Working Assemblies

From Submitted view you can create working assemblies to incorporate updates and changes for the next regulatory activity. These sequence assemblies are referred to as working assemblies, the assemblies you are working on in the lifecycle.

You can update a working assembly in the working view. In the working view, normally the modified file and operation attributes cannot be changed; changes are managed by the lifecycle change control process. In some cases, it may be necessary to change these values. In such a case, an administrator may use the Reset and Change Modified Leaf options on individual leaf elements to make changes. Ennov InSight calculates the correct modified file values based on the specified leaf element.

Working Assemblies and Assembly Specific Publishing Settings Library (APL)

When a working assembly is created, it copies the APL of the submitted view and it updates the submitted view to use the new copy of the APL. The previous sequence view still uses the previous APL. When you create multiple working assemblies, the submitted view is updated to the last created working assembly.

Working Assemblies Created from the eCTD 3.2 Assemblies

You can create the eCTD 4.0 working assembly from the locked eCTD 3.2 assembly submitted view. See: Submissions >Create Working Assembly from Locked eCTD 3.2 Assembly section.