AI for Validation. Validating AI
Validation cost and a shortage of AI talent have slowed AI adoption in regulated companies. AIValidator removes both barriers: pre-built AI agents do the work, and no AI expertise is required. Built on 30 years of CIMCON validation experience, it is the industry’s first 21 CFR 11 compliant AI lifecycle, validation and data migration suite.
- Know every AI agent you run: inventory, discovery and change control for every model and agent, in one system.
- Automatically generate or audit validation docs: generate validation documents, audit gap assessments and executed IQ/OQs with built-in AI agents.
- Move off legacy systems without an API [New]: AI agents navigate legacy systems screen by screen to extract and migrate data..
Benefits
- Validate AI agents, GenAI, LLMs and models using a curated test suite.
- Automatically generate credibility assessments and executed IQ/OQs.
- Inventory every AI agent and scan your landscape for third-party risks.
- Automate data migrations and system cutovers with no manual scripting or custom ETL.
- Human review and e-signature before anything enters a GxP record.
- Modular: Choose what you need today and expand later.
- Available as Validation as a Service: CIMCON generates the documents and validation costs fall by up to 60–80%.
Features
AI Lifecycle Management
Know, govern and control every AI model and agent in your environment.
- Inventory: Track every AI agent and use case in one register.
- Discovery: Scan for third-party risks and code-quality issues, and build AI knowledge bases.
- Change control: Keep audit trails for all records and AI agent outputs.
- Testing: Validate agents, GenAI and LLMs against adversarial prompts, hallucination, drift and fairness.
AI-Enabled Validation
Generate validation documents and executed IQ/OQs from the documentation you already have.
- Documents: Generate URS, IQ, OQ and RTMs from existing system documentation.
- Gap assessments: Run 21 CFR 11, Annex 11 or GxP assessments automatically.
- Custom agents: Build your own AI agents for document generation or requirement gap analysis.
- Credibility: Generate credibility assessments and export formatted IQ/OQ protocol reports.
AI-Enabled Data Extraction
AI agents work through your system UI, so no API is required.
- Integration: No API or custom connector needed; RPA, APIs, databases and spreadsheets also supported.
- Data quality: Agents transform, clean and verify the accuracy of extracted data.
- Automation: Outputs feed analysis, the database, workflows and dashboards end to end.
- Audit trail: Every click and extraction is logged, with reconciliation before go-live.
Consulting & Services
Expert help from AI policy through validated deployment.
- Policy: AI policy preparation and review.
- Validation as a service: CIMCON generates your validation documents.
- Development: Custom AI agents and workflows.
- Testing and training: Custom LLM and AI model validation, plus workforce AI preparedness, safety and compliance training.
AI Risk Management Framework
Explore the realm of Artificial Intelligence (AI) with our AI Risk Management Policy. This concise guide covers the spectrum of AI models, including supervised, unsupervised, and deep learning, and emphasizes making AI trustworthy based on the NIST AI Risk Management Framework.
Learn to assess and manage AI Risk, cultivate a culture of risk awareness, and utilize periodic testing with tools like ours. This policy is your essential toolkit for responsible and effective AI utilization in your organization.
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