Configuring Label Concept & Deviation Tracking (RIM)

When regulatory events and activities have labeling impact, Label Concept and Deviation Tracking in Vault 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 Event object types (e.g., Labeling Event) and their object page layouts, adding labeling-related fields and sections
  2. Configure the Activity object and object page layout with labeling-related fields and sections
  3. Configure the Activity Labeling Concept object lifecycle to create Labeling Deviation records based on the outcome of a labeling concept’s lifecycle
  4. Configure the Regulatory Objective object type and object page layout with labeling-related fields
  5. Configure the Labeling Concept and Labeling Deviation object page layouts to capture related documents and other information.
  6. Add 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:

Configuring the Event Object

  1. Navigate to Admin > Configuration > Objects > Event.
  2. Click Object Types. Select the desired object type (e.g., Labeling Event) and assign the following standard fields:
    • CCDS to be Updated
    • CCDS with Changes Reflected
    • Due Date
    • Labeling Impact
    • Safety Category
    • Trigger Date
  3. Optional (recommended): Update the Labeling Impact field to be required.
  4. Click Page Layouts.
  5. Update the object type’s page layout to display the new labeling-specific fields outlined above.
  6. Add a related object section for the Labeling Concept object.
  7. Configure a page layout rule to display the new labeling-specific fields and sections when the Labeling Impact field is Yes.
  8. Click Object Types, then select the desired object type and confirm its Status is Active.
  9. Repeat the steps above as applicable for other Event object types in your Vault (e.g., Manufacturing Event).

Configuring the Activity Object

  1. Navigate to Admin > Configuration > Objects > Activity.
  2. Click Page Layouts.
  3. Update the Activity object page layout to display the following fields:
    • Impacts Artwork
    • Labeling Impact
    • Resulting Local Label
    • Safety Category
  4. Add related object sections for the Labeling Deviation and Activity Labeling Concept objects.
  5. Configure a page layout rule to display the new labeling-specific fields and sections when the Labeling Impact field is Yes.

Configuring the Activity Labeling Concept Object 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 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

  1. Navigate to Admin > Configuration > Objects > Regulatory Objective.
  2. Click Object Types and assign 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 the Labeling Impact field to be required.
  4. Click Page Layouts.
  5. Update the Regulatory Objective object type page layout to display the new labeling-specific fields outlined above.
  6. Configure a page layout rule to display the new labeling-specific fields when the Labeling Impact field is Yes.

Configuring the Labeling Concept Object

You can configure the Labeling Concept object to capture impacted document versions by updating the object page layout 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

Configuration for Correspondence Documents

You can configure the Labeling Deviation object to capture document-related information:

  1. Add the Labeling Deviation shared document field to the Regulatory > Correspondence document type.
  2. Add a new Related Documents section 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 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.

Additionally, you can ensure users consistently complete this information by prompting them to populate the field during a review and dispositioning object workflow.

Automatic Record Creation & Automation

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.

To enable this feature:

  1. Complete all configurations described in Configuring the Activity Object, including the Activity Labeling Concept object lifecycle configurations.
  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 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 for more information on how Vault creates new Labeling Deviation records.

Splitting Activities & Labeling Concepts

During the splitting process, you can select Labeling Concepts to split from an existing Activity.

See Splitting Activities for more information.

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.