PV Monitor®PV Monitor® is a proprietary solution developed, hosted and managed in the FORESIGHT® Cloud to enable compliance with regulatory obligations to proactively monitor ICSR submission compliance to health authorities, track reasons for lateness per submission, perform root cause analysis and then implement corrective and preventive action plans (CAPA). The system also allows license partner agreements to be proactively monitored per partner.
PV Monitor® provides the best practices from our experience implementing compliance monitoring solutions for 7 of the top 10 pharmaceutical companies in the world over the past 14 years. The solution comes pre-configured with the management and compliance tracking reports, scorecards and metrics required for world-wide use by central case processing and affiliates. The hosted version of PV Monitor® has been in production since 2010 and is integrated with Argus SafetyTM with and without DLP, ARISgTM and Oracle AERS.
FeaturesPV Monitor® provides an integrated, world-wide and on-line solution that:
- Automatically calculates process performance information such as the on-time rate for major steps of case processing (collection, processing, and submission) and on-time rate for each organization (affiliates, processing centers, CROs, licensing partners, etc.) facilitating root-cause analysis for late cases
- Automatically calculates the compliance rate for each health authority and licensing partner
- Centrally captures the late reason, responsible organization and corresponding CAPA for each late metric of each case
- Provided the ability to set overrides and tag reports for exclusion to handle exceptions
- Provided a comprehensive set of global compliance reports for affiliates, processing centers, CROs, and license partners
- Provides the ability to create CAPAs on-line to resolve common reasons for lateness
- Provides trending reports to monitor the effectiveness of CAPA activities
- New Features in PV Monitor®
- A configurable management dashboard tab with graphical reports
- An inbox tab to enable users to easily find open tasks
- Role based security
Customers accesses the application via secure internet connection to the FORESIGHT® Cloud.