Health and life sciences
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- NIST 800-53 Rev 5 hub (universal control taxonomy)NIST 800-53 Rev 5 is the universal control taxonomy KYE Protocol™ uses as the hub for every regulatory crosswalk. 20 control families, 25 headline controls…
- CDSCO Medical Devices Rules 2017CDSCO Medical Devices Rules 2017 coverage by KYE Protocol™ — every requirement bijection-mapped to the KYE™ artefact that enforces it.
- CLIACLIA — US Clinical Laboratory Improvement Amendments (42 CFR Part 493) coverage by KYE Protocol™ — every requirement bijection-mapped to the KYE™ artefact that…
- COSHHCOSHH — Control of Substances Hazardous to Health Regulations 2002 (UK) coverage by KYE Protocol™ — every requirement bijection-mapped to the KYE™ artefact…
- FDA + EMAFDA + EMA — AI / Provenance Expectations for AI-Derived Candidates in Regulated Pipelines coverage by KYE Protocol™ — every requirement bijection-mapped to the…
- ICH Q1ICH Q1 — Stability Testing coverage by KYE Protocol™ — every requirement bijection-mapped to the KYE™ artefact that enforces it.
- ICH Q10ICH Q10 — Pharmaceutical Quality System coverage by KYE Protocol™ — every requirement bijection-mapped to the KYE™ artefact that enforces it.
- ICH Q2(R2)ICH Q2(R2) — Validation of Analytical Procedures coverage by KYE Protocol™ — every requirement bijection-mapped to the KYE™ artefact that enforces it.
- ICH Q3ICH Q3 — Impurities coverage by KYE Protocol™ — every requirement bijection-mapped to the KYE™ artefact that enforces it.
- ICH Q5ICH Q5 — Quality of Biotechnological Products coverage by KYE Protocol™ — every requirement bijection-mapped to the KYE™ artefact that enforces it.
- ICH Q6ICH Q6 — Specifications coverage by KYE Protocol™ — every requirement bijection-mapped to the KYE™ artefact that enforces it.
- ICH Q7ICH Q7 — Good Manufacturing Practice for Active Pharmaceutical Ingredients coverage by KYE Protocol™ — every requirement bijection-mapped to the KYE™ artefact…
- ICH Q8(R2)ICH Q8(R2) — Pharmaceutical Development coverage by KYE Protocol™ — every requirement bijection-mapped to the KYE™ artefact that enforces it.
- ICH Q9(R1)ICH Q9(R1) — Quality Risk Management coverage by KYE Protocol™ — every requirement bijection-mapped to the KYE™ artefact that enforces it.
- ISO 15189:2022ISO 15189:2022 — Medical laboratories — Requirements for quality and competence coverage by KYE Protocol™ — every requirement bijection-mapped to the KYE™…
- ISO 45001ISO 45001 — Occupational Health & Safety Management Systems coverage by KYE Protocol™ — every requirement bijection-mapped to the KYE™ artefact that enforces…
- MHRA Medical Devices Regulations 2002MHRA Medical Devices Regulations 2002 coverage by KYE Protocol™ — every requirement bijection-mapped to the KYE™ artefact that enforces it.
- MHRA Post-Market Surveillance Regulations 2025MHRA Post-Market Surveillance Regulations 2025 coverage by KYE Protocol™ — every requirement bijection-mapped to the KYE™ artefact that enforces it.
- MHRA SaMD & AI Change ProgramMHRA SaMD & AI Change Program coverage by KYE Protocol™ — every requirement bijection-mapped to the KYE™ artefact that enforces it.
- MSHAMSHA — Mine Safety and Health Administration standards (30 CFR) coverage by KYE Protocol™ — every requirement bijection-mapped to the KYE™ artefact that…
- OECD Good Laboratory Practice (Principles, 1998) + FDA 21 CFR Part 58OECD Good Laboratory Practice (Principles, 1998) + FDA 21 CFR Part 58 — non-clinical lab data integrity coverage by KYE Protocol™ — every requirement…
- PHIPA (Ontario)PHIPA (Ontario) — Personal Health Information Protection Act, 2004 coverage by KYE Protocol™ — every requirement bijection-mapped to the KYE™ artefact that…
- PMDA Software-as-a-Medical-Device (SaMD) PathwayPMDA Software-as-a-Medical-Device (SaMD) Pathway coverage by KYE Protocol™ — every requirement bijection-mapped to the KYE™ artefact that enforces it.