Assemblies for eCTD 4.0

An assembly is the logical bill of materials (BOM) or dossier as represented in a publishing product interface that represents one sequence.

When you create an assembly, you specify attributes like due date, owner, and output location. Some of these attributes are required, others are optional, and still others default to preconfigured values.

You must have the following modules to perform assembly activities:

— Electronic Lifecycle Publishing (ELP)

— Submission Planning and Tracking (SPT)

— Registered Document Analysis (RDA)

— Paper Review Publishing (PRP)

Create Assemblies

You can create a new empty assembly and then add the folders, leaf elements and assigning documents to them, or you can create an assembly from another entity. When you create an assembly from a template, an existing assembly, an application view or an assembly file many of that entity's attributes are inherited by the new assembly.

For details, see the following sections:

— Assembly Templates

  • Create an Empty Assembly Template
  • Create an Assembly Template from a Template, Assembly, or View
  • Use the Search Tab to Locate an Assembly
  • Create an Assembly from an Assembly File

— Sequence Assemblies

  • Create an Empty Sequence Assembly
  • Create a Sequence Assembly from a Template, Assembly, or View
  • Use the Search Tab to Locate a Sequence Assembly
  • Create a Sequence Assembly from an Assembly File

Build Assemblies

When you build an assembly you create its structure. You can add the folders, leaf elements, documents and document placeholders that make up the hierarchical content of the assembly. Throughout the life of the assembly, it may go through numerous changes and updates.

Delete Assemblies

Only an administrator can delete assemblies.

Ennov InSight Publisher 7.3: eCTD 4.0 Assemblies for eCTD 4.0