ICH Q2(R2) — Validation of Analytical Procedures — 75% covered.

4 requirements · 3 enforced · 0 designed · 0 advisory · 0 deferred.

Source: ICH Q2(R2) provides guidance on the validation of analytical procedures, defining the validation characteristics (specificity / selectivity, accuracy, precision, range, detection / quantitation limits, robustness) and the data to be reported to demonstrate a procedure is fit for its intended purpose. KYE Protocol™ governs whether an AI-generated analytical-method-validation package may PROCEED to a consequential action — Quality-Unit approval or reliance in a dossier — under a named authority, with the validation conclusion's justification recorded before the action and replay-provable provenance. KYE does not run the analytical method, compute the validation statistics, or judge whether the method is fit for purpose. · License: ICH guidelines are published by the International Council for Harmonisation; KYE registry paraphrases each requirement's intent and cites the official identifier for mapping purposes only.

By category

Category	Reqs	Enforced	Coverage
Validation-package authority at the action boundary	1	1	100%
Validation-conclusion justification recorded before the action	1	1	100%
Replay-provable validation-package provenance	1	1	100%
Analytical-method science & validation statistics	1	0	0%

Every requirement → the KYE™ artefact that enforces it

ID	Title	Status	KYE™ enforcement
`ich-q2.validation-package-authority`	AI-generated analytical-validation package proceeds only under a recorded named-authority decision	enforced	audit_events: `kye.purpose.request.v1`, `kye.purpose.admissibility.v1`, `kye.evidence.decision_map.v1` engines: `internal`, `internal` rule_packs: `kye:rule-pack:ich-authority` dictionaries: `internal` constitution_refs: `constitution/12-PURPOSE-PERMISSION.md`
`ich-q2.validation-conclusion-justification`	AI validation conclusion proceeds only with its justification recorded before the action	enforced	audit_events: `kye.evidence.decision_map.v1`, `kye.evidence.pack.v1` engines: `internal` rule_packs: `kye:rule-pack:ich-authority` constitution_refs: `constitution/13-RESILIENCE-LOOP.md`
`ich-q2.validation-package-provenance`	Replay-provable provenance pin for an AI-generated validation package relied on in a dossier	enforced	audit_events: `kye.evidence.tool_call.v1`, `kye.replay.context_seal.v1`, `kye.evidence.pack.v1` engines: `internal` rule_packs: `kye:rule-pack:ich-authority` constitution_refs: `constitution/13-RESILIENCE-LOOP.md`
`ich-q2.analytical-method-science`	Running the analytical method, computing accuracy / precision / specificity and judging fitness for purpose	out-of-scope	(no enforcement cited)