Rapid, compliant validation
without the headache

A modern, best practice assurance approach that gets you
up and running faster than any other eQMS

Embracing computerized system assurance



eQMS vendors continue to push traditional computerized system validation (CSV) approaches onto their customers.

Fear of regulatory punishment and reliance on outdated documents slow time to value and bog software customers down in stressful, time-consuming, and often unnecessary validation of every single software feature.



Qualio's modern computerized system assurance (CSA) approach does the bulk of the heavy lifting for you, freeing up your time for targeted and 'least burdensome' assurance completion.

Modern, appropriate document templates, a validation pack and a sensible, efficient shared roadmap minimize time and effort.

Less time on admin, more time getting value

  • Go live with Qualio 2 weeks faster than traditional methods
  • Receive assurance templates and automated document packs to accelerate or eliminate tasks
  • Enjoy more time using Qualio, sharpening your quality and focusing on your higher-risk software systems

CSA, not CSV

  • Modern validation approach based on the latest FDA and ISPE GAMP guidelines
  • Designed with minimal customer effort in mind
  • Appropriate, 'least burdensome' activity only!

Ditch old, time-consuming tasks

  • Make IQs, OQs, PQs and onerous system testing a thing of the past
  • Enjoy a fast, efficient assurance approach with no wasted activity or outdated documents
  • Start using Qualio 50% faster than
    any other eQMS

Be confident in your compliance

  • Fully aligns with industry expectations of modern, optimized software validation
  • Reviewed and approved by the editor of GAMP 5
  • Automated re-assurance packs keep you compliant with every new system release

Validation resources


Computerized system compliance guide

Learn why we do what we do by diving into the latest validation guidelines, trends and expectations.

Get my guide

Qualio validation

Dive deeper into how our validation approach works with our summary datasheet, from FAQs and process maps to real customer feedback.

Get my datasheet

3 top benefits of our validation approach


Less time validating

No more testing timesinks.

CSA tasks are weaved into your Qualio onboarding as you build and configure your system, getting you off the starting line quicker.


Sensible, appropriate work

Qualio is a low-risk, non-product system.

Our efficient, risk-based approach takes this into account, leaving you free to focus on your higher-risk systems.


High-touch support

CSA divides responsibilities between system (vendor) and config (customer) assurance.

Qualio provides templates and expert support to help you complete your tasks without fuss.

Don't just take our word for it!

Industry and customer feedback

“Qualio has all the elements of a modern software development quality system.
I was very happy to see those elements: modern processes with modern tools, information held in appropriate systems, the use of continuous monitoring, testing and building."
Sion W.
GAMP 5 editor
“The validation documentation provided by Qualio was easy to understand and execute. It’s easy to get in touch with Qualio’s team with questions or concerns, and the team responds quickly."
Soni M.
Director of QA/RA, NovoSource
"It was super easy. Qualio did all the heavy lifting and we just grabbed the validation package.
We’re in the business of precision oncology. Certainly we need a QMS, but let the experts be the experts. Cut that check and move on!"
Mike T.
VP of IT & Information Security, xCures
“I realized, ‘oh my God, this is fantastic!’ We could configure Qualio within its validated state almost unlimitedly.
I realized I could set up any process flow that matches us, rather than having to adapt to a system. The flexibility has been mind-boggling."
Michael H.
Quality Assurance Director, TriMed
"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

Ask us about our industry-leading validation approach