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Comment: TLS-3299


This is an increasingly requested requirement from customers and prospects in the Pharmaceutical sector who are required to adhere to this. An organisation using Totara Learn can be FDA CFR Part 11 Compliant, but it must be stressed that compliance is dependant on both the technical controls implemented by the LMS, and organisation controls such as policy and procedure that must be met by the organisation itself. For more information on the non-technical requirements please see this article.

You can read more about how Totara can help with compliance management on our website. 

Below we outline Totara Learn's position on CFR Part 11 compliance, for the specific sections where the LMS itself is responsible for meeting the requirement.