Comment from CIMCON Software
AnonymousSupportBusiness
Summary: CIMCON Software, a company specializing in AI and GRC software, supports the FDA's draft guidance on the use of AI in regulatory decision-making. They provide specific recommendations to enhance the guidance regarding 21 CFR Part 11 compliance, third-party risk management, explainability, data governance, fairness, and the unique risks associated with LLMs and Generative AI.
At CIMCON, we have been working with firms to help them comply with an ever-evolving regulatory landscape for over 25 years. We believe this guidance is a great step forward in clarifying how firms should handle the risk that comes from AI, but have a few suggestions for additional clarification that are attached.