Posts Tagged ‘Corrective and Preventive Actions’

21 CFR Part 11 Compliance For CAPAs In Argus Safety

  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. 

Ad Hoc Statistical Reports For CAPAs In Argus Safety

  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. 

Recording CAPA Issues And Resolutions In Argus Safety

  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 […]

New FDA Warning Letter Highlights Importance Of CAPAs

  On September 24, 2015, the FDA issued a Warning Letter to a manufacturer and distributor of medical devices for several violations. While the issues at hand may not seem severe, they do put the public at risk and reduce the confidence that the FDA has in the organization. Plus, they are inviting unwanted scrutiny […]

Attaching Supportive Info To CAPA Records In Argus Safety

  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.