Standard Operating Procedure for Data Integrity Investigation in Regulatory Documentation
| Department | Regulatory Affairs |
| SOP No. | RA/2026/780 |
| Supersedes | NA |
| Page No. | 1 of X |
| Issue Date | 17/04/2026 |
| Effective Date | 17/04/2026 |
| Review Date | 17/04/2028 |
Purpose
This SOP defines the systematic approach and control measures to be implemented for the investigation of suspected or confirmed data integrity issues within regulatory documentation. It aims to ensure complete transparency, accuracy, reliability, and traceability of regulatory records, supporting compliance with applicable regulatory requirements and maintaining the integrity of submissions to health authorities.
Scope
This procedure applies to all regulatory documentation, including but not limited to submissions, correspondence, dossiers, archives, electronic and paper records generated, maintained, or archived within the Regulatory Affairs department. It covers data integrity investigations related to handwritten, computerized, and scanned documents. The SOP excludes investigations related solely to laboratory or manufacturing records unless directly linked to regulatory submissions.
Responsibilities
- Regulatory Affairs Personnel: Execute initial identification and reporting of data integrity concerns.
- Quality Assurance (QA): Review and oversee investigations, ensure compliance and approval of outcomes.
- Investigation Team: Conduct detailed root cause analysis, corrective and preventive actions (CAPA).
- Document Control Coordinator: Ensure affected documents are identified, controlled, and archived properly.
- Management Representative: Provide oversight, resource allocation, and final approval of investigation reports.
Accountability
The Head of Regulatory Affairs holds accountability for ensuring full implementation, observance, and periodic review of this SOP. They are responsible for escalating unresolved or critical data integrity events to senior management and ensuring the effectiveness of corrective actions arising from investigations.
Procedure
The data integrity investigation procedure shall be conducted as per the following stages:
1. Detection and Initial Reporting: Any suspected data integrity concern within regulatory documentation shall be immediately reported to the Regulatory Affairs Quality Assurance representative, who records this in the Data Integrity Investigation Log.
2. Preliminary Assessment: The QA representative shall perform a preliminary review to confirm the validity of the concern and determine the potential impact on regulatory submissions or compliance.
3. Investigation Team Formation: Upon validation, a cross-functional investigation team shall be constituted including Regulatory Affairs, QA, and Document Control representatives, with others as required.
4. Collection of Evidence: Secure and review all related documentation, electronic audit trails, metadata, and any other pertinent records. Establish timelines, personnel involved, and identify the affected data or documents.
5. Root Cause Analysis: Analyze the findings to identify the cause of the data integrity breach using appropriate tools such as 5 Whys or Fishbone analysis. Determine if the issue arose from human error, system failure, procedural non-compliance, or deliberate misconduct.
6. Impact Assessment: Evaluate potential or actual impacts on regulatory submissions, patient safety, or compliance status.
7. CAPA Development: Define corrective and preventive actions to remediate the issue and mitigate recurrence, including training, process revision, system upgrades, or disciplinary actions if necessary.
8. Approval and Communication: Submit the investigation report and CAPA plan for review and approval by QA and management. Communicate findings and corrective measures to relevant stakeholders.
9. Documentation and Record Keeping: Archive all investigation-related documents securely in line with document retention policies, ensuring traceability and audit-readiness.
10. Closure and Review: Upon completion of CAPA implementation, perform effectiveness checks. Document results and formally close the investigation.
Notes and Compliance: Throughout all steps, ensure adherence to Good Documentation Practices (GDP), data integrity principles (ALCOA+), and regulatory guidance. Any significant findings shall be escalated promptly.
Abbreviations
- ALCOA+ – Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available
- CAPA – Corrective and Preventive Actions
- GDP – Good Documentation Practices
- QA – Quality Assurance
- SOP – Standard Operating Procedure
Documents
The following documents are essential for performing data integrity investigations in regulatory documentation:
- Data Integrity Investigation Report Template (Annexure-1)
- Data Integrity Investigation Log (Annexure-2)
- Corrective and Preventive Action (CAPA) Form (Annexure-3)
References
- FDA Guidance for Industry: Data Integrity and Compliance With Drug CGMP (2018)
- EMA Good Practice Guide on Data Integrity (2018)
- ICH Q7 Good Manufacturing Practice Guide
- ICH Q9 Quality Risk Management
- ICH Q10 Pharmaceutical Quality System
- EU GMP Annex 11 – Computerized Systems
- Internal Quality Management System Documentation
Version
1.0
Approval
| Prepared By | |
| Checked By | |
| Approved By |
Annexures
Annexure-1: Data Integrity Investigation Report Template
Purpose: To document detailed findings, root cause analysis, impact assessment, and corrective actions of a data integrity investigation related to regulatory documentation.
| Investigation ID | DI-RA-2026-001 |
| Date Opened | 15/04/2026 |
| Reported By | Regulatory Affairs Staff |
| Description of Issue | Inconsistency detected in submission document versioning and metadata timestamps |
| Investigation Team Members | Regulatory Affairs, QA, Document Control |
| Root Cause Analysis | Lack of adherence to version control SOP and incomplete metadata audit trail |
| Impact Assessment | Potential risk to submission integrity; no patient safety impact identified |
| Corrective Actions | Retraining on document control procedures; audit trail system update; enhanced review steps |
| Preventive Actions | Periodic data integrity audits; strict enforcement of SOP compliance; automated alerts for metadata discrepancies |
| Investigation Closure Date | 30/04/2026 |
| Prepared By | Regulatory Affairs Staff |
| Reviewed By | Quality Assurance |
| Approved By | Head of Regulatory Affairs |
Annexure-2: Data Integrity Investigation Log
Purpose: To maintain a centralized record of all data integrity investigation events reported within regulatory documentation processes.
| Investigation ID | Opening Date | Reported By | Issue Summary | Status | Closure Date |
|---|---|---|---|---|---|
| DI-RA-2026-001 | 15/04/2026 | Regulatory Affairs Staff | Document version control inconsistency | Closed | 30/04/2026 |
| DI-RA-2026-002 | 10/05/2026 | Regulatory Affairs Staff | Discrepancy in scanned submission metadata | Open | – |
Annexure-3: Corrective and Preventive Action (CAPA) Form
Purpose: To document detailed corrective and preventive measures taken to rectify and prevent recurrence of data integrity breaches in regulatory documentation.
| CAPA ID | CAPA-RA-2026-001 |
| Related Investigation ID | DI-RA-2026-001 |
| Description of Non-Conformance | Failure to properly control document versioning leading to questionable submission data integrity |
| Corrective Action(s) | Conducted training on version control SOP; implemented audit trail reviews |
| Preventive Action(s) | Automation of metadata monitoring; quarterly data integrity audits established |
| Target Completion Date | 30/05/2026 |
| Actual Completion Date | 28/05/2026 |
| Effectiveness Check Date | 15/06/2026 |
| Effectiveness Review Comments | No recurrence detected; improved compliance with version control SOP |
| Prepared By | Regulatory Affairs Staff |
| Reviewed By | Quality Assurance |
| Approved By | Head of Regulatory Affairs |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
| 17/04/2026 | 1.0 | Initial issue | New SOP creation |