CIMCON PRODUCTSProducts

AI AGENT SUITE

Pre-built AI agents for validation document generation and gap assessments, with custom agent building capabilities and agentic workflows

AI/GENAI VALIDATION & COMPLIANCE PLATFORM

Compliance Suite for AI, GenAI, LLMs and Agents with Validation, Discovery, Inventory and Change Control Modules

LAB/INSTRUMENT FILE MANAGEMENT

Secure your lab/instrument files with continuous monitoring, workflow management and Part 11 compliance.

FORM MANAGEMENT

Digitize your Paper Forms with E-Signatures

Quality Management System (QMS)

Store all your enterprise content in one centralized repository, with an integrated training module.

eInfotree Excel Desktop

Simple and effective remediation of Excel Spreadsheets for 21 CFR Part 11 Compliance.

XLValidator Spreadsheet Validation Software

Quick and easy generation of validation documentation for your Excel spreadsheets with just a few mouse clicks.

eInfotree Access Desktop

Simple and effective remediation of Access databases for 21 CFR Part 11 Compliance.


WebinarsOn Demand Webinars

  • Revolutionizing Validation & Risk Assessments: Introducing Fast and Low Cost AI-enabled Validation as a ServiceTM (VaaS)

    For companies that are not ready to implement AI, CIMCON offers Validation as a Service™ where its Validation Consulting group will use AIValidator® agents to generate validation protocols, dramatically reducing the time and validation.

    Benefits:
     > Lower validation costs by up to 60-80%
     > Fast, immediate validation documents
     > Frictionless - no infrastructure required!
     > Data remains fully secure

    Register

  • Audit Trails and E-Signatures for Your Spreadsheets
    21 CFR Part 11 Compliance in Seconds

    Make your spreadsheets 21 CFR Part 11 compliant in seconds! Additionally, the XLValidator software helps you validate spreadsheets by automatically generating validation documents. In this webinar, learn how you can achieve data integrity for your spreadsheets with just a few clicks, minimal user training, or changes to your existing process.

    Register

  • Get Ready for AI with Digital Transformation of Paper Forms

    Paper forms are among the last remaining barriers to full digital transformation — and a persistent source of data integrity risk. CIMCON's TransForm solution enables both.

    Learn how organizations are replacing paper-based processes with fully digital, Part 11-compliant forms — without redesigning what already works.

     > Digitize Without Disruption: Import existing paper forms directly or build new ones with the built-in Form Designer. Web-based and accessible from anywhere, with centralized storage and retrieval from day one.
     > Workflows That Work: Field-level validation, configurable workflows with email alerts, interactive reporting, and instant data retrieval — all in one system.
     > Compliance Out of the Box: Fully 21 CFR Part 11 compliant with complete audit trails, e-signatures, and role-based access controls .

    Register

Additional On Demand Webinars







Download the following mobile apps as handy reference guides at your fingertips at all times!

CIMCON DATA INTEGRITY APP
CIMCON 21 CFR APP
CIMCON 21 CFR Part 58 APP
CIMCON 21 CFR 210 APP
CIMCON 21 CFR 211 APP
CIMCON 21 CFR 820 APP

FDA Warning Letter

"Due to this unrestricted access, there is no assurance that the formulas in the Excel spreadsheets are accurate and valid."

TestimonialTestimonials

"Charles River Labs (CRL) has implemented and is using the eInfotree Excel Desktop for over 2 years now. eInfotree has been deployed enterprise-wide in North America and Europe, and the scope of the implementation includes 17 sites (and counting) within Charles River with nearly 7,000 eInfotree Excel desktop client installations at these sites, using a centralized server model.

eInfotree has been a valuable tool in our Digital Transformation journey helping us to make our spreadsheets 21 CFR Part 11 compliant as well as adhering to our Data Integrity plan and governance. It has saved us hours of work that was earlier spent in verifying calculations, printing the spreadsheets and applying hand signatures, and then filing and storing all the printouts. It has also helped us in our audits since our spreadsheet controls are now automated with lower potential for human error. Resolving CAPA issues is now a breeze as the eInfotree audit trail provides an immediate history and timeline of any changes made. Furthermore, Charles River have now initiated the conversion of several paper forms into Excel forms, accelerating our digital efforts towards a paperless environment, applying not only further compliance but electronic approval of forms as well, significant paper reduction and increase efficiencies in form processing, archiving and retention. Overall, we estimate that eInfotree has reduced our costs by an estimated 20% in terms of the time and effort saved, while automating our data integrity and compliance processes.

The scalability and configurability of the product has been impressive, while the professionalism and responsiveness of CIMCON’s customer service team has been exemplary. It is clear to us that at CIMCON, the entire company is highly motivated and dedicated to ensure customer success, and it is not just a slogan. We look forward to working with them in the near future, on our Digital Transformation journey and Data Integrity initiatives."

Alain Fraser,

Director, Computerized Systems Validation at Charles River Laboratories
We are a pharmaceutical manufacturing company and we implemented the SaaS based eInfotree EDMS with eTraininfo Training Module provided by CIMCON earlier this year. I cannot say enough great things about the CIMCON Team. The team has been exceptional with maintaining frequent communication with our company for any questions we may have. CIMCON has also been very proactive in developing new features to fit our business-specific requirements and in an agreeable amount of time. I was impressed with the post implementation support that we received for any issues that arose after we went into production. Our issues were resolved in most cases over the phone. Our recent software upgrade went smoothly, thanks to the CIMCON team going into thorough detail about the changes we can expect to see.

The software has reaped us great benefits since its implementation. We have been extremely satisfied with the product, and have noticed a quicker streamlined process from the initiation of procedures to the subsequent training, in contrast to the manual process that we used before. The addition, the eTraininfo Training Module allows the training department to seamlessly transition a document from approval into training for all the affected users. The flexibility of the configurations to adapt to our company allowed us to rollout the system much quicker than expected without having to change our work processes. We were delighted that CIMCON offered the SaaS hosted service in contrast to supplying any on-premise hardware expenses that would’ve decelerated the implementation process. This technology also negated the need for capital expenses for the company so we were able to see a quicker ROI on the product.

I can say that this is certainly one of the most customer-driven companies that I have ever had the pleasure to work with, and I am excited to see what solutions the company will provide to us in years to come.

Quality Systems Specialist,

Pharmaceutical Company
We purchased CIMCON's eTraininfo and eInfotree Excel software about 2 years ago and couldn’t be happier with the results. Aside from keeping us Part 11 compliant, both solutions have made record keeping and reporting significantly easier and time efficient which is key in a regulated environment. The technical support response is always prompt and helpful in resolving any issues we encounter with CIMCON’s products.

Dale Smith, QA/QC Manager,

Austin Pharma/Insys Therapeutics Inc.