White Paper
Governing AI in GxP Operations: A Practical Guide to Credibility and Human Oversight
Overview
This white paper is for quality, manufacturing, regulatory, and technology leaders responsible for AI in GxP operations. It covers the governance decisions behind credible AI use, including risk assessment, controlled records, vendor oversight, and model changes.
It also examines how FDA guidance and Europe’s draft Annex 22 may affect organizations operating across jurisdictions.
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