Life Sciences Companies and 21 CFR Part 11 Compliance

In the digital age of the twenty-first century, it’s only natural for all kinds of companies to handle more and more of their business operations digitally. While this process of digitization marches forward, it comes with risks concerning the security of electronic records. For life sciences companies, the United States Food and Drug Administration (FDA) is the regulatory agency keeping an eye on their operations, including how the business maintains the trustworthiness and reliability of all electronic records and the use of electronic signatures. The FDA’s requirements around electronic records and signatures are described in this article, as well as how the right learning management system (LMS) can help a biopharmaceutical company comply with FDA regulations.

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