# Configuring Label Concept & Deviation Tracking (RIM) When regulatory events and activities have labeling impact, [Label Concept and Deviation Tracking](/en/lr/73795/) in RIM Registrations allows for detailed tracking and management of the resulting labeling concept updates and deviations. Organizations enter proposed changes and send them to affiliate teams to provide local disposition and capture deviations in local labeling; Vault makes the changes and timelines globally and locally visible while the label content is approved, updated, and submitted.
## Configuration Overview Vault primarily collects label concept and deviation tracking information within the _Labeling Concept_ and _Labeling Deviation_ standard objects. They relate to the _Event and Activity_ objects which include standard fields for label change management activities. The _Regulatory Objective_ object can also be configured with standard fields to collect locally-initiated label changes. Complete or confirm the following configuration steps to enable full use of the standard label concept and deviation tracking features in your Vault: 1. [Configure][1] _Event_ object types (e.g., _Labeling Event_) and their object page layouts, adding labeling-related fields and sections. 2. [Configure][2] the _Activity_ object and object page layout with labeling-related fields and sections. 3. [Configure][6] the _Activity Labeling Concept_ object lifecycle to create _Labeling Deviation_ records based on the outcome of a labeling concept's lifecycle. 4. [Configure][3] the _Regulatory Objective_ object type and object page layout with labeling-related fields. 5. Configure the [_Labeling Concept_][4] and [_Labeling Deviation_][5] object page layouts to capture related documents and other information. 6. [Add](/en/lr/4884/#use-shared-field) the below labeling-specific shared document picklist fields to any labeling document types, for example _Labeling > Artwork > Mock-Ups_: * _Carton or Container Label Type_ * _Labeling Components Included_ * _Tracked Changes/Redlines_ You may also choose to configure the _Labeling Concept_ and _Labeling Deviation_ objects with additional elements to accommodate your organization's processes: * [Custom fields](/en/lr/32857/) and [page layouts](/en/lr/26387/) * Additional or updated _Labeling Deviation_ [object lifecycle states](/en/lr/30683/) and [workflows](/en/lr/33550/), including a workflow to allow for review and dispositioning. ### Configuration for Creating & Managing Event Details When gathering an event's details, [Create & Manage Event Details](/en/lr/5498722/) wizard users may want to be able to include the _Event_'s related _Change Items_ and, optionally, any _Labeling Concepts_ related to those items. See [Configuration for Bulk Creating & Managing Event Details](/en/lr/549872/#supporting-event-change-items-and-labeling-concepts) for details. ## Configuring the Event Object {#configuring-the-label-event-object} 1. [Assign](/en/lr/32857/) the following standard fields to the _Labeling Event_ object type: * _CCDS to be Updated_ * _CCDS with Changes Reflected_ * _Due Date_ * _Labeling Impact_ * _Safety Category_ * _Trigger Date_ 2. Optional (recommended): [Update](/en/lr/32857/) the _Labeling Impact_ field to be required. 3. [Update](/en/lr/32857/) the object type's page layout to include: * The new labeling-specific fields outlined above. * A related object section for the _Labeling Concept_ object. * A [page layout rule](/en/lr/51632/) to display the new labeling-specific fields and sections when the _Labeling Impact_ field is _Yes_. Repeat the above steps for the remaining _Event_ object types in your Vault (for example, _Manufacturing Event_). ## Configuring the Activity Object {#configuring-the-activity-object} 1. Navigate to **Admin > Configuration > Objects > Activity**. 2. Click **Page Layouts**. 3. [Update](/en/lr/32857/) the _Activity_ object page layout to display the following fields: * _Impacts Artwork_ * _Labeling Impact_ * _Resulting Local Label_ * _Safety Category_ 4. [Add](/en/lr/32857/) related object sections for the _Labeling Deviation_ and _Activity Labeling Concept_ objects. 5. [Configure a page layout rule](/en/lr/51632/) to display the new labeling-specific fields and sections when the _Labeling Impact_ field is _Yes_. ### Configuring the Activity Labeling Concept Object Lifecycle {#configuring-the-activity-labeling-concept-lifecycle} You can configure Vault to create _Labeling Deviation_ records based on the outcome of a labeling concept's lifecycle. To take advantage of this automation, complete the steps described here and in [Labeling Automations][8] below. To configure the _Activity Labeling Concept_ object lifecycle to support automation: 1. Navigate to **Admin > Configuration > Object Lifecycles > Activity Labeling Concept**. 2. Associate the provided _Concept Rejected_ state type with the lifecycle state your organization will use to indicate that an activity's labeling concept is rejected. You may need to create a new state, for example the _Rejected_ state. ## Configuring the Regulatory Objective Object {#configuring-the-regulatory-objective-object} 1. Navigate to **Admin > Configuration > Objects > Regulatory Objective**. 2. Click **Object Types** and [assign](/en/lr/32857/) the following standard fields to the **Regulatory Objective** and **Worksharing** object types: * _Corresponding CCDS_ * _Due Date_ * _Labeling Impact_ * _Resulting Local Label_ * _Safety Category_ * _Trigger Date_ 3. Optional (recommended): [Update](/en/lr/32857/) the _Labeling Impact_ field to be required. 4. Click **Page Layouts**. 5. [Update](/en/lr/32857/) the _Regulatory Objective_ object type page layout to display the new labeling-specific fields outlined above. 6. [Configure a page layout rule](/en/lr/51632/) to display the new labeling-specific fields when the _Labeling Impact_ field is _Yes_. ## Configuring the Labeling Concept Object {#configuring-the-labeling-concept-object} You can configure the _Labeling Concept_ object to capture impacted document versions by updating the [object page layout](/en/lr/26387/) to include the _Document to be Updated_ and _Updated Document_ fields. You can also add the _Contains Core Safety Information_ Yes/No field. ## Configuring the Labeling Deviation Object {#configuring-the-labeling-deviation-object} ### Configuration for Correspondence Documents You can configure the _Labeling Deviation_ object to capture document-related information: 1. Add the _Labeling Deviation_ [shared document field](/en/lr/4884/#use-shared-field) to the _Regulatory > Correspondence_ document type. 2. Add a new [Related Documents section](/en/lr/26387/#related-documents) to the _Labeling Deviation_ object page layout with "Related Correspondence" as the recommended **Section Label**. 3. Update the _Labeling Deviation_ object page layout to include the _Resulting Local Label_ field. ### Configuration for Health Authority Questions To allow users to view _Health Authority Question_ records within the context of a _Labeling Deviation_, update the _Labeling Deviation_ object page layout to include a [Related Object section](/en/lr/26387/#related-object) referencing the **Related Object** _HAQ-Labeling Deviation > Health Authority Question_. ### Configuration for Review & Dispositioning The _Labeling Deviation_ object includes the _Deviation Review Disposition_ standard picklist field you can add to the [object page layout](/en/lr/26387/). Additionally, you can ensure users consistently complete this information by [prompting](/en/lr/33550/#prompt-for-fields-control) them to populate the field during a review and dispositioning [object workflow](/en/lr/33550/#create). ## Automatic Record Creation & Automation {#automatic-record-creation} ### Labeling Automations {#labeling-automations} Vault can maintain _Events_, _Activities_, and their labeling-related records through automatic record creation and automation. The feature also includes optional configuration to maintain an _Activity_'s _Due Date_ based upon the due dates of its dependent activities by referencing the _Lead Reference Market Due Date_ field in a [custom formula](/en/lr/42857/). To enable this feature: 1. Complete all configurations described in [Configuring the Activity Object][2], including the [Activity Labeling Concept object lifecycle configurations][6]. 2. Navigate to **Admin > Settings > Application Settings** > **Registrations Features** and select **Enable Labeling Automations**. 3. Optional: Your organization can streamline _Labeling Deviation_ record creation for dependent countries by configuring Vault to create new records in the _Reviewed_ state type and default certain record fields. To do this: a. Select the field(s) you wish to default in the _Enable Labeling Automations_ subsetting, **Add Labeling Deviation Fields to copy on Dependency Automation Trigger**. b. In the _Labeling Deviation_ lifecycle, [map](/en/lr/30683/#associate-state-type) the _Reviewed_ state type to a lifecycle state which indicates a record has been reviewed. (You may be required to create a new lifecycle state, for example _Reviewed_.) See [Label Concept & Deviation Tracking](/en/lr/73795/#automatic-record-creation) for more information on how Vault creates new _Labeling Deviation_ records. ### Creating Labeling Deviations for All Dependent Markets {#creating-labeling-deviations-for-all-dependent-markets} When enabled, the **Skip Duplicate Check for Dependency Automation Trigger** [automation subsetting](/en/lr/53688/#skip-duplicate-check) allows Vault to cascade deviation information to dependent markets. To do this, Vault skips the check which prevents the creation of more than one _Labeling Deviation_ per _Activity_ and _Labeling Concept_. This can be useful for organizations where a single labeling concept is associated with multiple deviations. This behavior requires that the _Labeling Deviation_ object's _CCDS Section_ field is configured to support multiple values. If your Vault's _CCDS Section_ field is not currently configured with the _Allow user to select multiple values_ option: 1. For the _Autoname Calculation_ field, copy the **Default Value** criteria, for example `Left(Text(ccds_section__v), 124)`, then delete it and click **Save**. You'll re-add the value later in this process. 2. For the _CCDS Section_ field, select the **Allow user to select multiple values** option. 3. Return to the _Autoname Calculation_ field and add the **Default Value** criteria you copied and removed in Step 1. ### Splitting Activities & Labeling Concepts You can configure the [splitting](/en/lr/4946040/) wizard to allow users to select _Labeling Concepts_ to [split](/en/lr/50545/) from an existing _Activity_. ## Related Permissions The following permissions are required for working with label concept and deviation tracking: |Type|Permission Label|Controls| |--- |--- |--- | |Security Profile|Object: Activity|Ability to create and edit records.| |Security Profile|Object: Activity Labeling Deviations|Ability to create, edit, and delete records.| |Security Profile|Object: Event|Ability to create and edit records.| |Security Profile|Object: Event Regulatory Objective|Ability to create, edit, and delete records.| |Security Profile|Object: Labeling Concept|Ability to create and edit records.| |Security Profile|Object: Labeling Deviations|Ability to create and edit records.| |Security Profile|Object: Regulatory Objective|Ability to create and edit records.| Learn more about [permission sets](/en/lr/22824/). [1]: #configuring-the-label-event-object [2]: #configuring-the-activity-object [3]: #configuring-the-regulatory-objective-object [4]: #configuring-the-labeling-concept-object [5]: #configuring-the-labeling-deviation-object [6]: #configuring-the-activity-labeling-concept-lifecycle [7]: #automatic-record-creation [8]: #labeling-automations