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.
This guide analyzes how artificial intelligence – including machine learning – can be used by pharmaceutical and medical device companies to improve the clinical data review and cleansing process.
11.2 – Implementation[table “11” not found /]
Check back for the next post, in which we’ll wrap up the mini-series on Subpart A with Section 11.3 – Definitions.