Cloud PV Revolution: How a Pharma Leader Transformed Safety Compliance with PvEdge®

About Client

A global pharmaceutical manufacturer operating from Greece, handling drug and device safety compliance for multiple regulatory regions. The organisation had a legacy on-premise PV system, which posed major hurdles in scalability, agility, and compliance efficiency. 

Hassel

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Cumbersome Upgrades

Cumbersome Upgrades

Every version update, customisation, or regulatory patch required on-site deployment, making upgrades time-consuming and costly.

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Regulatory Readiness Delays

Implementation of new regulatory features (like USFDA R3 compliance) involved manual testing and a delayed rollout.

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High Operational Overhead

High Operational Overhead

On-premise model meant constant coordination between teams for validation, support, and change management.

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Manual Reporting and Submission Gaps

Lack of automation in report generation and acknowledgements increased the chances of errors and missed deadlines.

Tackling the Challenges

cloud-service

Cloud-Ready Migration

Migrated to PvEdge® Build 8.05.00 – a cloud-ready system allowing remote updates, customisations, and faster deployment of new guidelines.

Smart automation

Smart Automation in Reporting

Features like auto-acknowledgement, enhanced XML validation, and dynamic filters drastically reduced manual dependencies.

Data integrity

Enhanced Data Integrity

Submission compliance reporting now includes Super User cases, ensuring 100% traceability and visibility.

workflow

Workflow Optimisation

Dynamic workflow and bulk action tools accelerated case processing by auto-skipping steps based on seriousness and allowing batch operations.

Transformation Business Impact

  • Zero On-Site Deployments: Cloud-based platform now enables remote upgrades, eliminating travel and downtime.
  • Faster Compliance Readiness: New regulatory features like USFDA R3 support are deployed in record time.
  • Effortless Report Generation: Submission, CIOMS, MedWatch, and PADER reports are now auto-sent and pre-validated.
  • Time Saved on Case Processing: Auto-populated fields, filters, and causality reduce turnaround time significantly.
  • Improved Audit Outcomes: Every action logged and tracked, aiding in smoother audits and inspections.

About PvEdge® - A Trusted Pharmacovigilance Software

PvEdge® is an advanced AI-enabled, cloud-ready and trusted pharmacovigilance software for safety database management. PvEdge® helps companies manage safety data and stay compliant with regulations. The platform makes tasks like data migration and reporting easier with its simple interface and useful analytics. By connecting different systems, PvEdge® allows organizations to work more efficiently and accurately. With a focus on improving productivity, it helps pharmaceutical companies overcome challenges and remain competitive. 
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