21 CFR Part 11

U.S. Federal Drug Administration's (FDA) Mission Statement: "The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health." (Source: http://www.fda.gov/opacom/morechoices/mission.html)

How the FDA Fulfills Their Mission:

In order to fulfill its mission, the Food and Drug Administration provides guidance for the quality control and assurance of manufacturing processes, laboratories (in the case of environmental labs, also regulated by the EPA), and clinical testing operations. All of these quality guidelines include a heavy emphasis on documentation.

21 CFR Part 11:

Chapter 21 of the Code of Federal Regulation's Part 11, Electronic Signatures and Records, includes standards for the archiving and retention of documents, including long-term (by some interpretations, indefinite) retention of all documentation in both human and machine-readable form. That is, regulated industries must retain reports, graphs, numerical output, pictures, x-rays, and other forms of records for a period of at least five years (and possibly much longer) in a format that can be both reviewed by FDA investigators, and can also be electronically re-evaluated by those investigators.

Other provisions of 21 CFR Part 11 call for electronic audit trails of data files in all automated systems; controls on electronic signatures and automated approvals; and validation of electronic systems. Throughout the application of Part 11, however, the FDA exercises enforcement discretion, inviting regulated organizations to utilize a Risk Assessment Policy to classify systems according to their impact on public health and safety.