Scientific Software Validation Plan Scientific Software Validation Plan Scientific Software Validation Plan Define scope, strategy, and testing for regulated software (e.g., FDA/GxP compliance). 1. Project Identification & Scope Software Name / Version Plan Date Scope of Validation Regulatory Requirements/Standards 2. Validation Strategy & Methodology Software Category / Risk Level Low Risk (e.g., Spreadsheets) Medium Risk (e.g., Configuration) High Risk (e.g., Patient/Batch Release) Validation Type Full Validation (New System) Revalidation (Major Change) Retirement Validation Approach Summary (V-Model, Agile, etc.) 3. Testing Phases & Acceptance Criteria Installation Qualification (IQ) Summary Operational Qualification (OQ) Summary Performance Qualification (PQ) Summary Final Acceptance Criteria (Success Definition) Generate & Download Validation Plan (PDF)
