Quality management software built by regulatory experts
One connected platform to simplify quality management, accelerate regulatory readiness and support your business from your first product to global commercialization.
Aligned with Global Markets, Regulatory Frameworks & Standards
FDA 21 CFR 820FDA 21 CFR Part 11EU MDREU IVDRISO 13485ISO 9001ISO 14971IEC 62304UAE EDE
Why companies choose QraOne
Built for regulated teams
Powerful enough for regulated organizations, designed for growing companies. Get the capabilities you need without the cost and complexity of traditional enterprise eQMS platforms.
Other eQMS
What it means
for you
for you
QraOne
Generic quality softwareDesigned for general use, then adapted for compliance.
Use processes shaped around real QA/RA requirements.
Built by regulatory expertsPractical domain expertise is built into the platform.
Disconnected workflowsDisconnected systems mean more manual work and duplication.
Maintain one source of truth across your quality system.
One connected platformDocuments, training and quality processes work together.
Lengthy implementationsMonths of setup before teams see value.
Go live sooner and reduce disruption for your team.
Quick to get startedGuided onboarding and practical implementation support.
Difficult to scaleRigid systems that become harder to manage as you grow.
Scale users, processes and modules without rebuilding your QMS.
Scales with your businessStart with what you need and expand over time.
Software vendorA transactional relationship focused only on the tool.
Gain a partner invested in your long-term quality and regulatory success.
Long-term quality & regulatory partnerTechnology and expert support as your needs evolve.
