ICH Q2(R2) — Validation of Analytical Procedures

ICH Q2(R2) — Validation of Analytical Procedures — 100% of in-scope requirements covered.

4 requirements · 3 in scope (3 enforced) · 1 out-of-scope (outside KYE™’s authority layer). The 100% is weighted over the in-scope base.

ICH Q2(R2): 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. validation-package-authority · enforced

    AI-generated analytical-validation package proceeds only under a recorded named-authority decision

    Audit events: kye.purpose.request.v1, kye.purpose.admissibility.v1, kye.evidence.decision_map.v1 · Rule packs: kye:rule-pack:ich-authority · Constitution: 12 purpose permission

  2. validation-conclusion-justification · enforced

    AI validation conclusion proceeds only with its justification recorded before the action

    Audit events: kye.evidence.decision_map.v1, kye.evidence.pack.v1 · Rule packs: kye:rule-pack:ich-authority · Constitution: 13 resilience loop

  3. validation-package-provenance · enforced

    Replay-provable provenance pin for an AI-generated validation package relied on in a dossier

    Audit events: kye.evidence.tool_call.v1, kye.replay.context_seal.v1, kye.evidence.pack.v1 · Rule packs: kye:rule-pack:ich-authority · Constitution: 13 resilience loop

  4. analytical-method-science · out-of-scope

    Running the analytical method, computing accuracy / precision / specificity and judging fitness for purpose

    (no enforcement cited)

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: 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

CategoryReqsEnforcedDesignedAdvisoryDeferredCoverage
Validation-package authority at the action boundary11000100%
Validation-conclusion justification recorded before the action11000100%
Replay-provable validation-package provenance11000100%
Analytical-method science & validation statistics100000%

Every requirement → the KYE™ artefact that enforces it

IDTitleStatusKYE™ enforcement
ich-q2.validation-package-authorityAI-generated analytical-validation package proceeds only under a recorded named-authority decisionenforcedaudit_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-justificationAI validation conclusion proceeds only with its justification recorded before the actionenforcedaudit_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-provenanceReplay-provable provenance pin for an AI-generated validation package relied on in a dossierenforcedaudit_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-scienceRunning the analytical method, computing accuracy / precision / specificity and judging fitness for purposeout-of-scope(no enforcement cited)

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