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What is Qualio?

Qualio is an all-in-one quality management platform helping companies maintain compliance, managed documents, audits, suppliers and complaints in one place.

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TrustRadius Insights

Qualio is a versatile quality management system that offers a range of features to address various organizational needs. Users have found …
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Qualio User

9 out of 10
May 31, 2022
The platform Qualio Is the Quality Management System used At the Dot Corporation, a contract Labeler / Manufacturer company, in the …
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Qualio Reviews

8 out of 10
May 19, 2022
Qualio helps us create, manage and share documents easily on the cloud using a highly collaborative approach- no matter using it at work, …
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What is Qualio?

Qualio is an all-in-one quality management platform helping companies maintain compliance, managed documents, audits, suppliers and complaints in one place.

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Product Details

What is Qualio?

Qualio is an all-in-one quality management platform helping companies maintain compliance, managed documents, audits, suppliers and complaints in one place.

Qualio Video

Meet Cindy, a quality manager at a life sciences startup who spent most of her time managing spreadsheets and managing complex processes. Qualio helped orient Cindy and her team to meet regulations and scale successfully. Qualio is the first cloud QMS for the entire life sci...
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Qualio Technical Details

Deployment TypesSoftware as a Service (SaaS), Cloud, or Web-Based
Operating SystemsUnspecified
Mobile ApplicationNo
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Reviews and Ratings


Community Insights

TrustRadius Insights are summaries of user sentiment data from TrustRadius reviews and, when necessary, 3rd-party data sources. Have feedback on this content? Let us know!

Qualio is a versatile quality management system that offers a range of features to address various organizational needs. Users have found Qualio to be intuitive and easy to navigate, thanks to its user-friendly interface and navigation bar. The software's powerful search engine has been highly appreciated by users, enabling them to conduct audits, locate files, and compile 'where used' documents with ease.

One of the key use cases of Qualio is its employee training module. This feature allows users to track and manage employee training requirements effectively. The software automatically sends training assignment notices, ensuring that employees stay up-to-date with their training obligations.

Another advantageous aspect of Qualio is its customizable templates. Users find it easy to create, update, and apply templates in order to meet evolving quality management systems and regulatory requirements. This flexibility helps organizations keep their processes aligned with industry standards.

Furthermore, Qualio supports extensive linking capabilities, providing easy access to open tasks through individual employee dashboards. This feature streamlines workflow management and enhances collaboration within the organization.

In terms of compliance, Qualio offers a robust review and approval process using compliant e-signatures. This ensures regulatory compliance and helps organizations maintain their Document Control, Quality Event, Training, and Supplier Programs.

Additionally, Qualio continuously improves its capabilities by introducing new modules such as the supplier management module. These updates are communicated effectively through notices of changes in an audit trail and validation packets where appropriate.

System administrators also benefit from Qualio's user-friendly interface. They can easily manage employee additions, roles, and statuses within the software.

When it comes to document management, Qualio provides a centralized environment for creating managed documents and records. Users can easily collaborate on documents from anywhere since Qualio is cloud-based. This feature supports organizations in maintaining a paperless workflow and serves as their primary quality document resource.

Organizations across different industries can leverage Qualio for a variety of purposes such as implementing corrective actions, non-conformance reporting, employee training, and HR processes. The software is designed to support ISO 13485:2016 and 21 CFR 820 certifications for obtaining CE for EU and ARTG listing in Australia, making it suitable for medical device quality management systems.

Overall, Qualio serves as a comprehensive quality management solution that addresses various key challenges faced by organizations. Its user-friendly interface, customizable templates, extensive linking capabilities, compliance features, and cloud-based accessibility make it a valuable tool for maintaining quality standards and regulatory compliance.

Staged task module: Users appreciate the software's staged task module, which allows for the review and approval of individual stages of an activity. This feature has been mentioned by several reviewers as particularly useful for handling complaints and CAPAs.

Comprehensive training module: The training module in the software provides a comprehensive view of training completion by groups, individuals, and procedures. Many users have praised this feature for offering trending information and tracking overdue assignments.

Efficient document search engine: The software's search engine allows users to easily locate specific documents or groups of documents based on various criteria such as title, reference, template type, or attached tags. Several reviewers have mentioned how this flexibility and efficiency in document searching has been beneficial to their workflow.

Challenging Document Editor: Some users have found the editor for creating documents to be challenging and different from MS Word, leading to difficulties in formatting and navigating through the document. These challenges can slow down productivity and require additional time to learn how to effectively use the editor.

Inefficient Search Functionality: Several users have expressed frustration with the search function within the software. They have reported that it is not efficient and needs improvement. Users find it difficult to locate specific information or documents quickly, which can result in wasted time and decreased efficiency when using the system.

Lack of Mobile App: Many users have indicated their disappointment over the absence of a mobile app for accessing and working on documents while on-the-go. Without a mobile app, users are unable to conveniently access important documents or make updates when they are away from their computers. This limitation restricts flexibility and convenience for users who frequently work outside of traditional office settings.

Users commonly recommend considering all major players before making a decision and ensuring that the software is a good fit for their quality management system (QMS) needs. They suggest looking into all the features and having a complete demo to evaluate the software's capabilities.

Another recommendation is to use the self-hosted version of the software instead of the cloud version. Users also emphasize the importance of planning enough time for transitioning to the software. Additionally, they suggest using the sandbox to test out the software before making a purchase.

Users think that the software is easy to use and has a user-friendly interface. They also believe that it is competitively priced and offers a good value for streamlining certification processes. However, some users mention that while the software is suitable for documentation review and approvals, it may not be ideal for detailed deviations, investigations, and change control.

In summary, users recommend considering all major players, evaluating the software's features through demos, and planning ahead for transitioning to the software. They also highlight the ease of use and competitive pricing as favorable aspects of the software, while emphasizing its suitability for documentation review and approvals.

Attribute Ratings


(1-13 of 13)
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Maureen Njeru | TrustRadius Reviewer
Score 10 out of 10
Vetted Review
Verified User
Qualio enables us to create managed documents and records in a more integrated environment. With Qualio, we are able to create quality management documents such as forms, work instructions, policies, SOPs and other related content. Some of the key problems solved by Qualio in my organization include maintaining our Document Control, Quality Event, Training, and Supplier Programs.
  • Document control
  • Training
  • Integrating teams, processes, and documents throughout the organization
  • I would appreciate if similar documents are grouped together. For instance if engineering documents are put in one category and management document in a different category
  • Qualio has links to external documents but it would be helpful if it linked the user to sections within the document also
  • I would prefer that users be able to purchase licences directly without contacting a representative
Based on my experience, Qualio is best suited in aiding document control, supplier programs, training, team collaboration, and overall compliance, besides, Qualio is best suited for an organization that wants to eliminate the use of paper and bring a more easy system onboard. Essentially, Qualio is best suited to eliminate human error and creating a more effective quality management system.
Score 10 out of 10
Vetted Review
Verified User
My last company onboarded Qualio to assist with the maintenance of our Document Control, Training, Quality Event and Supplier programs
  • Supplier Control
  • Document Control
  • Event Notifications
  • Team Collaboration
  • Overall Compliance
  • Reporting exporting
  • Formatting of Documents
  • Nomenclature - allowing clients to use their own/already existing
Qualio did a great job in really controlling our QMS with less labor on staff to follow up for things needed in a timely manner.
Jen Baird | TrustRadius Reviewer
Score 8 out of 10
Vetted Review
Verified User
We use Qualio as a software medical device quality management system as well as a document management system for other quality and information security applications.
  • Is flexible enough to customize for use for different types of medical devices, enabling us to integrate it into our processes and support our quality automation initiatives.
  • Supports a distributed/remote workforce by enabling electronic record-keeping and signatures.
  • Generally supportive of the quality system regulations we are subject to.
  • The search function is poorly implemented and should be improved.
  • There is a tendency to rollout new features before they are robustly tested. We would prefer not to be the user acceptance testing.
Qualio is much better than a manual QMS system, especially for a distributed/remote workforce and for medical devices. It is flexible enough to adapt well to a pure software medical device. Qualio's strength is that it enables customization/adaptation to fit the users' needs and is not overly prescriptive in most cases.
May 31, 2022

Qualio User

Score 9 out of 10
Vetted Review
Verified User
The platform Qualio Is the Quality Management System used At the Dot Corporation, a contract Labeler / Manufacturer company, in the Fulfillment and Distribution department, to control the manufacture, labeling, and distribution processes, and aftermarket vigilance activities for medical devices and to maintain the organization's compliance with the ISO13485 and ISO 9001 Standards.
  • Qualio Plus offers excellent professional counseling and expertise in Regulatory and Quality assurance areas.
  • The platform is very intuitive and easy to use.
  • The reporting tools are excellent, easy to pull out reports of KPIs, and makes it very easy to read data.
  • By the time I used the platform one area that needed more development was the supplier management tools. This may have changed by now.
  • At the beginning the text editing tools were very limited.
  • No mobile app
For a small-sized company that is starting in a heavily regulated field like pharmaceuticals or medical devices, Qualio is without a doubt the best choice. It is very easily tailored to the organization's specific needs and the customer success teams are very professional and talented, they will make the adoption and deployment of the QMS a very easy task. It may be difficult for a bigger organization with a more embedded quality culture to transition to a system like Qualio as it has scalability challenges.
May 27, 2022

Quality is Qualio!

Score 9 out of 10
Vetted Review
Verified User
Good software for using QMS, easy to set up and use.
  • Qualio is a really simple and easy to use program.
  • Users require very minimal training to navigate the system.
  • Possibility of easily writing and editing documents from the software.
  • In the dashboard, you can see all of your pending and completed trainings.
  • The search tool is just not efficient.
  • A number of users have a maximum limit. It is not possible to select a seasonal employee or intern.
The user interface of Qualio is pretty simple. The Qualio Plus subscription is an excellent value. With users dispersed and working from different locations, a web-hosted QMS with a certified electronic signature is a necessity. For revision control, smart links eliminate the requirement for cross-references across documents. It's a good all-in-one QMS platform.
Drew Mateya | TrustRadius Reviewer
Score 10 out of 10
Vetted Review
Verified User
We utilize Qualio as our electronic quality management system. Prior to Qualio we had utilized a paper-based system and upgraded to Qualio. The reason we moved to Qulaio was to eliminate paper, bring an easy-to-use system in-house, and ultimately eliminate human error which can be a result of using a paper system.
  • Training
  • Document creation, reviews, revisions
  • Events (deviations, equipment complaints, customer complaints, etc.)
  • Reporting
  • An easy to use dashboard custom to each user
  • Qualio does not currently offer electronic batch record capabilities. However, we are still able to generate paper batch record and upload then into Qualio.
During my initial phase of selecting an eQMS system to utilize, we evaluated 4 systems and ended up selecting Qualio. I needed to select a system that was easy to use to ensure all employees could be trained quickly and so that the system had all of the major functions that any quality management system would require. We also required a system that could be validated and would hold up when audits are conducted.
Score 7 out of 10
Vetted Review
The company is a startup with no prior experience with medical device development or quality management. It is being implemented to support ISO 13485:2016 and 21 CFR 820 certifications for obtaining CE for EU and ARTG listing in Australia. The scope is a full implementation, training, and maintenance, and as a consultant, I have been given that responsibility.
  • Document and record control
  • Risk management
  • Design and Development
  • Attachment of records without need to change revisions or keep in Draft
  • Training records for groups
  • CAPA escalation process and review of metrics
Very suited to managing documents and records although cannot download word versions of documents and records but can with forms.
Well suited to managing D&D and risk assessments.
Not so good at managing training or suppliers.
Score 9 out of 10
Vetted Review
Verified User
Qualio is our primary electronic document management system. It houses our company's procedures and records and manages several regulated quality functions, such as complaint handling and CAPA. Because the software is part 11 compliant, it is compatible with our heavily regulated business. Users find it intuitive to navigate using the navigation bar, and the software employs a very capable search engine for conducting audits, locating files, and compiling "where used" documents. The business uses the employee training module that tracks and automatically sends training assignment notices. Since the training module is within the software program, any procedure update automatically triggers retraining when the option is selected. Custom templates are easy to create, update, and apply to keep up with evolving Quality Management systems and regulatory requirements. The software supports links extensively, including providing easy open task access through individual employee dashboards. A review and approval process is managed within the software using compliant e-signatures. New modules are introduced to continuously improve the capability of the software system. Our business is in the process of implementing a supplier management module. With updates to the software come notices of changes in an audit trail, and validation packets to support validations when appropriate. Employee addition, role, and status are readily managed by the system administrators.
  • The software has a staged task module that allows a review and approval of individual stages of an activity. This is very useful for complaints and CAPAs.
  • The training module provides a view of training completion by groups, individuals, and by procedures. It also provides trending information and tracks overdue assignments.
  • The dashboard is a personal view of all open tasks, what those tasks are, when the tasks are due, and provides a link to go directly to that task. It can be for a training assignment, a procedure to review or approve, or an open document draft under construction by the individual, for examples.
  • The search engine allows a search for a document or group of documents by a number of criteria, including part of the title, a reference in the document, the template type, and a tag that is attached (tags are configurable), as examples.
  • The editor for creating documents can sometimes prove challenging, as it operates differently than MS Word. Tables can be created but cannot be picked up and moved.
  • The document change history, which is on a separate tab in the document configuration, is sometimes forgotten by the person creating or updating a document. Although I personally like the arrangement of change history not being embedded within the document content, it would be good to steer people back through that history tab after editing a document, because not all changes may be captured initially when creating a new draft.
  • The metrics provided for training include open and overdue assignments in the calculation of completed assignments. I would like the option of considering just the overdue assignments in the metrics
This is one of the most user-friendly QMS programs I have used because it does not require lengthy training to navigate the system. We are able to bring on a new employee and have them start their own initial onboard training in Qualio with only a simple introductory message that shares a few key instructions. The available training in Qualio Help has proved very effective when needed. An individual can pick whatever training is appropriate at that moment and there will be instructions on demand on any topic related to Qualio operations. Qualio is relatively new software and is maturing with a responsive staff that releases new updates on a monthly, weekly, or even daily basis. It has grown incapability in the two years I have used it and it continues to evolve through customer inputs and looking at other state-of-the-art products. The staff listen and respond quickly compared to my past experiences with other QMS software. There is an opportunity for them to provide more and better features, but the gap is closing and the Qualio engineers have been very collaborative to work with, providing us opportunities to participate in their directions for growth.
May 19, 2022

Qualio Reviews

Score 8 out of 10
Vetted Review
Verified User
Qualio helps us create, manage and share documents easily on the cloud using a highly collaborative approach- no matter using it at work, from home, or on the go. Autosaving is also a helpful feature when working on documents to prevent potential loss of information, putting us in complete control of our documentation.
  • Quick to onboard and implement
  • Comprehensive document controls
  • Built in semantic and grammar checks
  • Limitations with search functionality
  • Lack of audits in some areas
  • Some formatting options
We use Qualio for creating, building, and sharing business documents in a matter of seconds while ensuring compliance related to ISO, also enabling business users to collaborate on the content simultaneously. The tool also helps us organise files, make them searchable and keep them accessible to the intended audience with complete control over file sharing and file editing.
Abraham Smythe | TrustRadius Reviewer
Score 8 out of 10
Vetted Review
Verified User
Qualio makes it easy to view and collaborate on documents, no matter if using it at work, from home, or on the go. Forms are used as an attachment to ensure easy printouts once approved. It also allows ensuring training is provided before the document becomes effective. It helps to be compliant as well. Being able to use Qualio has given us the ability to go paperless.
  • Signing Documents Remotely.
  • We are in charge of our documentation without limitations.
  • Organize our quality events and keep track of them.
  • Broaden our distribution abilities.
  • Complaint and Continuous improvement tracking and trend analysis.
  • Limited in users your subscription.
  • There should also be more detail for product or customizable categories.
  • The search function is not super efficient.
  • Formatting has always been a little different than what we are use to with Word.
  • The lack of 'track changes' when making edits to a document.
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 a lot of good information, up-to-date information. 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
Score 9 out of 10
Vetted Review
Verified User
It is the #1 cloud-based quality management system for life sciences and much more, Qualio replaces our legacy systems with a centralized, cloud-based single source of truth that's accessible from anywhere. Flexible workflows and templates give room to mature and scale your quality processes with our business and design controls, documents, training and more are all handled in a consistent way
  • It centralizes our biotech quality management system into a single source of truth.
  • Integrate teams, processes and documents from across our business, Apply customizable templates and workflows for flexibility without sacrificing efficiency
  • complete visibility of our quality landscape for airtight and constant compliance
  • SaMD teams, building with velocity and delivering quality are often opposing forces
  • With engineering teams in one system and quality teams in another, balancing speed and compliance throughout the product lifecycle is nearly impossible
  • We are often forced to make difficult choices about quality management: work across multiple, siloed modules, or slow down progress with a paper-based system?
Qualio makes it easy to manage pharmaceutical quality demands, from GxP to ICH, no matter how many products we have.With flexible workflows and templates tailored to our needs. And you’ll always be compliant with detailed reporting on training, change control and audit trails. Get our SaMD product to market quickly without sacrificing oversight and quality.
Gene Vought | TrustRadius Reviewer
Score 10 out of 10
Vetted Review
Verified User
We are using Qualio as our quality document resource. All of our processes, procedures, quality manuals, and work instructions are found here. We are finding more ways to use this awesome program every day. We implement corrective actions, non-conformance reporting, and employee training, which includes videos as well as PowerPoint presentations, HR processes, and information for employees. It is so versatile, we've created unique formats that make each type of document custom-tailored to fit with just what we need.
  • Custom document formatting. Make it your way!
  • Online customer service. Knowledgeable personnel that can help you with any question about Qualio in just a few minutes. Usually less than 15.
  • Keep track of all document changes and keeps a running master documents List with all the latest revisions.
  • Custom review and approval routing ability.
  • Online training for employees with automatic documentation of the training.
  • All and all this makes it very easy to be audited. And the external auditors give us all the credit.
  • The "Quality Events" are not included in the tasks to be done menu. This makes these documents not get the attention needed.
  • If you could group like documents together such as all engineering documents grouped together on one shelf and manufacturing on another, etc.
  • Links within a document. Qualio has links to other documents, but it would be very helpful in long documents to be able to link to sections within the document itself.
As a very customizable documentation software. It is awesome. With the tools they give you and the ease of training made available, you are up and running quickly. I had a 1-hour training after the purchase and by the next day, I had 15 procedures entered. Within a month, I had all 201 documents moved to Qualio, reviewed and approved.
Score 10 out of 10
Vetted Review
Verified User
Qualio is being used to store all of our regulatory and product development documentation. This allows for audits to run smoothly due to the ease of locating all of the essential documents as requested.
  • Allows for tags to be applied to each document for easy categorization
  • Automatically tracks when the documents have become effective and when they should be reviewed again for compliance.
  • The system allows for multiple people to be able to review and approve the documents to meet requirements and greater accuracy.
  • I would like to be able to purchase licenses without having to contact a representative.
  • Allows to send alerts for any training that have not been completed by X time
Qualio is highly recommended for small medical device companies that are still developing their quality and regulatory system. It is well suited for audits and maintaining all documents that are to be shared with the team and customers.
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