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AIValidator Risk Platform

AI/GenAI/LLM testing and validation with automated risk assessment, inventory management, and 21 CFR Part 11 compliance.

Solution by CIMCON Software
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Overview

AIValidator® Risk Platform by CIMCON Software is an end-to-end, modular AI risk management system designed to make it straightforward for non-AI experts to test, validate, and govern AI models using best-of-breed methodologies. The platform addresses the dynamic and complex nature of the AI compliance landscape by combining automated validation, discovery, inventory management, and change control into a single, 21 CFR Part 11 compliant integrated solution. It is built for organizations operating across multiple jurisdictions that need to meet stringent regulatory requirements without requiring deep AI expertise from their teams.

The platform's Validation module automates AI development, testing, validation, and documentation workflows, while the Discovery, Inventory, and Change Control modules work together to provide comprehensive lifecycle governance of all AI use cases within an organization.

Comprehensive AI/GenAI/LLM/Agent Testing Suite

  • Test AI, GenAI, LLM, and Agent models for hallucinations, vulnerabilities, ground truths, and source attribution
  • Test model validity, data drift, and interpretability
  • Automatically generate validation documentation, including Credibility Assessment Reports and executed IQ/OQ Validation Protocols, based on test results
  • No expert AI skills required to operate the testing suite

Discovery

  • Perform automated code quality and vulnerability analysis on AI models
  • Conduct automated risk assessments and map model interdependencies
  • Identify AI models embedded within third-party applications

No-Code Inventory Management

  • Maintain a centralised inventory of all AI use cases and track their status
  • Create custom forms to capture all relevant use case information without coding
  • Store all AI test results and view historical trend data

Change Control

  • Maintain version control and a full audit trail of all changes to AI models and use cases
  • Perform side-by-side comparisons of model versions
  • Detect high-risk changes directly from the audit trail

Key Platform Features

  • 21 CFR Part 11 compliant across all modules
  • Validate AI, GenAI, LLMs, and Agents with a comprehensive test suite
  • Automated code quality analysis and risk assessment
  • Monitor changes across the AI model lifecycle
  • Manage an inventory of all AI use cases and track their status over time

CIMCON also provides an AI Risk Management Policy framework aligned with the NIST AI Risk Management Framework, covering supervised, unsupervised, and deep learning model types. This resource supports organizations in assessing and managing AI risk, cultivating a culture of risk awareness, and implementing periodic testing practices for responsible AI utilization.

Meta

Domain
Quality, Compliance & Regulatory
Subdomain
Computer System Validation (CSV)
Software type(s)
Workflow Automation
Deployment type(s)
Cloud / SaaS
Industry vertical(s)
PharmaBiotechCRO
Development stage(s)
ClinicalManufacturingPreclinical / Pre-Market
Target user(s)
QA / Regulatory AffairsIT / Systems Admin / Data Engineer
Compliance standard(s)
21 CFR Part 11GxP
Tag(s)
Uses AI