Assembly Templates

An assembly template enables you to set up an assembly structure that you can use to create similar assemblies. The template can include the elements and metadata that are common to the assemblies you create.

You must have any of the following modules to perform assembly template activities:

— Electronic Lifecycle Publishing (ELP)

— Registered Document Analysis (RDA)

— Submission Planning and Tracking (SPT)

— Paper Review Publishing (PRP)

Create an Assembly Template

You can create an assembly template by using the New menu or by using existing assembly elements.

On the Ennov InSight New menu, click Assembly Template to create an assembly template from one of the following sources:

— New (Empty) - to create a new template containing no existing assembly elements

— Existing Template, Assembly or View - create a new template from an existing template or assembly, or from a current or active view

— Assembly File - create a new template from an assembly or view that has been exported as an XML file — Virtual Document - create a new template from a Documentum virtual document

Using a template, an existing assembly, or a virtual document to create a new assembly template streamlines the process because existing attribute values are inherited by any new assembly you create. A template or an existing assembly can contain publishing settings, the assembly structure, the hierarchical order of folders and leaf elements, documents, document placeholders, publishing elements, and default mappings to DMS attributes for leaf and study report attributes. This minimizes the need for you to enter data already captured in the DMS.

Note: When creating a new assembly template, from an assembly file, if the repository path in Technical Administration does not relate to any location within assembly file, the location path will not be populated.

Create an Empty Assembly Template

You can create an empty assembly template from the home page. An empty assembly template provides the structure for a new assembly without existing documents.

Note: To create an assembly template, you must have the appropriate security privileges.

To create an empty assembly template:

  1. On the home page, click New > Assembly Template.
  2. On the Create Template page, select New (Empty) to create an empty assembly template.
  3. Click and select the Publishing Settings Library to use with the assembly template.
  4. Save.

    The Create Assembly window appears.

  5. Enter attribute values for the assembly template.

    Note: The Created From attribute is always blank.

  6. Click Create.

Create an Assembly Template from a Template, Assembly, or View

You create an assembly template from an existing template, assembly, or a submitted or approved view.

The existing attribute values of the selected element is inherited to the new assembly template, minimizing the need for you to enter data.

To create an assembly template, you must have the appropriate security privileges.

To create an assembly template based on a template, assembly, or a submitted or approved view:

  1. On the home page, click New > Assembly Template.
  2. On the Create Template page, click Existing Template, Assembly or View.
  3. Click Browse to find and select the template, assembly, or view using the Search Assembly Wizard.
  4. On the Search Options window, choose an assembly type from the Assembly Type to Search list, and click Next.
  5. On the Assembly Query Parameters window, use Search to find an assembly, or you can choose an assembly from one of the other tabs: Assembly Templates, Standalone Assemblies, Sequence Assemblies, or Views.

    — Columns in the grid can be sorted in ascending or descending order using the options for each column heading.

    — Columns in the grid can be shown or hidden using the options for each column heading.

    — Move your pointer over a column heading and click the arrow next to the heading name to view the options.

  6. Select an assembly and click OK.

    On the Create Template window, the assembly you selected appears in the Browse field.

  7. Choose a Use Source Assembly Publishing Settings Library option:
    Option Description
    Yes : The new assembly template inherits the Publishing Settings Library used in the source assembly you have selected. Selecting Yes also provides the option to Import Publishing Elements (choose Yes or No).
    No : You must select a PLT from the Publishing Settings Library field that appears when you choose No.

    Note: If an Approved View is selected as the source assembly for creation, the Publishing Settings Library option will appear in place of the Use Source Assembly Publishing Settings Library option. Choose a Publishing Settings Library from the list.

  8. In the Retarget Copied Reference Leafs field, set the option for reference leafs in your new assembly template:
    Option
    Retarget Copied Reference Leafs
    Preserve Copied Reference Leafs
  9. Save.
  10. On the Create Assembly window, enter a name for your new assembly and enter attribute values for the assembly.

Note: Priority numbers in eCTD 4.0 assembly correspond to the source assembly number and cannot be recalculated.

Use the Search Tab to Locate an Assembly

When creating a new assembly template from an Existing Template, Assembly or View, you can use the Search tab options to locate an assembly.

  1. On the home page, click New > Assembly Template.
  2. On the Create Template page, click Existing Template, Assembly or View .
  3. Click Browse to find and select the template, assembly, or view using the Search Assembly Wizard.
  4. On the Search tab, choose an assembly type from the Assembly Type to Search list, and click Next.
  5. On the Assembly Query Parameters window, set your search parameters and click Next.
  6. On the Matching Assemblies window, select an assembly.
  7. After selecting an assembly, click Next.
  8. On the Selected Assembly window, click OK.

    On the Create Template window, the assembly you selected appears in the Browse field.

  9. Choose a Use Source Assembly Publishing Settings Library option:
    Option Description
    Yes : The new assembly template inherits the Publishing Settings Library used in the source assembly you have selected. Selecting Yes also provides the option to Import Publishing Elements (choose Yes or No).
    No : You must select a PLT from the Publishing Settings Library field that appears when you choose No.

    Note: If an Approved View is selected as the source assembly for creation, the Publishing Settings Library option will appear in place of the Use Source Assembly Publishing Settings Library option. Choose a Publishing Settings Library from the list.

  10. In the Retarget Copied Reference Leafs field, set the option for reference leafs in your new assembly template:

    — Retarget Copied Reference Leafs — Preserve Copied Reference Leafs

  11. Save.
  12. On the Create Assembly window, enter a name for your new assembly and enter attribute values for the assembly.

Create an Assembly Template from an Assembly File

When importing an assembly file, the documents in the file are not synchronized automatically with the mapped

DMS.

They appear as placeholders, which prevents import failures if the referenced DMS does not exist in the current system. You must run a DMS synchronization immediately after importing to assign placeholders automatically to the DMS documents.

Note: You must have the appropriate security privileges to create an assembly template.

To create an assembly template based on an assembly exported as XML to an assembly file:

  1. On the home page, click New > Assembly Template.
  2. On the Create Template page, click Assembly File.
  3. To find the assembly file, click Browse and do either of the following:
    Option Action
    On the Documents tab, navigate to the assembly file: Click OK.
    On the Search tab, find the assembly file: Click OK.
  4. For Use Source Publishing Settings Library, click Yes or No to indicate whether the new assembly template will use the publishing settings library that the source assembly uses.
    Option Action
    If you clicked Yes, then for Import Publishing Elements: Click Yes or No to indicate whether the new assembly template will use the publishing elements that the source assembly uses.
    If you clicked No for Use Source Publishing Settings Library, then: Click the publishing settings library that the new assembly template will use.
  5. Save.

Create an Assembly Template from a Virtual Document

You can create a standalone assembly template based on an assembly exported to a Documentum virtual document.

Note: To create an assembly template, you must have the appropriate security privileges.

To create a assembly template from a virtual document:

  1. On the home page, choose New > Assembly Template.
  2. On the Create Template page, click Virtual Document.
  3. To find the virtual document, click Browse and do either of the following:
    Option Action
    On the Documents tab, navigate to the virtual document: Click OK.
    On the Search tab, find the virtual document: Click OK.
  4. Click the publishing settings library to use with the assembly template.
  5. Save.
  6. Enter attribute values for the assembly template.
  7. Click Create.

Assembly Template Attributes

You can use the assembly template attributes and descriptions to enter attribute values while creating assembly templates.

Attributes marked with an asterisk (*) are mandatory.

Attribute Description
Assembly Type*

Defines the output type of the Assembly. Required. The default eCTD. When set to eCTD, all folder names, file names, and paths are normalized during publishing.

When set to CN eCTD, all folder names, file names, and paths are normalized during publishing, but underscores are not replaced.

When set to US eCTD, all folder names, file names, and paths are normalized during publishing, but capital letters and underscores are not replaced.

When set to Standard, all paths are based on the entries for the output folder and file. All output files will maintain the original context of the source:

— Source document name = Tabular_Listings-1.pdf

— eCTD name = tabular-listings-1.pdf

— CN eCTD name = tabular_listings-1.pdf

— US eCTD name = Tabular_Listings-1.pdf

— Standard name = Tabular_Listings-1.pdf
Auto Populate Output Folder Determines whether the Output Folder attribute of a folder is populated with the name of the object used to create the folder when a vdoc structure, folder structure, Veeva binder, or Veeva section is assigned to an assembly.
Auxiliary Output Location Alternate location for saving a published version.
Category High level category associated with the assembly. The available Subcategory options are dependent on the selected category.
Comments Comments about the assembly.
Create Leaf Elements Determines if leaf elements are created automatically when you assign documents to assemblies you create from the template, as when using a dragand-drop action to add files into folders. Default is Yes.
Created From The name of the Assembly that was used to create the current Assembly. This field is blank if no Assembly was used to create the current Assembly.
Creation Date The date the assembly was created.
Attribute Description
Default Binding Rule

The binding rule that will be applied to documents from the DMS assigned to assemblies created using the template.

— Bind to Label binds documents to a label you choose.

— Bind to Status binds documents to a status you choose.

— Bind to Version binds documents to the version number you enter.

When you create a template from a virtual document or you assign a virtual document to a template, no warning is displayed if the virtual document contains binding rules that are not defined in Ennov InSight by the administrator.
Description Text that describes the assembly.
Due Date The date the assembly is due to be complete for submission.
Electronic Output Location The specified storage location for electronic output.
Keywords Words you can use to search for the assembly.
Last Repository Data Retrieval The date the last DMS Sync was executed. View only, not available for editing.
Lock Indicator Indicates if the assembly has been locked. If the standard lock has been applied to the assembly, set to Yes.
Name* Name of the assembly, which appears in the assembly tree.
Owner Person responsible for the assembly.
Paper Output Location The specified storage location for paper output.
Reference Location (SPT only) The location within the DMS of a reference to the assembly. If you try to create a reference location in a repository folder to which you do not have access, a message informs you that you do not have permission to write to the folder. This field is populated automatically when Set Reference Location is selected from the More menu, after an Assembly has been created.

Reference Location

Name

 The name of the reference object.
Status The current status of the assembly. Default is In Draft (unless modified in Data Administration - Assembly Status Values). Can be updated using Update Assembly Status.
Status Date The current status date of the assembly. Default is Date of Assembly Creation.
Subcategory The subcategory to further classify the assembly.
Attribute Description
Version Number (SPT only) Indicates the version of the assembly. Default is 1.0, CURRENT.

Modify an Assembly Template

You can modify the assembly template attributes to create additional, reusable assembly templates.

You can also set default folder and leaf attributes for the assembly and specify the referenced DTDs/schemas for assembly publishing.

Note: The assembly attributes that you can modify depend on your security privileges.

To modify an assembly:

  1. Click a link for the assembly template you want to modify.
  2. Click Edit.
  3. On the Edit Assembly page, enter your changes.
  4. Save.

Delete an Assembly Template

Only an administrator user can delete an assembly template.

To delete an assembly template:

  1. Click the link for the assembly template you want to delete.
  2. Click Delete.
  3. When you are prompted to confirm the deletion, click OK.