# Configuring Global Change Impact Assessments (Registration & Dossier Management)

[ Registration & Dossier Management](/en/lr/71498/) provides Regulatory Specialist users with the ability to [ assess the potential impact of a global operational change](/en/lr/512729/) 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_.
 
Before configuring your Vault for Global Change Impact Assessments, you must first [configure Local Impact Assessments](/en/lr/76906/#object-types).
 
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      <p><strong>Note</strong>: In Vaults created prior to 21R2, the <em>Registration Item</em> object may be labeled <em>Request</em>.</p>
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## Configuration Overview {#overview}
 
Configuring your Vault to use Global Change Impact Assessments involves the following steps:
 
1. [Configure the _Event_ object layout][3]
2. [Configure _Global Operational Changes_][4]
3. [Map Registration Attributes][9]
4. [Configure _Registration Item_ fields][7]
5. [Configure the _Run Global Impact Assessment_ action][11]
6. [Configure user permissions][13]

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      <p><strong>Note</strong>: 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.</p>
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## Configuring the Event Object Layout {#event}

You must make the following changes to the _Event_ [object layout](/en/lr/26387/):

* 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](/en/lr/51632/) so that this section only shows on the appropriate types of _Events_.

## Configuring Global Operational Changes {#goc}

You must configure _Global Operational Changes_ and [link them to Registration Attribute components to map custom fields to _Registration Item_ fields][9]. 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 {#about-goc}

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_, Vault automatically adds two (2) _Global Operational Changes_ to the _Global Operational Changes_ section of the _Event_, one (1) of each type. If users modify an existing _Event_, they must manually add the two (2) _Global Operational Changes_ 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 {#example}

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][10] and fields you've [mapped in Registration Attributes][9] linked to Relational Tokens, which are blank in the new records.
 
### Configuring Global Operational Change Fields {#goc-fields}

You must [add relevant custom fields](/en/lr/15057/#how_to_add_object_fields) to the _Global Operational Change_ object that you will [map to fields on the _Registration Item_ object][9]. You must add fields for all _Registration Item_ fields that users would need to modify to reflect operational changes.
 
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      <p><strong>Note</strong>: The <em>Run Global Impact Assessment</em> action will fail if users enter “from” or “to” values for any <em>Global Operational Change</em> field that you have not <a href="#mapping">mapped</a> to a <em>Registration Item</em> field.</p>
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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][11] for the _Event_ to identify _Registration Items_ with the field values specified in the _From_ type of _Global Operational Change_.

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      <p><strong>Note</strong>: Vault does not support <a href="/en/lr/15057/#roll-up-fields">roll-up fields</a> for <em>Global Operation Change</em> fields.</p>
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### Configuring the Global Operational Change Object Layout {#goc-page-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](/en/lr/26387/). 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](/en/lr/26387/#how-to-edit-related-object-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 {#mapping}

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][11]. See [Defining Registration Attributes](/en/lr/761426/) for more details.

## Configuring Registration Item Fields {#ri-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][11] by selecting the [**Do not copy this field in Copy Record** checkbox](/en/lr/15057/#how_to_add_object_fields) 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 {#gia-action}

You must configure the _Run Global Impact Assessment_ action as a [user action](/en/lr/59885/#user-actions) on the _Event_ object to allow users to run Global Impact Change Assessments. When users populate the _Global Operational Changes_ on an _Event_ 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][9].
* 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][9] 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][10].
  * Inactive, uneditable, and system-managed fields.
  * Any [_Specific version_ types of document reference fields](/en/lr/35045/#create-field).
  
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 {#user-permissions}

You must ensure users have the appropriate read and create [permissions](/en/lr/22824/) 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 _Events_ 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 Items_ in the _Search: Select Registration Item Records_ dialog and copies _Registration Items_ that users have permission to view.

## Related Permissions {#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](/en/lr/22824/):
 
<table>
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   <th><strong>Type</strong></th>
   <th><strong>Permission</strong></th>
   <th><strong>Controls</strong></th>
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   <td>Security Profile</td>
   <td>Admin: Configuration: Objects: Create, Edit</td>
   <td>Ability to create and modify Vault objects.</td>
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   <td>Security Profile</td>
   <td>Admin: Security: Permission Sets: Edit</td>
   <td>Ability to modify permission sets for users.</td>
 </tr>
</table>

[2]: #overview
[3]: #event
[4]: #goc
[5]: #about-goc
[6]: #example
[7]: #goc-fields
[8]: #goc-page-layout
[9]: #mapping
[10]: #ri-fields
[11]: #gia-action
[12]: #user-permissions
[13]: #permissions
