Regulatory Compliance

  This is bizarre. It turns out that many doctors don’t know what the real, FDA-approved indications are for the medications they’re prescribing. In a Wall Street Journal article that discusses the risks of off-label uses for prescription drugs, the author cites a 2009 study of 1,199 physicians (mostly primary care doctors and psychiatrists) that […]

  We recently discussed how Oracle’s safety system has the ability to produce ad hoc descriptive statistical reports on quality data. This brings us to the last rule we’ll discuss in our “Argus Safety for CAPAs” blog series. 

  For several years, the FDA has been the center of scrutiny for not having an official social media policy available on its website. According to the Union of Concerned Scientists, the FDA was the only one of 17 government agencies not to have social media policy…until now. 

  We recently touched on how Argus Safety enables you to track product complaint data and follow it through resolution. Today, we’ll discuss another CAPA rule the safety system supports. 

  Megan Thielking from Stat News reports that a scientific journal took a close look at the impact nutritional supplements are having on U.S. military personnel. According to the article, 75% of people in the U.S. military take some type of dietary supplement every month. Since dietary supplements, such as weight-loss pills and multivitamins, don’t […]

  Now that November is here, I thought it would be neat to look back at what our readers found most interesting last month. Below are the top five blog posts Perficient’s life sciences practice wrote in October – they’re ranked in order of popularity, with number one being the most viewed piece. 

  In our last CAPA-related blog post, we talked about the ability to attach supportive information to CAPA records (case data) in Argus Safety, Oracle’s drug safety and pharmacovigilance system. Today we’ll discuss another way the system can help comply with CAPA rules. CAPA Rule: System must allow the recording of issues and track their […]

  We recently talked about Argus Safety’s ability to able to uniquely identify cases. Today, we’ll touch upon how Oracle’s drug safety and pharmacovigilance system supports CAPA rule #3. 

  Last time, we discussed how Oracle’s drug safety and pharmacovigilance system provides workflow configurations that can handle internal quality control, quality assurance and/or quality management issues. Today, we’ll talk about how Argus Safety supports rule #2. 

  According to the September/October edition of the Impact Report released by the Tufts Center for the Study of Drug Development (CSDD), the reporting of adverse events (AEs) by healthcare professionals is inadequate. In particular, regulatory submissions are an issue due to the lack of critical information provided on submission forms, which can inadvertently alter […]

  Over the last few posts, we’ve discussed CAPAs at a very high level. Now we’ll move on to discussing Oracle Argus Safety’s ability to comply with various CAPA rules. CAPA Rule: System must provide workflow configuration to handle internal quality control, quality assurance and/or quality management issues How does Argus Safety support this rule? 

ThinkAdvisor recently published a list of the top 5 compliance headaches faced by advisors and BDs. Mandatory Succession Planning Rules for RIAs, which could require advisors to “plan for market stress and other events that may prevent an advisor from serving its clients.” These new rules are expected by the end of 2015. Form ADV – […]