Regulatory Compliance

  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.” 

  Last week, the FDA released a new draft guidance document called Adaptive Designs for Medical Device Clinical Studies. While the title specifically calls out “medical device,” the document states the following: 

  I’m not going to get into whether prescribing or using drugs for off-label purposes makes sense – you can decide that for yourself. However, what I will tell you is that it’s a hot topic in the industry right now. Pharmaceutical companies continue to lobby the FDA to eliminate any prohibition of off-label promotion […]

  When it comes to periodic reporting, we feel that the generation and tracking of periodic reports in Oracle’s Argus Safety is far easier than in other safety and pharmacovigilance systems. In the system, periodic reports are all created and generated from a central screen within the application.   The four basic kinds of periodic […]