CSV

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.

1. SOP for Computer System Validation
2. Template 01 – Computer Validation Plan
3. Computer System Validation Master Plan
4. Computer Validation User Requirements Specification (URS)
5. Computer Validation Installation Qualification (IQ)
6. Computer Validation Operational Qualification (OQ)
7. Computer Validation Operational Qualification Performance Qualification (OQPQ)
8. Computerized Systems Risk Assessment
9. 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:
  1. Planning – URS, Risk Assessment, Validation Plan
  2. Specification – FS, DS
  3. Testing & Qualification – IQ, OQ, PQ
  4. Release – Validation Summary Report (VSR)
  5. Operation & Maintenance – Change Control, Periodic Review
  6. 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