On 20 February 2003, the US Food and Drug Administration (FDA) published a new draft guidance relating to 21 CFR Part 11. The new guidance mainly affects the compliance requirements of systems with a ...

21 CFR Part 11 (Part 11) establishes U.S. Food and Drug Administration (FDA) regulations on electronic records and signatures. In the pharmaceutical world, some of the first questions we get asked is: ...

This article examines the application of 21 CFR Part 11 to those areas of research and development (R&D) where compliance is not strictly required and the response of R&D equipment vendors to the rule ...

The FDA rule relating to the use of electronic records and electronic signatures is 21 CFR Part 11. In the early 1990s, the FDA convened a meeting with members of the pharmaceutical sector after ...

Part 11 in Title 21 of the Code of Federal Regulations includes the US Federal guidelines for storing and protecting electronic records and applying electronic signatures. The intent of these ...

The regulations for food and drugs in the United States, described in Title 21 of the Code of Federal Regulations (CFR), are critical in ensuring safe and ethical drug administration. Whether you are ...