CIMCON Software: Compliant AI™  — AI Agents to Automate IQ/OQ Generation, AI Model Validation & AI-Enabled Validation as a Service

With 25 years of experience, CIMCON Software is a trusted partner to over 1,000 customers across 32 countries, providing Compliant AI and Digital Transformation™ products and validation services to FDA, EMA, and globally regulated life science organizations — including 8 of the top 10 global pharma companies.

AIValidator® is the industry’s first 21 CFR Part 11 compliant, end-to-end AI Risk Management platform, purpose-built for pharmaceutical and life science environments. It includes AI Agents to automatically generate IQ/OQ, URS, and RTM documents from available system documentation; an AI Validation Module to validate GenAI/AI use cases against FDA-recommended tests and generate Credibility Assessment Reports and IQ/OQ protocols; Discovery for scanning AI knowledge bases and assessing third-party risks with automated risk scoring; Inventory for tracking and managing all AI models and use cases; and Change Control with full audit trails.

CIMCON also offers Validation as a Service™ (VaaS™), combining AIValidator® AI Agents with CIMCON’s experienced validation consulting team to deliver high quality, fast, and cost-effective validation services.

Additional solutions include eInfotree Excel Desktop, XLValidator, and eInfotree QMS with modules for documents, electronic forms (Transform™), lab data (LabMonitor™), training (eTraininfo), drawings (eCADinfo), CAPA, and Audits. CIMCON also provides specialized AI Compliance and Spreadsheet Validation Services.

Website: https://www.part11solutions.com/