A Computer System Validation (CSV) Master Plan is a high-level document that defines the overall approach, strategy, and methodology for validating computer systems in a pharmaceutical or GMP-regulated environment. It ensures that all computerized systems are fit for their intended use and comply with regulatory requirements like 21 CFR Part 11, EU Annex 11, and GAMP 5.
- SOP for Computer System Validation
- Template 01 – Computer Validation Plan
- Computer System Validation Master Plan
- Computer Validation User Requirements Specification (URS)
- Computer Validation Installation Qualification (IQ)
- Computer Validation Operational Qualification (OQ)
- Computer Validation Operational Qualification Performance Qualification (OQPQ)
- Computerized Systems Risk Assessment
- Computer Validation Summary Report
Here’s a comprehensive structure for a Computer System Validation Master Plan (CSV MP):
1. Introduction
- Purpose of the CSV Master Plan
- Scope of computer system validation
- Regulatory requirements and guidelines (e.g., FDA, EMA, WHO, GAMP 5)
- Definitions and abbreviations
2. Objective
- To establish a structured framework for CSV activities
- To ensure compliance with GMP, GxP, 21 CFR Part 11, Annex 11
- To provide a consistent methodology for validation across all systems
3. Scope
- Systems covered: Laboratory systems (LIMS, CDS), Manufacturing (MES, SCADA), ERP, DMS, etc.
- Exclusions (if any)
- Life cycle stages applicable (planning → retirement)
4. Responsibilities
- Quality Assurance (QA): Oversight, approval, and compliance verification
- IT / Engineering: System implementation and technical support
- User Department: User Requirement Specification (URS) and functional ownership
- Validation Team: Planning, execution, and documentation of CSV activities
5. Validation Strategy
- Risk-based approach per GAMP 5
- Categorization of systems (GAMP Category 1–5)
- Validation life cycle approach:
- Planning – URS, Risk Assessment, Validation Plan
- Specification – FS, DS
- Testing & Qualification – IQ, OQ, PQ
- Release – Validation Summary Report (VSR)
- Operation & Maintenance – Change Control, Periodic Review
- Retirement / Decommissioning – Data migration, archiving, disposal
6. Risk Assessment
- System criticality evaluation (GxP impact)
- Data integrity assessment (ALCOA+)
- Cybersecurity and backup considerations
7. Documentation Requirements
- Validation Plan (VP)
- User Requirement Specification (URS)
- Functional Specification (FS) / Design Specification (DS)
- Risk Assessment (RA)
- Traceability Matrix (TM)
- IQ / OQ / PQ Protocols and Reports
- Validation Summary Report (VSR)
- SOPs for system operation, backup, recovery, and change control
8. Change Control and Periodic Review
- Management of changes during system lifecycle
- Periodic system review to ensure ongoing compliance
- Re-validation triggers
9. Training and Competency
- Training requirements for users, administrators, and validation teams
- Maintaining training records as part of validation evidence
10. References
- GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems
- 21 CFR Part 11
- EU GMP Annex 11
- WHO Technical Report Series guidelines
- Internal SOPs and quality manuals