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