ICH software for compliance in all layers of your operation
Challenge
Bare-minimum cGMP compliance might get you to market - but it doesn't insulate your business from the risk of quality failure.
Regulators are pushing harder than ever for pharmaceutical companies to embrace proactive, continuously improving quality.
ICH guidelines offer a stepping stone to new levels of pharmaceutical quality maturity - but legacy tools and clunky processes make adherence all but impossible.
Solution
Qualio's ICH quality risk management software makes it easy to connect your business to a living, cloud-based pharmaceutical quality system (PQS).
From Q8 QbD to Q9 risk management and Q10 continuous improvement, companies use Qualio to embed lasting ICH adherence that satisfies patients, customers and regulators.
Quality excellence becomes natural and cultural.
ICH compliance software: how it works
Automatic gap analysis for total audit readiness
- Automated gap analysis scans your entire quality system in 30-40 minutes, highlighting every ICH and GMP compliance gap in your organization
- Allocate tasks and automatically gather evidence to get 100% audit-ready in weeks, not months
- Enjoy full ICH inspection confidence with constant monitoring and standard-by-standard compliance health dashboards
Build a vibrant PQS
- Build a fully documented, cloud-based pharmaceutical quality system
- Centralize your entire quality landscape for instant visibility and control
- Enjoy automatic GDocP and ALCOA+ adherence with a controlled digital source of truth
Control your pharmaceutical quality elements with ease
- Manage CAPAs, product risks, OOS investigations, product monitoring and more
- Enforce quality by design with controlled electronic action workflows
- Share and access process and product knowledge quickly and easily
Embed total audit readiness
- Push and track training by company, department, team and individual to plug compliance gaps
- Use powerful in-system analytics to spot trends and address issues early
- Slice audit prep times with AI-powered gap detection and remediation
ICH quality management system resources
ICH Q8 compliance guide
Make quality by design your way of doing things.
ICH Q9 compliance guide
Lock down your pharmaceutical quality risks.
ICH Q10 compliance guide
Construct an industry-leading PQS.
Pharmaceutical quality management software datasheet
Learn how Qualio gives your business everything it needs for natural, long-term ICH adherence.
Don't just take our word for it!
Hear from our many happy 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