eNovator's Quality Management System

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Now more than ever, companies are striving to implement efficient information management solutions to ensure that they comply with all regulatory requirements. This is further complicated by the current paper based and disconnected electronic systems used in most organizations. For people responsible for Quality Management, it is a constant challenge to manage and control the current processes. The solution to the many problems related to compliance and quality lies in the implementation of an integrated, enterprise-wide quality management system that encompasses all aspects of Quality Management. This is eNovator’s Quality Management System (QMS), the only solution to provide a Quality Management System that will map, control and manage all areas of quality within your organization

Configurable Quality Management Workspaces
There are many areas in an organization that are governed by Quality Management Processes (CAPA, NCP, etc.). eNovator’s QMS allows these areas to be configured within the solution along with their respective quality processes. This allows the Corrective Actions and Preventative Actions (CAPAs), Non-conforming Product (NCP), Internal and External Audits and Customer Complaints (CC) to have their own independent workspace and processes, as well as providing the ability to centralize the Quality Management System. Sources for all processes can also be configured ensuring the causes of all Quality Records are captured. This configurable approach provides an organization with a completely scaleable and highly flexible solution.

Task Management and Automated Reporting
The FDA report that 50% of all warnings are CAPA related. This has been attributed to the fact that the tasks associated with CAPA’s are never fully resolved by their due dates. This is primarily due to that fact that is very difficult to track and report on tasks for across different groups, functions, sites and people. eNovator’s QMS provides the solution for managing all Quality Management activities and reporting on a real-time basis. The eNovator QMS has reporting capabilities that allows for the reporting on Quality Records (e.g. CAPAs) across various sources (NCP, Audits and Customer Complaints), Date Ranges, Employees and Project Tasks, to name but a few.

Workflows and Forms
The powerful workflow engine of eNovator’s QMS allows highly complex and scaleable quality processes to be implemented and automated. The Quality workflows can be associated to individual or integrated multiple workspaces. For example, a Customer Complaint would feed into a CAPA and its associated workspace. In addition, eNovator’s QMS contains configurable electronic forms that can be tailored to meet individual clients quality processes requirements and are integrated into automated workflows.

Benefits Overview