CHANGE CONTROL

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

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Challenge

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.

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Solution

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
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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
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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
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Change management resources

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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
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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.

Read the guide

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

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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.

Don't just take our word for it!

Hear from our many happy customers

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"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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"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
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“Qualio has helped make my life as a quality manager very easy.”
Gene V.
Quality Manager, Cirris
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"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
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"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
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"Qualio’s become a verb here. When people need things, Qualio is the word that’s used."
Chris R.
QA Associate, AGADA Biosciences
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"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
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"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
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"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
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“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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"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
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"I entered a world with Qualio where quality is no longer a hassle."
Fedora B.
Co-Head of Biopharma Corporate Finance, JMP Securities
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“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
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“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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"Qualio keeps us in a constant state of audit readiness."
Deb G.
Director of Quality, Dimension Therapeutics
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"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
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"A game-changer for a paper-heavy QMS. Qualio is a breath of fresh air."
Gareth Q.
Director of Quality, iMIX
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"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
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"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
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"We passed our MDSAP recertification audit with Qualio!"
John P.
Quality Assurance Manager, KUBTEC Medical Imaging
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"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
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"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
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"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
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“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
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"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
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"I’ve never been more confident in my 27 years of being audited."
Lowell H.
Director of Quality Assurance, Restech
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