1. Industry’s First 21 CFR Part 11 Compliant AI Risk Management Platform CIMCON Software part1 1solutions.com The dynamic nature of the AI landscape makes it challenging to implement a risk and compliance framework. CIMCON’s AIValidator® software is an easy to use, fexible and modular end to end risk management system that makes it easy for non-AI experts to test and validate AI models, using best of breed test methodologies. The Validation module automates AI development, testing, validation and documentation to meet stringent regulatory requirements in multiple jurisdiction, while the Discovery, Inventory and Change Control modules provide a single 21 CFR Part 11 compliant integrated Risk Management Platform. Features: 21 CFR Part 11 Compliant Validate AI/GenAI/LLMs/Agents with a comprehensive Test Suite Generate Credibility Assessment Reports and executed IQ/OQ Validation Protocols Test GenAI/LLM/Agents for hallucination, vulnerabilities, ground truths, and source attribution Test Model Validity, Data Drift and Interpretability Automated code quality analysis and risk assessment Manage an Inventory of all AI use cases and track status Monitor Changes Inventory $9,000 $8,000 $7,000 $6,000 $5,000 $4,000 $3,000 $2,000 $1,000 Jul Test Suite Dec Nov Oct Sep Aug Jun $0 300000 250000 Benefts: Automate model development, testing and validation Generate validation documentation End to End Risk Management Platform Track compliance with various jurisdictions Reduce need for expensive AI talent Leverage risk and compliance expertise 150000 150000 Change Control 100000 Discovery 12 50000 10 8 6 0 4 2 0 Comprehensive AI/GenAI/LLM/Agent Testing Suite Test for hallunications, hallucination, vulnerabilities, ground truths, and source attribution Test Suite Automatically create validation documentation based on test results Expert AI skills not required Discovery Code quality and vulnerability analysis Automated risk assessment and model interdependencies Discovery Identify AI Models in Third Party Applications No Code Inventory Maintain an inventory of all AI use cases, and track status Create your own forms to capture all relevant use case information Store all AI Test results and view trend history Inventory Change Control Version control and audit trail of all changes Side by side comparisons Detect high risk changes from audit trail Change Control About CIMCON Software With 28 years of experience and 1000 clients in 32 countries including 8 of the Top 10 Life Science frms, CIMCON Software is a recognized market leader in AI Model and data governance and risk management. CIMCON pioneered the AI Model and data governance marketplace and has won numerous accolades since then. US Corporate Ofce 234 Littleton Road Westford, MA 01886, USA Tel: +1 (978) 464 9180 E-mail: info@cimcon.com www.part11solutions.com UK Ofce 400 Thames Valley Park Drive Reading RG6 1PT, UK Tel: + 44 (0) 118 466 1048