gaqreview.blogg.se

Part 11, essentially, allows any paper records to be replaced by an electronic record, and allows any handwritten signature to be replaced by an electronic one. In order to do this, they have enacted various regulations that businesses must follow to comply.Ī regulation by the name of CFR 21, Part 11 was established by the FDA which basically ensures that companies and organizations implement good business practices, by defining the criteria under which electronic records and signatures are considered to be accurate, authentic, trustworthy, reliable, confidential, and equivalent to paper records and handwritten signatures on paper. It is also responsible for protecting public health, by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation. Beginning in 1906, the FDA is still responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices. The Food and Drug Administration, in short FDA, is the oldest comprehensive consumer protection agency in the U.S. Using SharePoint For Compliance Issues Of FDA Regulated Industries