21 CFR Part 11

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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 view how eLab addresses each of the regulations to help make your laboratory compliant.