Standard Operating Procedure for Control of Shared Drives and eDMS Use in Regulatory Affairs
| Department | Regulatory Affairs |
| SOP No. | RA/2026/781 |
| 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 a controlled and standardized approach for managing shared drives and electronic Document Management Systems (eDMS) within the Regulatory Affairs department. It ensures the integrity, security, accessibility, and traceability of regulatory documents and records in compliance with applicable regulatory requirements and internal quality management systems. This SOP supports the control objective of safeguarding document integrity while facilitating efficient regulatory operations and collaboration.
Scope
This SOP applies to all Regulatory Affairs personnel involved in creating, reviewing, approving, storing, retrieving, and archiving regulatory documents within shared drives and the eDMS platform. It covers electronic and digital document control processes for regulatory submissions, labeling, dossiers, correspondence, and other regulatory documentation. The SOP excludes systems and repositories outside Regulatory Affairs and internal IT infrastructure management activities not related to document control.
Responsibilities
- Regulatory Affairs Staff: Create, upload, and maintain regulatory documents on shared drives and eDMS as per SOP requirements.
- Document Controllers: Monitor access rights, maintain filing structures, ensure completeness, and assist in audits relating to document management.
- Reviewers and Approvers: Review and approve documents within eDMS workflows to ensure accuracy and compliance prior to release.
- Quality Assurance (QA): Conduct periodic audits and verify compliance with this SOP and applicable regulatory requirements.
Accountability
The Head of Regulatory Affairs is accountable for ensuring the implementation, adherence, periodic review, and continuous effectiveness of this SOP. This role is responsible for escalation of non-compliance, arranging necessary training, and ensuring all regulatory documentation management meets applicable internal and external standards.
Procedure
The management and control of shared drives and eDMS use in Regulatory Affairs shall be conducted as follows:
1. Preparation and Access Control: Prior to document upload or access, personnel must have appropriate system credentials granted by the Document Controller, based on their role and job function. Access rights shall be reviewed and updated quarterly to ensure compliance with the principle of least privilege.
2. Document Creation and Upload: All regulatory documents must be created in approved templates. Upon completion of draft versions, documents shall be uploaded to the designated shared drive folder or directly into the eDMS repository with appropriate metadata (title, version, author, date, classification).
3. Version Control and Review Workflow: In the eDMS system, documents enter a controlled workflow requiring review and approval through assigned users. Each version must be distinctly numbered, and previous superseded versions archived but accessible for audit purposes.
4. In-Process Controls and Verification: Document Controllers must periodically verify folder structures, naming conventions, metadata accuracy, and completeness of files. Any discrepancies or non-conformance shall be logged, investigated, and corrected promptly.
5. Document Retrieval and Usage: Authorized personnel shall retrieve documents through the eDMS interface or shared drive paths. Retrieval logs must be maintained automatically by eDMS or manually tracked to ensure traceability of document usage.
6. Data Integrity and Security: Backup schedules and access logs shall be maintained by IT in line with company policies. Users must never share login credentials and must log out when not using the system. Sensitive documents may be restricted to “read-only” where applicable.
7. Record Retention and Archival: Upon document obsolescence, superseded or outdated files shall be archived within the eDMS archive module or moved to designated archival shared drive folders. Retention periods shall follow regulatory and company policies.
8. Handling Deviations: Any deviation from this SOP, including unauthorized access, accidental deletion, or data loss, must be reported immediately to the QA and IT departments for investigation and corrective action.
9. Training and Competency: All users shall receive training on shared drive and eDMS SOPs during onboarding and periodic refresher training thereafter. Training records shall be maintained according to internal procedures.
10. Documentation and Audit Trails: All activities within the eDMS, including document creation, modification, approvals, and retrievals, are automatically logged and maintained for audit purposes. Manual records such as access request forms or exception reports shall be maintained as applicable.
Abbreviations
- eDMS – electronic Document Management System
- QA – Quality Assurance
- SOP – Standard Operating Procedure
- IT – Information Technology
- GMP – Good Manufacturing Practice
Documents
- Access Request Form for Regulatory Shared Drives and eDMS (Annexure-1)
- Regulatory Document Upload and Version Control Checklist (Annexure-2)
- Deviation Report Form for Document Management Incidents (Annexure-3)
References
- 21 CFR Part 11 – Electronic Records; Electronic Signatures
- EMA Guidelines on Quality Systems
- ICH Q10 Pharmaceutical Quality System
- Company Quality Management System Document Control Policy
- GAMP 5 – A Risk-Based Approach to Compliant GxP Automated Systems
Version
1.0
Approval
| Prepared By | |
| Checked By | |
| Approved By |
Annexures
Annexure-1: Access Request Form for Regulatory Shared Drives and eDMS
Purpose: To document requests and approvals for access rights to shared drives and eDMS systems within Regulatory Affairs.
| Field | Details |
|---|---|
| Request Date | 10/04/2026 |
| Requester Department | Regulatory Affairs |
| Requester Role | Regulatory Specialist |
| Requested Access Type | Read/Write |
| System Requested | eDMS – Regulatory Module |
| Justification | Need to upload and review regulatory submissions documents |
| Reviewed By | Regulatory Document Controller |
| Approval Status | Approved |
| Approval Date | 12/04/2026 |
| Access Granted By | IT Administrator |
| Access Granted Date | 13/04/2026 |
Annexure-2: Regulatory Document Upload and Version Control Checklist
Purpose: To verify compliance with document upload procedures and version control requirements in Regulatory Affairs shared drives and eDMS.
| Checklist Item | Yes / No | Comments |
|---|---|---|
| Document created using approved template | Yes | |
| Appropriate metadata entered (title, version, author, date) | Yes | |
| Uploaded to correct folder or repository location | Yes | |
| Version number correctly updated | Yes | |
| Document routed for review and approval via eDMS workflow | Yes | |
| Superseded versions archived properly | Yes | |
| Access rights verified for document | Yes | |
| Audit trail available and complete | Yes |
Annexure-3: Deviation Report Form for Document Management Incidents
Purpose: To record and manage deviations related to the control of shared drives and eDMS use within Regulatory Affairs.
| Field | Details |
|---|---|
| Deviation ID | DM-2026-001 |
| Date of Incident | 05/04/2026 |
| Reported By | Regulatory Associate |
| Description of Deviation | Unauthorized deletion of draft submission document from shared drive. |
| Impact Assessment | Potential delay in submission; data recovery initiated. |
| Immediate Corrective Actions | Access privileges reviewed; backup restored document. |
| Root Cause Analysis | Incorrect access rights assigned to temporary user. |
| Permanent Corrective Actions | Revised access control process implemented; additional training conducted. |
| Status | Closed |
| Reviewed By | QA Manager |
| Review Date | 10/04/2026 |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
| 17/04/2026 | 1.0 | Initial issue | New SOP creation |