A fully paperless quality approach
Challenge
38% 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.
Solution
Qualio provides an integrated, cloud-powered and fully digital eQMS 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 resources
-submission-guide.png?width=768&height=576&name=thumbnail-image_complete-510(k)-submission-guide.png){kind=icon}
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.
The case for electronic document management
Learn the 6 key reasons your life science business should embrace an electronic document management system.
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
"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
"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
"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
"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 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
“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
"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
“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
"My favourite thing is how Qualio keeps us in a constant state of audit readiness."
Deb G.
Director of Quality, Dimension Therapeutics
"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
"A game-changer for a paper-heavy QMS. Qualio is a breath of fresh air."
Gareth Q.
Director of Quality, iMIX
"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
"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
"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
"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
"A big step up for our small company. Much easier than digging through a file repository manually!"
Matt S.
Senior Software Engineer, ArcScan
"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
"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
“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
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