CIMCON for Health
The Pharma & Life Sciences industry was one of the first industries that CIMCON entered in the Risk Management & Compliance space. It has since spent decades helping clients such as 8 of the Top 10 Global Life Science companies manage risk from their data, lab equipment, models, AI, as well as GenAI and has even submitted feedback on the new FDA AI Draft Guidance to the FDA.
CIMCON provides end to end Risk Management for clients in this industry from digital transformation tools that help turn paper into high quality training data, to aggregating data across silos with proper controls, a compliant QMS, as well as the first ever CFR Part 11 Compliant AI Validation Product Suite with complete digital signature and audit trail functionality.
Through these tools you can aggregate data with confidence, automate the generation of SOPs related to AI Validation, and seamlessly meet regulatory requirements through exporting reports in formats such as the IQ/OC Protocol for GxP compliance as well as the Credibility Assessment Report from the FDA’s AI Draft Guidance.
Regulations
CIMCON’s product are built to help you meet pharmaceutical compliance mandates from around the world, including:
Data Integrity & GxP
- FDA Draft Guidance on AI/ML (2025)
- 21 CFR Part 11
- GxP (Good Practice) Compliance
- IQ/OQ Protocols
AI & Model Regulations
- FDA Draft Guidance on AI/ML (2025)
- State-level AI legislation (e.g., California, New York)
- EU AI Act
- GMLP (FDA, Health Canada, MHRA)
- EMA Reflection Paper on AI (2024)
- EMA AI Workplan (2025–2028)
Key Features
AIValidator
Data, Model, AI, & GenAI testing suite available as a Python Package as well as Low-Code Web Interface to help clients automate validation, with full model agnostic support for tests such as data drift, bias, accuracy, and reproducibility in accordance with FDA and EMA AI guidance.
Risk Assessment & Shadow AI Monitoring
With the Discovery module, clients can scan entire networks, whether on-prem or on the cloud, for spreadsheets, data sources, AI models, and much more. Clients can also detect the use of Shadow AI, or the unauthorized use of AI tools internally or by 3rd party vendors, across your organization.
Inventory & Workflows
With the Inventory Module, clients can seamlessly maintain a self-organizing and dynamic inventory of all models, EUCs, and GenAI tools used across lab, clinical, and manufacturing operations. Create custom workflows for approval and validation using our no-code Workflow Designer, tailored to CFR Part 11-compliant.
Monitoring & Regulatory Reporting
Track performance changes across time and automatically generate export-ready reports:
- FDA Credibility Assessment Reports
- IQ/OQ formatted outputs
- Custom templates for internal QA or global regulatory audits
Controls & Audit Trail
Ensure traceability as well as data integrity through setting permissions at the file, record, and user level as well as through the version control functionality. Ensure Part 11 compliance with our audit trail and control system.
XL Audit
Audit data and models in Excel without ever having to leave the tool through our Excel Plug-in – quickly find formula errors, ensure consistency, and validate spreadsheets as part of your GxP documentation.
TransForm: Digitize Paper Forms
Digitize paper forms into compliant electronic documents, complete with electronic signatures as well as centralized data storage for easy retrieval, reporting, and AI training.
LabMonitor: Real-Time Lab Monitoring
eInfotree QMS: Quality Management System
With eInfotree, our complete QMS, clients can create a centralized platform for the management of documents and data, ensuring regulatory compliance, efficient workflows, collaboration, and full traceability with 21 CFR Part 11 compliance.
Resources
AI Risk Management Policy
Leveraging collective wisdom from experts in the domain, regulatory recommendations, and our 25+ years of experience, this policy outlines step by step recommendations for AI & GenAI Risk Assessment, Controls, Testing, Monitoring, Compliance Reporting and everything in between,
Why EUC Risk Matters
EUC risk, often seen as errors or confidential data loss, can have a material impact. Based on our experience with hundreds of customers, this white paper outlines how to understand your risk level, implement best practices, and align stakeholders on Why EUC Risk Matters?
