AI Compliance
AI compliance intelligence for clinical research
Regulatory frameworks for AI in drug development are converging fast. We map the landscape, break down each framework, and provide tools to assess your readiness.
1,060+
AI submissions to FDA
1,300+
EMA consultation responses
290pg
ISPE GAMP AI guide
10
FDA-EMA joint principles
Compliance guide series
Guide 01Published
FDA's 7-step AI credibility framework
Step-by-step breakdown of the risk-based credibility assessment with clinical trial and manufacturing examples.
FDA21 CFR 11
Guide 02Published
EMA reflection paper on AI in the drug lifecycle
How the EMA's lifecycle approach maps specific requirements to each development stage. Risk categories, GxP compliance, and comparison with the FDA framework.
EMAEU AI Act
Guide 03Published
GAMP 5 & the ISPE AI guide
Translating the 290-page framework into actionable validation approaches for GxP environments.
ISPEGAMP 5
Guide 04Planned
21 CFR Part 11 in the age of AI
Electronic records, audit trails, and model versioning for AI systems.
FDAPart 11
Guide 05Planned
EU AI Act & pharma
Mapping risk classification tiers to specific clinical research use cases.
EU AI ActEMA
Guide 06Planned
AI vendor qualification
How to assess and manage AI suppliers for regulated use.
GAMP 5GxP