SafeVig PSMF
Streamlined Pharmacovigilance System Master File Management
Centralized, automation-enabled PSMF management for compliance, audit-readiness, and cross-team collaboration.
Automated PSMF Document Creation & Updates
- • Preconfigured global-compliant templates (EU, US, Japan)
- • Real-time updates as regulations or data change
- • Eliminates manual errors and accelerates revisions
Comprehensive Section Management
- • Dynamic management of all PSMF sections
- • Centralized documentation of SOPs, workflows, and more
- • Seamless integration of procedural & organizational changes
Audit-Ready & Compliance Assurance
- • Full version control and change tracking
- • Regulatory alignment (EMA, FDA, PMDA, Health Canada)
- • Comprehensive audit trail for 21 CFR Part 11 & EU Directive 2001/83/EC
Integration with PV & Safety Systems
- • Integrates with Argus, Veeva Vault QMS, and more
- • Real-time syncing with safety data and signal updates
- • Ensures PSMF always reflects current system status
Collaboration & Task Management
- • Assign section ownership by team or user
- • Real-time collaboration & change tracking
- • Supports cross-functional workflow and accountability
Real-Time Notifications & Regulatory Alerts
- • Automated update and regulatory reminders
- • Alerts for new guidance or compliance requirements
- • Keeps your PSMF current and audit-ready
Why Choose SafeVig PSMF?
- Increased Efficiency & Time Savings: Automates and accelerates PSMF management—reducing manual workload and turnaround time.
- Improved Compliance & Risk Mitigation: Built-in compliance checks and automated updates reduce inspection risk.
- Streamlined Collaboration: Aligns safety, regulatory, and quality teams with clear accountability.
- Scalability & Flexibility: Configurable for organizations of all sizes and operational complexity.
- Audit-Ready & Transparent: Versioning, logs, and tracking ensure audit-readiness at any time.
- Cost Efficiency: Optimizes resources and cuts compliance costs with intelligent automation.
Enhance Your Pharmacovigilance with SafeVig PSMF
Transform compliance, accuracy, and collaboration in PSMF management—automatically.
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