How to be 21 CFR Part 11 FDA Compliant
How to be 21 CFR Part 11 FDA Compliant
13 PagesHow to be 21 CFR Part 11 FDA Compliant with an LMS solution Can a learning management system (LMS) software provider offer a 21 CFR Part 11 FDA compliant “solution”? It is not possible for any vendor to offer a turnkey 21 CFR “Part 11 compliant system.” Any vendor who makes such a claim is incorrect. Part 11 requires that both procedural controls (i.e. notification, training, SOPs, administration), and administrative controls are put in place by the user, in addition to the technical controls that the vendor can offer. At best, the vendor can offer an application containing the technical requirements of a compliant system. It is not possible for any vendor to offer a turnkey solution. Prior to 1997 companies had to maintain quality documents on paper.
