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.
Note: If you are new to 21 CFR, check out this article: What is 21 CFR? Everything a Maintenance Team Needs to Know.
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.