Compliance Management

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...

Inventory

Regulatory Agencies Inventory and Attributes

The Regulatory Agencies Inventory is the governed root of the enterprise compliance hierarchy, identifying every body whose authority, standards, or market-access requirements create formal obligations for the enterpr...

Best Practice

Systems Development Lifecycle (SDLC) Best Practices

The IF4IT Systems Development Lifecycle (SDLC) is an IT management governance framework for leaders and managers—not merely a software-development process. It provides a comprehensive, tailorable 13-phase lifecycle fo...