You can't fix what your PMS program can't see.
Regulators want evidence that your post-market surveillance program is working, not just complaint logs. Qualio assesses your PMS and pharmacovigilance processes against clause-level FDA, ISO, and GxP requirements, so you always know where your evidence stands.
How it works
Updated guidance? No problem. Qualio automatically maps your evidence to requirements, monitors for regulatory changes, and continuously updates our framework library.
Audit gaps come from evidence that was never assessed against the right requirements. Qualio evaluates your PMS processes and records against both your internal policies and clause-level regulatory frameworks, so nothing falls through.
Know where your evidence stands against every requirement. Most PMS programs check evidence against internal SOPs. Regulators check it against theirs. Qualio assesses both simultaneously, so the gap between your program and their expectations doesn't show up for the first time in an audit.
One place for every post-market signal. Connect complaint records, adverse event logs, and escalation workflows in a single unified system. Understand impact across your QMS without switching tools.
Stay current without manual tracking. Qualio monitors regulatory updates and flags what's relevant to your active frameworks before your next audit cycle so your program adapts when requirements change, not after.
Walk into every surveillance audit prepared. Qualio ties your PMS evidence to clause-level requirements as you work, so there's no scramble to assemble proof when an auditor asks for it.
“CI surfaces gaps automatically. We resolve issues faster and walk into audits with confidence.”
Site Quality Manager, Sentec
“I contacted Qualio in November. We went live mid-December. We had all users in by January. And we had our ISO 13485 certification in July. Without Qualio, we'd never have done that.”
Head of Quality & GxP Compliance, 30 Technology
“Qualio gives everyone a roadmap in this time when we're having to move very quickly. Having that structure for everyone to work within is going to be essential for us to really succeed.”
CEO, EvoEndo
Most QMS tools tell you whether your documents are current. Qualio tells you whether your evidence actually maps to what FDA, ISO, and GxP require and flags the gaps your internal review would miss.
PMS isn't a once-a-year exercise. Qualio runs ongoing assessment across your surveillance program so your compliance posture reflects reality at any given moment, not just when you go looking.
Complaint records, AE logs, PMS reports, SOPs: when these live in separate tools, gaps are inevitable. Qualio centralizes your post-market evidence and quality processes so everything is traceable when it matters.
Get a demo and see how Qualio keeps your post-market surveillance evidence audit-ready without the manual overhead.
