Posts Tagged ‘21 CFR Part 11’

  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 […]

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, […]

Now that February is here, I thought it would be neat to look back at what our readers found most interesting last month. Below are the top five blog posts Perficient’s life sciences practice wrote in January – they’re ranked in order of popularity, with number one being the most viewed piece. 6 Trends In Life Sciences […]

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 […]

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 […]

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 […]

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 […]

Validation. Admit it – you cringed a little. It’s almost like a dirty word in our industry. That thing that slows down system implementations. That thing that adds a bunch of time and cost to IT projects. That annoying, but necessary, evil. Well, okay, it’s not really “evil,” per say. It is, after all, designed […]

It’s probably a safe assumption that your organization made the switch to an electronic document management system (e.g., SharePoint, Office 365, Documentum, Alfresco, NextDocs, eDOCs DM) some time ago. Take a few minutes and think back on the underlying reasons for that investment. I’m sure the list you came up with includes things like keeping […]

It’s no secret that validation can be a bear. All of that documentation and testing, the multiple phases with pesky transition gates, a million reviews and approvals…it can really slow down an IT project, which often leads to questions about why on Earth we bother with it. Well, it all traces back to rules and regulations […]

Digitally signing documents is easier than you might think. It’s also much faster than having to print, sign, and scan them. And, of course, there’s a significant cost-savings for companies that frequently mail and store hardcopy documents. A product like CoSign can be a great solution for companies, especially those in highly-regulated industries that require […]