Regulatory Compliance

This post is the fourth in a brief series about the FDA drug approval process. The series is designed to answer the question about why U.S. prescription drugs are so expensive by illuminating the FDA drug approval process, stage by stage. In my last post in this series, I focused on the clinical stage, and […]

A few weeks back, I described how to determine the risk level of a proposed change to a regulated IT system. I also talked about how the system risk level (SRL) and change risk level (CRL) work together to determine the level of rigor required to implement a proposed change without disrupting its validated state. […]

Last time, I published the second in a brief series of blog posts designed to provide insight into why prescription drugs in the U.S. cost as much as they do. The series is focused on explaining the FDA drug approval process in layman’s terms. My previous post focused on the first stage in the process, […]

Disciplinary actions. Government fines. Victim restitution. There is no shortage of regulatory compliance issues hitting the headlines these days. In recent years, however, it is news of aggressive sales tactics that has had the general public and several regulatory bodies that oversee financial institutions very concerned. Most financial institutions have critical cross-selling initiatives that encourage […]

A regular risk control self-assessment, commonly referred to as RCSA, is a process of identifying and assessing operational risks to ensure the appropriate controls and oversight are in place so that business objectives can be met. It provides the ability to monitor the gaps and what is being done to close them. RCSAs can lead […]

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 […]