The #1 cloud-based quality
management system for life sciences

Qualio’s ready-to-use QMS unites your teams, processes and data in one
place - so you can get to market quickly and scale successfully.

THE QUALIO PLATFORM

Qualio offers a scalable system for your team that is easy to implement and use

Our platform scales across teams and products as your company grows and, unlike paper or spreadsheets, is completely flexible.

Qualio is rated as the #1 “easiest setup” and “easiest to use” of all eQMS reviewed on G2. Our expert team ensures a quick implementation and our intuitive platform is loved by everyone from quality experts to basic users.

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QUALIO+ SERVICES

Have quality and regulatory
experts on your side

Add Qualio+ to your plan and receive expert quality assurance
support to help your business scale, mature and get to market.
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Ready-to-go regulatory content

Access pre-configured templates and documentation for faster and smoother FDA & ISO compliance.

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Quality assurance
experts

Work with our team of seasoned quality experts to ensure you meet - and exceed - your QA goals.

OUR SOFTWARE

Qualio is purpose-built for life sciences

We provide targeted software for the entire life sciences ecosystem.
Find out how we are the right fit for your company.
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Medical Devices

Streamline your medical device product development while ensuring your teams stay compliant.

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Pharmaceutical

Embed industry-leading pharmaceutical quality processes that simplify and unlock FDA, ISO and ICH Q10 compliance.

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Biotech

Connect and centralize your document management, lab investigations, batch records, suppliers and more.

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Cannabis

Earn regulatory trust and position your business for growth with a robust and quality-first approach.

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Software as Medical Device

Unlock end-to-end control of your SaMD product lifecycle, from design controls to risk management.

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Contract Research Orgs

Deliver a compliant and continuously improving CRO service, from R&D to clinical trials and post-market surveillance.

QUALIO INTEGRATIONS

We do the heavy lifting - so you can
focus on what matters most

Qualio integrates with your business-critical applications to let you
automate cross-functional workflows, share data and build a
single source of truth for all your quality information.
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Don't just take our word for it!

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“You can look at an SOP in Qualio, see the list of associated documents, and click hyperlinks to retrieve information immediately. That’s one feature I’m greatly enjoying.”
Tyler C.
Executive Director of Quality, Linical Americas
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“Qualio has helped make my life as a quality manager very easy. For the documentation side, as soon as an auditor comes in and audits, they can see everything in the audit trail. Nothing is missing, nothing can be changed without it being documented - and the auditors think that is so great.”
Gene V.
Quality Manager, Cirris
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“Qualio gives me everything in one place. I can connect or link documents to other documents and keep the traceability of any changes made or decisions made.”
Dragan V.
Software Engineer, Axiom
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“Qualio has made it so much easier to review and edit documents prior to document release. This has improved the quality of our documentation and reduced the amount of time spent on getting documents through our release process.”
User
Medical Device SME
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”I like the very flexible approach that Qualio offers to deal with document types. A document can be anything from an SOP to a HR file to an equipment log. This is very powerful, particularly in combination with the tagging feature.“
Christian S.
Quality Consultant
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“The best thing I like about Qualio is how simply the documents are prepared for easy understanding by anyone who has no knowledge of what they're reading, be it a policy or a basic learning document.”
Sravya D.
Medical Fulfillment Specialist
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"Kelly Stanton and her team, along with our Customer Success Manager Steven Vander Hoek, made a big difference to our company by providing amazing help and guidance at a critical time in our QMS development."
Jackie L.
Managing Director, Auxilio Pharmaceuticals
SEE QUALIO IN ACTION

Learn why we're the quality management platform of choice