Posts Tagged ‘Regulatory’

  Getting informed consent from patients is one of the most critical aspects of a clinical trial. The objective is simple: provide patients with information about the study plan (doctor visits, tests, etc.) and risks/benefits, make sure they understand the information, and get their (legally effective) consent to participate. The faster this is done, the […]

  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 […]

There has always been value in being able to reach healthcare consumers remotely, however, the fee-for-service model and health plans have not supported it. Rising expenses, increasing number of Accountable Care Organizations, elevated interest in consumer engagement, focus on population health management and a shortage of healthcare providers are all driving telehealth. Andrew Watson, MD […]

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 […]

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 […]

Just kidding. You may have read the story on TMZ of a New York businessman making big bucks off the panic surrounding Ebola. Guess what? The FDA hit him where it hurts. His site is down. Stop trying to trick the public. Stop being sleazy. That’s the message the FDA is sending to pharmaceutical, medical […]

The life sciences industry is one of the most heavily regulated in the world, which can make it a frustrating space to do business. But, retracing the current mass of regulations back to their roots can be like the spoonful of sugar that makes the medicine go down…and might even make you feel kinda good […]

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 […]

On November 6, 2014, Canada passed Vanessa’s Law, a new piece of legislation designed to protect patients from unsafe drugs and medical devices. The law comes after many complaints from citizens that the country wasn’t doing enough to oversee the safety of products sold in the marketplace or the clinical trials being conducted in the […]

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 […]