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PLANREFERENCE OUTLINE
Computer System Validation (CSV) Plan
CSV plan scoping a GxP computerised system by GAMP category and risk, defining IQ/OQ/PQ deliverables, Part 11 applicability, and requirements traceability. Maps to GAMP 5, Part 11, and Annex 11.
REGULATIONS MAPPED
ISPE GAMP 521 CFR Part 11EU GMP Annex 11
DOCUMENT TYPE
PlanLAST UPDATED
January 2025PURPOSE
A computer system validation plan that scopes a GxP computerised system, sizes the validation effort by risk and GAMP category, and defines the deliverables that demonstrate fitness for intended use.
What's Inside
✓System description and intended use
✓GxP assessment and Part 11 applicability
✓GAMP software category and risk assessment
✓Validation deliverables and lifecycle
✓Roles, supplier assessment, and traceability
How to Use It
1Describe the system and its GxP intended use
2Confirm Part 11 / Annex 11 applicability
3Assign the GAMP category and risk level
4Scale IQ/OQ/PQ and testing to that risk
5Maintain requirements-to-test traceability
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
1System Description and Intended Use
2GxP and Part 11 / Annex 11 Assessment
3GAMP Category and Risk Assessment
4Validation Strategy and Deliverables
5Roles and Supplier Assessment
6Requirements Traceability Approach
7Acceptance and Release Criteria
8Periodic Review and Retirement
REGULATORY CONTEXT
ISPE GAMP 5 (2nd ed.), 21 CFR Part 11, and EU GMP Annex 11 govern computerised system validation. This plan applies the risk- and category-based scaling GAMP 5 expects.