Qualio

We can quickly access any office policy to support customers by searching with a single keyword. We advise new team members to use Qualio for instant and accurate policy and procedure information. I appreciate Qualio Team for this.

• Saves time on audits and keeps things organized.
• Depends on good internet; any downtime can hurt.

Microsoft 365, Keka HR, Microsoft Teams, SonicWall TZ

Qualio was used in our organization for a limited period of time. The system had originally been purchased in order to streamline processes and to create an electronic batch record. The organization had begun implementation of the document control module, but that is as far as we had gotten at the time of my arrival. We had also assessed training and custom modules as well.

• Negative impact: Cost and Time of Implementation
• Negative impact: Customer Support/Response
• Positive impact: Increased rigor when determining which site to replace qualio with.

Intellect QMS and SimplerQMS

NetSuite ERP, Intellect QMS, QuickBooks Commerce

We utilize Qualio for the management of all our quality documents, implementation of our training program, supplier approval, equipment-related documentation management, and investigation of quality events. Having all of these different services streamlined into one system has been a game-changer for us in terms of efficiency.

• We save time and money by getting so many needs met through one single system.

1LIMS

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.

• 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.

Agile CRM and OpenText Documentum

monday.com, Matrix, Slack

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 creation and review
• Collaboration
• Audit trails and employee training

• Qualio enabled my organization to creat a more effective quality management system that made work easier
• Speedy implementation because it does not require lengthy training to navigate
• It improved document sharing within the organization

Intellect, QT9 QMS, Q-Pulse QMS