Qualio

4.5 (124)
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Life science quality software for start-ups and scale-ups

About Qualio

Qualio is a cloud-based quality management software system designed for growing life science start-ups and scale-ups.

Qualio empowers medical device, pharmaceutical, biotech and contract organizations to get to market faster, boost revenue and cut risk. Over 650 companies in 80 countries trust Qualio to embed and automate unshakeable compliance with the demands of GxP, the FDA, ISO standards and more. Qualio unites your teams, processes and data in a single source of truth that supports a culture of quality and makes your business stronger, fitter and more competitive.


Key benefits of Qualio

- Built for medical device, pharmaceutical, biotech and contract research/manufacturing organizations

- Designed for start-ups and scale-ups who need to optimize their quality maturity

- Manage quality documentation, training, CAPAs, deviations, change control, suppliers, medical device design controls and more

- Voted the #1 easiest eQMS to set up and use

- The only eQMS with in-app document editing for total control of your document lifecycle

- Connect your entire business to a single source of quality trust backed by powerful analytics and full audit traceability

- Stay compliant with real-time and detailed insights into documents, people and actions. Monitor content sent for review, approval and training. Track change controls in progress and completed training.

- Create your own templates for documents, forms and records - or access pre-built industry-ready Qualio+ templates for accelerated compliance

- Used by over 650 companies to comply with:
- ISO 9001
- ISO 13485
- ISO 14971
- GxP, from GCP to cGMP and GDocP
- The EU MDR/IVDR
- UK Medical Devices Regulations
- ICH Qx guidelines

And more!


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 - Configure and manage suppliers with ease
Qualio Software - See and track your entire quality landscape
Qualio Software - Control all your medical device's design elements
Qualio Software - All your change control reports in one place
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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 - Configure and manage suppliers with ease
Qualio Software - See and track your entire quality landscape
Qualio Software - Control all your medical device's design elements
Qualio Software - All your change control reports in one place

Not sure about Qualio? Compare with a popular alternative

Starting Price

US$0.00
month
US$20,000.00

Pricing Options

Free version
Free trial
Free version
Free trial

Features

90
30

Integrations

9
1

Ease of Use

4.5 (124)
4.3 (65)

Value for Money

4.5 (124)
4.4 (65)

Customer Service

4.7 (124)
4.8 (65)
Green rating bars show the winning product based on the average rating and number of reviews.

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Reviews

Overall rating

4.5 /5
(124)
Value for Money
4.5/5
Features
4.3/5
Ease of Use
4.5/5
Customer Support Software
4.7/5

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Software buyers need your help! Product reviews help the rest of us make great decisions.

Showing 5 reviews of 124
Verified Reviewer
Overall rating
  • Industry: Biotechnology
  • Company size: 11–50 Employees
  • Used Daily for 2+ years
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 10.0 /10

The perfect system for startups and young organizations

Reviewed on 2019-01-17

Pros

I like the simplicity of the software, and the ease of configuration for the user. If a new document type is needed, it's literally just a few clicks away. I like the intuitive navigation and the ease of adoption by the end users.

Cons

At this time, the only place I can fault Qualio is in the data reporting capabilities. Running basics like how many open/closed NCRs or how many SOPs approved is fine, but without more capability built out, or an external API (like a BI report or crystal intelligence tool), I can't get to more data within records. I do know they are working on this however, and generally at the start up level, you're not yet in need of super detailed reporting within your QMS yet anyway. The basics they provide will more than get you off the ground!

Response from Qualio

An intuitive and simple interface is at the core of Qualio's software, so it's fantastic that you've really benefited from this. Thank you for your feedback on our data reporting capabilities too we are looking to rollout improvements to this functionality soon.

Karl
Overall rating
  • Industry: Pharmaceuticals
  • Company size: 51–200 Employees
  • Used Daily for 1+ year
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 7.0 /10

A Great Quality Management System to get you started.

Reviewed on 2023-08-15

I have been with Qualio for more than a year now and my company have bought into their first...

I have been with Qualio for more than a year now and my company have bought into their first Quality Management System for the first time thanks to Qualios fantastic interface and ease of use. That is the priority for any QMS.

Pros

Qualio has a great user interface for anyone needing to create, edit, review, find and extract documents from a reliable document control system. This experience also spills over to their events module allowing me to personalise an audit and risk functionality that fit the mould of my companies quality journey. The Customer Service both supporting the induction of the platform and the every day query customer service is outstanding and could not compliment them more. The Help features of the platform make it easy for me to find quick assistance on what I need to do and the regular webinars are a blessing for me to understand what is in production to improve my experience with Qualio. Sandbox environment is great and much welcomes to play around before doing something you will regret in the live environment.

Cons

Qualio still have some sticking points with the document creation journey and while they are improving every day, they are still sorely lacking ease with the creation, reviewer and approval experience. Supplier event is also brand new and not quite the finished product yet. But its heading in the right direction.

Alternatives Considered

MasterControl Quality Excellence and ServiceNow

Reasons for Switching to Qualio

Cost and the 'all in one' presentation was a huge reason.
Pam
Overall rating
  • Industry: Medical Devices
  • Company size: 501–1,000 Employees
  • Used Daily for 1+ year
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 8.0 /10

Qualio Implementation

Reviewed on 2024-04-22

It is mainly positive, still early days, it would have been good to have more training and a more...

It is mainly positive, still early days, it would have been good to have more training and a more global presence for Qualio

Pros

Document control, supplier control, CAPA control

Cons

Setting up the system for our use was more complex than expected

Arslan
Overall rating
  • Industry: Medical Devices
  • Company size: 51–200 Employees
  • Used Daily for 1+ year
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 6.0 /10

Customer Support

Reviewed on 2024-04-12

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

Lowell
Overall rating
  • Industry: Medical Devices
  • Company size: 11–50 Employees
  • Used Daily for 1+ year
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 10.0 /10

Customer Questionnaire

Reviewed on 2023-08-08

100% document implementation into Qualio. Internal and third party audits directly from Qualio....

100% document implementation into Qualio. Internal and third party audits directly from Qualio. Complete integration into Qualio for SD team and the sales and marketing team.

Pros

Aesthetically pleasing, Ease of use, ease of support, at a competitive cost. Qualio meets all expectations. Qualio gives us the ability to work remotely. This seems like the norm since Covid but the last few years cannot erase generations of employees being required to be in a brick in mortar location to work. Having our products available throughout the world keeps a little stability during a US economic downturn.

Cons

There is not a well defined way to get feedback to the Qualio team for improvement suggestions. The Qualio has addressed my ideas but there needs to be a ticket system with feedback from the suggestion. This just needs to be addressed as a system. A ticker could be made in Qualio and assigned to the IT department. The idea can be approved or denied. The ticket can be closed. Super simple.

Alternatives Considered

Greenlight Guru

Reasons for Switching to Qualio

Ease of finding documents during an audit. Ease of change control for documents. Creating customizable forms. Reporting features. Assigning and keeping track of training records. Supplier ASL. One dashboard for all assignments.
Showing 5 reviews of 124 Read all reviews

Qualio FAQs

Below are some frequently asked questions for Qualio.

Qualio offers the following pricing plans:

  • Starting from: US$0.00/month
  • Pricing model: Subscription
  • Free Trial: Not Available

Please contact Qualio for pricing details.

Qualio has the following typical customers:

Self Employed, 2–10, 11–50, 51–200

Qualio supports the following languages:

English

Qualio supports the following devices:

Qualio integrates with the following applications:

Asana, Azure DevOps Services, ComplianceWire, Confluence, Jira, Jira Work Management, Okta, TestRail, Xray

Qualio offers the following support options:

Email/Help Desk, FAQs/Forum, Knowledge Base Software, Phone Support, 24/7 (Live rep), Chat

Related categories

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