---
title: "ICH Q2(R2) — Validation of Analytical Procedures — KYE Protocol™ coverage"
description: "ICH Q2(R2) — Validation of Analytical Procedures coverage by KYE Protocol™ — every requirement bijection-mapped to the KYE™ artefact that enforces it."
url: https://kyeprotocol.com/compliance/ich-q2/
lang: en
source: "KYE Protocol"
---

> ICH Q2(R2) — Validation of Analytical Procedures coverage by KYE Protocol™ — every requirement bijection-mapped to the KYE™ artefact that enforces it.

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.

**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 | Designed | Advisory | Deferred | Coverage |
| --- | --- | --- | --- | --- | --- | --- |
| Validation-package authority at the action boundary | 1 | 1 | 0 | 0 | 0 | **100%** |
| Validation-conclusion justification recorded before the action | 1 | 1 | 0 | 0 | 0 | **100%** |
| Replay-provable validation-package provenance | 1 | 1 | 0 | 0 | 0 | **100%** |
| Analytical-method science & validation statistics | 1 | 0 | 0 | 0 | 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)_ |

Canonical KYE™ surfaces referenced on this page: [KYE Protocol™](https://kyeprotocol.com/).