CIMCON Software is an industry leader providing AI/GenAI/LLM validation solutions and 21 CFR Part 11 compliance to FDA-regulated clients. Our revolutionary Agentic AI platform delivers the industry's first end-to-end 21 CFR Part 11 compliant AI lifecycle suite—featuring pre-built AI agents for automated validation document generation, GxP gap assessments, and audit-ready documentation that requires no AI expertise to deploy.

With 25 years of experience and over 700 customers, including 8 of the Top 10 life science companies, CIMCON offers proven solutions that address validation and compliance cost challenges. Our platform includes out-of-the-box AI agents that generate URS, IQ, OQ, and RTMs, perform 21 CFR Part 11 and Annex 11 gap assessments, and enable custom agent building and agentic workflows—all backed by FDA AI Guidance-compliant testing and comprehensive AI lifecycle management for discovery, inventory, change control, and validation.

CIMCON Software

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CIMCON Software

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