Manage change
with complete control

Change is inevitable. Airtight control is not.
Drive smart, effective change control that doesn't threaten your business.

Confident, compliant change control



It can be difficult in a manual paper-based quality system to know the downstream impacts of any change.

Suboptimal change control can halt your product development process and introduce unforeseen risks, complications and defects.



Use Qualio to give yourself total command, control and visibility of any change made in your quality landscape.

Drill into incorruptible change histories and audit trails, and drive fully traceable action workflows to manage change properly.

Drive the fundamentals of change control in one place

  • Document, review and approve changes on documents, design controls, quality artifacts and more — all in one system
  • Replace insecure and time-heavy paper and spreadsheet processes with automatic digitized change control and recording
  • Show changes driven by a quality event, like a complaint or audit finding, to your auditors to demonstrate continuous improvement

Full traceability and auditability for every change

  • Whether a change was driven by an event or an expected process improvement, show the what, when, why, and how of any change
  • Ensure everyone is up-to-date on changes with automated notifications, approvals and training workflows
  • Connect your team’s tech stack via API integrations, then run change control on artifacts from those systems directly in Qualio

Make vital changes quicker and more easily

  • Connect your entire quality system and review, document, implement and train colleagues on changes as they occur in real time
  • Export change documents and change logs as required
  • Stay compliant and audit-ready 100% of the time

Change management resources


Quality event software datasheet

See how Qualio Events empowers your business with flexible action workflows to drive change in response to any quality event.

Get my datasheet

Remote quality management webinar

Controlling change remotely across cities, countries and continents is the future of life science quality management. Learn how.

Watch webinar recording

See other features that make Qualio
the #1 top-rated cloud QMS


Document management

Make paper, filing cabinets, folders and spreadsheets a thing of the past.


Design control management

Supercharge your product development from a single source of truth.


Risk management

Detect and mitigate risks and comply with
ISO 14971
and ICH Q9.


Training management

Build a competent, confident, compliant, continuously improving workforce.


Audit management

Make compliance and audit readiness the natural core of your business DNA.


CAPA & NCR management

Build automated response workflows for any quality event.

Don't just take our word for it!

Hear from our many happy customers

"Qualio is a superb eQMS solution for medical devices."
Andrew R.
Director of Tech & Quality, Medbaye
"Qualio is the best QMS cloud-based system I have ever seen."
Paul H.
Senior VP of Ops, Tech & Quality, Advantice Health
"I joined in November 2020. I contacted Qualio 2 weeks later. We went live mid-December. We had all users working in the system by the January. And we had our Stage 2 certification by July.

Without Qualio, we'd never have done that."
Karen H.
Head of Quality & GxP Compliance, 30 Technology
“Qualio has helped make my life as a quality manager very easy.”
Gene V.
Quality Manager, Cirris
"Qualio is flexible and easily adaptable with excellent auditing features."
Tom D.
Quality Engineer, Carestream Health
"I'm wearing about sixteen hats here. So 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 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
“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
"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
"We needed something that was user-friendly, easy to onboard and easy to get up and running. Qualio has surpassed our expectations on those metrics."
Stephana P.
VP of Quality, Alphazyme
"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 impact was immediately felt in terms of version management and training. Qualio simplified things immensely."
Andrew B.
Director of Quality Assurance, VitaCyte
"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

Learn why we're ranked the quality management platform of choice