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

  • Compliance

    Software built to comply with 21 CFR part 11 and 820, ISO 13485, GMP, GLP, and ISO 9001.

  • Validation

    Validation testing performed by Limble for every software release at no extra cost to you.

  • Documentation

    Receive copies of our validation documents as well as templates that you can use for your own validation protocols and procedures.

  • Expertise

    Access to a regulatory specialist to help you with your validation process design.

  • Support

    Access to a dedicated Customer Success Manager to help you set up your account to comply with 21 CFR.

Take a tour

Learn how Limble CMMS can help streamline your maintenance.

  • Increase productivity by 41%
  • Decrease downtime by 37%
  • Reduce part expenses by 29%
Custom Dashboard
Limble logo

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

[Case Study] Spectrum Solutions

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

Myriad Genetics Logo
Genetic Testing
Ellume Logo
In Vitro Diagnostics
BD Logo
Medical Device
Euclid Systems Logo
Medical Device
Honibe Logo
Nutraceutical
Invitae Logo
Genetic Testing
SINTX Logo
Medical Device
BD Logo
Medical Device
Tela Bio Logo
Medical Device
DisGenics Logo
Cell Therapy
Synecco Logo
Medical Device
Locus Biosciences Logo
Biologic
Spectro Solutions Logo
In Vitro Diagnostics
Sientra Logo
Medical Device
Codex DNA Logo
DNA Synthesis
Ellume Logo
Medical Device
Take a tour

Learn how Limble CMMS can help streamline your maintenance.

  • Increase productivity by 41%
  • Decrease downtime by 37%
  • Reduce part expenses by 29%

    21 CFR FAQs

  • 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 about our release schedule, click here.

  • 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.
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Limble Ranked #1 by maintenance experts in the field

G2 - Easiest to use 2022Software Advice - FrontRunners 2022Capterra - Shortlist 2022G2 - Best Support 2021
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  • Nov 07
    5 Star Rating

    Very easy to use, functionality is great

    "I can track my inventory and it sends me emails when I'm running low on an item. Also that I can track how much time I'm spending on certain jobs over an extended period of time."

    Dec 19
    5 Star Rating

    Very easy to use, access

    "I like the price, the fact I can see it on my phone or the computer. I like that it is internet-based."

    Dec 03
    5 Star Rating

    It just works

    "Honestly - the customer support has been fabulous. We had a minor feature request that was deployed within 24 hours - which is unheard of. Even better when you consider our business is located in a completely different time zone (somewhere in Australia). Limble is quite intuitive and I love the ability to have assets nested within each other."

  • Jan 30
    5 Star Rating

    Great for smaller or larger facilities

    "We haven't fully integrated Limble yet but we are already seeing improvements in our efficiency. As we fully integrate Limble we expect to see more benefits and increase our response and completion times. The customer support has been outstanding. The Limble team is very quick to respond to any questions and they are very open to suggestions."

    Jan 18
    5 Star Rating

    Limble is the best thing to happen to this company

    "Limble does such a good job at keeping track of what's been done and letting me know when and what I need to do next."

    Jan 11
    5 Star Rating

    Great product at a great price

    "Terrific customer service, easy to use, and at a great value. Our old Maintenance software was very difficult to use and was very expensive."

Download our Preventative Maintenance Checklist

Take the management stress away from preventative maintenance.

Preventative Maintenance Checklist
  • Cheat-sheet to better productivity and reliability
  • Steps we've learned over years working with thousands of customers
  • Important tips to help you avoid common costly pitfalls when creating your PM plan

13 Easy to-do Steps to Improved Preventative Maintenance