# Qualio Reviews 2026. Verified Reviews, Pros & Cons | Capterra > Is Qualio the right Quality Management solution for you? Explore 128 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 4.6 (128) 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 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. “The document editor is not as robust as microsoft word.“ May 27, 2025 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 PS Paul S PresidentMedical Devices, 2 - 10 employeesUsed the software for: 6-12 months. “This makes custom documents harder to create“ May 27, 2025 Patricia M Administrative DirectorMedia Production, 2 - 10 employeesUsed the software for: 6-12 months. “ant the customer support is top tier“ January 26, 2026 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 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 MH Muhammad H GM QA and RAMedical Devices, 11 - 50 employeesUsed the software for: More than 2 years. “This hinders the log control in Qualio.“ April 29, 2024 ## Showing most helpful reviews Showing 1-25 of 128 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 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 team is quick to remediate bugs and provide module upgrades that address new user needs! Reason for choosing Qualio The selection of 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! SC Savneet C. Senior Quality Manager Cosmetics Used the software for: 6-12 months ### "Qualio set up and execution" August 8, 2023 5.0 Training has become much easier. Pros User Friendly, Team that helps you onboard and provides help along the way is amazing!! Having access to Quality specialist is a big plus and both the onboarding manager and Quality specialist have been knowledgeable, patient and great. Feedback is taken positively and shared with internal teams. Cons Complaints module - having editable udf's (feedback shared with team). Document collaboration could be improved. Tag- ability to type in a tag instead of selecting from a drop-down list. Categorizing tags in the drop-down Template- linking a template in documents. Sending a template for review prior to approval Forms- Revision control. Stamping a form with the form number automatically instead of a manual addition. Alternatives considered [QT9 QMS](https://www.capterra.com/p/97557/QT9-Quality-Management/) Reason for choosing Qualio Access to Quality staff and user-friendly system 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 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 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 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 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 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 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 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, '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. 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 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, 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 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 . Alternatives considered [Greenlight Guru](https://www.capterra.com/p/140578/greenlight-guru/) Reason for choosing 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 RN Robert N. Quality Medical Devices Used the software for: 2+ years ### "AMM Qualio Review " August 8, 2023 5.0 My overall experience with 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 .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 does offer weekly webinar trainings on many of the useful features. Qualio is easy to navigate. Pros 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 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. MH Muhammad H. GM QA and RA Medical Devices Used the software for: 2+ years ### "Quality Review" April 29, 2024 4.0 Overall, the experience with is good so far. Pros The best thing about is that you can customise it according to you own operations. The second-best thing about Qualio is their support team. Cons Document management needs to be improved a bit. Resonance Health has faced a lot of issues when people with access to create drafts created drafts without prior permission and without any need of new document. This hinders the log control in . Review Source KS Karthi S. Head of Manufacturing Medical Devices Used the software for: 1-2 years ### "A true QMS for the Cloud" February 8, 2022 4.0 Pros The level of learning required to understand 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 . 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. Review Source Response from Qualio February 15, 2022 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. KD Kristi D. Associate Director of Quality Medical Devices Used the software for: 1-2 years ### "Good for start ups" February 2, 2022 4.0 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 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. Reason for choosing Qualio Price, customer service, features, flexibility. Review Source TM Todd M. VP of Quality Assurance Semiconductors Used the software for: 2+ years ### "Qualio Implementation, QMS Creation, and ISO Audit." April 17, 2024 5.0 Great experience, allowed me implement a company wide QMS, passing ISO registration audits both times. Pros Simple but complex at the same time, great features. Cons Docuemnt formatting could be improve, but very good currently. Review Source CM Claire M. QARA Engineer Medical Devices Used the software for: 6-12 months ### "Qualio has potential" April 12, 2024 3.0 Overall I think 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. Review Source BL Brian L. Quality Manager Medical Devices Used the software for: 1-2 years ### "Qualio disappointing" April 22, 2024 4.0 Poor - I came in late (hardly anything was done) with the implementation and just wasn't aware of the capabilities of , and Qualio was backing out of the on-boarding process. I don't believe Qualio provided me with a good understanding of the capabilities of the system and how best to set it up. Pros I do like the Document Lifecycle management and the control of documents. Need the ability to have separate libraries, (i.e for Technical Documents) and not by tag! Cons Cost....Not much of a value when compared to manual systems Most everything in requires the same effort as a manual system (document control/life cycle is the exception, although some software offers version control!) I also resent the price increase applied this past year and the inability of Qualio to negotiate or justify the increase. We are actively evaluating other suppliers. Review Source ML Michelle L. Production Manager Medical Devices Used the software for: 1-2 years ### "Qualio Review" August 3, 2023 4.0 Pros 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 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. Review Source BR Bonnie R. Quality Coordinator Medical Devices Used the software for: 6-12 months ### "Qualio review" August 3, 2023 4.0 Our company loves that the training of our entire company Nationwide can train all at once without having to use a separate program Pros Getting used to this system was a challenge. But once I learned to navigate it became quite easy. I love that this program works as Quality should and is always improving. Cons The fact that I can not archive and retrieve expired supplier documents Review Source SD Sasiporn D. Clinical Quality and Training Manager Research Used the software for: 1-2 years ### "Always support, continuous improvement and system is really easy to use" August 12, 2023 5.0 Pros flexible, able to customize as per company's requirments. Cons document editable format is still have some limit function Review Source JP Joel P. Quality Manager Food & Beverages Used the software for: 1-2 years ### "Start up company with Qualio" April 17, 2024 5.0 Overall very happy, but it is my understand there may be some very significant price increases coming our way which could cause us to look at alternate systems Pros \*Customer Service \*Ease of initial installation \*Sandbox feature Cons \*Suppliers module \*Improvement suggestions not always acted up efficiently Reason for choosing Qualio Presage Analytics, QT9 Quality Management RedZone Intellect Infinity Quality Suite Batchmaster Salesforce Siemens PLM Teamcenter Review Source FF Fabio F. VP Technology Pharmaceuticals Used the software for: 6-12 months ### "Very good user interface, ease of access and responsive tool" August 3, 2023 4.0 Overall QMS management efficacious and well used by the whole company Pros Easiness to find the documents and manage deviations/CAPAs Cons Customizing reminders not possible, this is useful to increase compliance and respect deadlines Review Source JE Joe E. Director-Product Management Biotechnology Used the software for: 2+ years ### "Qualio for biotechnology " April 17, 2024 5.0 Pros Ease of use. Compliance with FDA, CE, and TGA requirements for QMS. Cons Nothing. The team really listens and implements changes requested by the customer. Review Source JB Jessica B. Chief Commerical Officer Medical Devices Used the software for: 6-12 months ### "Beware, Qualio is not a Turnkey Solution" August 3, 2023 2.0 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 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. Review Source ## 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.