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About Qualio

QMS for Medical Devices, Pharma and Biotech. 100% FDA/ISO/GxP compliance. 5x faster Document Control, Training, CAPA, NCRs, Audits and more.

Learn more about Qualio

Pros:

Qualio is very well and highly integrated. There is a relatively short learning curve, then quite intuitive.

Cons:

It is a bit tricky to understand the management of NCRs.

Qualio ratings

Average score

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

Likelihood to recommend

8.5/10

Qualio has an overall rating of 4.5 out 5 stars based on 124 user reviews on Capterra.

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Filter reviews (124)

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 2 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

2 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.

Dexter
Dexter
QA Document Speacialist in US
Verified LinkedIn User
Food Production, 201–500 Employees
Used the Software for: 6-12 months
Reviewer Source

User friendly, sleek eQMS software

4.0 10 months ago

Comments: 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
QA RA in France
Medical Devices, 11–50 Employees
Used the Software for: 6-12 months
Reviewer Source

Decent QMS support system

4.0 2 months ago

Comments: 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
Firmware Engineer in Canada
Medical Devices, 11–50 Employees
Used the Software for: 1+ year
Reviewer Source

Good but could be better

3.0 2 months ago

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
Manager of Islet Product Manufacturing in US
Biotechnology, 11–50 Employees
Used the Software for: 6-12 months
Reviewer Source

Good but could be great

4.0 2 months ago New

Comments: 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).

Klaus
Head of Regulatory in Switzerland
Hospital & Health Care, 11–50 Employees
Used the Software for: 6-12 months
Reviewer Source

Easy to use and integrate with JIRA

5.0 2 months ago

Comments: 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, Confluence and Google Sheets

Reasons for Switching to Qualio: Integration capability with JIRA and dedicated technical and quality templates available

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 2 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.

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 4 weeks ago New

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.

chandini
Clinical data associate in India
Writing & Editing, 51–200 Employees
Used the Software for: 2+ years
Reviewer Source

The best app for using your and reviewing your documents during your work.

5.0 2 months ago

Comments: I must say that its the best and Excellent everyone must OWN.

Pros:

The things i like the most is the interface that the Qualio provides which is very user friendly and easy to access and its development through year is incredible

Cons:

I never saw anything that is troubling me in Qualio till date thats what made me impressed to use this daily at work.

Joel
Quality Manager in US
Food & Beverages, 201–500 Employees
Used the Software for: 1+ year
Reviewer Source

Start up company with Qualio

5.0 2 months ago New

Comments: Overall very happy, but it is my understand there may be some very significant price increases coming our way which could cause us to look at alternate systems

Pros:

*Customer Service *Ease of initial installation *Sandbox feature

Cons:

*Suppliers module *Improvement suggestions not always acted up efficiently

David
Director Quality Assurance and Regulatory Affairs in US
Medical Devices, 51–200 Employees
Used the Software for: 1+ year
Reviewer Source

Qualio as a Quality Management Software

5.0 10 months ago

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.

Alternatives Considered: SAP S/4HANA Cloud, Harrington Quality Management System (HQMS) and Greenlight Guru

Reasons for Choosing Qualio: Compliance problems with current software and poor customer support to make required changes.

Switched From: Harrington Quality Management System (HQMS)

Reasons for Switching to Qualio: Best fit needs of business at the time.

Barbara
Sr Q Mgr in US
Medical Devices, 51–200 Employees
Used the Software for: 2+ years
Reviewer Source

Qualio as a regulated quality management system

5.0 2 years ago

Comments: 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

Qualio Response

2 years ago

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.

Jigar
Quality Auditor in India
Information Technology & Services, 201–500 Employees
Used the Software for: 6-12 months
Reviewer Source

Qualio Review

5.0 10 months ago

Comments: 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.

Drew
Director of Quality in US
Biotechnology, 51–200 Employees
Used the Software for: 2+ years
Reviewer Source

Qualio for Biotech

5.0 9 months ago

Comments: 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.

Robert
Quality in US
Medical Devices, 2–10 Employees
Used the Software for: 2+ years
Reviewer Source

AMM Qualio Review

5.0 10 months ago

Comments: My overall experience with Qualio is good. It has helped our company grow and pass many audits. It also helped us reduce a headcount by serving as a document control solution. Qualio solves our companies Quality Management Software needs and helps us to maintain all of our documents in a controlled system. Qualio also helps us organize our training and events such as CAPA's and NCMR's.

Pros:

The user interface is very good. It is easy to train new people how to use Qualio.The file organization and linking abilities from documents within documents is very good.

Cons:

I do not like how the change control history only limits you to see the last change control. If you want to see previous change control history of older versions of a document you have to create a draft and delete it once you are finished.

Michelle
Production Manager in Canada
Medical Devices, 11–50 Employees
Used the Software for: 1+ year
Reviewer Source

Qualio Review

4.0 10 months ago

Pros:

Qualio is the first cloud-based QMS I've used and it was relatively easy to learn due to its no frills UI. Their platform is updated from time to time which improves the experience (for example, document editing and reviewing has been improved over the past couple years).

Cons:

Perhaps out of scope, but Qualio would be great if it could be linked to some form of inventory management system. For example, in quality events sometimes specific materials need to be identified and currently there is a lot of double-entry in our system (Qualio, then in another spreadsheet or software). Also, there are some minor inconveniences that continue to exist, such as links that go to a superceded document. Perhaps there could be a feature which allows for smart linking to a specific version vs. most current version.

Kim
Quality Specialist in US
Medical Devices, 51–200 Employees
Used the Software for: 2+ years
Reviewer Source

I would choose Qualio every time!

5.0 10 months ago

Comments: 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.

Karthi
Head of Manufacturing in Australia
Medical Devices, 2–10 Employees
Used the Software for: 1+ year
Reviewer Source

A true QMS for the Cloud

4.0 2 years ago

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.

Qualio Response

2 years ago

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.

Jonas
Quality Manager in Norway
Information Technology & Services, 2–10 Employees
Used the Software for: 1+ year
Reviewer Source

Perfect for Medical Device startups

5.0 8 years ago

Comments: Without Qualio we would not have been able to achieve our critical milestone of ISO 13485 certification before the end of 2015. We are now prepared to take the next steps towards compliance with European regulatory requirements and the CE mark.

Pros:

Easy to use with a very intuitive user interface, compliance with CFR 21 part 11, outstanding customer support, swift document navigation

Cons:

Author change does not generate notification for new author which makes multiple authoring somewhat cumbersome. Currently lacks CAPA handling.

Qualio Response

5 years ago

Thank you for your feedback Jonas we're pleased that Qualio was so key in achieving your ISO 13487 certification in such a short timeframe. Our software has since been updated with CAPA-handling capabilities, and we are always utilizing our customer feedback to enhance Qualio's features.

Bastien
Production lead in Canada
Medical Devices, 11–50 Employees
Used the Software for: 6-12 months
Reviewer Source

Qualio for the win !

5.0 2 years ago

Comments: We transitioned from a paper qms to Qualio and we save so much time for archiving, tracking and finding documents !
It is also much more easy and efficient to update documents.

Pros:

Very nice users interface Easy to use contains mostly everything we need for an eQMS review and approval process flows well

Cons:

- it would be nice if the NCR and CAPA module could be linked to in documents (hyperlink) - Currently the comments can only be placed at the end of each document section, however if a section is long it is not the most efficient way to put comment. Comment applicable directly to the text would be ideal.

Qualio Response

2 years ago

Bastien, we love to hear that you were able to successfully transition from paper to Qualio's eQMS! We appreciate the detailed feedback and have passed this along to our product team.

Melanie
CLinical Research Associcate in US
Research, 501–1,000 Employees
Used the Software for: 2+ years
Reviewer Source

Great software for Required Training

5.0 2 years ago

Comments: I use Qualio daily to sign off on required training provided by my employer. It is easy to use and find documents.

Pros:

Qualio is very easy to navigate. The library of stored documents is easy to find. The main tab showing your assigned tasks on the homepage is a nice feature.

Cons:

N/A Very easy to use and find documents in the library.

Richard
Director, Data Analytics in Netherlands
Research, 201–500 Employees
Used the Software for: 1+ year
Reviewer Source

Qualio review by CRO director

4.0 2 years ago

Comments: Overall the system looks good, easy to work with, not completely fulfulling all our needs though.

Pros:

tracking of documents and CAPAs as well as ease of navigation in the system are great.

Cons:

missing a project specific documents training tracker / training sign-off module

Qualio Response

2 years ago

Thanks for your review, Richard! We appreciate and have submitted your feedback to our product team.

jocelyn
Materials Manager in US
Medical Devices, 51–200 Employees
Used the Software for: 1+ year
Reviewer Source

Not efficient to run report

4.0 10 months ago

Comments: Fair

Pros:

It documented all the changes and updates.

Cons:

Can't run report or easy access to report even though the data are in Qualio. Will be great if user can run a table report and export the information into excel sheet.

Caldin
Quality control manager in Kenya
Pharmaceuticals, 51–200 Employees
Used the Software for: 1+ year
Reviewer Source

Best eQMS

5.0 10 months ago

Comments: It's the best eQMS I have used so far

Pros:

The access controls , events segmentation and the audit trail feature.

Cons:

It could be better for each lauch train to have an independent industry centric webinar for trainings

Jessica
Chief Commerical Officer in US
Medical Devices, 2–10 Employees
Used the Software for: 6-12 months
Reviewer Source

Beware, Qualio is not a Turnkey Solution

2.0 10 months ago

Comments: 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.