What are Qualio users saying about the software?
Read what people like you have said about using Qualio software through verified user reviews
User Review Highlights
4.66
56 Reviews
Ease-of-use
out of 5Customer Support
out of 5Value for money
out of 5Functionality
out of 5"The documents are clean and easy to read. Overall, I enjoy logging into Qualio and navigating the system to quickly get what I need."
"It gives alot of good information, up to date information."
"Qualio team was awesome helping us migrate to their system. Streamlined employee quality training, SOPs, and overall QMS efficiency."
"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."
"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."
"One feature that is missing is automatic reminders of incomplete assigned training (supposed to be on the roadmap, though!)."
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Showing 1 - 25 of 56 reviews

Andrew
Verified reviewer
Company size: 11-50 employees
Industry: Medical Devices
Time used: Less than 12 months
Review Source: Capterra
April 2020
Easy to use and implement eQMS
Qualio team was very supportive with the transition to an eQMS system.
Pros
- Qualio team was awesome helping us migrate to their system - streamlined employee quality training, SOPs, and overall QMS efficiency - clear audit trail for signatures and approvals - east to navigate and simple interface
Cons
- none thus far, we continue to find more and more value from this eQMS system

Response from Qualio
Thanks for the review, Andrew! So happy to hear you've enjoyed your experience so far.
Replied May 2020
Mickey
Verified reviewer
Company size: 11-50 employees
Industry: Biotechnology
Time used: Less than 12 months
Review Source: Capterra
This reviewer was invited by us to submit an honest review and offered a nominal incentive as a thank you.
January 2022
Great Software
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.
Reasons for choosing Qualio
Greenlight also seemed like a great product but the implementation speed and ease of Qualio was out deciding factor.

Response from Qualio
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.
Replied February 2022
Irma
Company size: 11-50 employees
Industry: Biotechnology
Time used: More than 2 years
Review Source: Capterra
This reviewer was invited by us to submit an honest review and offered a nominal incentive as a thank you.
January 2022
Needs basic improvements
Document Management works well
Pros
Training process works well. The system can generate reports for each employee.
Cons
Change control and periodic review reports need improvement. I cannot generate proper reports that provide visibility of these processes. The change control report is less than acceptable. Please fix this. I have explained this in the past.
Reasons for choosing Qualio
Price

Response from Qualio
We appreciate your feedback regarding change control and periodic review reports and have provided this to our product team.
Replied February 2022
Barbara
Company size: 51-200 employees
Industry: Medical Devices
Time used: More than 2 years
Review Source: Capterra
This reviewer was invited by us to submit an honest review and offered a nominal incentive as a thank you.
February 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
Reasons for choosing Qualio
I was told the choice considered price, intuitiveness and regulatory compliance.

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 February 2022
jared
Company size: 501-1,000 employees
Industry: Medical Devices
Time used: Less than 2 years
Review Source: Capterra
This reviewer was invited by us to submit an honest review and offered a nominal incentive as a thank you.
February 2022
Excellent people supporting an excellent product
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.
Reasons for choosing Qualio
Their people. Their value.

Response from Qualio
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.
Replied February 2022
Cynthia
Company size: 11-50 employees
Industry: Medical Devices
Time used: More than 2 years
Review Source: Capterra
This reviewer was invited by us to submit an honest review and offered a nominal incentive as a thank you.
January 2022
Qualio Review
I am very satisfied with Qualio.
Pros
Ease of use, search feature, and the dashboards for overdue training, deviations.
Cons
Quality events feature is a little confusing.
Reasons for choosing Qualio
Cost and ease of use.

Response from Qualio
Hi Cynthia, we're happy to hear that so many of Qualio's features are enabling your QMS processes. If you'd like to provide any additional details on improvements to our Events feature, please feel free to reach out to me directly.
Replied February 2022
John
Verified reviewer
Company size: 51-200 employees
Industry: Medical Devices
Time used: More than 2 years
Review Source: Capterra
This reviewer was invited by us to submit an honest review and offered a nominal incentive as a thank you.
February 2022
Qualio helps lead the way through our MDSAP recertification audit.
Qualio serves as my document repository, my "source of truth" for all required records within our 13485/MDSAP compliant QMS. Recertification was completed in 2021 and the auditor noted the speed with which all document records were presented, without a backroom runner!
Pros
Software is easy to use and navigate, and to train others to use at different levels. Record and report output is quick and organized.
Cons
Software has presented with many fix opportunities. That said the Qualio team is quick to remediate bugs and provide module upgrades that address new user needs!
Reasons for choosing Qualio
The selection of Qualio was made by my predecessor most likely based on value for the price.

Response from Qualio
Hi John, congrats on your 13485/MDSAP recertification and we're ecstatic to hear positive feedback from your auditor as well!
Replied February 2022
Gareth
Company size: 11-50 employees
Industry: Pharmaceuticals
Time used: Less than 2 years
Review Source: Capterra
This reviewer was invited by us to submit an honest review and offered a nominal incentive as a thank you.
February 2022
Very efficient, user friendly tool for our QMS
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.
Reasons for choosing Qualio
Cost and implementation time was way better than competitors.

Response from Qualio
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.
Replied February 2022
Nihal
Verified reviewer
Company size: 201-500 employees
Industry: Pharmaceuticals
Time used: Less than 6 months
Review Source: Capterra
This reviewer was invited by us to submit an honest review and offered a nominal incentive as a thank you.
January 2022
Qualio Review
We have a very high Qa workload and especially during inspections were reliant on a couple of people. One thing forgotten or not done on time can lead to critical or major reviews. We want to avoid that and also ensure the QA managers are using their time effectively and not chasing paper. We are still Completing implementation and will be able to measure the efficiency, time saved and capacity developed by end of the year!
Pros
I think the ease of implementation and support. Ease of use… “does what it says”. We still need more time with it but my employees seem excited about it!
Cons
I am not sure at the moment. There were some Minor hitches with implementation . But no feedback on this yet!
Reasons for choosing Qualio
Ampleloguc was a bit convulated. More of a tracker than a true work on line software. We would not have been 100% paperfree! Implementation timelines were long with extremely high upfront costs!
Eyüp
Company size: 1 employee
Industry: Financial Services
Time used: Less than 6 months
Review Source: Capterra
This review was submitted organically. No incentive was offered
April 2022
Qualio EO
Pros
It is also very easy to learn because it is very easy to use. The interface is simple and very understandable.
Cons
It's a little more expensive than other software, but that's because it has better features.

Response from Qualio
Thank you for the positive feedback! We're so glad to hear you're finding our eQMS is meeting all your quality needs.
Replied April 2022
Donna Lee
Company size: 51-200 employees
Industry: Medical Devices
Time used: More than 2 years
Review Source: Capterra
This reviewer was invited by us to submit an honest review and offered a nominal incentive as a thank you.
February 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.
Reasons for switching to Qualio
Change in ownership of company, poor functionality of previous product

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 February 2022
Anonymous
Company size: 11-50 employees
Time used: More than 2 years
Review Source: Capterra
This review was submitted organically. No incentive was offered
January 2019
The perfect system for startups and young organizations
Pros
I like the simplicity of the software, and the ease of configuration for the user. If a new document type is needed, it's literally just a few clicks away. I like the intuitive navigation and the ease of adoption by the end users.
Cons
At this time, the only place I can fault Qualio is in the data reporting capabilities. Running basics like how many open/closed NCRs or how many SOPs approved is fine, but without more capability built out, or an external API (like a BI report or crystal intelligence tool), I can't get to more data within records. I do know they are working on this however, and generally at the start up level, you're not yet in need of super detailed reporting within your QMS yet anyway. The basics they provide will more than get you off the ground!

Response from Qualio
An intuitive and simple interface is at the core of Qualio's software, so it's fantastic that you've really benefited from this. Thank you for your feedback on our data reporting capabilities too we are looking to rollout improvements to this functionality soon.
Replied June 2019
Rob
Company size: 201-500 employees
Industry: Health, Wellness and Fitness
Time used: More than 2 years
Review Source: Capterra
This review was submitted organically. No incentive was offered
June 2018
This is one of the most often used apps and was selected for its ease of use and compliance focus
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.

Response from Qualio
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!
Replied June 2019
Thomas
Company size: 11-50 employees
Industry: Biotechnology
Time used: Less than 2 years
Review Source: Capterra
This reviewer was invited by us to submit an honest review and offered a nominal incentive as a thank you.
February 2022
Qualio user
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.

Response from Qualio
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.
Replied February 2022
Jonas
Company size: 2-10 employees
Industry: Information Technology and Services
Time used: Less than 2 years
Review Source: Capterra
August 2016
Perfect for Medical Device startups
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.

Response from Qualio
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.
Replied June 2019
Karthi
Company size: 2-10 employees
Industry: Medical Devices
Time used: Less than 2 years
Review Source: Capterra
This reviewer was invited by us to submit an honest review and offered a nominal incentive as a thank you.
February 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 February 2022
Mallory
Company size: 51-200 employees
Industry: Research
Time used: Less than 12 months
Review Source: Capterra
April 2020
User friendly platform
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.

Response from Qualio
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.
Replied April 2020
Bastien
Company size: 11-50 employees
Industry: Medical Devices
Time used: Less than 12 months
Review Source: Capterra
This reviewer was invited by us to submit an honest review and offered a nominal incentive as a thank you.
January 2022
Qualio for the win !
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.

Response from Qualio
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.
Replied February 2022
Daryl
Company size: 2-10 employees
Industry: Wholesale
Time used: More than 2 years
Review Source: Capterra
This reviewer was invited by us to submit an honest review and offered a nominal incentive as a thank you.
January 2022
Qualio User Review
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
Reasons for choosing Qualio
Good reviews and initial contact with the sales / techical team

Response from Qualio
Thank you for your input, Daryl! We've provided your feedback to our product team.
Replied February 2022
Kristi
Company size: 11-50 employees
Industry: Medical Devices
Time used: Less than 2 years
Review Source: Capterra
This reviewer was invited by us to submit an honest review and offered a nominal incentive as a thank you.
February 2022
Good for start ups
Overall, as a small startup it worked for our needs. As we grew and more people from larger companies joined, there were struggles. I think if you are open to making Qualio work for you and you have stakeholders onboard during implementation its great. If you bring people in who are used to expensive widely used tools its a learning curve. I would use it again if I were starting a company.
Pros
I liked the ability to build and edit the event flows (NCR, CAPA, etc).
Cons
Redline feature is not great right now.
Reasons for choosing Qualio
Price, customer service, features, flexibility.
Richard
Company size: 201-500 employees
Industry: Research
Time used: Less than 2 years
Review Source: Capterra
This reviewer was invited by us to submit an honest review and offered a nominal incentive as a thank you.
January 2022
Qualio review by CRO director
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
Reasons for switching to Qualio
Company merge

Response from Qualio
Thanks for your review, Richard! We appreciate and have submitted your feedback to our product team.
Replied February 2022
Stephen
Company size: 11-50 employees
Industry: Health, Wellness and Fitness
Time used: Less than 12 months
Review Source: Capterra
This reviewer was invited by us to submit an honest review and offered a nominal incentive as a thank you.
January 2022
Qualio - Quality Control, Document Management and Traceability
Overall, the Qualio product has improved our workflow processing ability with excellent artifact collection and retention.
Pros
Qualio is a robust document management system with the ability to link documents and evidence for healthcare GRC needs as well as traceability in the process from cradle to grave.
Cons
The text editing features in Qualio are basic but strides are being taken to improve the features to meet most document composition and updating standards.
Reasons for choosing Qualio
We chose Qualio based on its experience in the Healthcare field and GRC capabilities.

Response from Qualio
Hi Stephen, we are always looking to improve our product and appreciate your feedback.
Replied February 2022
Inge
Company size: 201-500 employees
Industry: Research
Time used: Less than 2 years
Review Source: Capterra
This reviewer was invited by us to submit an honest review and offered a nominal incentive as a thank you.
February 2022
Good software for keeping up to date with documentation
Easy to use. Easy to find documents that you are looking for with search function
Pros
Training and searching, ease of finding and dowloading forms
Cons
I am not sure what liked least as for what ever I am using it it is doing a good job.
Reasons for switching to Qualio
Company made the switch

Response from Qualio
Hi Inge, we're happy to hear that Qualio is meeting all your needs and more! Thank you for your input.
Replied February 2022
Kristinn
Company size: 51-200 employees
Industry: Medical Devices
Time used: Less than 2 years
Review Source: Capterra
This reviewer was invited by us to submit an honest review and offered a nominal incentive as a thank you.
February 2022
Focus on being a QMS
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
Reasons for choosing Qualio
More focused on the needs we had.

Response from Qualio
Thank you Kristinn, we're happy to hear you've had a positive experience with the Qualio team.
Replied February 2022
Colin
Company size: 51-200 employees
Industry: Hospital & Health Care
Time used: Less than 2 years
Review Source: Capterra
August 2016
A quick path to SOC II type II
With Qualio we were able to get SOC 2 Type II certified in about a year and a half, which is very impressive. This has lead to increased trust with our customers and helps us grow our business faster.
Pros
User interface, ease of use, ability to get staff to love using it.
Cons
Nothing.

Response from Qualio
It's always great to be told there are no cons to our software, so thank you very much for your positive feedback Colin! We're glad that we've enabled you to gain certifications quicker and unlock business growth.
Replied June 2019

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