FDA + EMA — AI / Provenance Expectations for AI-Derived Candidates in Regulated Pipelines

FDA + EMA — AI / Provenance Expectations for AI-Derived Candidates in Regulated Pipelines — 50% of in-scope requirements covered.

4 requirements · 4 in scope (4 designed). The 50% is weighted over the in-scope base.

FDA + EMA: requirement → the KYE™ artefact that enforces it

Demo data

You learn: Which requirements KYE™ enforces at runtime and with which artefact. You can: Walk the requirements.

  1. design-provenance · designed

    AI-derived candidate carries documented design provenance into the pipeline

    Rule packs: kye:rule-pack:bio-chem-governance · Constitution: 13 resilience loop

  2. reproducibility · designed

    AI-derived candidate's generation is reproducible from the provenance record

    Rule packs: kye:rule-pack:bio-chem-governance · Constitution: 13 resilience loop

  3. gxp-data-integrity · designed

    GxP data integrity (ALCOA+) for AI-supported regulated decisions

    Rule packs: kye:rule-pack:bio-chem-governance · Constitution: 30 audit worm retention

  4. human-accountability · designed

    Named human accountability for an AI-derived candidate entering a regulated stage

    Rule packs: kye:rule-pack:bio-chem-governance · Constitution: 36 governedui

How this widget is built
Demonstrates
KYE™ Compliance Mapping Rail™
Components
  • Framework requirement (clause)
  • Coverage status
  • KYE™ enforcement artefact (event, decision-record field, Evidence Pack™ entry)
Flow
Clause → status → the KYE™ artefact that enforces it, enforced requirements first. Architecture diagram
Used on

Source: FDA's framework / draft guidance on the use of AI in the development of drug and biological products, and the EMA's reflection paper on the use of AI across the medicinal-product lifecycle, set expectations for AI-derived candidates entering regulated drug / device pipelines: documented provenance of AI-generated designs, reproducibility, model transparency, and GxP data-integrity (ALCOA+) for AI-supported decisions. KYE Protocol™ governs whether an AI-derived candidate may PROCEED to a regulated stage, binding replay-provable provenance and human oversight. KYE™ does not design candidates, run trials, or determine clinical efficacy. · License: FDA and EMA guidance / reflection-paper documents are published by the agencies; KYE™ registry cites their AI-provenance and data-integrity expectations for mapping purposes.

By category

CategoryReqsEnforcedDesignedAdvisoryDeferredCoverage
AI design provenance & reproducibility2020050%
GxP data integrity (ALCOA+)1010050%
Human oversight & accountability1010050%

Every requirement → the KYE™ artefact that enforces it

IDTitleStatusKYE™ enforcement
fda-ema.design-provenanceAI-derived candidate carries documented design provenance into the pipelinedesignedrule_packs: kye:rule-pack:bio-chem-governance
dictionaries: internal
constitution_refs: constitution/13-RESILIENCE-LOOP.md
fda-ema.reproducibilityAI-derived candidate's generation is reproducible from the provenance recorddesignedrule_packs: kye:rule-pack:bio-chem-governance
dictionaries: internal
constitution_refs: constitution/13-RESILIENCE-LOOP.md
fda-ema.gxp-data-integrityGxP data integrity (ALCOA+) for AI-supported regulated decisionsdesignedrule_packs: kye:rule-pack:bio-chem-governance
constitution_refs: constitution/30-AUDIT-WORM-RETENTION.md
fda-ema.human-accountabilityNamed human accountability for an AI-derived candidate entering a regulated stagedesignedrule_packs: kye:rule-pack:bio-chem-governance
constitution_refs: constitution/36-GOVERNEDUI.md

Canonical KYE™ surfaces referenced on this page: KYE Protocol™.