About Qualio

Qualio is a cloud-based quality management software system designed for quality-centric 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.
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 video
Qualio Software - Automate document and record control - thumbnail
Qualio Software - Effortlessly capture training progress - thumbnail
Qualio Software - Track any kind of quality event to completion - thumbnail
Qualio Software - Configure and manage suppliers with ease - thumbnail
Qualio Software - See and track your entire quality landscape - thumbnail

Qualio pricing

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

Starting Price:
Free Version:
No
Free trial:
No

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Browse Qualio Reviews

124 of 124 reviews
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Dexter
Dexter
  • Industry: Food Production
  • Company size: 201–500 Employees
  • Used Daily for 6-12 months
  • Review Source
Value for Money
3
Functionality
4
Ease of Use
5
Customer Support
5

4
Reviewed on 03/08/2023

User friendly, sleek eQMS software

The implementation and support team from Qualio are knowledgeable, courteous and extremely helpful with the onboarding and implementation process making for a very smooth transition.The support team is also very responsive and open to suggestions for changes to the software, and software versions are implemented quickly and efficiently to improve based on customer feedback and needs.

Pros

The software is very intuitive and easy to use. We have little to no issues with implementation and understanding of how the system functions and documents/revisions move through the established workflows. New employees and users are onboarded into the program with relative ease.

Cons

The pricing and user license tiers/packages could use a bit of rethinking. It would be nice if Basic users (which are essentially read-only with access to Training and the Document Library only) did not take up a license from our annual subscription.Preferably, would like the user packages to be paid for only the Quality/Normal users that are actually creating and revising documents, or working on CAPAs, Nonconformances, Supplier Approval features, while Basic (read-only) users are able to login and view approved, effective documents for training purposes only without taking up a user license since they don't have access to the rest of the software's features.Other eQMS software and programs will have a separate training portal that can be accessed by any basic users without impacting the user licenses taken up.

Alternatives Considered

MasterControl Quality Excellence and QT9 QMS

Reasons for Switching to Qualio

Ease of use and features available for implementation.
Melissa
  • Industry: Medical Devices
  • Company size: 11–50 Employees
  • Used Daily for 6-12 months
  • Review Source
Value for Money
0
Functionality
4
Ease of Use
3
Customer Support
5

4
Reviewed on 12/04/2024

Decent QMS support system

Overall I'm satisfied with the product but I don't love it enough to recommend strongly. It's getting the job done, but I feel like that's with a number of (minor) workarounds. However, based on the experience in the last 9 months, I do expect it to continue to improve.

Pros

I appreciate that all of the main functionalities (document management, CAPA, Complaint, Supplier Management, etc.) are available in the system. The referencing between events and between documents works very well. It's also reasonably easy to customize templates and certain workflows. I also appreciate that they are regularly improving the system and that there is good attention on providing supporting validation documentation.

Cons

There are certain features that should have more control such as the implementation of new Event templates. This can be a major change to the quality system and essentially there is no workflow around it. Anyone with the access level can make the change with no review or approval. The formatting of documents is sometimes also very inconsistent and difficult to use. The final complaint is the inability to migrate from the sandbox to the production instance.

Hady
  • Industry: Medical Devices
  • Company size: 11–50 Employees
  • Used Daily for 1+ year
  • Review Source
Value for Money
4
Functionality
4
Ease of Use
3
Customer Support
5

3
Reviewed on 12/04/2024

Good but could be better

Pros

Document control and revision workflows are intuitive and easy to use. The application is all on the web which makes it portable. No required desktop software or storage.

Cons

- Collaborators on the same document would be a huge win.
- The editor usually does not utilize the full width of the browser. Makes editing difficult in some cases.
- NO DARK MODE. This is by far my most requested feature. There is lots of documentation needed in the medical devices work and I dread the those days if I need to work on qualio. I've used chrome extensions to get around it but nothing will work as nicely as a native solution. Please introduce dark mode for your fellow software developers that have to work on qualio for days at a time.
- Page timeout can also be frustrating when working on a couple of documents in parallel through the day. I've noticed at least that when I re-login, I land on the page I was originally working on, but that hasn't been consistent.
- Cannot exit an attachment preview unless scrolling to the top of the window and pressing the X. That can be frustrating when viewing multiple page word or PDFs. Most of the time I end up downloading the attachment to preview just so I don't have to scroll all the way up to close it :)

Ben
  • Industry: Biotechnology
  • Company size: 11–50 Employees
  • Used Daily for 6-12 months
  • Review Source
Value for Money
5
Functionality
3
Ease of Use
4
Customer Support
5

4
Reviewed on 26/04/2024

Good but could be great

I'd rate Qualio an B+ to A-. It would be a perfect A if the word processor built into the program was a little more user friendly when it comes to formatting things like Worksheets.

Pros

Super easy to use (with one exception which I'll describe below). Great at reminding me of tasks that need completion. Easy for people to pick up with a little instruction. Onboarding was easy.

Cons

The word processing portion is often frustrating. It is designed for ease of use, but coming from Microsoft word, Qualio's word processing unit is lacking in a few things. First, the toolbar is minimal. I'd like more tools when I'm formatting. Second, the formatting in the online word processing is atrocious. I have to constantly export the documents to ensure the worksheets I make aren't broken up between pages (I suggest some sort of preview of page alignment, so that I don't constantly have to DL a PDF when I'm formatting Worksheets).

Jennifer
  • Industry: Medical Devices
  • Company size: 2–10 Employees
  • Used Daily for 1+ year
  • Review Source
Value for Money
5
Functionality
5
Ease of Use
5
Customer Support
5

5
Reviewed on 20/03/2024

Great Experience

Pros

I love using Qualio because it is very user friendly and the system has a modern feel to it. Qualio is constantly making improvements to the system making it more efficient. They are super responsive when it comes to new inquiries for product enhancements or general support questions.

Cons

At the moment we have not experienced any major issues with Qualio.

Alternatives Considered

Greenlight Guru

Reasons for Switching to Qualio

Qualio had a better user interface, customer service, and ease of use.
Karl
  • Industry: Pharmaceuticals
  • Company size: 51–200 Employees
  • Used Daily for 1+ year
  • Review Source
Value for Money
4
Functionality
4
Ease of Use
5
Customer Support
5

5
Reviewed on 15/08/2023

A Great Quality Management System to get you started.

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.
Lowell
  • Industry: Medical Devices
  • Company size: 11–50 Employees
  • Used Daily for 1+ year
  • Review Source
Value for Money
5
Functionality
4
Ease of Use
5
Customer Support
4

5
Reviewed on 08/08/2023

Customer Questionnaire

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.
Klaus
  • Industry: Hospital & Health Care
  • Company size: 11–50 Employees
  • Used Daily for 6-12 months
  • Review Source
Value for Money
4
Functionality
4
Ease of Use
5
Customer Support
5

5
Reviewed on 12/04/2024

Easy to use and integrate with JIRA

Overall have met most of their promises and our expectations

Pros

Integration options, easue of Use, flexibility of system, good customer support

Cons

should provide more consukting when needed by client, also the cost to run the system forward is quite high

Alternatives Considered

Greenlight Guru and Confluence

Reasons for Switching to Qualio

Integration capability with JIRA and dedicated technical and quality templates available
Savneet
  • Industry: Cosmetics
  • Company size: 51–200 Employees
  • Used Daily for 6-12 months
  • Review Source
Value for Money
4
Functionality
3
Ease of Use
5
Customer Support
5

5
Reviewed on 08/08/2023

Qualio set up and execution

Training has become much easier.

Pros

User Friendly, Team that helps you onboard and provides help along the way is amazing!! Having access to Quality specialist is a big plus and both the onboarding manager and Quality specialist have been knowledgeable, patient and great. Feedback is taken positively and shared with internal teams.

Cons

Complaints module - having editable udf's (feedback shared with Qualio team). Document collaboration could be improved. Tag- ability to type in a tag instead of selecting from a drop-down list. Categorizing tags in the drop-down Template- linking a template in documents. Sending a template for review prior to approval Forms- Revision control. Stamping a form with the form number automatically instead of a manual addition.

Alternatives Considered

QT9 QMS

Reasons for Switching to Qualio

Access to Qualio Quality staff and user-friendly system
Neil
  • Industry: Medical Devices
  • Company size: 11–50 Employees
  • Used Daily for 1+ year
  • Review Source
Value for Money
4
Functionality
4
Ease of Use
5
Customer Support
5

5
Reviewed on 08/08/2023

Easy to use eQMS

Qualio has made our document management must simpler and easier to access. At our most recent audit, the auditor commented how much better structured our technical files were now that we had switched to Qualio

Pros

We've found Qualio is easy and intuitive for non-expert users to work with. Moving our most common forms directly into Qualio has cut out a lot of minor errors which in turn saves QA a lot of time.

Cons

It took us a bit of time to get our training set up properly although that was partly because we weren't clear what our aims were. When we first started the timings and content of updates was somewhat confusing, however the new system of planned and notified release schedules has made this much simpler and easier for users

Alternatives Considered

SimplerQMS

Reasons for Switching to Qualio

Ease of use for infrequent users, ease of implementation
David
  • Industry: Medical Devices
  • Company size: 51–200 Employees
  • Used Daily for 1+ year
  • Review Source
Value for Money
5
Functionality
5
Ease of Use
5
Customer Support
5

5
Reviewed on 03/08/2023

Qualio as a Quality Management Software

Pros

User interface and scalability/adaptability to business needs

Cons

Inability to lock values and text fields in Events and documents. Inability to run reports, or export data for tracking/reporting outside of Qualio. Interface with other data sets.

Reasons for Choosing Qualio

Compliance problems with current software and poor customer support to make required changes.

Reasons for Switching to Qualio

Best fit needs of business at the time.
Kim
  • Industry: Medical Devices
  • Company size: 51–200 Employees
  • Used Daily for 2+ years
  • Review Source
Value for Money
5
Functionality
3
Ease of Use
5
Customer Support
5

5
Reviewed on 03/08/2023

I would choose Qualio every time!

The speed of being able to receive comments or suggestions within the change control process has made the process of getting documents and events approved much more quickly and efficiently.

Pros

I like that it is easy to use and understand. The training documents and virtual assistance has been extremely useful in teaching new staff how to use the program.

Cons

The formatting capability of documents and information contained in events.

Drew
  • Industry: Biotechnology
  • Company size: 51–200 Employees
  • Used Daily for 2+ years
  • Review Source
Value for Money
5
Functionality
5
Ease of Use
5
Customer Support
5

5
Reviewed on 31/08/2023

Qualio for Biotech

Qualio is an affordable option that includes all of the features you would want to see in an electronic quality management system.

Pros

Qualio provides a seamless transition from the first inquiry to the product handover. Qualio is easy to use and implement which was the most important thing when selecting a system to use at my company. I needed to ensure that employees are comfortable using a system and focusing on creating documentation and other items and not worrying about how to use the software.

Cons

As with any system there are always features that you wish existed. However, Qualio does a great job at accepting ideas and implementing them over time.

Jigar
  • Industry: Information Technology & Services
  • Company size: 201–500 Employees
  • Used Daily for 6-12 months
  • Review Source
Value for Money
5
Functionality
5
Ease of Use
5
Customer Support
5

5
Reviewed on 07/08/2023

Qualio Review

Yeah, it is good to use, good to show someone your documentation and completes the process flow with respect to the features and configurations.

Pros

It is the best document management system which consist of whatever things you required with respect to ISO standards and as well as the company standards. It can be configurable. Best interface, controlled documentation, easy to use and to show external parties.

Cons

There are no such thing that i dislike, but some sort of feature incorporation while releasing a patch or full release can be taken as feedback from current users so that the new feature or full release can contains the things which are mostly required by the end users.

Salvador
  • Industry: Pharmaceuticals
  • Company size: 501–1,000 Employees
  • Used Monthly for 6-12 months
  • Review Source
Value for Money
0
Functionality
4
Ease of Use
4
Customer Support
0

4
Reviewed on 15/04/2024

Reviewing Qualio

Pros

I think Qualio is a good tool to improve the training of the company's staff.

Cons

I think Qualio could be more visually appealing.

TAYDIS
  • Industry: Medical Devices
  • Company size: 51–200 Employees
  • Used Daily for 6-12 months
  • Review Source
Value for Money
0
Functionality
5
Ease of Use
5
Customer Support
0

5
Reviewed on 17/04/2024

Easy to use

Pros

User friendly.
Training, electronic signatures.

Cons

Good experience so far. I like everything about Qualio.

Luke
  • Industry: Biotechnology
  • Company size: 2–10 Employees
  • Used Weekly for 1+ year
  • Review Source
Value for Money
4
Functionality
5
Ease of Use
5
Customer Support
0

5
Reviewed on 08/08/2023

A User-friendly and Efficient System

Pros

Qualio is extremely easy to use, with a streamlined interface that ancitipates the user's needs. In doing this, it streamlines the time required to create, edit, and access documentation in a secure way, and does not require a large amount of training or time to get used to.

Cons

Small cosmetic and quality of life improvements are needed in specific areas, yet they are the exception to the rule in most cases and do not seriously impact the system's value.

Bonnie
  • Industry: Medical Devices
  • Company size: 51–200 Employees
  • Used Daily for 6-12 months
  • Review Source
Value for Money
5
Functionality
4
Ease of Use
3
Customer Support
5

4
Reviewed on 03/08/2023

Qualio review

Our company loves that the training of our entire company Nationwide can train all at once without having to use a separate program

Pros

Getting used to this system was a challenge. But once I learned to navigate it became quite easy. I love that this program works as Quality should and is always improving.

Cons

The fact that I can not archive and retrieve expired supplier documents

Sasiporn
  • Industry: Research
  • Company size: 11–50 Employees
  • Used Daily for 1+ year
  • Review Source
Value for Money
5
Functionality
5
Ease of Use
5
Customer Support
5

5
Reviewed on 12/08/2023

Always support, continuous improvement and system is really easy to use

Pros

flexible, able to customize as per company's requirments.

Cons

document editable format is still have some limit function

Jessica
  • Industry: Medical Devices
  • Company size: 2–10 Employees
  • Used Daily for 6-12 months
  • Review Source
Value for Money
2
Functionality
2
Ease of Use
2
Customer Support
2

2
Reviewed on 03/08/2023

Beware, Qualio is not a Turnkey Solution

The drafted documents and form templates make starting easier, but they must be tailored to the company's needs, which requires a quality person. Plus, just having the documents does not create a quality system. Please don't be fooled by the pitch that Qualio is a turnkey solution. Be aware that Qualio will not let you out of your contracted commitment.

Cons

It is not easy to create QMS with the documents alone.

Peggy
  • Industry: Biotechnology
  • Company size: 11–50 Employees
  • Used Weekly for 1+ year
  • Review Source
Value for Money
4
Functionality
4
Ease of Use
4
Customer Support
5

5
Reviewed on 14/08/2023

User

Pros

The plamform is simple. It can be sorted and search by keyword. Any new training, it will release letter to inform users.

Cons

1) Training vedio can not be watched in the platform.2) CAPA creation is make by special users. When I use VeevaVault before, it can be created by any users.3) For almorst due training, I do not see the reminder letters. (maybe I missed them.)

Barbara
  • Industry: Medical Devices
  • Company size: 51–200 Employees
  • Used Daily for 2+ years
  • Review Source
Value for Money
5
Functionality
4
Ease of Use
4
Customer Support
5

5
Reviewed on 02/02/2022

Qualio as a regulated quality management system

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.

Replied 14/02/2022
Karthi
  • Industry: Medical Devices
  • Company size: 2–10 Employees
  • Used Daily for 1+ year
  • Review Source
Value for Money
0
Functionality
5
Ease of Use
4
Customer Support
3

4
Reviewed on 08/02/2022

A true QMS for the Cloud

Pros

The level of learning required to understand Qualio is very light and I have noted that new staff learn how to use it very quickly. Being able to access the software over a browser is powerful without requiring special installations and access installed and setup on a PC.

Cons

It is not easy or flexible to create a document in Qualio. I still find myself reaching for Microsoft Word for the first draft of a document as I am familiar with page setup options, formatting and layout in that application. Qualio is useable but highly annoying to use.

Response from Qualio

Hi Karthi, thank you for your review. We're happy to hear of your team's smooth onboarding process and have shared feedback regarding documentation with our product team.

Replied 15/02/2022
Donna Lee
  • Industry: Medical Devices
  • Company size: 51–200 Employees
  • Used Daily for 2+ years
  • Review Source
Value for Money
0
Functionality
2
Ease of Use
4
Customer Support
0

4
Reviewed on 08/02/2022

Medical Device/Pharma CRO

Pros

This software is easy to use, intuitive, and straight forward. the search functions work well. The dash board is comprehensive and is critical is assessing status of activities.

Cons

The inability for a manger (such as myself) to have visibility to my direct reports training status as well as the status of other assigned activities for items that I have to manage. Our Quality group has full access but there is no intermediate option to control access to certain areas while allowing operational managers to be able to manage applicable information. So I have to resort to asking QA "where is this SOP in the approval process" , "who's training is outstanding", or " who started the draft version for a SOP?" etc. Since we are so restricted, it hurts work flow. Another layer, just below full access, to allow us to manage our over arching responsibilities, would be helpful.

Response from Qualio

Hi Donna, thanks so much for your detailed review and insightful feedback regarding access control. This feature is in progress and we've relayed these details to our product team.

Replied 15/02/2022
Peter
  • Industry: Pharmaceuticals
  • Company size: 11–50 Employees
  • Used Daily for 1-5 months
  • Review Source
Value for Money
5
Functionality
4
Ease of Use
5
Customer Support
5

5
Reviewed on 27/01/2022

Qualio at Arovella Therapeutics

Pros

The modularised way that Qualio prepares templates really helped with the transition of our exiting documentation. I like how it uses tags to categorise specific document groups which can then be set for specific job roles. I also like the training options and overview.

Cons

There are some font and text options that could be improved.

Response from Qualio

We are happy to hear that you were able to smoothly transition existing documentation with Qualio! Thank you for your feedback.

Replied 02/02/2022
124 reviews

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