Change Control & Management Software — Qualio

CHANGE CONTROL

Change control connected to your entire quality system

Drive effective change control that doesn't slow your business down. Every change is tracked, reviewed, and connected to the documents, training, and CAPAs it affects.

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

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Ultimate guide to change control

Robust change control sets the great companies apart from the rest. Brush up on everything you should know.

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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.

Read the 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.

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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.

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Design control management

Supercharge your product development from a single source of truth.

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Risk management

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

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Training management

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

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Supplier management

Control and categorize suppliers and third parties with complete visibility.

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Audit management

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

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CAPA & NCR management

Build automated response workflows for any quality event.

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Compliance management

Get audit-ready in weeks, stay audit-ready forever.

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Trusted by 500+ life sciences companies

Hear from our customers

“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

"Qualio is the best QMS cloud-based system I have ever seen."

Paul H.

Senior VP of Ops, Tech & Quality, Advantice Health

"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

"We were able to complete a demanding audit thanks to Qualio. The smart links made navigating between processes seamless and easy to understand."

Thais S.

Head of Quality & Regulatory Affairs, Cergenx

“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!"