eNovator’s Quality Management module is fully configurable to comply with the latest regulatory requirements, thus ensuring that you are prepared to meet audit and compliance regulations. Many organizations 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 into an electronic system. There are also out-of-the-box industry standard processes for those companies who need to get up and running quickly.

QMS Module Benefits

  1. Configurable workspaces. Typically organizations find it hard to manage a single quality process, let alone multiple. eNovator’s QMS module allows multiple quality systems to be configured along with their respective quality processes, forms and workflows. This allows the Corrective Actions and Preventative Actions (CAPAs), Non-conforming Product (NCP), Internal and External Audits and Customer Complaints (CC) etc. to have their own independent workspace and processes, in one centralized system. This configurable approach provides an organization with a scalable, highly flexible solution.
  2. 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 tasks across different groups, allows you to manage all Quality Management activities and reporting on a real-time basis. eNovator’s reporting capabilities 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, to name a few.
  3. Configurable, automated workflows. eNovator’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. eNovator 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.