On October 1, 2024, the US Food and Drug Administration (FDA) finalized its guidance on the use of electronic records in clinical investigations of drugs, devices, biologics, foods, tobacco products ...

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: ...

CFR Part 11 compliance helps companies in industries such as pharmaceutical, biotechnology, healthcare, clinical research, medical devices, and financial services keep electronic records compliant ...

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 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 ...