CSV vs. CSA: How the FDA’s Risk-Based Approach Is Transforming Quality Management Systems
15 min read
The Evolution of Software Validation in Quality Management Systems The pharmaceutical and medical device industries are witnessing a fundamental shift in how software validation is approached. For over two decades, Computer System Validation (CSV) has governed how organizations ensure software quality in Quality Management Systems (QMS). The structured, documentation-heavy approach required rigorous testing to confirm […]
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