TRUSTED BY 50,000+ PROFESSIONALS AROUND THE WORLD
Limble CMMS can help you every step of the way
Compliance
Built to comply with 21 CFR parts 11 and 820, ISO 13485, GMP, GLP, and ISO 9001.
Validation
Validation testing for every software release at no extra cost to you.
Documentation
Copies of our documentation and templates you can use for your validation procedures.
Expertise
A regulatory specialist to guide you through your validation process design.
Support
A dedicated Customer Success Manager to help you set up your account.
With Limble, all your maintenance needs are covered
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Frequently Asked Questions
Has the Limble software been validated?
Yes! Limble has a 21 CFR version of the software, which we have validated internally.
Our customers who purchase the 21 CFR version of our software receive copies of all of our validation documents, including our Risk Assessment, User/Functional Requirements, Validation Plan, IQ/OQ/PQ, Trace Matrix, etc. We are also happy to help walk you through the validation process and provide document templates if you would like.
Note: Many companies choose to accept Limble’s validation documents in lieu of performing their own validation. Your Quality Department will know the off-the-shelf software validation requirements for your company.
Does Limble perform validation testing of every software update?
Yes! We perform validation testing and share those results with you before the software is updated for your account.
We also provide a “validation account” so your team can test the upcoming version, if desired. If you would like to learn more, please review our release schedule.
Who uses Limble to comply with GxP and/or 21 CFR requirements?
Many companies across the globe use Limble as an essential part of complying with their regulatory requirements.
Here are are just a few: Beckton Dickinson (“BD”, medical device), Myriad Genetics (genetic testing), Euclid Systems (contact lenses manufacturer), Synecco (medical device manufacturer), and Spectrum Solutions (in vitro diagnostics).
How can I learn more about using Limble for Regulatory Compliance?
For more FAQs about how Limble can help you with regulatory compliance, visit our help center.
To request a software demo, click here.