# Qualio Reviews 2026. Verified Reviews, Pros & Cons | Capterra > Is Qualio the right Quality Management solution for you? Explore 129 verified user reviews from people in industries like yours to make a confident choice. Source: https://www.capterra.com/p/134050/Quality-Management-Software/reviews --- Qualio 4.5 (129) Provider data verified by our Software Research team, and reviews moderated by our Reviews Verification team. [Learn more](https://www.capterra.com/our-story/) * * * Last updated March 13th, 2026 # Reviews of Qualio Ease of use 4.5 Customer Service 4.7 ## Pros and Cons in Reviews VS Victoria S Laboratory TechnicianMedical Devices, 2 - 10 employeesUsed the software for: 6-12 months. “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.“ August 3, 2023 CC Christina C EngineerMedical Devices, 11 - 50 employeesUsed the software for: 6-12 months. “It was not my favorite. When I identified issues, the customer care team stopped responding.“ May 3, 2026 Patricia M Administrative DirectorMedia Production, 2 - 10 employeesUsed the software for: 6-12 months. “ant the customer support is top tier“ January 26, 2026 PS Paul S PresidentMedical Devices, 2 - 10 employeesUsed the software for: 6-12 months. “The document editor is not as robust as microsoft word.“ May 27, 2025 HN Hanifa N Quality Assurance OfficerPharmaceuticals, 51 - 200 employeesUsed the software for: 1-2 years. “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.“ May 16, 2024 PS Paul S PresidentMedical Devices, 2 - 10 employeesUsed the software for: 6-12 months. “This makes custom documents harder to create“ May 27, 2025 RN Robert N Quality Medical Devices, 2 - 10 employeesUsed the software for: More than 2 years. “Qualio solves our companies Quality Management Software needs and helps us to maintain all of our documents in a controlled system.“ August 8, 2023 RN Robert N Quality Medical Devices, 2 - 10 employeesUsed the software for: More than 2 years. “I do not like how the change control history only limits you to see the last change control. If you want to see previous change control history of older versions of a document you have to create a draft and delete it once you are finished.“ August 8, 2023 ## Showing most helpful reviews Showing 1-25 of 129 Reviews Sort by: Most Helpful Rating Company Size Reviewer's Role Length of Use Frequency of Use John P. Quality Manager Medical Devices Used the software for: 2+ years ### "Qualio helps lead the way through our MDSAP recertification audit." February 1, 2022 4.0 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! Reason for choosing Qualio The selection of Qualio was made by my predecessor most likely based on value for the price. Review Source Response from Qualio February 8, 2022 Hi John, congrats on your 13485/MDSAP recertification and we're ecstatic to hear positive feedback from your auditor as well! MF Melissa F. QA RA Medical Devices Used the software for: 6-12 months ### "Decent QMS support system" April 12, 2024 4.0 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. Switched from [Veeva QualityOne EQMS](https://www.capterra.com/p/178567/Vault-Quality-Suite/) I switched companies, and my previous company used the Veeva platform. Review Source NP Neil P. Sr. Director of Quality Biotechnology Used the software for: 6-12 months ### "Qualio is a great flexible QMS tool for small companies" August 16, 2023 3.0 Overall, my experience with Qualio is positive and I would recommend other small business owners to purchase this system. The system was fairly easy and quick to implement and covers the basics of what is needed to establish an ISO based QMS. The customer service is excellent and it appears that they are trying to improve both the quality of the product and the features. Pros Qualio has great customer service and and the onboarding team was incredibly helpful in setting up the system quickly. The system has great flexibility in setting up customized processes using their Events feature and I'm excited to implement their new analytics features. The process for change control is simple and intuitive. Cons As compared to other eQMS systems, there seems to be some basic functionality that is missing. For example, change control must be applied to one document at a time where most eQMS can revise multiple documents at a time. The system does unfortunately have bugs throughout all of their modules and the editing tool and tracking changes tool is quite tedious and burdensome. Lastly, their design control module is really a requirements management tool and does not actually assist with design control. Review Source NC Neil C. Head of QA/RA Medical Devices Used the software for: 1-2 years ### "Easy to use eQMS" August 8, 2023 5.0 Qualio has made our document management must simpler and easier to access. At our most recent audit, the auditor commented how much better structured our technical files were now that we had switched to Qualio Pros We've found Qualio is easy and intuitive for non-expert users to work with. Moving our most common forms directly into Qualio has cut out a lot of minor errors which in turn saves QA a lot of time. Cons It took us a bit of time to get our training set up properly although that was partly because we weren't clear what our aims were. When we first started the timings and content of updates was somewhat confusing, however the new system of planned and notified release schedules has made this much simpler and easier for users Alternatives considered [SimplerQMS](https://www.capterra.com/p/235957/SimplerQMS/) Reason for choosing Qualio Ease of use for infrequent users, ease of implementation Review Source BT Ben T. Manager of Islet Product Manufacturing Biotechnology Used the software for: 6-12 months ### "Good but could be great" April 26, 2024 4.0 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). Switched from [Dot Compliance](https://www.capterra.com/p/192574/Dot-Compliance/) QA was unhappy with Dot. Older members of the team had issues adopting Dot. Review Source MK Michele K. Head of Regulatory & Quality Assurance Medical Devices Used the software for: 1-2 years ### "Qualio is the Perfect eQMS - Simple and easy to use " August 15, 2023 4.0 Experience overall has been great. Qualio has been super responsive to all questions and issues. They recognize where problems exist and where improvements can be made. They pay attention to the customer's requirements (needs and wants) and they implement them to improve the functionality and performance of the eQMS' features. Qualio is always working on new things to help facility the end user's IeQMS and remain compliant within the industry. Pros The ability to have all documents maintained electronically in one system. I managed a manual QMS for 13+ years...it was manageable, but Qualio made it so much easier! The change control element and the Training module was a huge bonus - especially when this was originally done manually all those years. Cons The cumbersome document editor seemed old and outdated and was not easy to use. However, Qualio has made many improvements to the document editor making it much easier to create and edit documents. Alternatives considered [Polarion ALM](https://www.capterra.com/p/192715/Polarion-ALM/) Reason for choosing Qualio The price was a huge factor as well as the Design module. Review Source JH Jennifer H. Regulatory Affairs Representative Medical Devices Used the software for: 1-2 years ### "Great Experience" March 20, 2024 5.0 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](https://www.capterra.com/p/140578/greenlight-guru/) Reason for choosing Qualio Qualio had a better user interface, customer service, and ease of use. Review Source KH Klaus H. Head of Regulatory Hospital & Health Care Used the software for: 6-12 months ### "Easy to use and integrate with JIRA" April 12, 2024 5.0 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](https://www.capterra.com/p/140578/greenlight-guru/)[Confluence](https://www.capterra.com/p/136446/Confluence/)[Google Sheets](https://www.capterra.com/p/169718/Google-Sheets/) Reason for choosing Qualio Integration capability with JIRA and dedicated technical and quality templates available Review Source MH Michael H. QA Director Medical Devices Used the software for: 1-2 years ### "Excellent solution for most quality management systems" August 8, 2023 5.0 Pros Almost endless configuration capabilities allowing the creation of documents and events that fit your QMS instead of rebuilding your QMS to fit the software. Cons Inability to hot-swap an approver when they are not available. Instead the document needs to be reverted to draft, the approver changed, and then the document rerouted. Switched from [Greenlight Guru](https://www.capterra.com/p/140578/greenlight-guru/) Previous software structure was too restrictive and didn't allow for efficiency improvements. Review Source Nihal S. Ceo Pharmaceuticals Used the software for: Less than 6 months ### "Qualio Review" January 27, 2022 5.0 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! Reason 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! Review Source RN Robert N. Quality Medical Devices Used the software for: 2+ years ### "AMM Qualio Review " August 8, 2023 5.0 My overall experience with Qualio is good. It has helped our company grow and pass many audits. It also helped us reduce a headcount by serving as a document control solution. Qualio solves our companies Quality Management Software needs and helps us to maintain all of our documents in a controlled system. Qualio also helps us organize our training and events such as CAPA's and NCMR's. Pros The user interface is very good. It is easy to train new people how to use Qualio.The file organization and linking abilities from documents within documents is very good. Cons I do not like how the change control history only limits you to see the last change control. If you want to see previous change control history of older versions of a document you have to create a draft and delete it once you are finished. Reason for choosing Qualio Price Review Source TD Thomas D. QA Engineer Biotechnology Used the software for: 1-2 years ### "Qualio user" February 2, 2022 4.0 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. Review Source Response from Qualio February 15, 2022 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. LA Laura A. VP, Quality Pharmaceuticals Used the software for: 2+ years ### "Choose Qualio for your eQMS needs" August 15, 2023 5.0 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. Reason for choosing Qualio Ease of use and implementationregulatory compliance (particularly with Part 11)Support teamOverall cost at the time Review Source cV chandini V. Clinical data associate Writing and Editing Used the software for: 2+ years ### "The best app for using your and reviewing your documents during your work." April 12, 2024 5.0 I must say that its the best and Excellent everyone must OWN. Pros The things i like the most is the interface that the Qualio provides which is very user friendly and easy to access and its development through year is incredible Cons I never saw anything that is troubling me in Qualio till date thats what made me impressed to use this daily at work. Review Source MB Michael B. Sr PD Engineer Biotechnology Used the software for: 1-2 years ### "An excellent software for newer startups focused on Quality. " August 9, 2023 5.0 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. Reason for choosing Qualio Document Tags and E-QMS features (Design control, DIOVV) Review Source AR Arslan R. QARA Manager Medical Devices Used the software for: 1-2 years ### "Customer Support" April 12, 2024 3.0 Pros Customer Support is Amazing as I used to do regulars meeting with them Cons Not user friendly as my CS team didn't like their complex processes Review Source NB Nesh B. software engineer Medical Devices Used the software for: 6-12 months ### "Qualio review" April 17, 2024 4.0 Pros I like that it is easy to use. Has good version control. It facilitates good review process Cons Qualio does not keep resolved comments. When someone completes review and click ‘Mark as reviewed’ in Qualio, no email notification is received. For an existing table, adding multiple rows at a time is not possible. Only one row can be added. Unable to copy the contents across multiple rows. There is no functionality to replace one character string with another. Doesn’t notify if a particular reviewer completed review. Doesn’t allow comments by a particular reviewer if that reviewer completed review. Not possible to filter for comments from a particular reviewer. Can not add multiple rows in table. All documents in all states should be visible to all users. Can not delete comments. Review Source RÄ Riikka Ä. Ho Regulatory and Scientific Affairs Medical Devices Used the software for: 6-12 months ### "Extremely satisfied with Qualio" August 4, 2023 4.0 Overall very satisfied Pros The whole management of quality system became so pleasant with Qualio compared to manual QMS. All the way from the purchase to implementation to going live all the needed support was available. Cons The process of implementing experienced some hick-ups with Qualio's change of employees... Document creation and management is still a bit non-optimal because text modification as in e.g., Microsoft Word is quite limited Review Source PR Pam R. Sr. Global Consultant QARA Medical Devices Used the software for: 1-2 years ### "Qualio Implementation" April 22, 2024 4.0 It is mainly positive, still early days, it would have been good to have more training and a more global presence for Qualio Pros Document control, supplier control, CAPA control Cons Setting up the system for our use was more complex than expected Reason for choosing Qualio Price was an important consideration, ease of use for all employees, help desk, Review Source DS Daryl S. Director Wholesale Used the software for: 2+ years ### "Qualio User Review" January 27, 2022 4.0 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 Reason for choosing Qualio Good reviews and initial contact with the sales / techical team Review Source Response from Qualio February 2, 2022 Thank you for your input, Daryl! We've provided your feedback to our product team. PO Peter O. QA Officer Pharmaceuticals Used the software for: Less than 6 months ### "Qualio at Arovella Therapeutics" January 27, 2022 5.0 Pros The modularised way that Qualio prepares templates really helped with the transition of our exiting documentation. I like how it uses tags to categorise specific document groups which can then be set for specific job roles. I also like the training options and overview. Cons There are some font and text options that could be improved. Review Source Response from Qualio February 2, 2022 We are happy to hear that you were able to smoothly transition existing documentation with Qualio! Thank you for your feedback. GQ Gareth Q. Head of Quality Pharmaceuticals Used the software for: 1-2 years ### "Very efficient, user friendly tool for our QMS" February 8, 2022 5.0 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. Reason for choosing Qualio Cost and implementation time was way better than competitors. Review Source Response from Qualio February 15, 2022 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. BS Bastien S. Production lead Medical Devices Used the software for: 6-12 months ### "Qualio for the win !" January 27, 2022 5.0 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. Review Source Response from Qualio February 2, 2022 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. SM Sharon M. HR Manager Computer Software Used the software for: 2+ years ### "Great way to manage quality " August 8, 2023 5.0 Pros Ease of use. Data storage. Ease of access Cons The document creation can be improved... Review Source RT Rob T. Sr Director of IT and Security Officer Health, Wellness and Fitness Used the software for: 2+ years ### "This is one of the most often used apps and was selected for its ease of use and compliance focus" June 11, 2018 5.0 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. Review Source Response from Qualio June 20, 2019 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! ## Send me user reviews about this product ### Fill out the form and we'll send a list of the top-rated software based on real user reviews directly to your inbox. Talk to a Capterra advisor for free and get results within 15 minutes.