Regulatory Compliance

If you had not heard about the latest NFL scandal with the New England Patriots leading up to the biggest football game of the season (the Super Bowl) surely you did during some of the coverage of the game. National news took time out of their normally depressing nightly news to cover the latest developments in Deflategate. I’ll preface […]

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, […]

Attaching files to a case is an important aspect of case management work processes. Typically one would attach source documents here, such as a discharge summary report, a hospitalization record, patient laboratory records, etc. Without formal integration to a document management system, it’s quite easy to maintain safety source documentation by attaching a file in […]

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 […]

Whether you’re using Oracle’s drug safety and pharmacovigilance solution, Argus Safety, a different application from another vendor, or even Excel to capture and manage adverse event data, our January 29th webinar, Features of a World-Class Safety System may be of interest. Dr. Rodney Lemery, the director of Perficient’s life sciences safety and pharmacovigilance division, is […]

While most banks have a better grip on Know Your Customer requirements than they did years ago, the challenges and risks of non-compliance continue to grow as regulators focus on sources outside the financial institutions’ walls. What is the impact of a failed risk management program as a result of actions committed by a vendor or service provider? Your financial institution may be […]

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 […]

There will undoubtedly be a wide range of financial services predictions and banking trends that will surface throughout the year which will make planning your organization’s top priorities in 2015 increasingly difficult. However, one thing is certain – risk and compliance continues to move to the top of the executive’s agenda. As financial institutions continue to experience an onslaught of cybersecurity threats, […]

Big pharma is big business. Well, if they have products on the market, that is! So, who were the lucky companies that got novel drugs approved by the FDA in 2014? What were the drugs? And, what were the therapeutic purposes? Flip through the slideshow to get a glimpse of who was popping champagne well […]

As we wrap up 2014, let’s take a look at the top 10 blog posts from our thought leaders. These blogs were published on Perficient’s Healthcare Industry Trends Blog. If you missed these you may want to take a look. #1. What the Market Says You Need in Your Patient Portal by Melody Smith Jones […]