Maximum control and efficiency with paperless QMS software

Cut the clutter, chaos and compliance complications.
Unlock a 100% paperless QMS that empowers your business.

A fully paperless QMS approach



42% of life science businesses still rely entirely on paper for their quality efforts.

Paper-based quality systems slow work, block visibility and breed risk.

From document version control to proving competence and tracing actions, your paper QMS quickly breaks down in the face of regulatory scrutiny and holds your business back from its true potential.



Qualio provides an integrated, cloud-powered and fully digital paperless QMS software system that makes paper a thing of the past.

Electronic documents, records, workflows and e-signatures embed complete control and visibility into the heart of your quality system.

Actions accelerate, compliance strengthens, insights sharpen, and quality becomes an agile tool for continuous improvement.

A single source of truth at your fingertips

  • Get back the 30 minutes each of your colleagues spends every single day looking for paper documents
  • See your entire quality landscape from a single cloud-based repository
  • Handle documents, training records, event workflows, suppliers and design controls with ease and without duplication

Lift the lid on growth

  • Replace paper admin time with value-add time
  • Build a culture of quality underpinned by real-time digital data
  • Redirect the time, energy and clutter of a paper system into agile, connected work

Cut costs

  • Jettison hard document production, usage and storage costs (AIIM estimate: $25,000 a year minimum!)
  • Get to market and generate revenue quicker with accelerated, digitized processes
  • Make your QMS leaner, sharper and less labor-intensive

Get confidence and control

  • Make GDocP, version control and ALCOA+ effortless and automatic
  • Be prepared for any audit - without the filing cabinet stress
  • Replace desk-to-desk wet signatures with cloud-based, fully compliant e-signatures

Keep up with industry expectations

  • Align with the digital best practice in the FDA's Case for Quality and QMM programs
  • Answer regulatory demands for optimal, digital quality management
  • Prove your business is a modern, quality-centric operation

Paperless QMS resources


Qualio vs. paper: functional comparison

Access a comprehensive comparison of our software versus a paper-based QMS, from costs and processes to scalability and usage.

Visit comparison page

The case for electronic document management

Learn the 6 key reasons your life science business should embrace an electronic document management system.

Get my whitepaper


Don't just take our word for it!

Hear from our many happy customers

"Qualio is the best QMS cloud-based system I have ever seen."
Paul H.
Senior VP of Ops, Tech & Quality, Advantice Health
"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
“Qualio has helped make my life as a quality manager very easy.”
Gene V.
Quality Manager, Cirris
"We looked a lot at how Qualio worked, its user interface, and the technology behind it. It was by far the freshest, most logical eQMS system out there."
Dmitry F.
Chief Technology Officer, ViQi
"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."
Karen H.
Head of Quality & GxP Compliance, 30 Technology
"Qualio’s become a verb here. When people need things, Qualio is the word that’s used."
Chris R.
QA Associate, AGADA Biosciences
"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
"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
"Me getting back hundreds of hours in a year thanks to Qualio is the equivalent of an 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
“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
"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
"I entered a world with Qualio where quality is no longer a hassle."
Fedora B.
Co-Head of Biopharma Corporate Finance, JMP Securities
“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
“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
"Qualio keeps us in a constant state of audit readiness."
Deb G.
Director of Quality, Dimension Therapeutics
"Qualio is far superior to other
systems I've worked with in the past.
The flexibility has been mind-boggling."
Michael H.
QA Director, TriMed
"A game-changer for a paper-heavy QMS. Qualio is a breath of fresh air."
Gareth Q.
Director of Quality, iMIX
"Document control took anywhere from 5 hours to 3 days. Now things get done in hours, even minutes. I can send training out in seconds now. Qualio has made my life 100% better!"
Angela P.
QA Manager, Akadeum Life Sciences
"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 U.
CEO, EvoEndo
"We passed our MDSAP recertification audit with Qualio!"
John P.
Quality Assurance Manager, KUBTEC Medical Imaging
"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
"I feel 100% ready in our 510(k) and ISO 13485 preparations.
Qualio let us bring quality in-house in a way that will make us successful."
Hilary B.
VP of Regulatory & Quality, SimBioSys
"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
“We’re building a quality product. So we bought a tool that gives us a quality culture. Instead of pushing
quality to one department, Qualio breaks down that barrier.
Daniel A.
Chief Technology Officer, InVivo Bionics
"When you're using paper, you're not moving forward. You can't.
Now we're so streamlined, we're finally making progress. We're talking about bringing a new product into design controls right now.
I don't think that'd be possible if we didn't have Qualio."
Ami A.
Director of Ops & Quality Management, NeuFit
"I’ve never been more confident in my 27 years of being audited."
Lowell H.
Director of Quality Assurance, Restech

See how Qualio blows your paper QMS away