What is computer system validation and computer system assurance (CSV &CSA) CSV and SCA are the systematic process of verifying and assuring that any computer-based system or application performs and delivers results as intended, while ensuring compliance with regulatory standards such as FDA 21 CFR Part 11, GxP, and EU Annex 11 throughout its lifecycle. What are the Phases of computer system validation? The computer system validation consists Three major phases (1) Planning Phase (2) Execution Phase (3) Reporting Phase What else apart from CSV and SCA we do ? 1. GAP Assessment and remediation. 2. Project initiation and internal support for compliance oriented development. 3. Implementation support and documentation.