GAMP 5 AI Guide vs ISO 42001
Which framework does your organisation need — and how do they work together?
Two AI compliance frameworks are now active for pharmaceutical and medical device organisations: the ISPE GAMP AI Guide and ISO 42001:2023. Understanding how they differ — and where they overlap — determines the most efficient compliance pathway.
GAMP 5 AI Guide: Technical Validation Standard
The GAMP AI Guide is primarily a technical standard providing methodology for validating AI/ML systems in GxP environments — data governance, model validation, acceptance criteria, change control, and monitoring. It is the framework your QA team uses when validating a specific AI system.
ISO 42001: Governance and Management System
ISO 42001 is a management system standard establishing the governance framework for your AI programme: policy, risk management, oversight, supplier management, and post-market surveillance. It satisfies EU AI Act conformity assessment requirements. Most pharma organisations need both — GAMP AI Guide for each system, ISO 42001 for organisational governance.