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PLANREFERENCE OUTLINE
CAPA Plan & Effectiveness Review
Corrective and preventive action plan with owners, due dates, and a pre-defined effectiveness check — so the fix is verified, not assumed. Maps to 21 CFR 820.100 and ICH Q10.
REGULATIONS MAPPED
21 CFR Part 820ICH Q10
DOCUMENT TYPE
PlanLAST UPDATED
January 2025PURPOSE
A corrective and preventive action plan that turns an investigation finding into defined, owned, verifiable actions — with a built-in effectiveness check so the problem stays fixed.
What's Inside
✓Problem statement and source event
✓Root cause summary
✓Corrective actions (fix the occurrence)
✓Preventive actions (stop recurrence)
✓Effectiveness-check design and criteria
How to Use It
1Restate the confirmed root cause from the investigation
2Define corrective actions with owners and due dates
3Define preventive actions across similar processes
4Set a measurable effectiveness check and review date
5Verify effectiveness before closing the CAPA
DOCUMENT CONTENTS
The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.
—Document Control
› Document Information› Approval Signatures› Revision History› Distribution List
1Problem Statement and Source
› Problem statement
2Root Cause Summary
3Corrective Action Plan
4Preventive Action Plan
5Owners, Due Dates, and Dependencies
6Effectiveness Check and Acceptance Criteria
7Verification of Effectiveness
8Closure and Approval
REGULATORY CONTEXT
21 CFR 820.100 and ICH Q10 require a CAPA system with effectiveness verification. This template makes the effectiveness check a first-class, pre-defined step rather than an afterthought.