Complete CAPA (Corrective and Preventive Action) documentation package for FDA QMSR compliance. Includes policy, SOP, and ready-to-use forms aligned with FDA 21 CFR 820.198 and ISO 13485:2016.
Comprehensive CAPA Template Set for FDA 21 CFR 820 QMSR Compliance
This complete Corrective and Preventive Action (CAPA) template set is designed to help medical device manufacturers establish and maintain a robust CAPA system fully compliant with the FDA’s Quality Management System Regulation (QMSR) under 21 CFR 820.
CAPA is one of the most critical subsystems in any medical device quality management system and is consistently a top focus area during FDA inspections. This template set provides everything you need to implement an effective CAPA process from scratch or upgrade your existing system to meet QMSR requirements.
What’s Included (10 Templates)
| Document No. | Document Name | Format |
|---|---|---|
| MD-QMS-K17 | CAPA Policy (Corrective and Preventive Action Policy) | .docx |
| MD-QMS-S1701 | CAPA SOP (Corrective and Preventive Action Procedure) | .docx |
| MD-QMS-F1701 | CAPA Form | .docx |
| MD-QMS-F1702 | CAPA Log (Tracking Spreadsheet) | .xlsx |
| MD-QMS-F1703 | CAT Meeting Minutes (CAPA Action Team) | .docx |
Key Features
- Full QMSR Compliance: Aligned with FDA 21 CFR 820.198 and ISO 13485:2016 requirements
- Complete Process Coverage: From problem identification and root cause analysis to effectiveness verification
- Ready-to-Use Templates: Professional formatting with clear instructions and examples
- CAPA Tracking System: Excel-based CAPA log for systematic tracking and trending
- CAT Meeting Framework: Structured meeting minutes template for cross-functional CAPA review
CAPA Process Flow Covered
- Problem Identification & Data Collection
- Root Cause Analysis (RCA)
- Corrective Action Planning & Implementation
- Preventive Action Planning & Implementation
- Effectiveness Verification
- CAPA Closure & Documentation
Applicable Regulations & Standards
- FDA 21 CFR 820 QMSR (Quality Management System Regulation)
- FDA 21 CFR 820.198 (Complaint Files / CAPA)
- ISO 13485:2016 Clause 8.5.2 (Corrective Action) & 8.5.3 (Preventive Action)
Who Should Purchase This Template Set?
- Medical device manufacturers preparing for FDA submissions or inspections
- Quality managers implementing or upgrading CAPA systems
- Regulatory affairs professionals ensuring QMSR compliance
- Consultants supporting medical device companies with QMS development
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