CSA Vs. CSV: Why Risk-Based Thinking Is Transforming Life Sciences Validation

By Jak Kane

The life sciences sector is undergoing a major shift in how it approaches system validation. For years, Computer System Validation (CSV) has been the cornerstone of compliance, but its exhaustive documentation and lengthy timelines no longer align with today’s digital-first environment. The FDA’s newly finalized Computer Software Assurance (CSA) framework introduces a risk-based approach that prioritizes critical thinking over paperwork. This evolution enables organizations to streamline validation processes, reduce unnecessary effort, and accelerate innovation, all while maintaining the high standards required for patient safety. Understanding CSA is essential for companies looking to stay competitive and compliant in a rapidly changing regulatory landscape.

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