The FDA and 21 CFR 11

The Food and Drug Administration (FDA) is the US agency responsible for protecting public health. Its role is best described by the FDAs 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.”

In March 1997 the FDA issued 21 CFR Part 11, a set of regulations that apply to the use of electronic records by industry segments regulated by the FDA and to assist with industry guidance. The regulations enforce provisions related to the following:

The secure retention of electronic records
User-independent, time stamped audit trails
Requirements for the use of electronic signatures
Controls for open and closed systems
Appropriate controls over system documentation
The determination that users of electronic systems have the education, training and experience to perform their assigned tasks
Use of device and operational system checks
Limiting system access to authorized authenticated users

Click here to learn more about the FDA, and 21 CFR Part 11.