Configuring Bundling & Splitting

Vault provides wizards that allow users to bundle multiple Activity or Regulatory Objective records into logical groups for future submission to Health Authorities. Users can also split bundled activities and regulatory objectives to create separate activities, submissions and regulatory objectives. These wizards ensure that related records are updated when bundling or splitting occurs, reducing the risk that users overlook update tasks and headquarters loses traceability.

The bundling wizards are particularly useful when an organization initiates changes at the headquarters level that affect country-level teams. The country-level teams can bundle multiple global activities along with local changes to reduce the overhead of multiple submissions.

When changes are bundled, it is possible that Health Authorities will reject some changes, or that pending labeling changes must be deferred and tracked separately from completed ones. The splitting wizard helps users to separate the unapproved or incomplete changes from the approved or completed changes, helping to ensure global traceability of their status.

Prerequisites

Before starting configuration, you must:

  • Verify that the Activity and Regulatory Objective objects in your Vault use object lifecycles. If either does not, you will need to set one up. The lifecycle does not need to be complex; a simple two-state lifecycle is sufficient.
  • Set the Enable Activity and Objective Bundling & Splitting checkbox from the Admin > Settings > Application Settings page. Once you enable this setting, you cannot disable it. See Settings below and RIM Application Settings & Configuration Options for information about additional bundling and splitting configurations.
  • Verify that your Vault uses the Submission Regulatory Objective join object. If this is not already set up, you’ll need to inactivate the Regulatory Objective field (regulatory_objective__rim) on the Submission object (submission__v). Then, update the Submission object page layout to display the Submission Regulatory Objective > Regulatory Objective join object and remove the Regulatory Objective field (now inactive). You will also need to modify or recreate any reports in your Vault that rely on the Regulatory Objective field.

Configuration Overview

You must complete the following steps to fully configure this feature:

  1. Configure the Bundle Activities user action on one or more of the Activity object lifecycle states. This allows users to initiate the bundling wizard. If needed, use Action Level Security to control which users can access the action.
  2. Configure the Start Splitting Process user action on one or more of the Activity object lifecycle states, for example the In Progress state. This allows users to initiate the splitting wizard. If your organization plans to split only Activities related to Labeling Concepts, you can configure the action conditionally, for when the Activity object’s Labeling Impact field equals Yes. If needed, use Action Level Security to control which users can access the action.
  3. Configure the Bundle Regulatory Objectives user action on one or more of the Regulatory Objective object lifecycle states. This allows users to initiate the bundling wizard. If needed, use Action Level Security to control which users can access the action.
  4. Configure the Split Regulatory Objectives user action on one or more of the Regulatory Objective object lifecycle states. This allows users to initiate the splitting wizard. If needed, use Action Level Security to control which users can access the action.
  5. Review the Bundling/Splitting Results (rim_bundling_splitting_results__v) notification from Admin > Configuration > Object Messages. This is the notification template that Vault will use to notify users who initiate the wizard of the results of the bundling or splitting action. If editing, be sure not to modify the tokens included; these tokens allow notification recipients to access the results of the wizard actions.
  6. Add the Reviewing Country and Worksharing Tracking Number fields to the Regulatory Objective object page layout.
  7. Optional: Enable system-managed object record naming on the Application Regulatory Objective object. Vault creates these records as part of the bundling and splitting processes. Vault also automatically creates Application Regulatory Objective records when a user creates a new Regulatory Objective record with the Application field populated.
  8. Optional: Configure Object Type Mapping to allow users to bundle activities or regulatory objectives for both drug products and medical device products.
  9. Optional: Enable Application relationships to reference Application relationship records when bundling.

About Object Type Mapping

Vault uses object type mapping to determine which object types to use for Submission or Regulatory Objective join records depending on the object type of Application related to the source record. This is especially important for objectives and submissions with a combination of drug product, medical device product, and packaging details. It is also important for Unique Device Identification (UDI) and shelf life details, which have multiple object record types that can be included on the same submission or regulatory objective, such as Device Description and Device Intended Use, which are both Submission Regulatory Text object types.

You can download a sample set of mappings for drug and medical device object types. This setup ensures that the correct details will be carried over to Submission and Regulatory Objective join records for drug products or for medical device products. You may create similar mappings for custom source Application object types or custom object types on target Submission and Regulatory Objective join objects.

Vault supports name-based object type mapping for creating the following Submission and Regulatory Objective join object records:

  • Active Substance
  • Authorization
  • Clinical Study
  • Inactive Ingredient
  • Indication
  • Nonclinical Study
  • Packaging
  • Packaging Characteristic
  • Product
  • Product Characteristic
  • Product Classification
  • Regulatory Text
  • Shelf Life Storage
  • Site Contact
  • Site Organization
  • Site Role

About the Object Type Mapping Object

The Object Type Mapping object supports customers who want to manually bundle activities or regulatory objectives for both drug products and medical device products.

See Configuring Object Type Mapping for Registrations for a sample set of mappings. This setup ensures that the correct details will be carried over to Submission and Regulatory Objective join records for drug products or for medical device products. You may create similar mappings for custom source Application object types or custom object types on target Submission and Regulatory Objective join objects.

You must add the Applicable Product Type field to all Application object types and populate this field for object type mappings to work.

Settings

When you select the Enable Activity and Objective Bundling setting in Admin > Settings > Application Settings, additional configuration settings related to bundling become available. See details about these settings below.

The Enable Application Relationships RIM Setting on this page is also available for use in Registrations Vaults. See details about configuring the supporting feature for Submissions.

Restrict Bundling by State

Two settings allow you to restrict the Activity and Regulatory Objective records that are eligible for bundling based on their lifecycle state:

  • Restrict Activity bundling by state
  • Restrict Regulatory Objective bundling by state

If you do not enable these settings, Vault will allow users to select activities or regulatory objectives in any lifecycle state.

How to Set State Restrictions

To set a lifecycle state-based restriction:

  1. From Admin > Settings > Application Settings, click Edit.
  2. Enable the Restrict Activity bundling by state and/or Restrict Regulatory Objective bundling by state settings.
  3. For each setting, select various Lifecycle States. Users will be unable to bundle activities or regulatory objectives that are in unselected states.
  4. Click Save.

Submission Copying for EU Worksharing

EU worksharing and EU grouping allow users to avoid duplicating work. If users choose to copy submissions for this purpose, Vault creates Related Submission records using the Worksharing Group object type. The Restrict Submission copying for worksharing setting allows you to restrict the types of submissions that users can copy for worksharing.

How to Restrict Copying for EU Worksharing

To restrict the submissions that users may copy for EU worksharing:

  1. From Admin > Settings > Application Settings, click Edit.
  2. Select the Restrict Submission copying for worksharing checkbox.
  3. In the Submission Types field, choose Controlled Vocabulary items. Only items where the Controlled Vocabulary type is Submission will appear in this list. When users choose to copy for EU worksharing, they will only be allowed to copy items with the selected type.
  4. Click Save.

Submission Copying for US Grouping

US grouping allows users to avoid duplicating work by applying the same submission to multiple applications, for example, if promotional material applies to a family of products where each has a unique application but not unique promotional materials. If users choose to copy submissions for this purpose, Vault creates Related Submission records using the US Grouping object type. The Restrict Submission record creation for US grouping setting allows you to restrict the types of submissions that users can copy for grouping.

How to Restrict Copying for US Grouping

To restrict the submissions that users may copy for US grouping:

  1. From Admin > Settings > Application Settings, click Edit.
  2. Select the Restrict Submission record creation for US grouping checkbox.
  3. In the Submission Types field, choose one or more Controlled Vocabulary items. Only items where the Controlled Vocabulary type is Submission will appear in this list. When users choose to copy for US grouping, they will only be allowed to copy items with the selected types.
  4. Click Save.

Marking Records as Inactive

You can configure your Vault to allow users to move unused Submission, Regulatory Objectives, or Activity Labeling Concept records into an inactive lifecycle state during the bundling or splitting process. This optional configuration helps your organization keep data clean and organized. If set up, this setting moves the records into the configured lifecycle state. The option is available for any records that are associated with the target record, but users must identify individual records to inactivate.

How to Configure for Marking Records Inactive

To set up the Vault’s bundling wizard to allow users to make records inactive:

  1. From Admin > Settings > Application Settings, click Edit.
  2. Enable the desired object setting(s):
    • Mark submissions as inactive during bundling
    • Mark regulatory objectives as inactive during bundling
    • Mark Activity Labeling Concepts as inactive during bundling
  3. For each setting, choose one (1) or more Starting States. Users will only be able to inactivate records in the selected lifecycle states.
  4. For each setting, choose a lifecycle state as the Target State. To make the records inactive, the state you select must be configured as inactive.
  5. Click Save.

Setting Default Filters for Activities & Regulatory Objectives

By configuring default filters, you can provide users with a shorter and better list of activities and regulatory objectives when it comes time for them to select these. Because users are able to remove and change the filters themselves, you can set default filters that will work for 80% of situations, and users will still be able to set their own filters for the other 20%.

Vault provides settings to filter both submissions and regulatory objectives:

  • Default filters for Regulatory Objectives
  • Default filters for Activities

How to Set Default Filters

To set default filters:

  1. From Admin > Settings > Application Settings, click Edit.
  2. Select the Default filters for Regulatory Objectives or Default filters for Activities checkbox.
  3. For Activity filters, select one (1) or more Activity Fields as filters.
  4. For Regulatory Objective filters, select one (1) or more Regulatory Objective Fields as filters.
  5. Click Save.

Setting Naming Patterns

Setting a naming pattern for regulatory objectives and activities allows you to define how Vault names new records created during the bundling and splitting process. From Admin > Settings > Application Settings, select the Regulatory Objective Naming Pattern and/or Activity Naming Pattern checkboxes and enter a naming pattern.

When you enable the setting and define a pattern, the name appearing in the wizard cannot be edited by users.

If you do not enable the setting and define a pattern, Vault populates the Name field according to its field configuration:

  • If the field is configured to be system-managed, Vault populates the Name based on that configuration.
  • If the field is not configured to be system-managed, Vault applies the default pattern ({application__rimr.name__v} - Bundle for Regulatory Objectives, and {impacted_market__rimr.country_code__rim}-{related_application__rimr.name__v} - Split for Activities), and users are able to edit the Name field once the record is created as an output of the wizard.

Relating Regulatory Objectives & Submissions to Events

When users bundle or split a Regulatory Objective or Submission, this setting allows Vault to relate the resulting records to the Event for any Activity selected in the wizard.

Enabling Application Relationships

Vault can reference Application relationship records as the source of truth when bundling Activities and Regulatory Objectives. This is useful, for example, when using the bundling wizard to create Activity groupings against a new or existing Regulatory Objective or Submission, or to consolidate multiple Regulatory Objectives into one.

This feature is only available in RIM Vaults enabled with both the Registrations and Submissions applications. It is also controlled by a one-way RIM Setting which first requires an Admin to configure and enable the Submission Wizard.