Redefining Computer System Validation: A GenAI-Powered Shift from Compliance to Continuous Assurance

For pharmaceutical and life sciences organizations, traditional Computer System Validation (CSV) has become a high-cost, rigid barrier to innovation. The exhaustive documentation and manual testing inherent in legacy processes impede agility and delay time-to-market for critical digital systems. This executive white paper details the strategic move from reactive CSV to Continuous Assurance powered by Generative AI (GenAI). We explore the FDA's guidance on Computer Software Assurance (CSA) and provide a blueprint for deploying GenAI to dramatically reduce documentation burden, implement predictive failure analytics, and establish dynamic, real-time traceability.