17 years helping Canadian businesses
choose better software
About Qualio
QMS for Medical Devices, Pharma and Biotech. 100% FDA/ISO/GxP compliance. 5x faster Document Control, Training, CAPA, NCRs, Audits and more.
Qualio is very well and highly integrated. There is a relatively short learning curve, then quite intuitive.
It is a bit tricky to understand the management of NCRs.
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Filter reviews (123)
Great Software
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.
User friendly, sleek eQMS software
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.
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 :)
The solution to management of QMS activities and Events
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.
Decent QMS support system
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.
A Great Quality Management System to get you started.
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.
Customer Questionnaire
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.
Good but could be great
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).
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.
Easy to use and integrate with JIRA
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
Excellent people supporting an excellent product
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.
Qualio for Biotech
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.
Qualio Review
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.
I would choose Qualio every time!
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.
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.
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.
Very efficient, user friendly tool for our QMS
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.
A useful and up to date QMS for businesses of all shapes and sizes
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.
Qualio User Review
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.
Outstanding eQMS!
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.
Qualio customer review.
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.
simple and effective
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.
Focus on being a QMS
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.
Beware, Qualio is not a Turnkey Solution
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.
Easy to Use
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.
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.