---
title: "OECD Good Laboratory Practice (Principles, 1998) + FDA 21 CFR Part 58 — non-clinical lab data integrity — KYE Protocol™ coverage"
description: "OECD Good Laboratory Practice (Principles, 1998) + FDA 21 CFR Part 58 — non-clinical lab data integrity coverage by KYE Protocol™ — every requirement bijection-mapped to the KYE™ artefact that enforces it."
url: https://kyeprotocol.com/compliance/oecd-glp/
lang: en
source: "KYE Protocol"
---

> OECD Good Laboratory Practice (Principles, 1998) + FDA 21 CFR Part 58 — non-clinical lab data integrity coverage by KYE Protocol™ — every requirement bijection-mapped to the KYE™ artefact that enforces it.

OECD Good Laboratory Practice (Principles, 1998) + FDA 21 CFR Part 58 — non-clinical lab data integrity

# OECD Good Laboratory Practice (Principles, 1998) + FDA 21 CFR Part 58 — non-clinical lab data integrity — 90% of in-scope requirements covered.

6 requirements · 5 in scope (4 enforced · 1 designed) · 1 out-of-scope (outside KYE™’s authority layer). The 90% is weighted over the in-scope base.

**Source:** OECD Principles of Good Laboratory Practice (ENV/MC/CHEM(98)17, as revised 1997) and the US FDA Good Laboratory Practice for Nonclinical Laboratory Studies (21 CFR Part 58) govern the organisational process and conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported. KYE Protocol™ governs the AI/automated-decision authority, the data-integrity (ALCOA+) and audit-trail slices, and the archive/retention slice for studies that use AI-supported or automated data capture and analysis. KYE™ does not run studies, calibrate apparatus, handle test items, or assess scientific validity. · **License:** OECD and FDA documents are published by the issuing bodies; 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 |
| --- | --- | --- | --- | --- | --- | --- |
| Study data integrity & raw-data traceability (ALCOA+) | 2 | 2 | 0 | 0 | 0 | **100%** |
| Audit trail & change control for electronic records | 1 | 1 | 0 | 0 | 0 | **100%** |
| Archive & retention of study records | 1 | 0 | 1 | 0 | 0 | **50%** |
| Quality assurance & study-director oversight of automated steps | 1 | 1 | 0 | 0 | 0 | **100%** |
| Physical study conduct & facilities | 1 | 0 | 0 | 0 | 0 | **0%** |

## Every requirement → the KYE™ artefact that enforces it

| ID | Title | Status | KYE™ enforcement |
| --- | --- | --- | --- |
| `oecd-glp.data-integrity` | Study data are attributable, legible, contemporaneous, original and accurate (ALCOA+) when captured or transformed by an automated/AI step | enforced | **audit\_events**: `kye.evidence.tool_call.v1`, `kye.evidence.decision_map.v1`, `kye.replay.context_seal.v1` **engines**: `internal` **constitution\_refs**: `constitution/13-RESILIENCE-LOOP.md` |
| `oecd-glp.raw-data-traceability` | Raw data produced by an automated step are traceable back to the inputs, model/version and decision that produced them | enforced | **audit\_events**: `kye.evidence.decision_map.v1`, `kye.replay.proof.v1` **engines**: `internal` **constitution\_refs**: `constitution/13-RESILIENCE-LOOP.md` |
| `oecd-glp.audit-trail` | Electronic study records carry a tamper-evident audit trail of every change (who, what, when, why) | enforced | **audit\_events**: `kye.evidence.pack.v1` **engines**: `internal` **worm\_tables**: `evidence_events` **constitution\_refs**: `constitution/30-AUDIT-WORM-RETENTION.md` |
| `oecd-glp.archive-retention` | Study records and the supporting evidence are retained under a defined retention policy and remain retrievable | designed | **engines**: `internal` **r2\_buckets**: `kye-evidence-archive` **constitution\_refs**: `constitution/30-AUDIT-WORM-RETENTION.md` |
| `oecd-glp.oversight-of-automated-steps` | A named study director / QA function authorises automated or AI-supported steps before they affect a GLP study | enforced | **audit\_events**: `kye.purpose.request.v1`, `kye.purpose.admissibility.v1` **engines**: `internal` **constitution\_refs**: `constitution/12-PURPOSE-PERMISSION.md` |
| `oecd-glp.physical-study-conduct` | Apparatus calibration, test/reference item handling, animal care and physical SOP execution | out-of-scope | _(no enforcement cited)_ |

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