KYE ICH Authority Pack™ for AI-generated submission evidence under the ICH Q-series.
ICH tells you what evidence regulators require; KYE Protocol™ proves how that evidence came into existence — who approved it, under what authority, valid at T=0, lawful delegation, replay-provable. When an AI agent drafts a quality-risk-management output, a pharmaceutical-quality-system record, an API GMP batch record, an analytical-method-validation package, or a development section and that artefact starts to move toward being approved by the Quality Unit, relied on in a dossier, released as a lot, or submitted to a Health Authority, the consequential moment has arrived. The KYE ICH Authority Pack™ governs that action boundary: it binds every consequential action to a named Qualified Person's or Quality Unit's authority, records the due diligence before the action, holds the artefact advisory until a named signing professional signs off — with two-person sign-off on the irreversible lot release or dossier submission — and seals it into a replay-provable provenance record. KYE Protocol™ governs whether the evidence may proceed — it does not perform the science, run the stability study, set impurity thresholds, validate the analytical method, or judge whether the quality is acceptable.
AI now drafts submission evidence — and the lot release and dossier submission are the irreversible actions where accountability concentrates.
Generative quality copilots, automated batch-record assistants, analytical-validation tools, and development-report drafters are producing evidence that moves quickly toward the Quality Unit, the dossier, and the regulatory record. The high-value problem is not the science — it is the action boundary. Three facts converge:
- The consequential moment is the approval, the release, and the submission — not the draft. An artefact in a model's output is inert; a quality record approved by the Quality Unit, a lot released, or a section submitted to a Health Authority is consequential. The lot release and the dossier submission are irreversible — once a lot is released or a dossier filed, it cannot be unwound. Qualified Person and Quality Unit accountability attaches at the moment an artefact proceeds — exactly where governance is weakest.
- The standards already exist; the enforcement of authority does not. ICH Q9 quality risk management, ICH Q10 pharmaceutical quality system, ICH Q7 API GMP and data integrity, ICH Q2 analytical validation, and ICH Q8 development define what evidence is required. KYE Protocol™ governs whether an AI-generated artefact may proceed under those standards, under whose authority, with due diligence recorded before the action.
- Provenance is now an inspection expectation. A GMP record's ALCOA+ data integrity (ICH Q7), a validation package relied on in a dossier, and a risk-based decision used to release a lot must each carry documented lineage. KYE Protocol™ produces a signed, replay-derivable provenance pin at the moment the action commits — reconstructable and valid at T=0.
- This is a governance wedge, not a quality engine. KYE Protocol™ does not compete with the LIMS, the QMS, the stability program, or the analytical laboratory. It governs the action boundary they feed — the named-authority + due-diligence + two-person sign-off + provenance layer the AI quality ecosystem currently lacks.
Survives a GMP inspection, an FDA / EMA review, or a Qualified Person spot check — due-diligenced, two-person-signed-off, and derivable from public keys alone.
- Due-diligenced by construction. An AI-generated artefact that moves toward an approval, release, or submission must carry a recorded due-diligence result — competence (ICH Q10 personnel competence), a decision / validation / justification basis (ICH Q9 / Q8), and a data-integrity / ALCOA+ screen (ICH Q7) where applicable. An unscreened, low-confidence, or data-integrity-deficient artefact is refused at the action-admissibility gate.
- Sign-off-gated, two-person on the release. An artefact stays advisory until a named Qualified Person, Quality Unit head, or responsible QA officer records sign-off. The irreversible lot release or dossier submission additionally requires GovernedUI two-person sign-off — the preparing quality reviewer and an approving Qualified Person. Unreviewed AI-driven consequential actions are refused and routed dual-channel.
- Authority-bound. Every consequential action maps to a recorded named-authority decision — the agent, the evidence artefact, the intended action, and the named Qualified Person or Quality Unit head under whose authority it proceeds. An AI authorised for one purpose cannot proceed under another.
- Replay-provable provenance. A signed provenance pin binds the model and version, the inputs and pinned source data, the decision / validation / justification basis, the due-diligence result, and the authority outcome — audit-grade lineage an inspector, a Qualified Person, or a Health Authority can verify offline, against published keys alone, reconstructable and valid at T=0 (ICH Q7 data integrity).
- Framework-anchored. ICH Q9, ICH Q10, ICH Q7, ICH Q2, and ICH Q8 each map to a control row — with a 90-day attestation cadence.
Every consequential submission-evidence action — authority-bound at the action boundary.
One coherent spine governs five specializations — quality-risk-management, pharmaceutical-quality-system, api-gmp, analytical-validation, and development — with no parallel packs. Each AI-generated artefact that moves toward a consequential action flows through the same four rules, on the canonical KYE Protocol™ envelopes.
- 1 — Artefact proposed. An AI agent produces a quality-risk-management output, a pharmaceutical-quality-system record, an API GMP batch record, an analytical-method-validation package, or a development section that begins to move toward being approved, relied on, released, or submitted.
- 2 — Due diligence + authority check. The Action Admissibility™ Gate verifies a recorded due-diligence result (competence + decision / validation / justification basis + data-integrity / ALCOA+ screen) and the named-authority under which the artefact proceeds, under the §25 Edge Governance Safety Floor. No due diligence, no authority = no action.
- 3 — Advisory pending sign-off. The artefact is advisory until a named Qualified Person, Quality Unit head, or responsible QA officer records sign-off — with two-person sign-off (quality reviewer and Qualified Person) required on the irreversible lot release or dossier submission. Low-confidence or unreviewed artefacts are refused and routed dual-channel.
- 4 — Provenance pin sealed. The runtime emits kye.purpose.request.v1 + kye.purpose.admissibility.v1 + kye.evidence.decision_map.v1 + kye.evidence.pack.v1 in lockstep, binding the model and version, the pinned source data, the decision / validation / justification basis, the named signing professional, and the Authority Finality™ outcome — signed and replay-derivable for an inspector, a Qualified Person, or a Health-Authority spot check.
Bound to the AI submission-evidence authority + due-diligence + provenance perimeter.
The pack binds the canonical KYE™ artefact set to the ICH Q-series quality perimeter. Every claim resolves to a control row on the bound framework — the five guidelines are consumed by the rule pack, never re-mapped (all five are new ICH authority registries; the broader Q-series, Q1 / Q3 / Q5 / Q6, is registered honestly too).
| Framework | Control area | Pack coverage |
|---|---|---|
| ICH Q9(R1) | Quality risk management — risk-based decision authority, risk-decision justification, QRM provenance | partial |
| ICH Q10 | Pharmaceutical quality system — management responsibility, change-management authority, management review control | partial |
| ICH Q7 | API GMP — Quality-Unit release authority, ALCOA+ data integrity, GMP-record provenance, batch-release sign-off | partial |
| ICH Q2(R2) | Analytical validation — validation-package authority, validation-conclusion justification, validation provenance | partial |
| ICH Q8(R2) | Pharmaceutical development — development-content authority, development justification, development-content provenance | partial |
Honest scope. KYE Protocol™ governs the authority, due diligence, sign-off, and provenance of the AI instruction at the action boundary — whether the evidence may proceed and how it came into existence. It does not perform the science, run the stability study, set impurity thresholds, validate the analytical method, run the quality engine, or judge whether the quality is acceptable. Partial coverage means the bound surface satisfies the control area when paired with the firm’s own quality science and Quality-Unit attestation.
Qualified AI quality partners — apply through the Foundry.
The KYE ICH Authority Pack™ is a §68 sector product productised through the KYE Sector Pack Foundry™ Build tier, with Starter, Enterprise, and Regulated commercial tiers; commercial distribution is value-based, qualification-gated, and disclosed under NDA to qualified applicants.