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Unique Case IDs For CAPA Management In Argus Safety

unique-ids-argus-safety-capa

 

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. 

CAPA Rule:

System must be able to uniquely identify cases

How does Argus Safety support this rule?

Argus Safety contains the ability to create unique CASE_IDs for the data entered (i.e., separation of CAPA issues from SAE issues or product complaints). You can also configure the case reporting types to include a Quality Issue case type.

Unique-case-IDs-argus-safety-capa

 

To read other posts in our “Argus Safety for CAPAs” series, click here.

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Rodney Lemery

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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