How is GCube’s Pharma LMS 21 CFR Part 11 Compliant for Audit Trail Management?

Our clients in the USA, have complained of sleepless nights due to the fear of receiving FDA 483 letters. So, even before we start the conversation, we understand your pain. As many as 429 organizations have received warnings from the FDA for non-compliance related to creating or following SOPs and problems with record keeping. In our endeavor to build a pharmaceutical specific LMS, GCube has built a learning solution that not only manages your audit trails and learner records effectively but is also in compliance with 21CFRPart11 guidelines.

In our analysis of the problem of FDA fines pertaining to audit trail management that we were trying to solve for our pharma clients, the few major challenges that came up in our scrutiny were as follows.

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