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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 12 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.

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 2 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.

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 3 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 :)

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 3 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 11 months ago

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 11 months ago

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 3 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 4 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 3 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

Laura
VP, Quality in US
Pharmaceuticals, 201–500 Employees
Used the Software for: 2+ years
Reviewer Source

Choose Qualio for your eQMS needs

5.0 11 months ago

Comments: 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.

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

Qualio Review

5.0 11 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.

Rob
Sr Director of IT and Security Officer in US
Health, Wellness & Fitness, 201–500 Employees
Used the Software for: 2+ years
Reviewer Source

This is one of the most often used apps and was selected for its ease of use and compliance focus

5.0 6 years ago

Pros:

- ease of use! It's all right there, easy to find and easy to teach! - compliance: we pull multiple reports from Qualio for our compliance audits and they are never questioned - reporting: very thorough, detailed reports for training completion and distribution - support listens to both feature requests and existing changes that are needed and addresses all promptly

Cons:

- one feature that is missing is automatic reminders of incomplete assigned training (supposed to be on the roadmap, though!) - most software will encounter an error now and then. While it is infrequent with Qualio, the error messages can be vague, prompting support calls that could be avoided with better detail.

Qualio Response

5 years ago

Ease of use and compliance are key parts of Qualio's offering, so it's great to hear you're benefiting from these in particular. We're also pleased that you've found our support department so valuable. We will be continuing with this approach to customer service, and will take on board the improvements you have suggested. Thank you so much for your feedback Rob!

Thomas
QA Engineer in US
Biotechnology, 11–50 Employees
Used the Software for: 1+ year
Reviewer Source

Qualio user

4.0 2 years ago

Comments: Very positive experience using Qualio. Qualio does offer weekly webinar trainings on many of the useful features. Qualio is easy to navigate.

Pros:

Qualio is very customizable. We have built our QMS using Qualio and being that it is cloud based it is available in house or remotely. Documents are easily shared with other members of the team. The support staff at Qualio is outstanding.

Cons:

I feel if Qualio had a bulk download feature where you are able to do a download of all of the documents to a secondary location for data redundancy, that would be helpful. Currently you can download the documents, but is is a single download, and not the entire QMS.

Qualio Response

2 years ago

Hi Thomas, thank you for your wonderful review and we're so happy to hear you're enjoying Qualio's customizable features and easy navigation. We're sharing your feedback regarding bulk downloads to our product team.

Claire
QARA Engineer in UK
Medical Devices, 51–200 Employees
Used the Software for: 6-12 months
Reviewer Source

Qualio has potential

3.0 3 months ago

Comments: Overall I think Qualio has a lot of potential. It has a lot of functions which just need slight improvements before they can be fully effective.

Pros:

I like the version control of documents and that minor changes can be made without sending the document for re-training. Customer service is exceptional with issue and queries being addressed as soon as possible.

Cons:

The 'compare against' function is not very useful as often it highlights entire sections of text instead of the specific changes. It also shows code when changes are made to tables or images. The inability to revision control templates directly. If templates update, changes within sections have to be applied manually to documents in draft.

Michael
Sr PD Engineer in US
Biotechnology, 2–10 Employees
Used the Software for: 1+ year
Reviewer Source

An excellent software for newer startups focused on Quality.

5.0 11 months ago

Comments: Overall, feel like value for dollars spent, an excellent system for first implementation. Qualio staff are reachable.

Pros:

The e-QMS feature and pairing with Adobe makes this a eco-friendly and high quality QMS. Drafting, review, approval and change management are intuitive.

Cons:

Inability to view what the exported PDF looks like. Makes it difficult when working with data table entries.

Mallory
Clinical Trial Associate in US
Research, 51–200 Employees
Used the Software for: 6-12 months
Reviewer Source

User friendly platform

5.0 4 years ago

Comments: Being able to easily access crucial training documents and processes is paramount. Qualio makes it easy to locate and review said documents.

Pros:

Our company uses Qualio to house our Quality Management System. The homepage is simple with links that are appropriate for diving into the system. The documents are clean and easy to read. Overall, I enjoy logging into Qualio and navigating the system to quickly get what I need!

Cons:

The login process is split into two pages, enter email first then the password page appears. If the email and password pages could be grouped and the extra page eliminated, that would be ideal! Along with the option to remember the login credentials.

Qualio Response

4 years ago

Thank you, Mallory! We're so glad you can get to what you need in Qualio. Excellent feedback too! We'll get that shared with the product team for review.

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

Qualio User Review

4.0 2 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

2 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 12 months ago

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 11 months ago

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 12 months ago

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 2 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

2 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 12 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.

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

Easy to Use

5.0 11 months ago

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 11 months ago

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.