OECD Good Laboratory Practice (Principles, 1998) + FDA 21 CFR Part 58 — non-clinical lab data integrity · v1998 (No. 1) + FDA 21 CFR 58

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 — 75% covered.

6 requirements · 4 enforced · 1 designed · 0 advisory · 0 deferred.

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

CategoryReqsEnforcedDesignedAdvisoryDeferredCoverage
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

IDTitleStatusKYE™ 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)