents are reviewed periodically during internal and external audits.
7. Periodic Review and Continuous Improvement
Conduct periodic reviews of backup and recovery processes, including risk assessments to adapt procedures to evolving regulatory requirements and technological changes. Provide training to involved personnel to maintain compliance awareness.
Abbreviations
- CAPA – Corrective and Preventive Action
- IT – Information Technology
- SOP – Standard Operating Procedure
- GMP – Good Manufacturing Practice
- CFR – Code of Federal Regulations
Documents
The following documents are required to support this SOP:
- Backup Schedule and Log Sheet (Annexure-1)
- Backup Verification Report Template (Annexure-2)
- Backup Recovery Request Form (Annexure-3)
References
21 CFR Part 11 – Electronic Records; EMA Data Integrity Guidance; ICH Q7 and Q10; FDA GMP Documentation Guidance; ISO 27001 – Information Security Management; Internal Quality Management System Manual.
Version
1.0
Approval
| Prepared By | |
| Checked By | |
| Approved By |
Annexures
Annexure-1: Backup Schedule and Log Sheet
Purpose: To schedule and record the routine backup activities of all regulatory records, ensuring traceability and compliance.
| Date | Record Type | Backup Method | Backup Location | Performed By | Remarks |
|---|---|---|---|---|---|
| 15/04/2026 | Electronic Regulatory Submissions | Automated Cloud Backup | Remote Secure Server | Regulatory Executive | Completed Successfully |
| 15/04/2026 | Physical Correspondence Files | Scanned and PDF Archive | Onsite Document Vault | Document Control | All files accounted |
| 14/04/2026 | Certificate Archives | DVD Backup | Offsite Storage | Regulatory Executive | Verified |
Annexure-2: Backup Verification Report Template
Purpose: To document the verification of backup integrity and completeness for regulatory records.
| Date | Backup ID | Records Covered | Verification Method | Result | Verified By | Comments |
|---|---|---|---|---|---|---|
| 15/04/2026 | BK20260415-01 | Regulatory Submissions | Checksum Validation | Pass | Regulatory Executive | No discrepancies found |
| 15/04/2026 | BK20260415-02 | Correspondence Files | File Count Matching | Pass | Document Control | All files intact |
| 14/04/2026 | BK20260414-01 | Certificate Archives | Manual Sampling | Pass | Regulatory Executive | Backup verified physically |
Annexure-3: Backup Recovery Request Form
Purpose: To formally request and document the recovery of regulatory records from backup storage in case of data loss or corruption.
| Request Date | 16/04/2026 |
| Requested By (Role) | Regulatory Affairs Executive |
| Nature of Data Lost/Corrupted | Electronic Submission Files (Module 3) |
| Backup ID(s) to Recover | BK20260415-01 |
| Reason for Recovery | Accidental deletion due to system error |
| Recovery Approved By | Regulatory Affairs Manager |
| Date of Approval | 16/04/2026 |
| Recovery Completion Date | 17/04/2026 |
| Remarks | Data successfully restored and verified |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
| 17/04/2026 | 1.0 | Initial issue | New SOP creation |