Скачать или смотреть AI Change in Regulated Systems

This video details the rigorous governance and technical frameworks required to manage artificial intelligence within GxP regulated environments. The documentation emphasizes that AI systems are inherently dynamic, requiring continuous change management and revalidation even when traditional software code remains static. This involves monitoring for model drift, data fluctuations, and configuration shifts to ensure system behavior stays aligned with its intended use. Accompanying these guidelines is a visual control plane architecture that illustrates the intersection of IT and operational technology. This diagram maps out the necessary approval gates, audit paths, and emergency rollback mechanisms essential for maintaining compliance. Together, these materials provide a blueprint for responsible AI evolution by integrating impact assessments into the core lifecycle of the technology.

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