Whitepaper
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.
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Inside, you will find:
- Intelligent Documentation Generation: How GenAI streamlines the creation of URS, FRS, and qualification protocols, achieving up to a 60% reduction in preparation time.
- AI-Driven Risk Intelligence: Methods for using predictive failure analytics and augmented risk categorization to focus validation efforts on high-risk areas, aligning with CSA principles.
- Dynamic Traceability: Insights on moving from static spreadsheets to living RTMs that automatically link requirements to test cases and update in real-time.
- Continuous Validation as a Service (CVaaS): The blueprint for integrating validation directly into CI/CD pipelines for always-on, audit-ready compliance.
- Implementation Blueprint: A practical guide for CIOs and Quality Heads covering AI-readiness assessment, core technology stack, and governance for AI validation.
