Standard Operating Procedure for Monthly Regulatory Operations Dashboard Review
| Department | Regulatory Affairs |
| SOP No. | RA/2026/620 |
| Supersedes | NA |
| Page No. | 1 of X |
| Issue Date | 08/04/2026 |
| Effective Date | 08/04/2026 |
| Review Date | 08/04/2028 |
Purpose
This Standard Operating Procedure (SOP) establishes a systematic and controlled process for the monthly review of the Regulatory Operations Dashboard. The objective is to ensure consistent monitoring, evaluation, and documentation of regulatory activities, submission statuses, compliance metrics, and workflow performance. This review supports regulatory compliance, timely decision-making, audit readiness, and continuous improvement of regulatory operations.
Scope
This SOP applies to all Regulatory Affairs personnel involved in preparing, reviewing, and approving the monthly Regulatory Operations Dashboard within the organization. It covers data collection, consolidation, analysis, and reporting functions related to regulatory submissions, documentation control, compliance tracking, and quality system metrics. The SOP excludes activities beyond regulatory operations such as clinical trial management, manufacturing operations, or external vendor audits.
Responsibilities
The following roles are responsible for the activities defined in this SOP:
- Regulatory Operations Coordinator – prepares and consolidates dashboard data.
- Regulatory Affairs Manager – reviews and approves the dashboard summary.
- Quality Assurance Representative – verifies compliance of metrics and documentation.
- Regulatory Compliance Officer – monitors adherence to timelines and addresses deviations.
- Head of Regulatory Affairs – oversees the process and ensures corrective actions are implemented if required.
Accountability
The Head of Regulatory Affairs holds overall accountability for the implementation, compliance, periodic review, effectiveness, escalation of issues arising from the dashboard review, and ensuring continuous improvements are integrated into regulatory operations.
Procedure
1. Preparation: At the beginning of each month, the Regulatory Operations Coordinator collects updated data from regulatory submissions, compliance logs, and quality systems. Sources include submission tracking software, document control databases, and regional regulatory updates.
2. Data Consolidation: All relevant metrics such as submission statuses, pending actions, audit outcomes, training compliance, and change management activities are compiled into the standardized dashboard template (Annexure-1). Ensure data integrity and verify entries against source documents.
3. Prerequisites and Checks: Verify that all required data inputs are complete and validated. Confirm all entries meet the defined acceptance criteria, such as submission dates matching authorized documents, compliance percentage thresholds, and error rate limits.
4. Initial Review: The Coordinator reviews the dashboard for completeness and accuracy. Any discrepancies or missing data must be clarified with respective functional units before submission.
5. Managerial Review and Approval: The Regulatory Affairs Manager evaluates the dashboard, focusing on trends, deviations, and areas requiring corrective or preventive action. Comments and approvals are documented on the review checklist (Annexure-2).
6. Quality Assurance Verification: Quality Assurance reviews the dashboard data and associated documentation to ensure compliance with internal policies and external regulatory expectations. Any findings must be communicated promptly to the Regulatory Compliance Officer.
7. Addressing Deviations: If the dashboard identifies deviations or non-compliance, a defined CAPA process is initiated. Relevant stakeholders must document root causes, action plans, and timelines for resolution.
8. Documentation and Record Retention: The final approved dashboard, review checklists, deviation reports, and CAPA records are scanned and archived in the designated electronic document management system with version control for future reference and audit purposes.
9. Reporting: Summarized findings and key performance indicators from the dashboard review are communicated monthly to senior management and relevant regulatory authorities as applicable.
10. Continuous Improvement: Periodically, the effectiveness of this review process is assessed through internal audits and management reviews to incorporate improvements and align with evolving regulatory requirements.
This procedure ensures a controlled, transparent, and efficient review mechanism for monthly regulatory operations, supporting both compliance and operational excellence.
Abbreviations
- CAPA – Corrective and Preventive Action
- GMP – Good Manufacturing Practice
- QA – Quality Assurance
- RA – Regulatory Affairs
- SOP – Standard Operating Procedure
Documents
- Monthly Regulatory Operations Dashboard Template (Annexure-1)
- Regulatory Operations Dashboard Review Checklist (Annexure-2)
- Corrective Action Plan Form (Annexure-3)
References
- ICH Q10 – Pharmaceutical Quality System
- FDA Guidance for Industry – Quality Systems Approach to Pharmaceutical CGMP Regulations
- EMA Guidelines on Good Pharmacovigilance Practices
- Internal Document Control and Compliance Policies
- ISO 9001:2015 Quality Management Systems Requirements
Version
1.0
Approval
| Prepared By | |
| Checked By | |
| Approved By |
Annexures
Annexure-1: Monthly Regulatory Operations Dashboard Template
Purpose: To provide a standardized template for collecting and consolidating monthly regulatory operations metrics to support timely review and decision-making.
| Category | Metric | Target | Current Month | Previous Month | Comments |
|---|---|---|---|---|---|
| Submission Status | Submissions Completed | >=95% | 97% | 96% | On schedule |
| Submission Status | Pending Submissions | <=5% | 3% | 4% | Minor delay in one region |
| Compliance | Documentation Accuracy | >=98% | 99% | 98.5% | Consistent quality |
| Training | Regulatory Training Completion | >=100% | 100% | 100% | All staff compliant |
| Deviations | Open CAPAs | 0 | 1 | 2 | Ongoing CAPA for labeling error |
| Audit | Open Non-Conformances | 0 | 0 | 0 | No open findings |
Annexure-2: Regulatory Operations Dashboard Review Checklist
Purpose: To document review steps, observations, and approvals for the monthly regulatory operations dashboard ensuring completeness and compliance.
| Review Item | Reviewed By | Date | Comments | Signature |
|---|---|---|---|---|
| Data Completeness | 08/04/2026 | Complete and validated | ||
| Compliance Metrics | 08/04/2026 | Within acceptable limits | ||
| Deviation Summary | 08/04/2026 | CAPA initiated for open issue | ||
| Overall Approval | 08/04/2026 | Approved for distribution |
Annexure-3: Corrective Action Plan Form
Purpose: To formally document the identification, evaluation, and resolution plan for deviations or non-compliances identified during the monthly dashboard review.
| Issue Reference | CAPA-2026-001 |
| Date Identified | 08/04/2026 |
| Issue Description | Labeling discrepancy found in submission batch 03/2026 |
| Root Cause Analysis | Incorrect template used during documentation finalization |
| Corrective Actions | Retrain document controllers and update templates |
| Preventive Actions | Implement additional review step in SOP Document Control |
| Responsible Person | Regulatory Operations Coordinator |
| Target Completion Date | 30/04/2026 |
| Status | Open |
| Reviewed By | |
| Approved By |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
| 08/04/2026 | 1.0 | Initial issue | New SOP creation |