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Key Requirements of Annex 22 for AI Models in Regulated Environments
The pharmaceutical and life sciences sectors are currently a major transformation in the way that technology supports manufacturing. As AI and ML technologies are transitioning from research labs to production facilities, regulators have bodies in to keeps in mind that innovation does not put safety at risk. The publication of the Annex 22 guideline is a represents a landmark moment in this journey, being the first well, articulated framework of how AI can be used in good manufacturing practice (GMP) environments. Understanding the nuances of Annex 22 is no longer optional for Quality Assurance (QA) groups and information scientists; it's a fundamental requirement for final compliant in an increasingly automated world. Overview of Annex 22 Applicability to AI Models Annex 22 was created to fill the void left by old regulations, like Annex 11, which were mainly concerned with traditional computer...
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