GxP

Article

GxP and AI: Governing Machine Learning Models in Regulated Pharmaceutical Environments

Governing AI and machine learning models used in GxP-regulated processes doesn't require inventing a new governance framework — it requires applying the enterprise AI governance disciplines IF4IT already establishes t...

Framework

GxP Compliance Framework

GxP is not a single regulation to satisfy once — it is a governed family of over twenty \"Good x Practice\" disciplines, each defined by its own regulatory body, spanning an enterprise's product lifecycle from researc...

Article

How the SDLC Changes When You're in a GxP Environment

The Systems Development Lifecycle doesn't change shape inside a GxP-regulated environment — each of its phases gains a formal validation gate layered on top of the work already being done. Teams new to GxP often treat...