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:
Does Limble provide software validation?
Limble provides documentation of our internal validation as well as templates that you can use for your own validation. These documents include the documents needed for a full validation, including Validation Plan, IQ/OQ/PQ, Trace Matrix, etc. We are also happy to help walk you through the validation process if that is something you would like.
Note: Some companies choose to just use the validation documents that Limble provides and choose to not do their own internal 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 do for those who choose our "21 CFR Enterprise Plan." We perform validation testing and share those results with you before the software is updated for your account. We also provide a "sandbox 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.