CIMCON Software

CIMCON Software is the recognized leader in document control and compliance software for life sciences organizations, specializing in 21 CFR Part 11 compliance for pharmaceutical and biotech companies. With over 25 years of experience in validation and compliance, CIMCON delivers a comprehensive portfolio of enterprise and desktop solutions designed to support compliant digital transformation across regulated industries.

CIMCON serves a broad range of life sciences customers — including large enterprise organizations such as Charles River Laboratories — helping them achieve data integrity, streamline validation workflows, manage lab and instrument files, and adopt emerging AI technologies in a compliant manner. The company's platform spans traditional spreadsheet and document compliance tools through to cutting-edge AI agent-driven validation services.

Key Products and Modules

• AI Agent Suite: A library of pre-built AI agents designed for validation document generation and gap assessments, with custom agent building capabilities and support for agentic workflows. No AI expertise is required to put these agents to immediate use.
• AI/GenAI Validation & Compliance Platform (EUC Insight™ / AIValidator™): A comprehensive compliance suite for AI, GenAI, large language models (LLMs), and agents. Includes modules for Validation, Discovery, Inventory, and Change Control, providing an end-to-end AI lifecycle platform aligned with FDA AI guidance.
• Lab/Instrument File Management: Secures lab and instrument files with continuous monitoring, workflow management, and 21 CFR Part 11 compliance.
• Form Management: Enables organizations to digitize paper forms with electronic signatures, supporting a paperless environment.
• Quality Management System (QMS): Centralizes all enterprise content in a single repository with an integrated training module.
• eInfotree Excel Desktop: A widely trusted solution for remediating Excel spreadsheets to achieve 21 CFR Part 11 compliance. Adds audit trails and e-signatures to spreadsheets in seconds with minimal user training and no changes to existing processes. Available in a multi-lingual version including Spanish.
• XLValidator Spreadsheet Validation Software: Enables quick and easy generation of validation documentation for Excel spreadsheets with just a few mouse clicks.
• eInfotree Access Desktop: Provides simple and effective remediation of Microsoft Access databases for 21 CFR Part 11 compliance.

Core Capabilities and Services

• Validation as a Service™: CIMCON's flagship managed service offering that automatically generates validation documents from available documentation using AIValidator Agents. This service dramatically reduces the time and cost of document preparation, eliminates scope creep, and accelerates project timelines.
• FDA AI Guidance Compliance: CIMCON's AIValidator™ platform provides a proven, mature end-to-end AI Risk Management solution that automates model validation and supports compliance with the FDA's January 2025 draft guidance on the use of AI in regulatory decision-making for drug safety, effectiveness, and quality.
• Data Integrity and Audit Trails: Automated spreadsheet controls reduce human error, provide an immediate audit trail history for any changes made, and simplify CAPA resolution and audit readiness.
• Digital Transformation Support: CIMCON's tools help organizations convert paper forms into digital Excel forms, eliminate manual printing and hand-signing of documents, and progress toward a fully paperless regulated environment.

Deployment and Customer Highlights

• Solutions are available in both Enterprise Series and Desktop Series configurations, supporting centralized server models for large, multi-site deployments.
• Charles River Laboratories (CRL) has deployed eInfotree Excel Desktop enterprise-wide across North America and Europe, covering 17 sites with nearly 7,000 client installations using a centralized server model — demonstrating CIMCON's scalability for global regulated organizations.
• eInfotree has been trusted by hundreds of regulated firms for over 20 years, underscoring CIMCON's long-standing reputation in the life sciences compliance space.
• Mobile apps are available as handy reference guides, providing compliance resources at users' fingertips at all times.

CIMCON Software continues to innovate at the intersection of regulatory compliance and artificial intelligence, enabling life sciences companies to confidently adopt new technologies while maintaining the rigorous validation and data integrity standards required by global regulatory authorities.