Configuring Country Dependencies (RIM)

Your organization can define country-to-country dependencies to support planned changes in your Vault. Country dependencies allow Vault to create Activity Dependency records automatically each time an Activity record is created. This ensures that users working at the country level are aware of dependencies for each country. See About Activity Dependencies for more information.

Note: This feature is only available on RIM Registrations Vaults.

Configuration Overview

Complete the following steps to configure your Vault to support country dependencies:

Update the Activity object page layout to add a related object section for the Activity Dependency object. This allows users to see the Reference Activity records that Vault automatically creates when creating a new Activity record. Include the Section Help text “Reference Activity for which this Activity is dependent on (e.g., Waiting for Approval of Activity)”.
Update the Activity object page layout to add a related object section for the Activity Dependency object (second relationship) and apply the label “Dependent Activities”. This allows users to see the Dependency Activity records that Vault automatically creates when creating a new Activity record. Include the Section Help text “Activity which are depending of this Activity (e.g. Activities which are waiting for Approval of this activity)”.
Optional: Update the Event object page layout to add the Impacted Active Substance and Impacted Manufacturing Site fields. Ensure the page layout also includes the Impacted Product Family field. This step is only necessary if you want to use these fields when creating Country Dependency records.
On the Activity object lifecycle, add the Waiting for Reference Country and Reference Country Submitted/Approved states if they do not already exist.
On the Activity object lifecycle, add user actions to the Reference Country Submitted/Approved state to progress records to the Impact Identified, In Progress, and Planned states.
On the Activity object lifecycle, add user actions to the Planned and In Assessment states to progress records to the Waiting for Reference Country state.
On the Activity object lifecycle, add entry criteria to the Waiting for Reference Country state to validate that State of Related Record > Activity Dependencies (Dependent Activity) > At least one record exists.
Create an Activity Dependency object lifecycle and assign it to the Activity Dependency object. Add Submitted and Approved states to the lifecycle.
On the Activity object lifecycle’s In Progress state, add a Change related object lifecycle state entry action to move related Activity Dependency (Reference Activity) records to the Submitted state.
On the Activity object lifecycle’s Approved, Ready for Implementation state, add a Change related object lifecycle state entry action to move related Activity Dependency (Reference Activity) records to the Approved state.
On the Activity Dependency object lifecycle’s Submitted state, add an entry action to Perform with conditions: If Dependency Action equals On Submission perform the action Check sibling records before updating related record to ensure All sibling records are in lifecycle state Submitted or Approved before updating the Related Object Dependent Activity lifecycle state to Reference Country Submitted/Approved.
Optional: Create a new object message to notify users that the reference activity is complete. Add it as a Send a notification entry action on the Activity Dependency object lifecycle’s Submitted state.
On the Activity Dependency object lifecycle’s Approved state, add an entry action to Perform with conditions: If Dependency Action equals On Approval perform the action Check sibling records before updating related record to ensure All sibling records are in lifecycle state Submitted or Approved before updating the Related Object Dependent Activity lifecycle state to Reference Country Submitted/Approved.
On the Country Dependency object lifecycle’s Active state (active_state__c), add a user action to change records to the Inactive state (inactive_state__c). Additionally, for the Inactive state, select the Records in this state become inactive checkbox.
Optional: Create a new object message to notify users that the reference activity is complete. Add it as a Send notification entry action on the Activity Dependency object lifecycle’s Submitted state.
Update the Event Object Type (event_object_type__v) picklist with values corresponding to the object types of the Event object, ensuring the Picklist Value Name matches the Name of the corresponding object type. For example, the Regulatory Event object type Name is regulatory_event__rim, and so its corresponding picklist value name must be regulatory_event__c.
Optional: To support cross-functional Events:
- Enable the Rerun dependency checks when labeling impact is identified setting.
- Update the Activity object page layout to include the Local Labeling Impact field.
- Create or update Activity records with the appropriate Local Labeling Impact field value.
Optional: To support Application-level dependencies:
- Enable the Rerun dependency checks when labeling impact is identified setting. This setting is already enabled if your Vault is also configured to support cross-functional Events (Step 17).
- Update the Country Dependency and Activity Dependency object page layouts to include the Dependent Application and Reference Application fields.
- Create or update Country Dependency records with the appropriate Dependent Application and Reference Application field values.

Setting Up Country Dependencies

After your Vault is configured, you can set up Country Dependency records as a master list of all country dependencies that impact your organization. You will create and define these records to fit your organization’s business processes and the types of changes that may occur, such as a label change or a manufacturing change. When Activity records are created, Vault matches all fields on the Country Dependency records against the Activity and Event records to determine which Activity Dependencies to create.

How to Define a Country Dependency

To create a Country Dependency:

Navigate to Admin > Business Admin > Country Dependencies and click Create.
Select a Reference Country. This is the lead country for the dependency.
Select a Dependent Country. This is the country to which the dependency rule applies.
Select the Applicable Product Type. This is the type of product for which the dependency rule applies.
Select the Event Object Type. This determines the Event type for which Vault creates the Activity Dependency.
Select the Dependency Action. This lets users working with Activity Dependencies know whether the Dependent Country must wait to take action until the Reference Country submits changes or gets approval.
Select the Dependency Rule. This lets users working with Activity Dependencies know whether the dependency is optional or mandatory.
Optional: Enter Dependency Comments. This informs users working with Activity Dependencies about the dependency’s rules.
Optional: Select a Product Family, Active Substance, and/or Manufacturer. When any of these fields are populated on the Event record related to an Activity, Vault uses the field to determine which Activity Dependencies to create.
Optional: Select a Product, Product Variant, and/or Packaging record as applicable. When any of these fields are populated on the Registration object (Product, Product Variant) and Registration Packaging object (Packaging), Vault uses them to determine which Activity Dependencies to create.
Optional: Select a Dependent Application and Reference Application record. When the Dependent Application matches an Activity’s Related Application field and an existing Activity record’s Related Application matches the dependency’s Reference Application, Vault creates an Activity Dependency record with this value. Vault also sets the new record’s Related Application field with the Country Dependency’s Reference Application.
Click Save.

Repeat these steps for each Country Dependency you want to create.

Supporting Non-Labeling Events & Application-Level Dependencies

To support cross-functional Events where labeling impact is identified (for example, as the result of a manufacturing change control), Vault can create related Activity Dependency records based on the Country Dependency records you’ve defined with a Labeling Event Object Type.

Once enabled, Vault checks for dependencies based on the Local Labeling Impact field value of any related Activities for the cross-functional event. When a user sets this field to Yes, Vault assesses existing Country Dependency rules (with the Labeling Event Object Type) and creates the applicable Activity Dependency records.

If your Vault’s Country Dependency records are also configured to track a Reference Application and Dependent Application, Vault creates Activity Dependency records where:

The referenced activity matches the Dependent Activity.
The activity’s Related Application is the Dependent Application.
An existing Activity for the Event has a Related Application that matches the Reference Application.

This can be useful for managing Application-level dependencies across different markets, within the same market, and within the same Application.

Note: During splitting, Vault sets the field on target Activity records with the same Local Labeling Impact value as the source Activity record, and does not display the field in the wizard. To capture a value for the Local Labeling Impact, allow Vault to create the target Activity record, then edit and re-save the new record with the desired Local Labeling Impact.