Change management software for your evolving business
Challenge
It can be difficult in a manual paper-based quality system to know the downstream impacts of any change.
Weak change control management can halt your product development process and bring unforeseen risks, complications and defects.
Solution
Qualio’s change management tool gives you total command, control and visibility of any change made in your QMS.
Drill into change histories and audit trails, and drive configurable workflows to manage change properly.
A single change management platform for best-in-class compliance
- Document, review and approve changes on documents, design controls, quality artifacts and more — all from a single change management software system
- Replace insecure and time-heavy paper and spreadsheet processes with automatic 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 our change management software
Collaborate on change control management together
- See linked documents as you make changes, set change approvers, manage updates in bulk, and more
- Export change documents and change logs as required
- Stay compliant and audit-ready 100% of the time
Change management software resources
Change management software datasheet
See how our change management software arms your business with flexible action workflows to control any kind of change
Ultimate guide to
change control
Robust change control sets the great companies apart from the rest. Brush up on everything you should know.
What to know about document control software
How can you find the best tool for managing document change control? Find out with our breakdown blog post.
9 core elements of a quality management system
Learn how change control fits within the modern quality management system by exploring the 9 core elements you should get in place.
See other features that make Qualio
the #1 top-rated change management software system
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.
Training management
Build a competent, confident, compliant, continuously improving workforce.
Supplier management
Control and categorize suppliers and third parties with complete visibility.
Audit management
Make compliance and audit readiness the natural core of your business DNA.
Trusted by 500+ life sciences companies
Hear from our customers
"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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That's unique in this industry."
Becki N.
Quality & Regulatory Lead, Synthego
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Thais S.
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Gene V.
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Dmitry F.
Chief Technology Officer, ViQi
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Without Qualio, we'd never have done that."
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Head of Quality & GxP Compliance, 30 Technology
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Chris R.
QA Associate, AGADA Biosciences
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Phil C.
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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
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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
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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