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