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Agentic AI Is Entering Regulated Drug Development

A checkpoint can clear and the batch can still be wrong.

Cover of Agentic AI Is Entering Regulated Drug Development
© 2026 Maureen Doyle-Spare. All rights reserved.
Life Sciences · GxP Quality Operations

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A checkpoint can clear and the batch can still be wrong.

Governance connection

Why this development matters.

Validated execution does not prove that an agent resolved the authorized operational meaning behind a GxP decision. The Reasoning Baseline, Operational Interpretation, and Verification of Runtime Semantic Resolution add evidence at that pre-execution boundary.

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