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. It’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

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.