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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 4.6 out 5 stars based on 123 user reviews on Capterra.

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Filter reviews (123)

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.

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 last year

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.

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 5 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 :)

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 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.

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 5 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.

Karl
Quality and Compliance Director in UK
Pharmaceuticals, 51–200 Employees
Used the Software for: 1+ year
Reviewer Source

A Great Quality Management System to get you started.

5.0 last year

Comments: 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
Director, Quality Assurance in US
Medical Devices, 11–50 Employees
Used the Software for: 1+ year
Reviewer Source

Customer Questionnaire

5.0 last year

Comments: 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.

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 5 months ago

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).

Jennifer
Regulatory Affairs Representative in US
Medical Devices, 2–10 Employees
Used the Software for: 1+ year
Reviewer Source

Great Experience

5.0 6 months ago

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.

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 5 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

jared
Director, Strategic Projects in US
Medical Devices, 501–1,000 Employees
Used the Software for: 1+ year
Reviewer Source

Excellent people supporting an excellent product

5.0 3 years ago

Comments: Our Design Control process is much tighter. Document Control requires less time and effort. We have elevated our Risk Management game. Our Quality people are happier using such a well integrated tool.

Pros:

Qualio is very well and highly integrated. There is a relatively short learning curve, then quite intuitive. The materials available for on-boarding and learning are very well done and thorough. The built-in chat function for fast support is excellent - so easy to use. The people of Qualio are high caliber and there is clearly a culture of Customer Service. There is a very good balance between structure and customization - Qualio has found the sweet-spot. The SOPs and templates offered as a starting point are well written and concise.

Cons:

I am hard-pressed to describe an aspect of the platform or the company that I would like to see changed. We do more than Medical Devices. We are in the process of considering how we might use Qualio outside of Medical and what would have to happen to accomplish such a goal - this is perhaps something Qualio might consider as an evolutionary initiative.

Qualio Response

3 years ago

Hi Jared, thank you for your fantastic review and we're so happy to hear that Qualio has made life easier for your Quality team! We'd love to get more of your thoughts on scaling usage of Qualio outside of Medical Device and your CS contact can answer any questions you might have on this.

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

Qualio for Biotech

5.0 last year

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.

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

Qualio Review

4.0 last year

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 last year

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 3 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

3 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.

Gareth
Head of Quality in New Zealand
Pharmaceuticals, 11–50 Employees
Used the Software for: 1+ year
Reviewer Source

Very efficient, user friendly tool for our QMS

5.0 3 years ago

Comments: Fantastic, coming from older clunky more expensive QMS at other Pharma companies, Qualio was a breath of fresh air.

Pros:

The workflows are very intuitive and with basic training a new user can navigate very easily.

Cons:

There is huge potential within Qualio to add on things like calibration management or Internal audits management. So it would be great to see additional modules / use cases added. The ability to integrate with other systems is not very visible.

Qualio Response

3 years ago

Hi Gareth, thank you for your review and we're glad to hear Qualio has been efficient and easy to use thus far! We appreciate this insightful feedback and have shared with our product team.

Victoria
Laboratory Technician in Canada
Medical Devices, 2–10 Employees
Used the Software for: 6-12 months
Reviewer Source

A useful and up to date QMS for businesses of all shapes and sizes

4.0 last year

Comments: Qualio acts as our eQMS and streamlines our audit trail, document management, and workflows As a company with employees working in various locations, it is easy to collaborate and find documents. Overall, I do like Qualio. I feel that with time the platform will become even more useful as more features are added.

Pros:

I like how Qualio is constantly updating and improving. I particularly like how helpful they are with support, from webinars to onboarding support, you never feel lost of confused. Qualio does exactly what you need it to, and all the extra features are just really nice bonuses.

Cons:

There is a learning curve to figuring out Qualio in the beginning. The platform looks pretty simple and basic. but when you try to start doing advanced actions I felt lost. There is a sandbox mode, which is good for playing and learning, but anything you create in the sandbox cannot be moved into your actual account.

Daryl
Director in UK
Wholesale, 2–10 Employees
Used the Software for: 2+ years
Reviewer Source

Qualio User Review

4.0 3 years ago

Comments: Has given our QMS a firm foundation

Pros:

After the initial 'new interface' confusion which is normal for a new application, the product is actually very easy to use

Cons:

Can't use existing documents as a template for new documents

Qualio Response

3 years ago

Thank you for your input, Daryl! We've provided your feedback to our product team.

Judson
Plant Manager in US
Chemicals, 11–50 Employees
Used the Software for: 2+ years
Reviewer Source

Outstanding eQMS!

5.0 last year

Comments: We control almost every aspect of our manufacturing business in Qualio along with our MES. We love the system.

Pros:

We easily pass cGMP complaince audits utilizing all features of Qualio. The ease of use and being able to quickly pull up any documents requested has impressed many auditors.

Cons:

Initially the search feature was a bit clunky, but there has been improvements. No issues now.

Halyna
QA Senior Scientist in US
Medical Devices, 51–200 Employees
Used the Software for: 6-12 months
Reviewer Source

Qualio customer review.

5.0 last year

Comments: Qualio is much better if compared to HQMS. Since we have Qualio we never had an issue finding the information in our Quality System.

Pros:

Easy to follow the directions, and create new procedures, forms, and events. Easy to find any information, approve, and review the documents.

Cons:

It is hard to create forms in Landscape format (especially if you want the form to be on one page), not possible to play with font.

Warrick
sys eng in Australia
Medical Devices, 11–50 Employees
Used the Software for: 6-12 months
Reviewer Source

simple and effective

4.0 last year

Comments: Overall a huge improvement from the previous Sharepoint/paper based system.

Pros:

Qualio was quick to get used to for most of the workflows.

Cons:

Search functions are clunky. Document builder is ok but can be improved. Slow load time sometimes. Is there the ability to see other users draft docs? Need to be able to output the design controls into a doc and trace matrix.

Kristinn
Regulatory and Compliance Officer in Iceland
Medical Devices, 51–200 Employees
Used the Software for: 1+ year
Reviewer Source

Focus on being a QMS

4.0 3 years ago

Comments: It’s been great, especially the team behind it. They have been super helpful.

Pros:

That it’s focused on being a QMS and is not trying to solve all the world problems.

Cons:

It’s a little difficult to navigate at first

Alternatives Considered: Greenlight Guru and MasterControl Quality Excellence

Reasons for Switching to Qualio: More focused on the needs we had.

Qualio Response

3 years ago

Thank you Kristinn, we're happy to hear you've had a positive experience with the Qualio team.

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 last year

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.

Janelle
Biomanufacturing Lead in Canada
Biotechnology, 11–50 Employees
Used the Software for: 6-12 months
Reviewer Source

Easy to Use

5.0 last year

Pros:

I like that Qualio let you keep all your documentation and training in one place, organized and easy to change when its required.

Cons:

Some of the permissions assignment are a bit cumbersome and the change control is a bit longer than it needs to be for our company at this stage.

Luke
Lifescience Compliance Specialist in Ireland
Biotechnology, 2–10 Employees
Used the Software for: 1+ year
Reviewer Source

A User-friendly and Efficient System

5.0 last year

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.