18 years helping British businesses
choose better software

What is Qualio?

Rated #1 easiest and fastest QMS, CAPA, and Compliance software by Medical Device, Pharma, and Biotech organisations.

Hundreds of FDA, ISO, and GxP regulated companies in over 80 countries trust Qualio to bring their quality team, tools, processes, and data together in one easy to manage place.

With industry experts on staff and customer service on call, we partner with you to implement strategy, prepare for audits, and convert manual processes to digital. Get a personalised demo today!

Who Uses Qualio?

Quality-centric life science companies with 11-500 employees, focused on growth, unlocking new markets, and gaining a competitive edge through a culture of quality

Where can Qualio be deployed?

Cloud-based
On-premise

About the vendor

  • Qualio
  • Located in San Francisco, US
  • Founded in 2010

Qualio support

  • Phone Support
  • 24/7 (Live rep)
  • Chat

Countries available

Australia, Austria, Belgium, Canada, Denmark and 19 others

Languages

English

Qualio pricing

Starting Price:

€0.00
  • No free trial
  • No free version

Qualio does not have a free version and does not offer a free trial. Qualio paid version starts at €0.00.

Pricing plans get a free trial

About the vendor

  • Qualio
  • Located in San Francisco, US
  • Founded in 2010

Qualio support

  • Phone Support
  • 24/7 (Live rep)
  • Chat

Countries available

Australia, Austria, Belgium, Canada, Denmark and 19 others

Languages

English

Qualio videos and images

Qualio Software - Automate document and record control
Qualio Software - Effortlessly capture training progress
Qualio Software - Track any kind of quality event to completion
Qualio Software - See and track your entire quality landscape
Qualio Software - Configure and manage suppliers with ease
View 6 more
Qualio video
Qualio Software - Automate document and record control
Qualio Software - Effortlessly capture training progress
Qualio Software - Track any kind of quality event to completion
Qualio Software - See and track your entire quality landscape
Qualio Software - Configure and manage suppliers with ease

Features of Qualio

  • Access Controls/Permissions
  • Alerts/Notifications
  • Approval Workflow
  • Archiving & Retention
  • Assessment Management
  • Audit Management
  • Audit Planning
  • Audit Trail
  • Change Management
  • Change Planning
  • Collaboration Tools
  • Complaint Management
  • Compliance Management
  • Compliance Tracking
  • Corrective and Preventive Actions (CAPA)
  • Customisable Templates
  • Dashboard
  • Document Capture
  • Document Coding & Control
  • Document Management
  • Document Storage
  • Electronic Signature
  • Equipment Management
  • Forms Management
  • Full Text Search
  • Incident Management
  • Inspection Management
  • Maintenance Management
  • Monitoring
  • Nonconformance Tracking
  • Policy Management
  • Quality Control
  • Reporting & Statistics
  • Risk Analysis
  • Risk Assessment
  • Risk Management
  • Root Cause Analysis
  • Search/Filter
  • Task Management
  • Third-Party Integrations
  • Training Management
  • Version Control
  • Workflow Management

Alternatives to Qualio

Top SaaS Online Suite of Applications for Quality Management, DocControl and Training Management.
Cloud-based DMS to help healthcare institutions streamline document authoring, editing, approval, and employee sign-off processes.
*ONLY FOR MEDICAL DEVICE COMPANIES* #1 MedTech QMS Software to ensure ISO/FDA compliance, lower risk and increase speed. Pre-validated. Learn more about Greenlight Guru
Powerful document automation software to gather data that generates your forms and template documents and agreements.
ETQ is the world’s most flexible, powerful & easy-to-use advanced QMS for quality-centric organizations in dozens of industries. Learn more about ETQ Reliance
Interfacing’s EPC ensures full visibility from audit management, CAPA, regulatory training and management of standard operating procedu Learn more about Digital Business Transformation Suite
Trusted since 1992 with over 1.6 million users worldwide. Manage documents, audits, training, NCRs & CAPAs, ISO 9001 compliance & more.
SimplerQMS is a fully-validated and compliant Quality Management Software designed specifically for Life Science companies. Learn more about SimplerQMS
Greenlight is designed to help designers and product managers leave feedback on websites, conduct UX reviews, and track bugs.

Reviews of Qualio

Average score

Overall
4.6
Ease of Use
4.5
Customer Service
4.7
Features
4.3
Value for Money
4.5

Reviews by company size (employees)

  • <50
  • 51-200
  • 201-1,000
  • >1,001

Find reviews by score

5
64%
4
29%
3
6%
2
1%
Mickey
Mickey
Controller in US
Verified LinkedIn User
Biotechnology, 11–50 Employees
Used the Software for: 6-12 months
Reviewer Source

Great Software

5.0 3 years ago

Comments: It is very useful for anyone with or working towards ISO certification. Very audit friendly - would recommend.

Pros:

It is extremely straight forward to use. You can train managers quickly on it and use/adoption rate is very high.

Cons:

It is a bit pricey. However it is more versatile and easier to use than most major software - worth the extra costs.

Alternatives Considered: Greenlight

Reasons for Switching to Qualio: Greenlight also seemed like a great product but the implementation speed and ease of Qualio was out deciding factor.

Qualio Response

3 years ago

Hi Mickey, thank you for your review and we're happy to hear that Qualio has made your audit processes simpler and easier to manage.

Hanifa
Quality Assurance Officer in Kenya
Pharmaceuticals, 51–200 Employees
Used the Software for: 1+ year
Reviewer Source

The solution to management of QMS activities and Events

5.0 10 months ago

Comments: It has been an interesting learning experience and the solution to the tedious manual QMS.
Work is simplified and distributed evenly.
Is a fairly lean system.

Pros:

Qualio has been improving every quarter to satisfy customer needs by incorporating suggestions for improvements made by customers and advancement of the feature available for use as per the current GMP regulations.

Cons:

One has to adapt very fast with the changes to enjoy the benefits. So much good not to miss out on the advantages.

Arslan
QARA Manager in Canada
Medical Devices, 51–200 Employees
Used the Software for: 1+ year
Reviewer Source

Customer Support

3.0 11 months ago

Pros:

Customer Support is Amazing as I used to do regulars meeting with them

Cons:

Not user friendly as my CS team didn't like their complex processes

Jonathan
Quality Assurance Manager in US
Biotechnology, 11–50 Employees
Used the Software for: 2+ years
Reviewer Source

Quality is in it's name and it delivers!

5.0 11 months ago

Comments: I, and the company, have had a good experience with Qualio. Though there have been a few troubled spots we have always been reassured and received the improvements that have fixed issues. We are reassured that the Qualio team is working hard to give its clients the best quality management experience possible.

Pros:

Qualio is a platform that we've seen grow over the years. They are a team that strives to deliver a product that meets the needs of its clients and is continually improving upon past versions to deliver a product and experience that is unobtrusive to workflow at a reasonable cost. Their service team ensures you have what you need, and diligently works to implement needed changes if a feature is not available. It's clean and navigable. I highly recommend it for smaller businesses or startups.

Cons:

We have waited on occasion past a couple of feature releases for much-needed editor and supplier management changes. The review process and audit trail are good, but change control (requesting approval to create drafts, risk assessment features, and tracking changes between versions) are lacking. Sometimes it shows large chunks of text as removed and replaced when only a few changes were made. Sometimes it shows all it's changes in rich text code which is unreadable for most.

Muhammad
GM QA and RA in Australia
Medical Devices, 11–50 Employees
Used the Software for: 2+ years
Reviewer Source

Quality Review

4.0 11 months ago

Comments: Overall, the experience with Qualio is good so far.

Pros:

The best thing about Qualio is that you can customise it according to you own operations. The second-best thing about Qualio is their support team.

Cons:

Document management needs to be improved a bit. Resonance Health has faced a lot of issues when people with access to create drafts created drafts without prior permission and without any need of new document. This hinders the log control in Qualio.