The Food and Drug Administration (FDA) is a United States Federal regulatory agency that outlines requirements around the production and sale of human and veterinary drugs, vaccines, medical devices, food, cosmetics, and radiation-emitting products. 21 CFR, Chapter 1, Part 11 explicitly focuses on electronic records and signatures, outlining how these digital records can be considered secure and reliable, relative to paper records and signatures, with an end goal of ensuring the integrity of data that is connected with research and development of pharmaceuticals and medical devices.
This checklist outlines how healthcare, life sciences, and pharmaceutical organizations can use FileCloud to meet compliance objectives related to these FDA requirements.
