Article | March 11, 2022

20 Years Later, 21 CFR Part 11 Is More Relevant Than Ever

By David Jensen

medical data regulatory GettyImages-970438352

In the late 1990s, the U.S. Food and Drug Administration (FDA) published the 21 CFR Part 11 (aka Part 11) guidance. At a high level, the regulation made electronic records and signatures as valid as paper records and handwritten signatures. The guidance changed the dynamic of data and records management by ushering in a transformation toward modernized technology in the life sciences industry.

Technology is integral in all aspects of our lives. We are using more automation, mobile devices, apps, etc. Also, companies generate vast amounts of data as a byproduct of their processes, information management systems, equipment, personnel, products, and communications.

Part 11 is meant to allow the use of electronic records as much as possible while safeguarding the integrity of data and systems and the validity of electronic signatures. The prevalence of technology and data in life sciences product development makes the regulation more relevant than ever.

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