GxP

Framework International · 1978

GxP is the umbrella for the good-practice quality regimes governing regulated life-science work: GLP (21 CFR Part 58) for nonclinical safety studies, GCP (ICH E6) for clinical trials, GMP (21 CFR 210/211 and EU Annex 1) for manufacturing, and GVP for pharmacovigilance. Each requires documented, validated, inspectable process. Software used in a GxP process is subject to computerised system validation, which is why regulated life-science vendors describe themselves as GxP-ready before they describe themselves as API-first.

Sectoral regime. It binds the industries below; companies outside them generally fall outside it.

Regions

Industries

Each links to that industry as a scored cohort — so the question "how ready is this sector for the regime that governs it?" becomes one you can actually look at.

Implemented by these standards

A regulation is the law; a standard is the machine-readable contract that satisfies it. Almost every regime in this catalog restricts an interface rather than requiring one — where a standard exists, it is the part a provider can actually publish.