KineMatik Quality Management
Kinematik’s Quality Management module is fully configurable to comply with the latest regulatory requirements, thus ensuring audit and compliance regulations are maintained. Many organizations have existing processes in place to manage all their quality requirements. The QMS has been specifically designed to ensure that those processes can be electronically mapped and managed within Content Server. There are also out-of-the-box industry standard processes for those companies who need to get up and running quickly.
- Configurable workspaces. Typically organizations find it hard to manage a single quality process, let alone multiple. Kinematik’s QMS module allows multiple quality systems to be configured along with their respective quality processes, forms and workflows. This configurable approach provides an organization with a scalable, highly flexible solution.
- Task management and automated reporting. 50% of all FDA warnings are CAPA related due to the fact that tasks associated with CAPA’s are generally not resolved by their due dates. This is primarily attributed to the challenge of tracking and reporting on tasks across different groups. The Kinematik QMS allows all Quality Management activities to be reported on, in real-time.
- Relationships between Quality Records. The association of quality records to their source (e.g. other quality records, projects, protocols) allows for genealogies to be viewed. This allows for a greater understanding of where issues arise and ensures that quality processes can be improved based on the true root causes.
- Configurable, automated workflows. Integration to Content Server’s powerful workflow engine allows highly complex and scalable quality processes to be implemented and automated. Workflows can be automated to ensure that tasks are assigned to the correct person improving efficiencies across the organization. The system also allows replication of existing current forms to ensure continuation of internal best practices.