Qualsys’s software is used by medical device organisations and pharmaceuticals to systematically plan, manage and record all data and documentation in a logical, easy to use and scalable system.
Our powerful solution provides a framework for:
- Planning and managing all processes and policies
- Collaboration and communication
- Reducing compliance burden
- Traceability , CAPA and competency management
- Instant reporting
Assign roles and responsibilities
Use notifications and workflows to assign roles and responsibilities to individuals.
Manage employee competency
Manage competency and systematically maintain training records using the Training Record Manager module.
Manage any type of document, including Design History Files, traceability matrices, and technical drawings.
Demonstrate good governance
The system provides a central system for leadership to see dashboards, visual displays and data reports for a complete picture of the health of the business.
Manage documentation such as the study plan and final report in Document Manager. Version control, audit trails and electronic signatures make demonstrating compliance natural and easy.
Qualsys supports you throughout the entire computer system validation process.
Read how Qualsys helps you to manage your entire validation masterplan, from developing your User Requirements Specification to establishing an efficient process for re-validating your system when your business processes change.
Discover how the requirements of GDocP can be applied in each of Qualsys’s software modules.