Our Product
PSMF Manager
AI-powered end-to-end solution for Pharmacovigilance System Master File compliance. From version control to automated document generation — everything you need to streamline your PSMF lifecycle.
The Platform
AI-Powered PSMF Management
PSMF Manager is a web-based, fully automated SaaS platform built by PVCON to transform how pharmaceutical companies manage their Pharmacovigilance System Master File. Powered by AI, the platform simplifies complex compliance reviews with transparency and reliability — eliminating manual errors and keeping your PSMF always inspection-ready.
Whether you manage a single local PSMF or coordinate global and local files across multiple regions, PSMF Manager provides real-time coordination, automated change tracking, and instant regulatory-compliant PDF generation — all in one secure, cloud-based platform.
Platform Features
Everything You Need for PSMF Compliance
AI-Driven Compliance Review
Leverage artificial intelligence to simplify complex pharmacovigilance reviews. Our AI engine identifies gaps, suggests improvements, and ensures your PSMF meets all regulatory requirements with transparency and reliability.
Global & Local PSMF Management
Manage global and local PSMF versions from a single platform with real-time coordination. Eliminate redundancies, maintain consistency across regions, and ensure every version is aligned with both corporate and local regulatory requirements.
Full Version History & Audit Trail
Every change is time-stamped and securely logged with comprehensive audit trails. Maintain complete version history that demonstrates regulatory compliance and ensures you are always prepared for inspections.
Automated Tracked Changes
The platform automatically highlights every modification, reducing manual review effort significantly. Your team can instantly see what changed, when, and by whom — streamlining the review and approval process.
External Data Integration
Seamlessly sync with leading pharmacovigilance databases and enterprise systems. PSMF Manager integrates with your existing infrastructure to pull data automatically, eliminating duplicate data entry and reducing human error.
Automated PSMF Document Generation
Generate regulatory-compliant PSMF documents in PDF format instantly with a single click. No more manual formatting or version confusion — the platform produces audit-ready documents that meet EMA, MHRA, and global regulatory standards.
Compliance & Security
Built for Regulatory Excellence
EMA GVP Module II
Full alignment with European Medicines Agency Good Pharmacovigilance Practice requirements.
US FDA 21 CFR Part 11
Compliant with FDA electronic records and electronic signatures regulations.
EU GMP Annex 11
Meets EU Good Manufacturing Practice computerised systems requirements.
GAMP 5
Validated per ISPE GAMP 5 risk-based approach to compliant GxP computerized systems.
Two-Factor Authentication
Robust 2FA with password controls protecting every user session.
SSL/TLS Encryption
All data transmitted via industry-standard encrypted channels.
AWS Cloud Backup
Automatic backup protection on secure AWS cloud infrastructure.
Comprehensive Audit Trails
Every user action logged and traceable for full accountability.
Ready to Transform Your PSMF Management?
Experience the future of PSMF compliance with PVCON's AI-powered platform. Request a demo to see PSMF Manager in action.