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.
The Problem: Oversight Without Insight
The PSMF is supposed to reflect your current safety system. But if you can’t easily answer questions like:
- Which annexes are overdue for updates?
- Which affiliates haven’t aligned with the latest version?
- Where are the process bottlenecks?
…you’re flying blind.
This lack of visibility doesn’t just hurt efficiency—it makes inspections more stressful, and regulatory findings more likely. At Orbit, we believe that oversight should be built into the system—not added as an afterthought. Our PSMF tracking solution is designed to give QPPVs and global teams real-time insight into the health of their pharmacovigilance system.
QPPV Dashboard: Oversight at a Glance
- View the status of every annex and affiliate in one place
- Monitor who’s signed off, what’s pending, and what’s overdue
- Drill down into details—or zoom out for global trends
Perfect for regulatory reviews, internal audits, or just your Monday morning check-in.
Analytics & Reporting: Turn Data Into Action
- Track update frequency by annex, department, or country
- Identify which teams are consistently late (and why)
- Measure time-to-completion, responsiveness, and alignment rates
This isn’t just nice to have—it’s how continuous improvement happens.
Local Version Alignment Tracker
- Know instantly which affiliates are aligned with the global PSMF
- See which are pending, overdue, or out of sync—and why
- Request justifications or trigger local submission workflows
No more chasing down status updates by email. It’s all in one place.
Why It Matters
Regulators expect you to know your system—not just maintain it. With Orbit, QPPVs and PV leaders can confidently demonstrate oversight, enforce accountability, and drive smarter decisions based on real data.
Ready to See the Whole Picture?
Don’t settle for partial visibility and spreadsheet chaos.
See how Orbit puts you in control of your PSMF—at every level. Contact us info@workinorbit.com
