Audit management software for smarter, calmer audits
Challenge
Internal audits can be burdensome, resource-heavy slogs.
External audits can be stressful nightmares upon which the future of your business rests.
And failing to prepare can lead to fines, penalties or product recalls.
Solution
Qualio gives your team the audit management tool you need for maximum, constant audit readiness.
Access data, prove compliance, demonstrate improvement and respond to findings. Make internal and external audits quick, enjoyable growth drivers - not nail-biting tests.
Be 100% compliant and audit-ready
- Identify gaps and optimize quality performance with a connected audit management system
- Have confidence your QMS is fully compliant with ICH Q10, ISO 9001, ISO 13485, ISO 14971, FDA requirements, and the EU MDR (to name a few!)
- Prove continuous improvement from past audits with organized documents, procedures and automated internal QMS audit schedules and tasks
Save time with automated document and data processes
- Ditch the challenges of paper-based audits with cloud-based quality audit software that makes remote audits simple
- Find all audit artifacts with one click using document templates and tagging
- Build bespoke workflows to assign tasks and automate reminders from one place
Make audit readiness your competitive advantage
- Squash the risk of fines, penalties and product recalls by connecting your audit management program, data and teams to a centralized audit management software platform
- Easily assign QMS audit tasks, manage due dates and track findings to completion - all from a single audit management solution
- Enjoy end-to-end traceability for all CAPAs, non-conformances, and other quality events to demonstrate complete control and visibility to your auditors
Quality management audit resources
Audit readiness checklist
Pinpoint gaps, take targeted action and get your QMS ready for your next audit.
Passing an audit webinar
Hear tips, insight and best practice from a webinar panel of seasoned quality experts.
See other features that make Qualio
the #1 top-rated audit compliance software
Supplier management
Control and categorize suppliers and third parties with complete visibility.
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.
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