Definition
Computer System Validation (CSV) is an approach for establishing documented evidence that a computerised system consistently fulfils defined requirements and is fit for its intended use in a regulated environment.
Human Explanation
CSV confirms that the complete system can reliably support the work for which it is intended.
Why it Matters
Computerised systems can directly affect process quality, Data Integrity and regulatory compliance.
Conceptual Boundary
CSV is not limited to software testing. It addresses the computerised system, its intended use and its lifecycle controls.
Practical Perspective
CSV covers planning, risk analysis, requirements, design, testing, Documentation, controlled change and maintenance throughout the system lifecycle.