In the life sciences industry, many of the software systems we use must comply with federal regulations. The purpose of these regulations, such as U.S. FDA 21 CFR Part 11, is to ensure that the data being housed and produced by these software systems is accurate and trustworthy. When the FDA first introduced 21 CFR […]
Posts Tagged ‘Electronic Records’
21 CFR Part 11 Decoded: One Final Look
This is the final post on the series dedicated to decoding the mystical “21 CFR Part 11” regulation that governs IT systems in the life sciences industry. How does it feel to have made it all the way through? I hope that, by now, you’re feeling much more comfortable with the purpose, organization, and […]
21 CFR Part 11 Decoded: Signature/Record Linking
This is the final post in the 21 CFR Part 11 “mini-series” on Subpart B – Electronic Records. The last Section in Subpart B is 11.70 – Signature/Record Linking. 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 […]
21 CFR Part 11 Decoded: Signature Manifestations
This is the third post in the 21 CFR Part 11 “mini-series” focused on Subpart B – Electronic Records. This time, we’re decoding Section 11.50 – Signature Manifestations. Do you have your rings ready? In the table below, the actual language from each regulation is on the left, and my personal interpretation of what […]
21 CFR Part 11 Decoded: Controls For Closed Systems
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, […]
21 CFR Part 11 Decoded: Definitions
In the previous two posts in this 21 CFR Part 11 Subpart A “mini-series,” we decoded Sections 11.1 – Scope and 11.2 – Implementation. It’s time to wrap up this mini-series with Section 11.3 – Definitions. Make sure no one is looking and then grab your decoder rings! In the table below, the actual language […]
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 […]
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. Because Subpart A contains three Sections (Scope, Implementation, and […]
The 21 CFR Part 11 Decoder Ring
If you’re connected to the life sciences industry in one way or another, odds are you’ve heard the term “21 CFR Part 11.” You may have gathered that it’s a set of regulations related to computer systems, but, unless you work in some sort of compliance group, you might not understand what it’s about or […]