Registration & Dossier Management provides you 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. You 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. You can then conduct Local Impact Assessments on the new Registration Items.
Depending on your Admin’s configuration, object, field, and section labels may appear differently than the labels mentioned in this article.
About Global Operational Changes
Global Operational Changes capture the values that are changing as a result of an operational change. There are two (2) types of Global Operational Changes:
- From: Specifies the original field values that are changing and identifies which existing Registration Items are potentially impacted by the operational change.
- To: Specifies the updated or future field values that must be populated on new Registration Items to reflect the operational change.
When you 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 you modify an existing Event, you must manually add the two (2) Global Operational Change records to the Event. You can specify up to five (5) Global Operational Change field values that are impacted by a single operational change event.
When you run the Run Global Impact Assessment action on an Event, Vault identifies all existing Registration Items that include any of the “from” values you entered for the Event’s Global Operational Change as potentially impacted by the operational change. You can then filter the list of potentially impacted records to specify which ones are impacted and then generate new Registration Items with the “to” values that reflect the operational change.
Example Use Case
You must analyze the potential impact of shifting a manufacturing location from China to Taiwan. To do that, you create a new Event with the Global Operational Change checkbox selected. When you save the new Event, Vault automatically adds two (2) Global Operational Changes to the Event, one (1) of each type. You populate 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 you run 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 based on Admin-defined mappings. You can review and filter that list of Registration Items to specify which of those Registration Items you want to copy to use to generate new Registration Items.
After you click 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 your Admin has configured to not copy. You can then conduct Local Impact Assessments on the new Registration Items to identify any existing registrations that can be used for the new objective.
Conducting a Global Change Impact Assessment
When you complete the Run Global Impact Assessment action by clicking the Create Registration Items button in the Registration Item Record Dialog, Vault generates new Registration Items from the copied records with the “to” values you specified for the Event that reflect the operational change. Depending on your Admin’s configuration, some fields may be blank on the generated records. The new records are automatically related to the Event from which you ran the action and the Global Impact Assessment Source Record field on the new records is populated with the Name of the original record it was copied from so you can trace its origin.
How to Conduct a Global Change Impact Assessment
To initiate a Global Change Impact Assessment and create new Registration Items copied from existing records:
- Navigate to Registrations > Events.
- Click Create to create a new Event or click on a listed Event to open an existing record.
- Select the Global Operational Change checkbox.
- If you’re creating a new Event: Vault automatically adds two (2) Global Operational Changes to the Global Operational Changes section of the Event record: one (1) From type and one (1) To type.
- If you’re editing an existing Event: Navigate to the Global Operational Changes section and click Create to add two (2) Global Operational Changes to the Global Operational Changes: one (1) From type and one (1) To type.
- Click Save when you’ve entered all applicable details.
- Navigate to the Global Operational Changes section of the Event to specify the field values that are changing as a result of the operational change. You can customize the displayed columns to include fields you have permission to view. Enter up to five (5) fields that are changing for this Event:
- For the From type of Global Operational Change, click into a field and enter the original “from” value that is changing as a result of the operational change.
- For the To type of Global Operational Change, click into a field and enter the updated “to” value that reflects the operational change.
- From the All Actions menu, select Run Global Impact Assessment.
- In the Search: Select Registration Item Records dialog, review the list of potentially impacted Registration Items that have at least one (1) of the “from” values you entered for the Event. This list includes only records that you have permission to view and does not include any records that fit your criteria but were created or modified after you ran the action.
- Optional: Apply up to five (5) Filters to constrain the list of impacted Registration Items to copy.
- Click Create Registration Items to create new Registration Items based on your filtered list.
Vault copies Registration Items that exist in your Vault and fit your criteria at the time you click the Create Registration Items button, which may not exactly match the list you see in the Search: Select Registration Item Records dialog. For example, if another user creates a new Registration Item that fits your criteria between when you run the Run Global Impact Assessment action and when you click the Create Registration Item button, you won’t see that record listed in the Search: Select Registration Item Records dialog, but Vault will copy that record as it fits your criteria.
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.
Notifications
When Vault finishes generating Registration Items, you’ll receive an email and a Vault notification letting you know how many records were created or if there were any errors. When you receive the notification that the action is complete, you can navigate to the Registration Items section of the Event to review the new Registration Items.
Limitations
The following limitations apply to Global Change Impact Assessments:
- Vault copies up to 5,000,000 Registration Items asynchronously when you run the Run Global Impact Assessment action, which may take up to 24 hours to complete.
- Vault does not copy Registration Item field values for any version-specific document reference fields.
Conducting Local Impact Assessments
After you generate Registration Items for the operational change, you can conduct Local Impact Assessments on the new records to assess if any existing registrations can be applied or amended.