Risk management software solutions to give your business confidence
Challenge
Risks lurk in every nook and cranny of your business. Pinpointing and tackling every single one is extremely difficult.
And when you do get a risk management system in place, it doesn't always integrate with your product design and development processes - leaving crucial risks undetected and unresolved as you get to market.
Solution
Qualio's risk software embeds risk management into the heart of your product design and development activities.
Total visibility, bespoke action workflows and automated document stack creation removes the effort and headache of risk management and lets you bring a safe, compliant product to your patients and customers.
Detect vulnerabilities across your entire organization
- Build a single source of truth for risk identification, monitoring and remediation
- Save time and money by identifying risks early in product development
- Connect your quality and product teams in a single risk assessment software environment that keeps risk-based thinking front and center
Unlock deep risk visibility with an acceptability matrix
- Define your risk criteria then apply them across a connected risk management software platform
- Link risks to your product development design control and documentation processes to squash risks for a right-first-time approach
- Seamlessly access risk analysis and traceability matrices with one click
Embed ISO 14971 and FMEA
- Use our ISO 14971 software to embed lasting compliance into your medical device design controls
- Show complete FMEA-based risk control to your auditors
- Export risk records and link risks to CAPA plans and Qualio documents
Quality risk management system resources
ISO 13485 risk management plan template
Build a structured medical device risk management plan with our pre-built template.
Mastering risks and opportunities webinar
Build a holistic risk management system that squashes risk and harnesses opportunity.
See other features that make Qualio
the #1 top-rated compliance and risk management software
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.
Change control management
Manage change activity easily and effectively with complete traceability.
Audit management
Make compliance and audit readiness the natural core of your business DNA.
Supplier management
Control and categorize suppliers and third parties with complete visibility.
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
"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!"
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