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Automated Workflow

Configurable to Client Processes
The highly configurable and flexible workflow engine within the eNovator QMS allows the solution to be configured to specific clients requirements. This ensures that the in-house quality processes are replicated and completely automated.

Integrated PDF Forms
Tightly integrated to the automated workflows, are configurable PDF forms. The PDF forms are configured initially to match a clients current paper based documents, but can changed at any stage to meet improvements identified by the client as part of their continuous improvement process. By utilizing the PDF forms, the following functionality benefits associated with the forms are acquired:

customized report generation
archiving
automated report generation
searching.

Configurable Workspaces (Closed Loop Quality System)

Workspace Configuration
For the Quality Management Group within an organization, quality systems are spread across many different areas of the business. For example, there are CC’s, Audits (Internal and External), NCP’s, Manufacturing Projects and CAPA’s. Each of these has their own associated processes and procedures that need to be catered for. The eNovator QMS allows for such configuration through the use of different workspaces and specific workflows for each Quality System. However, they can all be integrated to ensure that the centralization, tracking, scheduling, reporting and monitoring can be done from a central point. This provides an organization with the Total Quality Management system, as it provides a "Closed Loop" approach to Quality Management.

21 CFR Part 11 Compliant
The eNovator QMS is designed to be 21CFR Part 11 compliant. It ensures that all Quality Management Requirements from an FDA perspective are fully met whether it be process, document, task or reporting related.

Task Management

Automated Task Assignment
eNovator QMS has the ability to automate all activities associated with task management through a flexible and configurable workflow engine. The solution can automate the assignment, reporting, completion, approval, notification and reporting of all tasks across the different quality workspaces according to a clients project management processes and FDA compliance requirements. The assignment of tasks can be done through an individual or through groups, while also facilitating the delegation and simultaneous review of tasks.

Report

Configurable Reports
The reporting capabilities within eNovator’s QMS are very powerful. A highly configurable reporting tool allows the user to generate specific reports of interest across the various quality workspaces within the system. The solution also contains a library of pre-configured reports that can be utilized and added to by the clients. Access to the reporting section is Role based.