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ROI CalculatorComputer System Validation (CSV) is a well-defined process of proving that a computerized system consistently performs as intended while maintaining data integrity in regulated use.
FDA CGMP expects systems used for manufacturing, testing, and quality records to be validated for accuracy, reliability, and consistent performance (21 CFR 211.68). For electronic records and signatures, 21 CFR Part 11 requires controls for security, audit trails, and record integrity. ISO 13485 and GAMP 5 provide widely used frameworks for a risk-based validation approach.
Why it matters: unvalidated systems can invalidate data, trigger inspection findings, and block batch release or approvals.
