Review of Qualio for Regulated Industries
May 24, 2022

Review of Qualio for Regulated Industries

Barbara Young | TrustRadius Reviewer
Score 9 out of 10
Vetted Review
Verified User

Overall Satisfaction with Qualio

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
  • Part 11 compliant software, with all the requirements, covered--a must-have in a regulated industry such as medical devices.
  • Flexibility in the organization of the QMS, providing broad control for establishing the hierarchy, formatting, and identification of the documentation through template configuration, which is so important in this industry.
  • Validation support for software updates and addition of new features.
  • Economical even for a small company, and that allows for incremental growth
  • Qualio software provides the necessary support for a very small company, with very limited, though talented, QA/RA resources, to achieve MDSAP certification in under a year from the start of a quality management system.
  • The improvements that have come along in the Qualio software have allowed the same quality staff to continue supporting required quality functions through leaner workflows while the company doubled in size.
  • The quality staff is actively working to replace a software development tool through the transfer of those tasks performed by the tool to a newly added Qualio feature, thus reducing overall costs by eliminating the tool.
Qualio is more intuitive to use and more economical for a small enterprise. I was not working for the company at the time it was selected, although I have experience with several other QMS systems and found Qualio to have some unique properties, such as the configurable templates and strong search engine.

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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.