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Qualio

Qualio

Overview

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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Recent Reviews

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
Incentivized
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
Incentivized
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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Awards

Products that are considered exceptional by their customers based on a variety of criteria win TrustRadius awards. Learn more about the types of TrustRadius awards to make the best purchase decision. More about TrustRadius Awards

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Pricing

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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.

Entry-level set up fee?

  • Setup fee optional

Offerings

  • Free Trial
  • Free/Freemium Version
  • Premium Consulting/Integration Services

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Product Demos

Qualio Medical Devices Tour

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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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Comparisons

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Reviews and Ratings

(17)

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

Reviews

(1-13 of 13)
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Maureen Njeru | TrustRadius Reviewer
Score 10 out of 10
Vetted Review
Verified User
Incentivized
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.
Jen Baird | TrustRadius Reviewer
Score 8 out of 10
Vetted Review
Verified User
Incentivized
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
Incentivized
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
Incentivized
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
Incentivized
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
ResellerIncentivized
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
Incentivized
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
Incentivized
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
Incentivized
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
Incentivized
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
Incentivized
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
Incentivized
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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