What Does "21 CFR Part 11" Mean?

"CFR" stands for Code of Federal Regulations and "21 CFR Part 11" refers to Title 21, Part 11 of the code. This section outlines the Food and Drug Administration Department of Health and Human Services policy on electronic records and signatures.

Title 21 CFR Part 11 specifies under what circumstances the department considers electronic records and signatures equivalent to handwritten ones. Electronic records submitted under the Public Health Service and Federal Food, Drug, and Cosmetic acts fall under this code, however, paper records transmitted electronically do not. The code stipulates that when people use identification codes with electronic signatures and passwords, they must utilize means to ensure the integrity and security of the data.