Automating AI Model Validation and Complying
with the FDA Guidance on Artificial Intelligence

Automating AI Model Validation and Complying with the FDA Guidance on Artificial Intelligence

The FDA recently issued a draft guidance on AI in January 2025. The guidance provides recommendations on the use of AI to produce information or data that supports regulatory decision making regarding the safety, effectiveness, or quality for drugs.

Learn more about this guidance, and review how CIMCON's AIValidator™ and EUC Insight™ software provides you with a proven and mature end-to-end AI Risk Management Platform that automates model validation and compliance with the FDA guidance.


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