Life Sciences

21 CFR Part 11 Decoded: Implementation

In the first post in this 21 CFR Part 11 Subpart A “mini-series,” we decoded Section 11.1 – Scope. 21-cfr-part-11-implementationIt’s time to grab your decoder rings again while we take a look at the next Section, 11.2 – Implementation.

In the table below, the actual language from each regulation is on the left, and my personal interpretation of what that language means is on the right. Keep in mind that I do not represent the FDA and nothing in the “Interpretation” column should be taken as fact.

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11.2 – Implementation

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Check back for the next post, in which we’ll wrap up the mini-series on Subpart A with Section 11.3 – Definitions.

If you have questions between now and the next post, feel free to contact us. To read past posts in the 21 CFR Part 11 Decoded series, click here.

About the Author

Marin joined the life sciences industry in 2001. Over the course of her tenure, she has held roles in clinical finance, IT, quality assurance, and validation. The diversity of her experience provides her with a unique perspective on the interconnectedness of this complex, multi-faceted industry. Marin Richeson is a lead business consultant in Perficient's life sciences practice.

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