Life Cycle

Life cycle enables you to track changes you make to a submission as it progresses through the approval process. When you are ready to submit an application to a regulatory agency for approval you must lock it to prevent additional 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 the drug's life for that application. The life cycle and change tracking in the life cycle are compliant with the ICH eCTD specification.

When you lock and add the first sequence assembly to life cycle, it becomes the finalized assembly. Keep in mind the following:

— Any assembly versions are rendered non-useable after you add the first sequence assembly to life cycle.

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

When the application life cycle contains only the first finalized life cycle assembly, the submitted view and sequence view look the same. After you add another assembly life cycle, the sequence view and the submitted view differ.

— 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 These changes can include new folders, leaf elements, documents and document placeholders, appended, withdrawn and replaced leaf elements, and deletions. 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 snapshot of the application's submitted view when the current sequence was created. If additional parallel sequences are created in the application, their changes are not included in the working view for the sequence.

— Only envelope information that is added to a life cycle will carry through to newly created life cycle assemblies. Planned life cycle assemblies created from a specific submitted view will not upgrade to the latest submitted view: they will not be placed in the context of the latest sequence until they are added to a life cycle, and they will not contain more recently added EU envelope information. However, any sequence added to a life cycle that shares leaf replaces with other sequence(s) in the same application will always have assigned the correct modified file for published output.

— The application's sequence view 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 what will be submitted as part of that sequence.

— Once there is a life cycle, you can create several supporting sequences. These can be separate assemblies that have no relation to the application life cycle, but instead support it. For example, you might create a Clinical Study Report to support an existing life cycle, or perhaps a paper reviewer's copy of the an eCTD sequence.

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

— If you are adding documents from a DMS (such as Documentum), you must log on to the DMS before you can add a sequence assembly to a life cycle.

Ennov InSight 7.2 Publishing

Working Assemblies and Assembly Specific Publishing Settings Library (APL)

Note: When using the Duplicate command on a folder that contains leafs with life cycle append operations, the duplicated structure is "flattened" and the appended documents are displayed as siblings (rather than as children) of the original source document.

Until a submission is added to a life cycle, the workflows associated to assembly nodes are displayed under the Working, Sequence and Publishing views of the sequence assembly. When a submission is added to a lifecyle, 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 and Publishing View of the life cycled assembly.

Life cycle procedures are applicable to the following Ennov InSight modules:

— Electronic Lifecycle Publishing (ELP)

— Registered Document Analysis (RDA)

— Submission Planning and Tracking (SPT)