CSV Validation
Computerised system validation for GxP compliance across all digital platforms and systems.
Overview
Our Computerised System Validation (CSV) services ensure that all computerised systems used in GxP-regulated environments are validated, compliant and fit for their intended purpose.
Service Scope
- GAMP 5 Risk-Based Approach
- System Life Cycle Management
- Validation Planning & Protocols
- User Requirements Specifications
- Functional & Design Specifications
- Testing (IQ/OQ/PQ)
- 21 CFR Part 11 Compliance
Regulatory Standards
GAMP 5FDA 21 CFR Part 11EU GMP Annex 11PIC/S PI 011WHO TRS 996 Annex 5
All Services
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