The pharmaceutical and biotechnology industry is an incredibly rewarding place to work. We get to help patients feel better, more effectively manage their conditions, cure their diseases, and even prevent them from getting sick all together. But the life sciences industry is not without its challenges. According to a recent Pharmaceutical Research and Manufacturers of […]
Regulatory Compliance
How To Determine Whether Your IT System Is Regulated
A couple weeks back, I launched a brief blog series about assessing and mitigating risk with regulated IT systems. This week’s post will cover the first part in a four-part approach you can use to do just that: assess and mitigate risk. Part One: System Regulated Status The first step is to determine whether a […]
It’s Official: Dr. Scott Gottlieb To Lead FDA
One of the key issues and perspectives we outlined in our recent State of the Life Sciences Industry guide was President Trump’s intention to reform the Food and Drug Administration (FDA) through the elimination or significant modification of regulations. Part of his recipe for reforming the FDA included bringing in a new head of the […]
How To Assess And Mitigate Risk With Your Regulated IT Systems
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 […]
Trends Impacting Governance: Residency Beyond the Perimeter
Along with Big Data is the recognition that much of the information to be governed is now beyond an enterprise’s firewall. Residency in the Cloud does not excuse an organization from effectively governing this information. If anything, it makes it even more critical for ensuring things like privacy, access and timeliness remain intact. The reality […]
21 CFR Part 11 Is Complicated Enough, So We Stripped The Legalese
If that title compelled you to open this post, then you know what 21 CFR Part 11 is, and you also know – as my 12-year-old step daughter would say – “the struggle is real.” 21 CFR Part 11 is perhaps the most famous (or infamous!) regulation published by the U.S. Food and Drug Administration […]
The Case For A Reformed FDA
Life sciences is one of the most heavily regulated industries in the United States. It takes 10 to 15 years and an average of $2.6 billion for a drug to reach pharmacy shelves. Stringent regulations formed by the FDA are major factors for the lengthy timelines and high costs, sometimes preventing people from receiving potentially […]
Relationships With Regulatory Authorities [Trend To Watch]
Tim Lind, global head of financial regulatory solutions at Thomson Reuters, sat down with Finextra at Sibos, the annual conference organized by SWIFT, to discuss the challenges financial services companies face when it comes to regulatory change. To put the regulatory climate into better perspective, Mr. Lind pointed out a few facts: Over the last […]
Regulatory Changes [Trend To Watch]
Financial services executives are likely tossing and turning at night, thinking about the shift to digital, stringent regulations. As the Financial Times reported: “Bank bosses perhaps are worried most about not being publically humiliated by a failing grade.” We at Perficient know this first-hand, as we regularly advise financial institutions on how to better measure […]
What Does President Trump Really Think Of Dodd-Frank?
Yesterday, President Donald Trump signed an executive order that is aimed at reducing regulation across all industries. Part of his push, which has been framed to help small and large companies alike, requires departments and agencies to “identify at least two existing regulations to be repealed” for every new one proposed. When it comes to […]
The OCC Highlights 4 Key Risks The Federal Banking System Is Facing
The Office of the Comptroller of the Currency (OCC), whose mission is to ensure that national banks and federal savings associations conduct business in a safe manner, provide fair access to services, treat customers fairly, and comply with applicable laws and regulations, released its Fall 2016 Semiannual Risk Perspective, which draws on data gathered from […]
Standards And Collaboration Can Help FSIs Survive Regulatory Fatigue
Tim Lind, global head of financial regulatory solutions, Thomson Reuters, sat down with Finextra at Sibos, the annual conference organized by SWIFT, to discuss the challenges financial services institutions face when it comes to regulatory change. To the put the regulatory climate in better perspective, Mr. Lind pointed out a few facts: Over the last […]