Qualio

4.6 (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 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

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Pricing Options

Free version
Free trial
Free version
Free trial

Features

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68

Integrations

8
No integrations found

Ease of Use

4.5 (124)
4.6 (21)

Value for Money

4.5 (124)
4.6 (21)

Customer Service

4.7 (124)
4.7 (21)
Green rating bars show the winning product based on the average rating and number of reviews.

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Reviews

Overall rating

4.6 /5
(124)
Value for Money
4.5/5
Features
4.3/5
Ease of Use
4.5/5
Customer Support
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
  • 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.

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

Overall rating

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

Qualio is the Perfect eQMS - Simple and easy to use

Reviewed on 2023/08/15

Experience overall has been great. Qualio has been super responsive to all questions and issues....

Experience overall has been great. Qualio has been super responsive to all questions and issues. They recognize where problems exist and where improvements can be made. They pay attention to the customer's requirements (needs and wants) and they implement them to improve the functionality and performance of the eQMS' features. Qualio is always working on new things to help facility the end user's IeQMS and remain compliant within the industry.

Pros

The ability to have all documents maintained electronically in one system. I managed a manual QMS for 13+ years...it was manageable, but Qualio made it so much easier! The change control element and the Training module was a huge bonus - especially when this was originally done manually all those years.

Cons

The cumbersome document editor seemed old and outdated and was not easy to use. However, Qualio has made many improvements to the document editor making it much easier to create and edit documents.

Alternatives Considered

Polarion ALM

Reasons for Switching to Qualio

The price was a huge factor as well as the Design module.
Irma
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
  • Likelihood to recommend 5.0 /10

Needs basic improvements

Reviewed on 2022/01/27

Document Management works well

Document Management works well

Pros

Training process works well. The system can generate reports for each employee.

Cons

Change control and periodic review reports need improvement. I cannot generate proper reports that provide visibility of these processes. The change control report is less than acceptable. Please fix this.
I have explained this in the past.

Alternatives Considered

Document Control

Reasons for Switching to Qualio

Price

Response from Qualio

We appreciate your feedback regarding change control and periodic review reports and have provided this to our product team.

Laura
Overall rating
  • Industry: Pharmaceuticals
  • Company size: 201–500 Employees
  • Used Daily for 2+ years
  • Review Source

Overall rating

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

Choose Qualio for your eQMS needs

Reviewed on 2023/08/15

They have been a wonderful partner for over 5 years. I have worked with many QMS and Qualio is by...

They have been a wonderful partner for over 5 years. I have worked with many QMS and Qualio is by far the easiest and most useful system I have ever worked with. A really important fact is that the support team at Qualio is about the best I have seen in the industry. They are responsive, well trained, and understand the criticality of getting you answers and assistance ASAP. Can't say enough about the support team... they are wonderful.

Pros

Qualio is simple to implement, maintain, deploy and use. It has a very straightforward administration and implementation.

Cons

As with any QMS, there are small things that could be improved. The editor is constantly being improved - which is great. One of the things that might have the most impact is if they could tailor it to "manager" users... so managers could see their employees training on procedures... assign documents for training, etc. instead of needing to go through the system administrators.

Barbara
Overall rating
  • Industry: Medical Devices
  • Company size: 51–200 Employees
  • Used Daily for 2+ years
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support
  • Likelihood to recommend 9.0 /10

Qualio as a regulated quality management system

Reviewed on 2022/02/02

Tech support is superior. They listen to suggestions and resolve problems quickly. I fully exercise...

Tech support is superior. They listen to suggestions and resolve problems quickly. I fully exercise the flexibility of the software without having to worry about obsolescence. The help videos and FAQ's are excellent

Pros

The software has flexibility in its use of configurable templates that allows custom formatting of procedures and records, although a basic set of templates is provided if customization is not needed. The audit trails are easily accessible and provide good detail. The Events module allows documenting actions that require staged approvals and tracking progress. Event types can be created and customized. The Dashboard is a quick view of all open tasks. Qualio is constantly improving and expanding their SW features.

Cons

Training metrics are not customizable. There is not a suspended status for people on extended leave, such as for pregnancy. the arrangement to provide limited access to some records could be better designed

Response from Qualio

Thank you for your thorough and excellent review, Barbara! We're happy to hear that our support team and customer resources have been helpful to you. Your feedback on training metrics and access customization has been relayed to our product team.

Showing 5 reviews of 124 Read all reviews

Qualio FAQs

Below are some frequently asked questions for Qualio.

Qualio offers the following pricing plans:

  • Free Trial: Not Available

Please contact Qualio for pricing details.

Qualio has the following typical customers:

11–50, 51–200, 201–500

Qualio supports the following languages:

English

Qualio supports the following devices:

Qualio integrates with the following applications:

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

Qualio offers the following support options:

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

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