Rodney Lemery

  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. 

  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. 

  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. 

  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? 

  Over time, the concept of Quality Control has evolved to become Total Quality Management (TQM). According to Wikipedia, the concept of TQM “…consists of organization-wide efforts to install and make a permanent climate in which an organization continuously improves its ability to deliver high-quality products and services to customers.” Since a CAPA system is […]

  We recently discussed what CAPA means and why it’s important. Since many people in our field express confusion between the “CA” and the “PA,” I’ll quickly explain the difference between corrective action and preventive action. To put it simply, a corrective action can be defined as specific steps taken to address observed non-conformities or […]

  In a handful of upcoming blog posts, we’ll be discussing a hot topic in our industry, along with a complementary piece of technology that might surprise you. The term Corrective and Preventive Actions, more commonly known as CAPAs, refers to an elaborate combination of processes and procedures used to maintain compliance with the following […]

Code list maintenance is critical in Oracle’s Argus Safety. These code lists often present as drop-downs in the case entry sub-system. While the entry, modification or removal of these list of value options are very convenient, it does take some effort to ensure the reliable data points that are used everywhere in the system are […]

  One of the other major benefits of Argus Safety, Oracle’s drug safety and pharmacovigilance system, is the ability to maintain administrative tasks in an easy-to-use interface. The following blog post reviews some of the very simple possibilities of configuring Argus Safety to your own needs with minimal technical effort. 

  We recently discussed the ability to access previously visited adverse event cases very quickly in Oracle’s safety and pharmacovigilance system, Argus Safety. For this post, we’ll cover a feature that many of our clients love. Argus Safety enables users to open multiple cases simultaneously, although it’s not possible to view both of the cases at […]