ISPE: New GAMP® Guide on Artificial Intelligence
ISPE has released the new GAMP® Guide: Artificial Intelligence, addressing the use of AI in GxP-regulated areas within the life sciences sector.
The guide provides a structured approach for the development, operation, and use of AI-enabled computerized systems, with a focus on patient safety, product quality, and data integrity. It reviews current regulatory expectations and introduces concepts for areas where limited guidance exists.
Key topics include:
- Lifecycle management of AI-based systems in regulated environments
- Roles and responsibilities of manufacturers, service providers, and suppliers
- Decision-making processes for implementing AI technologies
- Foundational principles for the design, deployment, and oversight of AI systems
The guide is intended as a standalone document, to be used alongside GAMP® 5 Second Edition and other ISPE GAMP® guides.
Source:
ISPE: Publications
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