Industry’s First 21 CFR 11 Compliant End To End AI Lifecycle Suite
Validation and compliance are a significant cost driver for Life Science companies. Though Agentic AI can significantly reduce these costs, a lack of sufficient AI talent and validation concerns have hindered their adoption.
Leveraging its 25 years of experience in validation and compliance, CIMCON has developed a revolutionary Agentic AI platform that provides an end to end solution that includes:
- A library of pre-built AI Agents for validation, gap A library of pre-built AI Agents for validation, gap assessments and much more that can be put to immediate use – no AI knowledge required!
- A suite of tests for validating AI agents, GenAI, LLMs and AI models that comply with the FDA AI Guidance.
- A 21 CFR Part 11 compliant , end to end AI Lifecycle Platform for Inventory, Discovery, Change Control, Use & Validation of AI models.
BENEFITS
- Simple and easy to use — no expert AI knowledge required!
- Modular system – choose what you need today and expand later
- Dramatically reduce your costs of validating systems and performing gap assessments
- Create your own AI Agents in just a few minutes!
- Validate AI Agents, GenAI, LLMs and Models using a curated Test Suite
- Automatically generate Credibility Assessments and executed IQ/OQs
- Manage an Inventory of all your AI models, agents, and outputs
- Scan your network folders to create an AI Knowledge Base
CIMCON's Product Suite
Use Out of the Box AI Agents – or Build your Own
- Generate URS, IQ, OQ & RTMs using available system documentation.
- Perform 21 CFR 11, Annex 11 or GxP Gap Assessments using available system documentation.
- Build your own AI Agents for Document Generation or any Requirement Gap Analysis
- Design and execute Agentic workflows
- Scan your network folders to identify source/input documents for the AI Agents
End to End AI Life Cycle Management
- Inventory : Create an Inventory of all AI Agents and Use Cases for visibility and tracking. Design your own Inventory form using a No Code Tool to capture owners, reviewers, purpose, scope, design, etc.
- Scan/Discover : 3rd party risks, vulnerabilities, code quality and automated risk scoring based on model complexity and use.
- Change Controls : Track changes.
Validate AI Agents
Using a suite of built-in Validation Test Cases for AI Agents, GenAI, LLMs and AI models
- Ground Truth Evaluation, LLM RAG Hallucination, Vulnerabilities & Source Attribution tests for GenAI and LLMs.
- Data Drift, Interpretability, Validity, Fairness & other tests for numeric models.
- Automated Credibility Assessment Reports.
- Export test results to a fully formatted IQ/OQ protocol report.
Consulting
CIMCON can help you with AI Readiness consulting with:
- AI Policy Preparation/Review
- SOP Preparation
- LLM/AI Model Development
- LLM/AI Model Validation and Testing
