■ What is stated in Title 21 CFR Part 11?
The Code of Federal Regulations (CFR), Title 21, Part 11 applies to a number of regulated industries such as pharmaceuticals, biology, medical devices and food (human and veterinary). Companies in these segments doing business in the US, as well as suppliers of raw materials and components to pharmaceutical companies and contract laboratories performing analyses, must ensure the reliability and trustworthiness of electronic records and electronic signatures.
