Life Cycle

Life cycle enables you to track changes you make to a submission as it progresses through the approval process.

When an application is ready to be submitted to a regulatory agency for approval, you must lock it to prevent further unsolicited changes. In addition, because the regulatory agency may require changes throughout the approval process, Ennov InSight enables you to track changes as they occur. You do this by creating a life cycle. A life cycle begins with the first sequence you submit for approval and continues through each additional sequence until the end of life of a drug for that application.

When you lock and add the first sequence assembly to a life cycle, it becomes the finalized assembly.

Note: the submitted view of an application is the accumulation of all sequence assemblies that have been added to the life cycle for an application. The submitted view, like all views, cannot be changed.

When an application life cycle contains only the first finalized life cycle assembly, the submitted view and sequence view look the same. The distinction between the sequence view and the submitted view is noticeable after another assembly life cycle is added.

— The working view is the submitted view plus any changes you have made. These changes can include new folders, leaf elements, documents and document placeholders, replaced (as one to one, one to many and many to one) and suspended elements. Sections of the working view that were added to life cycle in previous sequences (that is, the submitted view) cannot be changed. The working view initially represents a submitted view snapshot of an application when the current sequence is created. If additional parallel sequences are created in the application, the changes are not included in the working view for the sequence.

— The sequence view of an application contains only the changes that comprise the current sequence. As changes are made to the working view, these changes are reflected in the sequence view that represents exactly that which will be submitted as part of that sequence.

— You can add only assemblies with leaf elements to a life cycle. Leaf elements represent the final, published documents. You can use assemblies without leaf elements for study reports or paper output, but you cannot use them for eCTD that requires a document life cycle.

Until a submission is added to a life cycle, the workflows associated to assembly nodes are displayed under the Working and Sequence views of the sequence assembly. When a submission is added to a life cycle, the incomplete workflows associated with the assembly nodes are canceled. All current activities of the canceled workflows are deleted. All canceled and completed workflows for the sequence assembly will be available from the Sequence View of the lifecycled assembly.

Lifecycle procedures are applicable to the following Ennov InSight modules:

— Electronic Lifecycle Publishing (ELP)

— Registered Document Analysis (RDA)

— Submission Planning and Tracking (SPT)

Ennov InSight Publisher 7.3: eCTD 4.0 Move an Assembly Element