Maintenance Software with Regulatory Compliance
Limble CMMS can help you every step of the way
Be audit-ready at all times knowing compliance is designed into every facet of your team’s work
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Compliance
Software built to comply with 21 CFR part 11 and 820, ISO 13485, GMP, GLP, and ISO 9001.
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Validation
Validation testing performed by Limble for every software release at no extra cost to you.
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Documentation
Receive copies of our validation documents as well as templates that you can use for your own validation protocols and procedures.
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Expertise
Access to a regulatory specialist to help you with your validation process design.
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Support
Access to a dedicated Customer Success Manager to help you set up your account to comply with 21 CFR.
Learn how Limble CMMS can help streamline your maintenance.
- Increase productivity by 41%
- Decrease downtime by 37%
- Reduce part expenses by 29%
A CMMS made for maintenance professionals, by maintenance professionals
- Easy-setup maintenance schedules and reminders
- Enforce standard operating procedures with digital checklists
- Automated documentation with every task
- Single Source of Truth: An asset’s complete maintenance history in one place
See how one medical device manufacturer smashed FDA’s audit thanks to Limble
Learn how Spectrum Solutions:
- Passed their audit in just 3 days
- Completed 96% of all work on-time
- Achieved these results with a small team of 10
Our customers
With Limble, all your maintenance needs are covered
- Preventive Maintenance
- Calibration Management
- Tool Check-Out
- Work Order Management
- Asset Management
- Work Requests
- Spare Parts Inventory
- Vendor Management
- Mobile Management App
Learn how Limble CMMS can help streamline your maintenance.
- Increase productivity by 41%
- Decrease downtime by 37%
- Reduce part expenses by 29%
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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.
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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 about our release schedule, click here.
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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: Myriad Genetics (genetic testing), Euclid Systems (contact lenses manufacturer), Synecco (medical device manufacturer), and Spectrum Solutions (in vitro diagnostics).
Recently Spectrum Solutions let us know that they were really happy with the results of their most recent audit. They explained that their Limble account played an essential role in satisfying the auditor’s requests. They agreed to let us come over to film a short interview so they could tell us their story.
For more FAQs about how Limble can help you with 21 CFR, visit our help center.
