Posts Tagged ‘CAPA’

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. 

Top 5 Life Sciences Blog Posts From October 2015

  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. 

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. 

Unique Case IDs For CAPA Management In Argus Safety

  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. 

Workflow Configuration For CAPA Management In Argus Safety

  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? 

CAPA Systems Based On The TQM Model And Federal Regulations

  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 […]

The Difference Between Corrective And Preventive Action

  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 […]

Top 5 Life Sciences Blog Posts From August 2015

  Now that September 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 August – they’re ranked in order of popularity, with number one being the most viewed piece. 

What Are CAPAs And Why Are They Important?

  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 […]

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