Smarter PSMF management with Orbit
Centralized control. Local accountability. Global compliance. Orbit brings structure, accountability, and automation to every step of the process—from global coordination to local compliance.
Centralized PSMF Tracking
A Smarter Way to Manage the PSMF
Managing the Pharmacovigilance System Master File (PSMF) isn’t just about maintaining documentation—it’s about maintaining control. As regulations tighten and global operations expand, the following challenges have become all too common:
The Challenge
The Orbit Solution
Unclear Ownership
Annexes are scattered across teams, with no consistent responsibility.
Role-Based Assignment & Deadline Tracking
Assign clear owners, set deadlines, and automate reminders to keep updates on schedule.
Fragmented Communication
Critical discussions happen in email or get lost entirely.
Integrated Commenting & Review
Collaborate directly on annexes with traceable comments and @mentions.
Affiliate Misalignment
Local teams often work off outdated versions or are unaware of changes.
Affiliate Notifications + Local Version Tracker
Notify affiliates automatically and track alignment status across all regions.
Limited Oversight
QPPVs and global PV leads lack real-time insight into compliance.
QPPV Dashboard + Reporting
Monitor affiliate sign-offs, update status, and performance metrics—all in one place.
Global Notifications
Local workflows, simplified
Orbit provides smart tools to keep local operations informed and compliant. Our built-in workflow guides each local affiliate through the process of reviewing updates and submitting their local adaptations or confirmations. No more chasing emails or wondering who’s done what—just clear progress tracking and auditable submissions.
Instantly notify affiliates when updates are made, complete with a plain-language summary of what’s changed and why.
Affiliates can confirm alignment with the global PSMF or provide justification for any discrepancies. A central dashboard shows alignment status across all markets for quick oversight of global status.
Guide affiliates through a clear, auditable submission and approval process tailored to local needs and global timelines.
PSMF generation
Centralized PSMF Tracking
Track and maintain the PSMF and all its annexes in a single, secure platform. Assign owners and responsible parties to each annex for streamlined updates and full traceability. Automatically compile the annexes into a complete, inspection-ready master file—no manual collation needed.
Document Template Management
Detailed versioning and history
Regulatory Reference Linking
from the blog
From Blind Spots to Full Visibility: Rethinking Oversight in PSMF Management
Why QPPVs and global PV leads need better analytics—and how to get them.
For pharmacovigilance leaders, managing the Pharmacovigilance System Master File (PSMF) isn’t just a documentation exercise—it’s a regulatory responsibility. QPPVs and global PV teams are expected to demonstrate oversight, coordination, and alignment across all annexes and affiliates.
But here’s the reality in many organizations:
- Annex updates live in disconnected folders.
- Affiliate communications happen in email.
- There’s no single dashboard showing who’s updated what—or when.
This fragmented approach doesn’t just slow teams down—it creates serious risk.
Connected trackers
Safety Surveillance
Harmonize BRAT meetings and benefit-risk activities with each product’s signal periodicity
Document Exchange
Distribute periodic benefit-risk evaluations to global partners and affiliates
Ready to Simplify PSMF Management?
Let us show you how easy it can be to stay compliant, aligned, and inspection-ready—across every market you operate in.