Regulatory Compliance

One of my LinkedIn contacts shared the video Risk-Based Monitoring vs Remote Monitoring Finally Explained, in which Dan Sfera of www.theclinicaltrialsguru.com explains both concepts in layman’s terms. In essence, the idea of Risk-Based Monitoring (RBM) is to leverage the data in existing IT systems to spot, rectify, and prevent issues relating to the execution of […]

  You can’t argue with it because it’s a good idea. Yellow Cards have gone digital. Not the ones used in soccer/football, but the ones used in the UK for reporting adverse events. When governments undergo digital transformation, you know it’s not a fad. After all, they’re not typically early adopters…of anything. Last week, the […]

  Most of us “regular people” refer to pharmaceutical products by their trade name, but that’s not the case among life sciences professionals in research and development departments. In fact, during a product’s lifecycle, chances are it has been referred to by at least four names: a chemical compound, a company code, a generic name, […]

  Wow, it’s not often you hear about executives from life sciences companies getting jail time. But in the case of the former CEO of OtisMed, that’s just what he got: two years and a small fine. The company also agreed to pay more than $80 million to resolve other charges. Without receiving FDA approval, […]

  Coinciding with the Drug Information Association’s (DIA) 51st Annual Meeting in Washington, D.C. last week, Oracle announced the newest version of its drug safety and pharmacovigilance system. Argus Safety 8.0, considered a major release, offers new features and functionality to help life sciences companies comply with ever-changing global regulatory requirements. The Standard Edition of […]

  A couple of weeks ago, I wrote about a warning letter that was issued to a pharmaceutical company last month. I highlighted one of the FDA’s findings, which had to do with the company’s standard operating procedures (SOPs) having an insufficient amount of detail about their process for collecting adverse events. Today, I want […]

  On Thursday, April 23, 2015, we delivered a webinar on 21 CFR Part 11, based on a recent blog series. During the Q&A session at the end, someone asked the following question: Regarding user accounts: During the User Acceptance Testing (UAT) of a system, are these accounts regulated the same way or can ‘generic’ […]

  On Thursday, April 23, 2015, we delivered a webinar on 21 CFR Part 11, based on a recent blog series. During the Q&A session at the end, someone asked the following question: The Scope section requires access to electronic records and signatures (ER/ES) at all times. What if the electronic system used by a […]

  We recently discussed customizing and configuring clinical trial software that is hosted in the cloud. For the final post in our “cloud fact or fiction” blog series, we’ll discuss the hot topic of validation. 

Compliance has become a strategic and executive-level imperative for financial services organizations. Capturing data to meet regulatory requirements in reporting, risk management, and compliance is timely, expensive and challenging because it requires gathering, enhancing, and reporting the required data from multiple data sources. Thomson Reuters’ sixth annual “Cost of Compliance” study was just released this past […]

  On Thursday, April 23, 2015, we delivered a webinar on 21 CFR Part 11, based on a recent blog series. During the Q&A session at the end, someone asked the following question: What about GAMP 5? How does it fit into 21 CFR? How to combine both? 

  Warnings letters stink, as they can impact a company’s image, stock value, and much more. That’s why companies should do everything in their power to make sure they follow FDA regulations to a “T.”