Regulatory Compliance

This is post #4 in a short series about assessing and mitigating risk with regulated software. Over the past few weeks, I’ve discussed the rationale for taking a risk-based approach to this topic, as well as the first couple of steps to take: determining whether a system is regulated and, if so, determining its risk […]

Last time, I published a post that posed the question: why are prescription drugs in the U.S. so expensive? Today’s post is the first in a brief series that will attempt to provide an answer by looking each stage of the FDA drug approval process, starting with preclinical. Below are the key components of the […]

In the previous post in this series, I discussed the process you can use to determine whether a particular IT system is regulated. That post described the first part of a four-part approach to assessing and mitigating risk with regulated IT systems. Today’s post will cover the second part – what to do once you […]

While modifying sales goals can be a good place to start, artificial intelligence and intelligent machines (along with a comprehensive process) can be leveraged to analyze data and identify patterns. Aside from knowing the real identity of customers, companies are obligated to ensure that their customers have willingly opted to do business with them through […]

E2B(R3) So, there we have it, the European Medicines Agency (EMA) has finally issued a statement, which confirms the date of release for the bigger, better EudraVigilance: November 22, 2017. Time to go into panic mode? Absolutely not. But, here are some of the things you should be thinking about as the deadline approaches: Training […]

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]