This post marks the first in the 21 CFR Part 11 series that is focused on Subpart B – Electronic Records. Since Subpart B contains four sections, its “mini-series” will contain four posts. Do you have your decoder rings handy? It’s time to decode Section 11.10 – Controls for Closed Systems.
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.
11.10 – Controls for Closed Systems
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.
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Whew! That was a big one. Eleven Subsections! Are your decoder rings smoking?? When all of the dust settles, the most important takeaway here is that you MUST have procedures and controls for the above topics clearly documented and available for inspection. In the life sciences industry, documentation is paramount, so be sure to tell your QA department that you appreciate what they do.
Up next? Subpart B, Section 11.30 – Controls for Open Systems. Don’t worry – it’s short. 😉