KineMatik’s Quality Management System (QMS), part of the eNovator Application Suite, is fully configurable to comply with the latest government requirements and recommendations. The system can be configured to be 21 CFR Part 11 and DoD 17025 compliant thus ensuring that you are prepared to meet audit and compliance regulations.
Many government organizations and contractors currently have existing processes in place to manage all their quality requirements. eNovator has been specifically designed to ensure that those processes can be mapped into eNovator and utilized to create a seamless integration with OpenText Content Server and your other electronic systems. The QMS is also fully configurable in order to comply with changes to regulatory requirements and to easily align the system with existing quality processes.
- Manage multiple quality processes - Configurable workspaces. Typically organizations find it hard to manage a single quality process, let alone multiple. The QMS application allows multiple quality systems to be configured along with their respective quality processes, forms and workflows. This allows each quality system to have its own independent workspace and processes, in one centralized system. This approach is scalable and highly flexible in support of your quality systems such as:
- Corrective Actions and Preventative Actions (CAPAs)
- Non-conforming Product (NCP)
- Internal and External Audits
- Customer Complaints (CC)
- Change Management
- And more…
- Avoid warnings and penalties with real-time quality reporting - Task management and automated reporting. 50% of all FDA warnings are CAPA related due to the fact that tasks associated with CAPA’s are never fully resolved by their due dates. This is primarily attributed to the challenge of tracking and reporting on quality tasks across different groups and functional areas. The KineMatik QMS has reporting capabilities that allow for the reporting on any Quality Record (e.g. CAPAs) across various sources (NCP, Audits and Customer Complaints), date ranges, employees and project tasks and more, which allows organizations to manage all Quality Management activities and reporting on a real-time basis.
- Support even your most complex workflows and assign tasks to the right person/group ever time - Configurable, automated workflows. The KineMatik QMS’s powerful workflow engine allows highly complex and scalable quality processes to be implemented and automated. These workflows are configured to mirror processes that you may currently use, or to implement new processes that you are currently designing. Workflows can be automated to ensure that tasks are assigned to the correct person improving efficiencies across the organization. Workflows can be configured using simple drag and drop functionality. The system also allows you to replicate your current forms to ensure continuation of internal best practices.