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Life Sciences

21 CFR Part 11 Decoded: Scope

In the previous post in this series, we explained what the name “21 CFR Part 11” means and how the Code of Federal Regulations (CFR) is organized. In this post, we will actually dive into Part 11 and begin to decode Subpart A – General Provisions.21-cfr-part-11-scope

Because Subpart A contains three Sections (Scope, Implementation, and Definitions), I am going to divide it into three posts. The FDA might call these three posts a “Sub-Series” (they really like the prefix “sub-“!), but I prefer “Mini-Series.” Ha! Time to get out your decoder rings…

Let’s take a look at Subpart A, Section 11.1 – Scope. 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.

11.1 – Scope

Poll Results for What industry are you in?
Start Time: April 3, 2018 12:13:22 PM MDT

Total Responses: 222 of 428 (52%)

Results Summary
AnswerTotal NumberTotal %
Automotive70.03
Energy and Utilities140.06
Financial Services and Insurance470.21
Healthcare and Life Sciences600.27
Manufacturing140.06
Retail220.1
Other580.26


Now that we’ve decoded the scope of 21 CFR Part 11, let’s move on to 11.2 – Implementation.

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.

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Marin Richeson

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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