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FDA 21 CFR Part 11

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FDA 21 CFR Part 11

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The challenge

The Food and Drug Administration’s (FDA) standards for Title 21 of the Code of Federal Regulations (CFR), also known as the FDA 21 CFR, provide a clear and concise set of regulations.

A specific focus of FDA 21 CFR is Part 11, which details regulations for the use of electronic records and electronic signatures. For many companies that rely on digital data to monitor their products, such as those in the pharmaceutical, food and healthcare sectors, ensuring compliance with 21 CFR Part 11 is essential.

The most basic definition of 21 CFR Part 11 compliance is the submission of validation documents to the FDA. These materials contain a series of tests and reports to support the assessment that your systems and software are authentic, reliable, and valid.

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