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AI Governance in Validation: A Five-Pillar Framework
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As artificial intelligence becomes embedded in validation workflows, life sciences organizations face a governance gap that traditional validation frameworks were not designed to close. AI systems introduce non-deterministic outputs, model drift, data dependency risks, and opacity challenges that demand a structured, continuous approach to oversight — not a one-time compliance exercise. Kneat’s guide presents a five-pillar framework for AI governance in GxP environments, drawing on converging guidance from ISPE GAMP, the EU AI Act, FDA draft guidance, and the NIST AI Risk Management Framework. The framework addresses risk classification, data integrity, lifecycle validation, human oversight, and continuous monitoring as an integrated architecture — giving validation and quality teams a practical foundation for adopting AI responsibly in regulated manufacturing.

About Kneat

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Kneat Solutions Inc. (TSX: KSI) provides leading companies in highly regulated industries with unparalleled efficiency in validation and compliance through its AI-assisted digital validation platform, Kneat Gx. We lead the industry in customer satisfaction with an unblemished record for retention and implementation, powered by our user-friendly design, expert support, and on-demand training academy.

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