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.
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 | ||
| Answer | Total Number | Total % |
| Automotive | 7 | 0.03 |
| Energy and Utilities | 14 | 0.06 |
| Financial Services and Insurance | 47 | 0.21 |
| Healthcare and Life Sciences | 60 | 0.27 |
| Manufacturing | 14 | 0.06 |
| Retail | 22 | 0.1 |
| Other | 58 | 0.26 |
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.
