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QT9 QMS vs Qualio

QT9 is built for regulated industries broadly. Qualio is purpose-built for life sciences, with the compliance intelligence, integrations, and expert support your team actually needs to scale with confidence.

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Why Qualio over QT9 QMS

01

Built for all of life sciences

QT9 serves aerospace, automotive, food and beverage, and more. Qualio is built exclusively for life sciences, with pre-configured content packages, event templates, and expert support for the exact regulatory pathways your team needs.

02

Connect your entire ecosystem

QT9's out-of-the-box integrations are limited to Excel and Outlook. Qualio integrates natively with Jira, Salesforce, and your product development stack so your quality system works alongside your team, not in isolation.

03

Always-on compliance intelligence

Qualio delivers continuous compliance intelligence across 20+ FDA, ISO, and GxP frameworks. Cross-mapping across frameworks helps you stay audit-ready and meet regulatory milestones faster.

Compare features & functionality: Qualio vs QT9 QMS

Document management
Training management
Quality event management
Supplier management
Detailed quality analytics
Priced for start-ups and scale-ups
QMS-ERP integration focus
Audit scheduling and execution
Comprehensive integration suite
Designed for life science companies
Design control management
Pharmacovigilance and post-market surveillance
Resource library of cross-referenceable data objects
Lean, modern and easy to use
Configurable event workflows with form and document steps
Audit-tested pre-built life science document templates
Expert life science industry quality/regulatory support
AI automation of key quality tasks
Best practice CSA methodology for rapid validation
Native document building, editing and collaboration
Ranked easiest eQMS to use (G2)
Ranked strongest customer support (G2)
Ranked highest eQMS user satisfaction (G2)
Configurable to scale and evolve with you

Everything your team needs in one place

Qualio brings documents, training, and quality processes into a single connected system so your team spends less time managing tools and more time doing quality work.

One system for documents, training, and compliance

One connected system replaces the patchwork of SharePoint, Excel, and disconnected QMS platforms. Documents are version-controlled and audit-ready, training is automatically assigned based on role and updated when documents change, and everything stays linked and traceable across your quality system.

Qualio document editor with live collaboration

Automated workflows from deviation to corrective action

Qualio routes approvals, assigns tasks, and links every quality event to the corrective action that followed it — all without an email chain. Change control, CAPAs, and deviations run through configurable workflows with e-signatures built in, so nothing falls through the cracks.

Quality events and CAPA workflows in Qualio

Audit-ready documentation, always

Your quality system is monitored continuously, so you're not scrambling before an inspection. Whether it's an FDA audit, a quality system inspection, or EU MDR market entry, your documentation is organized, traceable, and ready when inspectors arrive.

Trusted by teams like yours

There are other eQMS providers that are very well-established, but not particularly accessible. Qualio is not overly complicated. It gives us those foundational aspects of a quality system in a way that people can actually get behind.

Phil C.
Quality Manager, Bond Digital Health

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.

Karen Hue
Head of Quality & GxP Compliance, 30 Technology

Qualio helps me sleep better at night. Having that structure for everyone to work within is essential for us to really succeed this year in getting onto the market and staying compliant.

Heather Underwood
CEO, EvoEndo

Built for life sciences — and the regulations that come with it

Qualio is purpose-built for life sciences companies across medical devices, pharmaceuticals, biotech, cannabis, software as a medical device, and contract research organizations.

FDA 21 CFR Part 11
ICH Q8
EU IVDR
EU MDR
ISO 13485

Connects with the tools your team already uses

Azure AD
Azure AD
Google Suite
Google Suite
Okta
Okta
Jira
Jira
OneDrive
OneDrive