Overview
Limble is used by companies that need to comply with regulatory requirements, such as 21 CFR. Here are some of the most Frequently Asked Questions (FAQs) about our 21 CFR product and support services.
If you are interested in using Limble to comply with 21 CFR, check out this article or talk to your Limble representative to learn more.
Table of Contents
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.
How often do you release?
21 CFR accounts are updated only twice per year, with a staggered release between validation and production to ensure our customers will always be working on a validated version of the software. If you would like to learn more about our release schedule, click here.
Which Limble features help customers comply with 21 CFR Part 11 and Part 820?
Each Limble user has unique login information, and settings can be configured to ensure that passwords must be a certain length and changed at regular intervals.
With over 200 unique permissions, Limble offers very strong access control capabilities.
All asset and maintenance history are recorded and stored in the system. The assigned user, date, and timestamp are recorded as part of this history.
Preventive maintenance (PM) task scheduling is automated once a schedule is created, and records of PM completion are stored and traceable.
An electronic signature feature is included with the Request Approval and Capture Signature instruction types available to include in task instruction sets.
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.
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Still don’t see what you’re looking for? Check out our YouTube channel for more tips and tricks! You can also reach out to us anytime at support@limblecmms.com.