We are a company that is FDA Regulated. My understanding is that to eliminate the requirement for paper documentation they require electronic systems used to document training to be compliant with CFR 820, Part 21 through some sort of validation process. Is there anyone out there working in an FDA regulated industry with an LMS that would meet these requirements?
I'm with a company that has specific food and OSHA regulations and we are looking for a LMS as well to help with track employee completion of compliance issues. After a few months research, from what I've found most of the bigger players (Learn.com, SumTotal, etc) can easily track this compliance for us, the key will be in the setup.....
I can recommend the LearnerWeb LMS as we use it internally. The vendor represents CFR 21 Part 11 compliance (FDA) although we do not use their electronic signature or advanced auditing.
