US FDA Title 21 CFR Part 11 Electronic Records; Electronic Signatures Regulations, which also includes Scope and Application 2003 - FDA Interpretation of Part 11 Requirements.
US FDA Title 21 CFR Parts 210/211 Good Manufacturing Practices - The regulations set forth in parts 210/211 contain the minimum current good manufacturing practice for methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packing, or holding of a drug product.
US FDA Title 21 CFR Part 820 Quality Systems Regulation The methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use.
