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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.

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  • Setup fee optional

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  • 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

(1-2 of 2)
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Gene Vought | TrustRadius Reviewer
Score 10 out of 10
Vetted Review
Verified User
Incentivized
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.
  • The old system we used was homegrown. It was 25 years old and it took 50% of my time to maintain, was very time consuming to make changes to documents, and it often broke down when you did. It required many hours to troubleshoot what went wrong. With Qualio, I've not had any problems. I've been able to spend the time I used in maintaining the old program, to concentrate on Quality improvement activities to further increase productivity with the company.
  • Every year when I'm audited by our 3rd party auditing company, I get caught with documentation problems. Everything was done manually. I'd make a change to a document and have to remember to make the note in the master document list. When things got busy, sometimes this didn't happen. But with Qualio, the master document list is automatically updated, and even more, the document being changed is now recorded in an archive with every change ever made. I don't have to worry about keeping updates on master lists or old revisions archived, which saves another bunch of time I can spend doing productive things instead of bookkeeping.
  • In the past, keeping a active Risk register was a real problem. Management didn't see the value vs the efforts that had to be spent managing it. But after creating a quality event for maintaining a risk register that management can edit in their meeting and it keeps records of all the changes being made, they have come to value the risk register we've created in Qualio as a great asset tool that they go through each week in a management meeting. That solved another great problem for me during an outside audit when it came to risks and opportunities.
We looked at 2 other systems. I'm sorry, but I don't remember what they were. But the reason Qualio stood out for us was the versatility and customizability it had. We could tailor it to be more like the way we wanted to look and feel. The others said that some of the aspects that we wouldn't need or want to see in our documentation were just built-in and couldn't be changed or removed. Qualio allowed us to custom build the documentation as we wanted, without any sections we didn't need or require.
Two great things Qualio has for customer support. 1. They are available online and on the phone, if needed, 24/7 with very friendly and knowledgeable people. Usually, the wait is no more than 10 or 15 min, and while you wait, you can search their online help library. I used to call first, but now I've found that their online help library usually has he answers already and the instructions are clear. Usually, I learn more than I needed. So I now go there first and only call if I don't find anything in the online help library.
Score 10 out of 10
Vetted Review
Verified User
Incentivized
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.
  • Its reliable platform contributed to the attainment of ISO 13485:2016.
  • Substantially improved the organization of documents and training
The representatives are very responsive and easy to contact when needed!
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