AIValidator - Turnkey AI Agent Solution

AIValidator by CIMCON Software is the industry's first 21 CFR Part 11 compliant, end-to-end AI lifecycle suite purpose-built for pharmaceutical and life science organizations. Leveraging CIMCON's 25 years of experience in validation and compliance, AIValidator addresses the unique challenges of deploying AI in regulated environments — from validation requirements to regulatory compliance — by providing a turnkey, agentic AI platform that requires no specialist AI knowledge to operate.

Designed for life science companies seeking to reduce the significant costs associated with validation and compliance, AIValidator combines a library of pre-built AI agents with comprehensive lifecycle management, a curated validation test suite, and full regulatory alignment with FDA AI Guidance. Its modular architecture allows organizations to adopt what they need today and expand capabilities over time.

Core Platform Components

• A library of pre-built AI agents for validation, gap assessments, and document generation that can be deployed immediately without AI expertise
• A suite of validation tests for AI agents, generative AI, large language models (LLMs), and AI models that comply with FDA AI Guidance
• A 21 CFR Part 11 compliant, end-to-end AI lifecycle platform covering inventory, discovery, change control, use, and validation of AI models

Key Benefits

• Simple and easy to use — no expert AI knowledge required
• Modular system allowing organizations to choose capabilities today and expand later
• Dramatically reduces costs of validating systems and performing gap assessments, with potential savings of up to 70%
• Create custom AI agents in just a few minutes
• Validate AI agents, generative AI, LLMs, and models using a curated test suite
• Automatically generate Credibility Assessments and executed IQ/OQ protocols
• Manage a full inventory of all AI models, agents, and outputs
• Scan network folders to create an AI Knowledge Base

Out-of-the-Box and Custom AI Agents

• Generate User Requirement Specifications (URS), Installation Qualifications (IQ), Operational Qualifications (OQ), and Requirements Traceability Matrices (RTMs) using available system documentation
• Perform 21 CFR Part 11, Annex 11, or GxP gap assessments using existing system documentation
• Build custom AI agents for document generation or any requirement gap analysis
• Design and execute agentic workflows
• Scan network folders to identify source and input documents for AI agents

End-to-End AI Lifecycle Management

• Inventory: Create a full inventory of all AI agents and use cases for visibility and tracking; design custom inventory forms using a no-code tool to capture owners, reviewers, purpose, scope, and design details
• Scan/Discover: Assess third-party risks, vulnerabilities, and code quality with automated risk scoring based on model complexity and use
• Change Controls: Track and manage changes across the AI lifecycle

AI Agent Validation

• Ground truth evaluation, LLM RAG hallucination detection, vulnerability assessment, and source attribution tests for generative AI and LLMs
• Data drift, interpretability, validity, fairness, and additional tests for numeric models
• Automated Credibility Assessment Reports
• Export test results to fully formatted IQ/OQ protocol reports

AI Readiness Consulting Services

• AI policy preparation and review
• Standard Operating Procedure (SOP) preparation
• LLM and AI model development
• LLM and AI model validation and testing

AIValidator also supports responsible AI governance through alignment with the NIST AI Risk Management Framework, covering supervised, unsupervised, and deep learning model types. The platform is suitable for organizations at any stage of their AI adoption journey in pharmaceutical operations, providing a trusted, compliant foundation for digital transformation.