PHARMACEUTICAL COMPUTER SYSTEMS VALIDATION (CSV) CHECKLIST 2026

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--- PRE-VALIDATION PLANNING & USER REQUIREMENTS ---
[ ] System Name and Identifier
[ ] Project Scope Overview
[ ] Validation Plan Approval Date
[ ] Criticality Level (Low, Medium, High, Critical)
[ ] Applicable Regulatory Standards (21 CFR Part 11, EU Annex 11, GxP, ALCOA+)
[ ] Approved User Requirements Specification (URS)
[ ] Project Manager Approval

--- RISK ASSESSMENT & IMPACT ANALYSIS ---
[ ] GxP Impact Level (High Impact, Medium Impact, Low Impact)
[ ] Risk Description
[ ] Risk Severity Score (1 - Negligible, 2 - Minor, 3 - Major, 4 - Critical)
[ ] Identified Risk Areas (Data Integrity, Patient Safety, Product Quality, Regulatory Compliance)
[ ] Mitigation Strategy
[ ] Risk Assessment Document
[ ] Assessor Signature

--- INSTALLATION QUALIFICATION (IQ) ---
[ ] Hardware Serial Number/ID
[ ] Installation Completion Date
[ ] Hardware Components Verified (Server/Workstation, Network Interface Card, Peripherals (Printers/Scanners), Storage Units)
[ ] Software Version Verified (Version Match with URS, New Version/Upgrade)
[ ] Installation Log/Evidence
[ ] IQ Performed By

--- OPERATIONAL QUALIFICATION (OQ) ---
[ ] Functional Test Areas Verified (User Access & Permissions, Audit Trail Functionality, Data Entry & Retrieval, Security & Authentication, System Alert & Notification, Data Backup & Recovery)
[ ] Test Case ID Reference
[ ] Test Execution Status (Pass, Fail, In Progress, N/A)
[ ] Description of Observed Deviations
[ ] Execution Date
[ ] Tester Signature
[ ] Supporting Evidence/Screenshots

--- PERFORMANCE QUALIFICATION (PQ) ---
[ ] Test Case Reference ID
[ ] Observed Performance Results
[ ] Test Outcome (Pass, Fail, , N/A)
[ ] Date of Execution
[ ] Tester Signature
[ ] Supporting Raw Data/Evidence

--- DATA INTEGRITY & SECURITY CONTROLS ---
[ ] Compliance Features Verified (21 CFR Part 11 Compliance, Audit Trail Functionality, User Access Management, Data Encryption & Security, Electronic Signatures, Data Backup & Disaster Recovery)
[ ] Audit Trail Configuration Details
[ ] Description of Security Incident Management Procedure
[ ] Last Security Audit Date
[ ] Evidence of Access Control Logs
[ ] Data Integrity Officer Verification

--- TRACEABILITY MATRIX (TM) REVIEW ---
[ ] Traceability Status (Complete, In Progress, Pending Updates, Incomplete - Critical Gaps Found)
[ ] Requirement ID Reference
[ ] Verified Traceability Components (URS to Functional Specs, Functional Specs to Design Specs, Design Specs to Test Scripts, Test Scripts to Test Results)
[ ] Traceability Review Date
[ ] Traceability Gaps or Observations
[ ] Updated Traceability Matrix Document
[ ] Reviewer Authorization

--- TESTING DOCUMENTATION & DEVIATION MANAGEMENT ---
[ ] Date of Deviation Discovery
[ ] Deviation Severity Level (Critical, Major, Minor)
[ ] Detailed Deviation Description
[ ] Root Cause Analysis (RCA) Summary
[ ] Corrective Actions Implemented (Retesting Performed, Software Patch Applied, Personnel Retraining, Document Update)
[ ] Supporting Evidence/Evidence Logs
[ ] Quality Assurance Approval Signature

--- SYSTEM RELEASE & FINAL VALIDATION SUMMARY REPORT ---
[ ] Report Completion Date
[ ] Validation Summary Report Reference ID
[ ] Final Validation Status (Approved, Approved with Deviations, Rejected)
[ ] Approved Deliverables Included (IQ Report, OQ Report, PQ Report, Traceability Matrix, Deviation Log)
[ ] Summary of Residual Risks
[ ] Upload Signed Validation Summary Report
[ ] Quality Assurance Approval Signature

--- POST-IMPLEMENTATION & PERIODIC REVIEW ---
[ ] Next Scheduled Periodic Review Date
[ ] Review Frequency (Quarterly, Bi-Annually, Annually, Every 2 Years)
[ ] Review Scope Areas (Audit Trail Review, User Access Audit, Backup/Restore Success Rate, System Incident Log Review, Hardware/Software Patch Levels)
[ ] Summary of Findings & Continuous Improvement Notes
[ ] Upload Periodic Review Report (PRR)
[ ] Quality Assurance Approval

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