Scalable eQMS software
to make quality easy

Trusted quality software to help growing
life science companies in the US 🇺🇸 get to market faster

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.

qualio-eQMS
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 science ecosystem.
Find out how we are the right fit for your company.
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Medical Devices

Streamline a fast, safe pathway to market for your medical device 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 compliance.

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Biotech

Beat the competition with quality-centric products that satisfy regulators, patients and stakeholders.

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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 entire product lifecycle, connecting teams and cutting stress.

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Contract Research Orgs

Deliver a compliant and continuously improving CRO service that delights clients and brings new ones flocking.

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!

Hear from our many happy customers

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"Qualio is the best QMS cloud-based system I have ever seen."
Paul H.
Senior VP of Ops, Tech & Quality, Advantice Health
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"When I recommend Qualio, one of the first things I say is: you're going to be able to get this thing in-house, validated, implemented and live in a short amount of time with limited resources.
That's unique in this industry."
Becki N.
Quality & Regulatory Lead, Synthego
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“Qualio has helped make my life as a quality manager very easy.”
Gene V.
Quality Manager, Cirris
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"I joined in November. I contacted Qualio 2 weeks later. We went live mid-December. We had all users working in the system by January. And we had our ISO 13485 certification by July.

Without Qualio, we'd never have done that."
Karen H.
Head of Quality & GxP Compliance, 30 Technology
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"We’ve been able to show certain clients what we’ve accomplished with Qualio, and they were very impressed.

The VP of Quality for a client company said, "If I could build from the bottom up, I’d do it exactly the way you guys did it"."
Stephana P.
VP of Quality, Alphazyme
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"There are other eQMS providers that are very well-established, but not particularly accessible to organizations that don't have the fundamental basics in place.

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
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"The perfect QMS system for a start-up. Everything, from validation to migration and training, was a positive experience."
Drew M.
Director of Quality, ECM Therapeutics
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"Me getting back hundreds of hours in a year thanks to Qualio is the equivalent of about one FTE. 

Qualio has given us one more staff member in a company where we throw nickels around like manhole covers!"
Mike T.
VP of IT & Information Security, xCures
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“The cost of our Qualio licenses is insignificant compared to what we've saved by just improving our processes.”
Peter B.
Director of QA, Watchmaker Genomics
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"The Qualio team 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
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"Set-up is easy and very user-friendly.  Qualio gets rid of the paperwork. Simple to use, affordable."
Rachel A.
Medical Outreach Specialist, eHealth Technologies
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“We evaluated all players on the market and came up with Qualio as the best balance of price, capability, and quality of support.”
Jeffrey B.
CEO, FifthEye
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“Once you understand how Qualio works, it's really easy to plan out processes and put them into place within the QMS.”
Sara V.
Quality Manager, Leaseir Technologies
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"My favourite thing is how Qualio keeps us in a constant state of audit readiness."
Deb G.
Director of Quality, Dimension Therapeutics
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"Any intelligent person would look at Qualio and say, "This is exactly what a cloud-based system should do". But when you actually see it in action, you still think it's pretty cool."
Andrew L.
CEO, ArcScan
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"A game-changer for a paper-heavy QMS. Qualio is a breath of fresh air."
Gareth Q.
Director of Quality, iMIX
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"I would recommend Qualio to small companies implementing a quality system for the first time. Qualio helped us reduce our workload and our paper trail."
Paul M.
CEO, Arann Healthcare
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"Qualio+ fits right in to ensure a smooth transition to an eQMS. The team offered excellent advice every step of the way."
Chris S.
Quality Manager, CureMetrix
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"The validation documentation provided by Qualio was easy to understand and execute. I really like the in-app support and chat function."
Soni M.
QA/RA Director, NovoSource
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"We passed our MDSAP recertification audit with Qualio!"
John P.
Quality Assurance Manager, KUBTEC Medical Imaging
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"Qualio has been great to work with. We implemented an entire QMS with them! Intuitive functionality, friendly staff."
Kim K.
Executive VP of Operations, VirTrial
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"A big step up for our small company. Much easier than digging through a file repository manually!"
Matt S.
Senior Software Engineer, ArcScan
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"Now that we’re electronic, we can grow to 500 or 1,000 employees.
Since we don’t need to grow the QA team as much, we can put more resources into employees who make us money, like scientists and manufacturing personnel."
Adolfo R.
Director of Information Systems & Data Compliance, IRISYS
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"With other vendors, we felt like just a number.
But this is like a true partnership. Qualio has definitely changed our world."
Eric D.
Director of Quality Assurance, Expression Therapeutics
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Qualio enabled us to seamlessly work through our ISO 13485:2016 requirements and design errors out of our quality management system. One way Qualio achieves this is to ensure that changes flow through our system and are applied globally.
David H.
CEO, Surfatek
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The support Kelly and the team gave us at the beginning was great and we were really leveraging them to build out our QMS from scratch.

It was so streamlined, it was so efficient, they were super helpful and communicative.

That's exactly what we needed - and that's why we went with Qualio.
Heather U.
CEO, EvoEndo
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"Qualio shows we're taking quality seriously and investing in quality improvement initiatives.

We plan to keep growing with Qualio, offering visibility, continuous improvement and knowledge management to our current and potential customers."
Edgar G.
Quality Assurance Specialist, The Dot
SEE QUALIO IN ACTION

Learn why we're the quality
management platform of choice