Registration & Dossier Management provides Regulatory Specialist users with the ability to assess the potential impact of a global operational change by identifying registration items that are potentially impacted by the operational change, such as a manufacturing location shift that impacts a number of products. Users can define specific field values to identify which existing Registration Items are potentially impacted by the change, then copy the impacted records to generate new records that reflect the change event. Users can then conduct Local Impact Assessments on the new Registration Items.
Note: Before configuring your Vault for Global Change Impact Assessments, you must first configure Local Impact Assessments.
Global Change Impact Assessment Objects
Registration & Dossier Management uses the following core objects to support Global Change Impact Assessments:
- Event (
event__v): This object represents a planned occasion that may need regulatory-related activities to be completed before it takes place. - Global Operational Change (
global_operational_change__v): This object represents a global operational change and maps to fields on the Registration Item object. - Registration (
registration__v): This object represents proof that validates clearance in a state, country, region, and by Third-Party Certification or Retailer. - Registration Item (
request__v): This object represents a request to identify or scope out what needs to be done to market or sell a product in a jurisdiction. - Regulated Category (
regulated_category__v): This object represents a category for regulation and contains information about location.
Note: In Vaults created prior to 21R2, the Registration Item object may be labeled Request.
Configuration Overview
Configuring your Vault to use Global Change Impact Assessments involves the following steps:
- Configure the Event object layout
- Configure Global Operational Changes
- Map Registration Attributes in MDL
- Configure Registration Item fields
- Configure the Run Global Impact Assessment action
- Configure user permissions
Note: Depending on your Vault’s creation date and which features are currently enabled and configured, some of the steps described in this article may be unavailable or already complete in your Vault.
Configuring the Event Object Layout
You must make the following changes to the Event object layout:
- Add the Global Operational Change field.
- Insert a related object section for the Global Operational Change object. If you have set up object types for the Event object, we recommend configuring layout rules so that this section only shows on the appropriate types of Events.
Configuring Global Operational Changes
You must configure Global Operational Changes and link them to Registration Attribute components to map custom fields to Registration Item fields. This identifies which Registration Item fields Vault uses as attributes to identify existing Registration Items that are potentially impacted by an operational change.
About Global Operational Changes
There are two (2) types of Global Operational Changes:
- From: Specifies original field values that are changing and identifies which existing Registration Items are potentially impacted by the operational change.
- To: Specifies updated or future field values that will be populated on new Registration Items to reflect the operational change.
When users select the Global Operational Change checkbox while creating a new Event record, Vault automatically adds two (2) Global Operational Changes to the Global Operational Changes section of the Event record, one (1) of each type. If users modify an existing Event, they must manually add the two (2) Global Operational Change records to the Event. Users can specify up to five (5) fields for each Global Operational Change that are impacted by a single operational change.
The Global Operational Change Type picklist defines the type of Global Operational Change. Do not add custom values to this picklist.
Example Use Case
To support manufacturing location operational change impact assessments, you add a Made In custom field to the Global Operational Change object and layout, then map that field to the Made In field on the Registration Item object in a Registration Attribute component.
A user then creates a new Event with the Global Operational Change checkbox selected to assess shifting the manufacturing location from China to Taiwan. When the user saves the new Event, Vault automatically adds two (2) Global Operational Changes to the Event. The user populates the Made In field with “China” in the From type of Global Operational Change and “Taiwan” in the To type of Global Operational Change. When the user runs the Run Global Impact Assessment action on that Event, Vault identifies all existing Registration Items with a Made In value of “China” as potentially impacted by the manufacturing shift. The user reviews and filters that list of Registration Items to specify which of those Registration Items they want to copy to use to generate new Registration Items.
After the user clicks the Create Registration Items button to complete the action, Vault creates new Registration Items based on the filtered list and populates the Made In field with “Taiwan” on all new records. Vault populates the other fields of the new records with the same values as the original record, excluding any fields you have configured to not copy and fields you’ve mapped in Registration Attributes linked to Relational Tokens, which are blank in the new records.
Configuring Global Operational Change Fields
You must add relevant custom fields to the Global Operational Change object that you will map to fields on the Registration Item object. You must add fields for all Registration Item fields that users would need to modify to reflect operational changes.
Note: The Run Global Impact Assessment action will fail if users enter “from” or “to” values for any Global Operational Change field that you have not mapped to a Registration Item field.
When users create an Event for an operational change, they will populate these fields on each Global Operational Change for the Event to specify the Registration Item fields impacted by the operational change. Users can specify which fields are impacted, and then enter the original values in the From type of Global Operational Change and the updated values in the To type of Global Operational Change for those fields. After populating the Global Operational Changes, users can run the Run Global Impact Assessment action for the Event to identify Registration Items with the field values specified in the From type of Global Operational Change.
Configuring the Global Operational Change Object Layout
After you add all relevant custom fields to the Global Operational Change object, add the same fields to the Global Operational Change object layout. This allows users to populate those fields for the Global Operational Changes on an Event to specify the Registration Item fields that are impacted by the operational change.
Select which columns appear to users to allow them to enter the appropriate “from” and “to” values using inline editing. Users can also customize the columns they see to include fields they have permission to view. We recommend adding the Global Operational Change Type field so that users can easily determine where to enter “from” and “to” values.
Mapping Registration Attributes
You must map Global Operational Change fields to Registration Item fields to specify which fields Vault uses as attributes to identify potentially impacted Registration Items when users create an Event for an operational change, populate the applicable Global Operational Change fields with “from” and “to” values, and run the Run Global Impact Assessment action. See About RegulatoryOne Component Types for details about how to create and alter Registration Attribute components in MDL to map Global Operational Change fields to Registration Item fields.
Configuring Registration Item Fields
You can specify which Registration Item fields Vault will not copy from original Registration Items into new records when users run the Run Global Impact Assessment action by selecting the Do not copy this field in Copy Record checkbox on any applicable fields. Vault does not populate those fields on generated Registration Items when users complete the Run Global Impact Assessment action.
Vault will not copy any inactive, uneditable, or system-managed fields.
Configuring the Run Global Impact Assessment Action
You must configure the Run Global Impact Assessment action as a user action on the Event object to allow users to run Global Impact Change Assessments. When users populate the Global Operational Changes on an Event record and then run the Run Global Impact Assessment action, Vault identifies all active Registration Items with the same values specified in the From type of Global Operational Change Type as potentially impacted by the operational change. Users can then filter the list of Registration Items to specify which records they want to copy.
When users complete the action by clicking the Create Registration Items button in the Registration Item Record Dialog, Vault generates new Registration Items from the copied records, relates them to the Event from which the user ran the action, and populates fields with the same field values in the original Registration Items, including fields the user does not have permission to view, with the following exceptions:
- All user-defined values in the To type of Global Operational Change for the Event are copied to the new Registration Items based on your attribute mappings.
- The Event field is populated with the label of the Event from which the user ran the action.
- The Global Impact Assessment Source Record field is populated with the Name of the Registration Item from which it was copied.
- The following fields are not populated:
- Any mapped fields linked to Relational Tokens specified in Registration Attributes unless those fields are specified as a user-defined “to” value (in those cases, the fields are populated with the appropriate “to” value).
- Any fields you configured not to copy.
- Inactive, uneditable, and system-managed fields.
- Any Specific version types of document reference fields.
Vault does not create duplicate records. If a Registration Item already exists for the Event and Global Impact Assessment Source Record field, Vault will not generate another Registration Item for the same Event and Global Impact Assessment Source Record field.
Configuring User Permissions
You must ensure users have the appropriate read and create permissions to access the appropriate objects and object fields in addition to the following permissions:
- For the Event object: Edit permission.
- For the Global Operational Change object: Edit permission and Read permission on any objects referenced in custom fields. Users can only add fields to display in the Global Operational Change section of Event records on which they have Read permission.
- For the Registration Item object: Read permission, including Read permission on relevant fields and object types.
- Vault only displays Registration Item records in the Search: Select Registration Item Records dialog and copies Registration Items that users have permission to view.
Related Permissions
You can complete all the steps in this article with the standard System Administrator or Vault Owner security profile. If your Vault uses custom security profiles, your profile must grant the following permissions:
| Type | Permission | Controls |
|---|---|---|
| Security Profile | Admin: Configuration: Objects: Create, Edit | Ability to create and modify Vault objects. |
| Security Profile | Admin: Security: Permission Sets: Edit | Ability to modify permission sets for users. |