Products
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.
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.
On Demand Webinars
Revolutionizing Validation & Compliance: Unleash the Power of AI Using CIMCON's Validated AI Agent Suite
Life science companies invest major resources in validation and compliance. 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 libary 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
Join CIMCON in this webinar to learn how you can convert the hype into reality and reap the benefits of Compliant AI™ in your organization.
Register
Automating AI Model Validation and Complying with the FDA Guidance on Artificial Intelligence
The FDA recently issued a draft guidance on AI in January 2025. The guidance provides recommendations on the use of AI to produce information or data that supports regulatory decision making regarding the safety, effectiveness, or quality for drugs.
Learn more about this guidance, and review how CIMCON's AIValidator™ and EUC Insight™ software provides you with a proven and mature end-to-end AI Risk Management Platform that automates model validation and compliance with the FDA guidance.Register
Audit Trails and E-Signatures for Your Spreadsheets
21 CFR Part 11 Compliance in SecondsAdd audit trails and e-signatures to your spreadsheets in seconds using CIMCON's eInfotree Excel Desktop Software. Trusted by hundreds of regulated firms for over 20 years, eInfotree makes your spreadsheets 21 CFR Part 11 compliant. Additionally, the XLValidator software helps you validate spreadsheets by automatically generating validation documents.
The use of compliant spreadsheets are endless - as a form, a calculator, or to capture e-signatures. No more re-calculating or printing and signing paper copies!! Start your Digital Transformation Journey with spreadsheets!
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
Testimonials
"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."
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.
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.
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