Having an FDA 21 CFR Part 11 compliant learning management system can be the difference between strong performance and success versus negative FDA audit findings. If you are in the life sciences industry which comprises organizations such as drug makers, medical device manufacturers, biotech companies, biologics developers, CROs, and other FDA-regulated organizations, you must validated systems. Connect with an expert. Companies in pharmaceuticals, biotechnology, biomedical technologies, life systems technologies, nutraceuticals, cosmeceuticals, food processing, environmental, biomedical devices are required to strictly adhere to the 21 CFR Part 11 standard when it comes to record keeping especially electronic signatures.

eLeaP is a validated learning management system which compliance with Part 11. Here are some terms and definitions you need to understanding when it comes to Part 11 compliance.

CFR Part 11 Terms

CFR Part 11 Definitions

CFR Part 11 Checklists

CFR Part 11 Examples