--- title: "Qualio Reviews 2026. Verified Reviews, Pros & Cons | Capterra" description: "Is Qualio the right Document Control solution for you? Explore 138 verified user reviews from people in industries like yours to make a confident choice." source_url: "https://www.capterra.com/p/134050/Quality-Management-Software/reviews/" page_type: "reviews" language: "en" publication_date: "2026-09-29" --- Qualio 4.6 (138) [View alternatives](https://www.capterra.com/p/134050/Quality-Management-Software/alternatives/) 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 September 29th, 2026 # Reviews of Qualio Ease of use 4.5 Customer Service 4.7 ## Pros and Cons in Reviews MS Madison S Clinical Research AssociateResearch, 11 - 50 employeesUsed the software for: Less than 6 months. “It's also very easy to store documents safely and securely.“ August 7, 2026 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 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 PV Panagiotis V Quality Control SpecialistPharmaceuticals, 51 - 200 employeesUsed the software for: 1-2 years. “The fact that reviewing aproval editing and scrolling though our documents is easy and fast“ October 15, 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 Patricia M Administrative DirectorMedia Production, 2 - 10 employeesUsed the software for: 6-12 months. “ant the customer support is top tier“ January 26, 2026 PV Panagiotis V Quality Control SpecialistPharmaceuticals, 51 - 200 employeesUsed the software for: 1-2 years. “The search engine is a little clunky sometimes“ October 15, 2024 ## Showing most helpful reviews Showing 1-25 of 138 Reviews Sort by: Most Helpful Rating Company Size Reviewer's Role Length of Use Frequency of Use Dexter S. QA Document Speacialist Food Production Used the software for: 6-12 months ### "User friendly, sleek eQMS software" August 3, 2023 4.0 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](https://www.capterra.com/p/148577/MasterControl/)[QT9 QMS](https://www.capterra.com/p/97557/QT9-Quality-Management/) Reason for choosing Qualio Ease of use and features available for implementation. Review Source KP Karl P. Quality and Compliance Director Pharmaceuticals Used the software for: 1-2 years ### "A Great Quality Management System to get you started. " August 15, 2023 5.0 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](https://www.capterra.com/p/148577/MasterControl/)[ServiceNow](https://www.capterra.com/p/254088/ServiceNow/) Reason for choosing Qualio Cost and the 'all in one' presentation was a huge reason. 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 MS Madison S. Clinical Research Associate Research Used the software for: Less than 6 months ### "Easy and Simple!" August 7, 2026 5.0 Qualio is very user friendly! I've only worked with it for 5 months, and I've already learned how to use it. It has become an essential part of my everyday workflow and houses all of our comp0any's essential documents. Pros The Qualio interface is very simplistic and easy to use. It very clearly separates my trainings that are due from completed trainings. It's also very easy to store documents safely and securely. Cons The search function could be a little more specific. I find that when I search for specific words or documents, the findings are too broad and end up not being very helpful. Review Source LH Lowell H. Director, Quality Assurance Medical Devices Used the software for: 1-2 years ### "Customer Questionnaire" August 8, 2023 5.0 100% 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](https://www.capterra.com/p/140578/greenlight-guru/) Reason for choosing 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. Review Source DV David V. Director Quality Assurance and Regulatory Affairs Medical Devices Used the software for: 1-2 years ### "Qualio as a Quality Management Software" August 3, 2023 5.0 Pros User interface and scalability/adaptability to business needs Cons Inability to lock values and text fields in Events and documents. Inability to run reports, or export data for tracking/reporting outside of Qualio. Interface with other data sets. Alternatives considered [SAP S/4HANA Cloud](https://www.capterra.com/p/152293/SAP-S-4HANA/)[Harrington Quality Management System (HQMS)](https://www.capterra.com/p/51448/HQMS/)[Greenlight Guru](https://www.capterra.com/p/140578/greenlight-guru/) Reason for choosing Qualio Best fit needs of business at the time. Switched from [Harrington Quality Management System (HQMS)](https://www.capterra.com/p/51448/HQMS/) Compliance problems with current software and poor customer support to make required changes. Review Source 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 Qualio 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 Qualio Quality staff and user-friendly system 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 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 Mickey T. Controller Biotechnology Used the software for: 6-12 months ### "Great Software" January 27, 2022 5.0 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. Reason for choosing Qualio Greenlight also seemed like a great product but the implementation speed and ease of Qualio was out deciding factor. Review Source Response from Qualio February 2, 2022 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. PS Paul S. President Medical Devices Used the software for: 6-12 months ### "User-friendly platform to integrate teams" May 27, 2025 5.0 Qualio offers a unified and user-friendly platform to integrate our teams, tools, and data. It streamlines critical quality processes, such as document control, training, non-conformances, CAPAs, audits, and supplier management, all within a single, collaborative system. Pros Very intuitive to use, The friendly interface does not require extensive training or uptime to get users on boarded and using the system Cons The document editor is not as robust as microsoft word. This makes custom documents harder to create 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 DM Drew M. Director of Quality Biotechnology Used the software for: 2+ years ### "Qualio for Biotech" August 31, 2023 5.0 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. Reason for choosing Qualio Ease of use, affordable, and the system includes all of the functions that I need. Qualio does not overcomplicate pricing and offer module add-ons which quickly add up. Review Source HY Halyna Y. QA Senior Scientist Medical Devices Used the software for: 6-12 months ### "Qualio customer review. " August 8, 2023 5.0 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. Review Source VR Verified Reviewer Senior Quality Assurance Manager Biotechnology Used the software for: 2+ years ### "The perfect system for startups and young organizations" January 17, 2019 5.0 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! Review Source Response from Qualio June 20, 2019 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. 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 Qualio, 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 Qualio 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 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. 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 Similar Products Featured ## 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.