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.
This guide analyzes how artificial intelligence – including machine learning – can be used by pharmaceutical and medical device companies to improve the clinical data review and cleansing process.
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.