PV Central

PV Central is a pharmacovigilance compliance monitoring platform developed by RxLogix. It is designed for PV teams — including QPPVs, compliance officers, vendor managers, and safety leaders — who need centralized, real-time oversight of submission timelines, SLA performance, and regulatory compliance across affiliates, CROs, and internal teams. The platform supports inspection readiness under FDA, EMA, and other global regulatory frameworks.

Rather than reacting after deadlines are missed, PV Central is built around proactive detection: tracking compliance timelines as they develop, flagging risks before breaches occur, and surfacing delay patterns through automated analytics. The platform claims a 50% reduction in manual compliance workload and 100% traceability from detection to resolution.

Key Compliance Monitoring Capabilities

• Real-time tracking of submission timelines across affiliates, CROs, and internal teams, with no manual data entry required — timelines are captured directly from case workflows and systems of record.
• Proactive alerts and SLA protection: instant notifications when deadlines or service-level agreements are at risk.
• AI-powered predictive insights that flag compliance risks before deadlines are missed and recommend corrective actions.
• Root cause analysis with built-in reason-of-delay tracking, with the platform citing up to 80% reduction in investigation time.
• Automated delay classification that trends delay reasons by vendor, region, or task to identify and prevent recurring bottlenecks.
• Global trend analytics tracking submission performance across affiliates, partners, and health authorities.
• PSMF (PV System Master File) metrics monitoring in real time for global compliance readiness.
• 100% audit traceability from issue detection through to resolution.

Role-Based Dashboards

• Tailored dashboard views for QPPVs, compliance officers, vendor managers, and operations teams.
• Filters by site, case type, and health authority to support targeted oversight.
• Dedicated views for site heads and safety leaders to monitor affiliate and partner performance.
• Inspection-ready architecture with GxP-compliant design to support regulatory confidence.

Workflow: How PV Central Operates

1. Ingest and track compliance timelines by capturing submission data directly from case workflows and systems of record.
2. Predict and prevent compliance breaches using AI-powered alerts that flag risks before deadlines are missed.
3. Analyse trends and remove bottlenecks by identifying recurring delays by vendor, region, or task through intelligent analytics.

Technical Architecture and Integrations

• Real-time API integrations with systems including Argus, Veeva, Salesforce, and Medidata.
• LLM-agnostic AI used for risk forecasting and corrective action recommendations.
• Hybrid and cloud-ready deployment architecture to support scalability.
• GxP-compliant design intended to meet global regulatory inspection standards.

PV Central is part of the broader RxLogix PV SaaS AI Platform, which also includes modules for case management, signal detection, risk management, quality, and clinical pharmacovigilance. It is positioned for use by global pharmaceutical safety teams requiring audit-ready, inspection-prepared compliance infrastructure.