System Validation (CSV) in the Era of Digital Transformation

Abstract

With increasing reliance on computerized systems, computer system validation has become essential to ensure data integrity and regulatory compliance. This paper analyzes CSV methodologies, including risk-based validation, lifecycle approaches, and documentation practices. It further evaluates the impact of cloud computing, automation, and artificial intelligence on validation strategies, emphasizing compliance with FDA 21 CFR Part 11 and GAMP 5 guidelines.