Posts Tagged ‘FDA’

  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 […]

  Welcome to the final post in the 21 CFR Part 11 “mini-series” on Subpart C – Electronic Signatures, which happens to be the final section in the 21 CFR Part 11 regulation. Let’s polish up our decoder rings one last time for Section 11.300 – Controls for Identification Codes/Passwords. In the table below, the […]

  The U.S. government recently disclosed the amount of time it takes to comply with the FDA’s requirements for the reporting and recordkeeping of human drugs and biologics, related to Investigational New Drug (IND) applications. It probably won’t come as a surprise that it takes an exhausting 22,801,297 total hours. Yes, you read that correctly. 

  This post is the second in the 21 CFR Part 11 “mini-series” that is focused on Subpart C – Electronic Signatures. Today, we’ll be using our decoder rings to learn the secrets in Section 11.200 – Electronic Signature Components and Controls. 

  Welcome to the first post in the 21 CFR Part 11 “mini-series” focused on Subpart C – Electronic Signatures. We’ve come a long way since that first post in which we decoded what the name “21 CFR Part 11” even means, haven’t we? We are in the final stretch! Let’s get out our decoder […]

  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 […]

  A recent article in Forbes reported that an astounding percentage of dietary supplements do not contain the main ingredient listed on the label. That’s concerning, considering there aren’t too many stringent regulations they have to follow, unlike pharmaceutical companies. 

  Soon after I published a post on the mention of precision medicine in President Barack Obama’s January 28, 2015 State of the Union address, The White House released additional information on their initiative. The President’s 2016 Budget is set to allocate $215 million to the National Institutes of Health (NIH), Food and Drug Administration […]

  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 […]

  This post is the second in the 21 CFR Part 11 “mini-series” focused on Subpart B – Electronic Records. Pull out your decoder rings and let’s look at Section 11.30 – Controls for Open Systems. In the table below, the actual language from each regulation is on the left, and my personal interpretation of […]

  As a company who implements and enhances clinical trial management systems (CTMS), a question we hear a lot is, “Do we need to validate our CTMS?” And, to be honest, it’s one we continue to debate internally. Why is the answer not black and white? Well, our internal debate always works its way back to […]

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, […]