The project scope: Automate compliance and quality metrics currently tracked and managed by the Compliance and Quality team.

RxLogix COTS products – PV Central and PV Quality will automate a highly manual process, minimize compliance risk, and save months of time it used to take our client to take appropriate corrective and preventive actions (CAPAs). The current process involved transcription of huge dataset from multiple stakeholders (70 countries + many central processing sites) through excel sheets, which leads to potential errors in collation and analyzing the Compliance and Quality parameters of the data.

Also saving months of time it used to take our client to take appropriate corrective and preventive actions (CAPAs), and minimising compliance risk.

RxLogix PV Central & PV Quality will allow our client to:

• Automatically capture, measure, analyze and visualize safety case regulatory compliance and safety case quality metrics.
• Capture, assimilation and analysis of compliance and quality data from multiple data sources.
• Automate the current manual process steps to reduce Turnaround Time and improve data accuracy.
• Provide accurate data to Health Authorities (HA) and Vigilance Alliance partners (VAP).
• Enable trending to predict and minimize compliance risks (data visualizations).
• Real-time compliance and quality monitoring with actionable insights.
• Capture and maintain KPIs, Root Causes (RCs) and CAPAs (Corrective and Preventive Action).
• Data trending and forecasting/prediction capability, along with data visualization.

If you would like to find out how RxLogix can support your own Compliance & Quality requirements, contact the team on info@rxlogix.com