In order to comply with evolving regulation guidelines, pharmaceutical companies are challenged with the resource-intensive process of monitoring and implementing regulatory changes, along with the risk of overlooking critical updates due to human error. This Work Product Team aims to use AI technology to streamline how regulatory updates are handled.

By automatically analyzing new regulatory changes and comparing them with internal documents, the AI system will help to pinpoint which documents might be affected and identify any discrepancies or omissions within internal documentation to ensure compliance.

Goal

To develop an AI workflow that streamlines the impact assessment of regulatory changes on the QMS and makes it highly efficient.

Expected Outcomes

A detailed white paper that outlines the entire process of developing and utilizing an AI-powered Regulatory Intelligence tool. This will include specifications for input formats, output details, AI modeling techniques, infrastructure requirements, and additional information.

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