Life Sciences

Recording CAPA Issues And Resolutions In Argus Safety

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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:

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System must allow the recording of issues and track their resolution to completion either in the form of Corrective, Preventative or both action types

How does Argus Safety support this rule?

Argus Safety provides a number of configurations that allow product complaint, device, drug, and other data to be stored separately. Additionally, configurable fields are available to provide a more granular or specific approach to storing data. 

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  • Case Classifications can be configured to track the outcomes of a case and the resulting quality endpoints
  • Quality control tracking information can be added to the case to create a cross-link between Argus Safety and external QC systems
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  • Comprehensive complaint investigation and analysis summary data can be tracked in the products area of Argus Safety
  • Specific laboratory or quality investigation actions and results can be tracked in the activities area of Argus Safety
  • CAPA-related data can be reported on using native Argus Safety functionality
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To read other posts in our “Argus Safety for CAPAs” series, click here.

About the Author

Dr. Rodney Lemery specializes in the implementation, support, and development of software used in the collection, management, and analysis of clinical data. His accomplishments as director of safety and pharmacovigilance at Perficient include the management of numerous clinical application implementation projects. In addition to his expertise in clinical and safety applications, Rodney is able to navigate between the technical and clinical worlds with ease due to his complementary educational background in epidemiology. He also holds a part-time professorship in the School of Health Sciences at Walden University, which solidifies his ability to lead global safety implementations at Perficient. Rodney has been with Perficient, via the acquisition of BioPharm Systems, since 2000. Prior to joining the company, he worked at Pfizer.

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