Complaint management software tools for long-term market success
Challenge
Getting your drug or device to market is only the beginning. Hundreds of life sciences products are recalled annually, resulting in hundreds of millions of dollars of revenue loss.
Complaints, adverse effects, feedback and continuous improvement opportunities all need to be monitored and acted on.
Disconnected manual tools block your visibility, hide trends, and make a full picture of market performance impossible.
Solution
Qualio's postmarket surveillance and pharmacovigilance software gives your business a connected web of information for snappy, data-driven postmarket activities.
Build market triggers to kick off automated quality management workflows.
Track every quality event and issue by product.
And use detailed analytics to spot and address trends before they become harmful.
Instant integration with your third-party tools
- Connect Qualio to your CRM and ticketing systems, such as Salesforce, Zendesk, Intercom or HubSpot
- Automatically trigger complaint management software workflows in Qualio as postmarket complaints are logged elsewhere
- Drive closed-loop actions to completion to keep your product compliant and your customers happy
Connected quality data to knit your postmarket activity together
- Build, collaborate on and distribute key PMS and pharmacovigilance documents like SOPs, CERs, RMPs and PSURs in a single source of truth
- Connect product data using system links and centralized data points like tickets and customers
- Pull tickets from design tools like Jira and GitHub into Qualio to inform design updates and continuous improvement
Take smarter action for optimal product quality
- Respond to market events in real time with automatic prompts and reminders
- Shape bespoke workflows to collaboratively manage adverse effect investigations, CAPAs, health authority notifications and more
- Pull key data like batch numbers, suppliers, materials and departments into forms and workflow actions for total traceability
Get the product insights you need
- View detailed quality histories by product, from past CAPA actions to design updates, procedural changes and non-conformance records
- Spot product trends and weaknesses early
- Demonstrate total control and traceability to your auditors and inspectors
Postmarket surveillance & pharmacovigilance resources
Understanding post-market surveillance for medical devices
Read our blog post guide to understand the key operational ingredients of modern post-market surveillance activity.
Medtech post-market essentials webinar recording
Catch our webinar recording for an expert-led walkthrough of the key postmarket requirements your medical device company needs to meet
Not just complaint management software...
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