Standard Operating Procedure for Metadata Review and Document Filing Standards
| Department | Regulatory Affairs |
| SOP No. | RA/2026/767 |
| Supersedes | NA |
| Page No. | 1 of X |
| Issue Date | 16/04/2026 |
| Effective Date | 16/04/2026 |
| Review Date | 16/04/2028 |
Purpose
This SOP establishes a standardized and controlled approach for the review of metadata and the filing of regulatory documents to ensure accuracy, traceability, data integrity, and compliance with applicable regulatory requirements. Its objective is to maintain organized document management that supports seamless retrieval and audit readiness while minimizing risks of misinformation or data loss in regulatory affairs operations.
Scope
This procedure applies to all activities involving metadata review, indexing, categorization, and filing of regulatory documents within the Regulatory Affairs department. It covers electronic and physical document management systems, including submission dossiers, correspondences, regulatory filings, and archival records. Excluded are non-regulatory and operational records managed by other departments unless interfacing with regulatory documentation.
Responsibilities
The Regulatory Affairs Document Control Team is responsible for executing metadata review and document filing activities. Regulatory Affairs Supervisors review and approve document organization and filing compliance. The Quality Assurance team oversees adherence to this SOP through audits and compliance verification. All personnel handling regulatory documents must adhere to the processes defined herein.
Accountability
The Head of Regulatory Affairs holds ultimate accountability for implementation, compliance monitoring, periodic review, escalation of issues, and effectiveness assessment of this SOP. This role ensures that metadata review and document filing standards meet internal quality policies and regulatory expectations.
Procedure
1. Preparation and Prerequisites: Ensure all documents to be filed are complete, signed, and approved as per their respective workflows. Access required document management systems with appropriate permissions and verify availability of metadata templates or indexing guidelines.
2. Metadata Review: For each document, review metadata fields including title, document type, version, date, author, regulatory classification, and keywords. Confirm accuracy, consistency, and compliance with regulatory filing requirements. Cross-check metadata against source documents, submission requirements, and filing protocols.
3. Filing Process: Assign documents to correct electronic folders or physical filing locations based on defined category structures. Use approved naming conventions and indexing formats. For electronic documents, upload files along with metadata into document management systems ensuring data integrity controls such as version locking and audit trails are active.
4. Verification and Quality Checks: Conduct a secondary review by a supervisor or designated reviewer to verify metadata correctness and filing accuracy. Address any discrepancies or errors through documented correction requests. Maintain a checklist to record completion of review and filing steps.
5. Acceptance Criteria: Metadata must fully and accurately represent document characteristics enabling traceability. Documents should be readily retrievable without ambiguity. Filing locations must conform strictly to approved directory structures or physical storage maps.
6. Handling Deviations: Any deviations observed during metadata review or filing (such as mislabeling, missing metadata, incorrect versioning) must be immediately reported, investigated, and documented. Corrective actions are to be implemented, and impacted documents reprocessed through this SOP.
7. Approvals and Documentation: Obtain all necessary approvals for final metadata and filing status. Document the entire process using specified forms and logs that capture metadata details, filing information, review remarks, and approvals.
8. Record Retention and Closure: Archive completed metadata review and filing records securely for the duration defined by company policy or regulatory guidelines. Conduct periodic audits to confirm ongoing compliance and continuous improvement.
Adherence to this procedure ensures robust regulatory document management, facilitating smooth regulatory submissions, compliance audits, and overall quality system integrity.
Abbreviations
RA – Regulatory Affairs
SOP – Standard Operating Procedure
GMP – Good Manufacturing Practice
QA – Quality Assurance
DMS – Document Management System
Documents
The following documents are required for implementation and record-keeping of this SOP:
- Metadata Review Checklist (Annexure-1)
- Document Filing Log (Annexure-2)
- Deviation Report Form for Metadata and Filing (Annexure-3)
References
ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
FDA 21 CFR Part 11: Electronic Records; Electronic Signatures
EMA Guidelines on Good Pharmacovigilance Practices (GVP)
Company Quality Management System Documentation
Annex 11: Computerized Systems (EU GMP)
Version
1.0
Approval
| Prepared By | |
| Checked By | |
| Approved By |
Annexures
Annexure-1: Metadata Review Checklist
Purpose: To verify the completeness and accuracy of metadata entries for regulatory documents before filing.
| Field | Entry |
|---|---|
| Document Title | Regulatory Submission Dossier – Module 3 |
| Document Type | Submission Dossier |
| Version | 1.2 |
| Date | 14/04/2026 |
| Author | Regulatory Affairs Team |
| Regulatory Classification | Marketing Authorization |
| Keywords | CTD, submission, dossier, regulatory |
| Reviewed By | Reg. Affairs Supervisor |
| Date of Review | 15/04/2026 |
| Remarks | Metadata verified and found compliant |
Annexure-2: Document Filing Log
Purpose: To record details of regulatory documents filed, including metadata and location for audit trail and retrieval.
| Document ID | Title | Version | Filing Date | Location/Folder | Filed By | Verified By | Comments |
|---|---|---|---|---|---|---|---|
| RA-DOC-0256 | Clinical Trial Application Form | 3.0 | 16/04/2026 | Submissions/CTA/2026 | Reg Document Controller | RA Supervisor | Filed per SOP requirements |
Annexure-3: Deviation Report Form for Metadata and Filing
Purpose: To document and track deviations related to metadata inaccuracies or filing errors, including corrective action plans.
| Deviation No. | DEV-2026-014 |
|---|---|
| Date Reported | 16/04/2026 |
| Description of Deviation | Incorrect version number entered in metadata for submission dossier |
| Impacted Documents | Submission Dossier Module 3 |
| Immediate Action Taken | Metadata corrected and supervisor notified |
| Root Cause | Manual entry error during metadata input |
| Corrective Action | Implement double-check verification step for metadata entry |
| Preventive Action | Training session for document controllers on metadata accuracy |
| Deviation Closed Date | 18/04/2026 |
| Reviewed By | Regulatory Affairs Supervisor |
| Approval Status | Closed |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
| 16/04/2026 | 1.0 | Initial issue | New SOP creation |