Standard Operating Procedure for Electronic Submission Archival and Retrieval
| Department | Regulatory Affairs |
| SOP No. | RA/2026/699 |
| Supersedes | NA |
| Page No. | 1 of X |
| Issue Date | 12/04/2026 |
| Effective Date | 12/04/2026 |
| Review Date | 12/04/2028 |
Purpose
This SOP defines the standardized method for the archival and retrieval of electronic submissions within the Regulatory Affairs department. It ensures secure, compliant, and efficient handling of electronic submission files to maintain regulatory record integrity, enable timely access for review or regulatory inspections, and support ongoing compliance with applicable regulatory requirements.
Scope
This procedure applies to all electronic regulatory submission documents and associated metadata generated, received, or managed by the Regulatory Affairs department across all product types, dosage forms, and therapeutic areas. It covers the archival, storage, indexing, retrieval, and disposal of electronic submission files within authorized electronic document management systems. Paper-based submissions and other departmental records are excluded.
Responsibilities
The following roles are involved in the execution and oversight of this SOP:
- Regulatory Affairs Executives: Prepare and upload submission files for archival, initiate retrieval requests.
- Document Control Personnel: Review completeness and integrity of submission files, perform archival and indexing.
- Quality Assurance: Review and approve SOP adherence, conduct periodic audits.
- IT Support: Ensure availability, security, and backup of electronic storage systems.
- Regulatory Affairs Manager: Supervise implementation and resolve escalations.
Accountability
The Regulatory Affairs Head is accountable for ensuring full compliance with this SOP, periodic review of archiving practices, timely update of the procedure, escalation of nonconformities, and ensuring the effectiveness of the archival and retrieval processes.
Procedure
1. Preparation: Verify that all electronic submission documents are complete, finalized, and approved in accordance with applicable submission standards before archival.
2. Prerequisites and System Checks: Confirm access permissions to the electronic document management system (EDMS) are current. Ensure system backups are up to date and audit trails are enabled. Perform integrity verification of files using appropriate checksum tools.
3. Archival Process: Upload the final submission dossier and associated documents to the designated folders within the EDMS. Use consistent and clear file naming conventions aligned with regulatory submission formats (e.g., eCTD structure). Assign indexing metadata to facilitate quick retrieval, including submission ID, product name, submission type, and submission date.
4. Verification and Documentation: Document the completion of archival in the Submission Archival Log detailing the file names, upload timestamps, responsible personnel, and verification outcomes. Conduct a peer review by Document Control personnel to confirm that all files are correctly archived.
5. Retrieval Process: Submission retrieval requests must be submitted in writing with clear justification. Retrieve files through the EDMS search or indexing system, verify file integrity, and provide access only to authorized personnel. Record retrieval activity in the Retrieval Log with requestor details, purpose, and date/time of access.
6. Acceptance Criteria: All files must be free from corruption and fully accessible; metadata must correctly describe the submission; logs must be complete and accurately signed off.
7. Deviations and Escalations: Any discrepancies, file corruptions, or unauthorized access attempts shall be reported immediately to the Regulatory Affairs Manager and Quality Assurance for investigation and corrective action.
8. Retention and Disposal: Adhere to regulatory and company record retention schedules. Dispose of electronic files only after authorized approvals and following validated data destruction methods ensuring irrecoverability.
9. Review and Audit: Conduct periodic reviews to ensure archival accuracy and compliance with the SOP. Internal or external audits may inspect archival and retrieval records.
10. Closure: Ensure all logs, reports, and system records related to the archival or retrieval activity are securely saved and backed up in accordance with data integrity requirements.
Abbreviations
eCTD: Electronic Common Technical Document
EDMS: Electronic Document Management System
SOP: Standard Operating Procedure
QA: Quality Assurance
RA: Regulatory Affairs
Documents
- Submission Archival Log (Annexure-1)
- Submission Retrieval Request Form (Annexure-2)
- Submission Retrieval Log (Annexure-3)
References
ICH M4 Guidelines for Electronic Common Technical Document (eCTD), FDA 21 CFR Part 11 for Electronic Records and Signatures, EMA Data Integrity Guidance, Company Document Management Policies, Good Manufacturing Practice (GMP) requirements for Documentation Control, ISO 27001 for Information Security Management.
Version
1.0
Approval
| Prepared By | |
| Checked By | |
| Approved By |
Annexures
Annexure-1: Submission Archival Log
Purpose: To record and verify all electronic submission files archived into the EDMS, ensuring traceability and completeness.
| Date | Submission ID | Product Name | Submission Type | File Names Archived | Uploaded By | Reviewed By | Remarks |
|---|---|---|---|---|---|---|---|
| 10/04/2026 | SUB2026-001 | Product X | New Drug Application | Module1.zip, Module2.zip | RA Executive | Doc Control | Complete and verified |
| 11/04/2026 | SUB2026-002 | Product Y | Annual Update | Update2026.pdf | RA Executive | Doc Control | File integrity confirmed |
Annexure-2: Submission Retrieval Request Form
Purpose: To formally request electronic submission files retrieval for review, audit, or regulatory purposes.
| Request Date | 13/04/2026 |
| Requestor Name/Dept. | Quality Assurance |
| Submission ID | SUB2026-001 |
| Product Name | Product X |
| Reason for Retrieval | Regulatory Audit Preparation |
| Requested Files | Module1.zip |
| Requested Access Period | 14/04/2026 to 20/04/2026 |
| Approvals: | Approved by Regulatory Affairs Manager on 13/04/2026 |
Annexure-3: Submission Retrieval Log
Purpose: To document all electronic submission retrieval activities for accountability and traceability.
| Date | Submission ID | Retrieved By | Purpose | Files Retrieved | Return Date | Remarks |
|---|---|---|---|---|---|---|
| 14/04/2026 | SUB2026-001 | QA Reviewer | Regulatory Audit Preparation | Module1.zip | 20/04/2026 | Files returned intact |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
| 12/04/2026 | 1.0 | Initial issue | New SOP creation |