When a person writes a document, they verify facts, figures, and claims continuously while creating it. When AI drafts the document, that implicit verification vanishes, and most teams never budget for its explicit replacement. This is why human review of AI output takes longer than expected.
The remedy has a regulatory root: 21 CFR 211.68(c) has required a human check that automated equipment performs properly since 2008. The operational version: AI drafts, a named human verifies explicitly and separately, and some of the time AI saves gets budgeted toward that verification. One speaker’s motto: “Never Trust! Always Verify!” That motto is the human half of Validate what you can, verify the rest, and the named human is Human-in-the-loop must be a named hard gate, not rubber-stamp oversight. An LLM judge is a GxP system and needs its own qualification pack is useful triage, but it does not replace the explicit check; In the GxP control loop, AI acts, humans decide, and the system remembers is the loop this verification sits inside. When the draft is confident over missing evidence, the human check is also what enforces An AI system in GxP must be able to answer unable to verify. Companies own the accuracy of AI-drafted submissions regardless of the drafting tool is the same rule when the document leaves the building.
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- An LLM judge is a GxP system and needs its own qualification pack
- Home
- Validate what you can, verify the rest
- Human-in-the-loop must be a named hard gate, not rubber-stamp oversight
- In the GxP control loop, AI acts, humans decide, and the system remembers
- Companies own the accuracy of AI-drafted submissions regardless of the drafting tool
- An AI system in GxP must be able to answer unable to verify