With every release, we update the data model to better support evolving needs and new feature functionality. With this release, we’ve added the following components to the Quality data model. These data model updates are automatically included in all Quality Vaults, but Admins must make configuration changes to make them available. For information on feature functionality, see New in 25R1 Limited Release.

In support of the QMS External Collaboration: Impact Assessments & Change Actions feature, the following data model changes were made:

  • Added the following object types to the External Collaborator Assignment (external_collaborator_assignment__v) object:
    • Change Action Collaborator Assignment (change_action_collaborator_assignment__v)
    • Impact Assess Collaborator Assignment (impact_assess_collaborator_assignment__v)
  • Added the following new fields to the External Collaborator Assignment (external_collaborator_assignment__v) object:
    • Change Action (change_action__v)
    • Impact Assessment (impact_assessment__v)
  • Added the following fields to the Change Action Collaborator Assignment (change_action_collaborator_assignment__v) object type:
    • Assignment Activity (assignment_activity__v)
    • Change Action (change_action__v)
    • Created By (created_by__v)
    • Created Date (created_date__v)
    • External Collaborator Assignment Type (object_type__v)
    • Global ID (global_id__sys)
    • ID (id)
    • Last Modified By (modified_by__v)
    • Last Modified Date (modified_date__v)
    • Link (link__sys)
    • Name (name__v)
    • Status (status__v)
    • User (user__v)
  • Added the following fields to the Impact Assess Collaborator Assignment (impact_assess_collaborator_assignment__v) object type:
    • Assignment Activity (assignment_activity__v)
    • Impact Assessment (impact_assessment__v)
    • Created By (created_by__v)
    • Created Date (created_date__v)
    • External Collaborator Assignment Type (object_type__v)
    • Global ID (global_id__sys)
    • ID (id)
    • Last Modified By (modified_by__v)
    • Last Modified Date (modified_date__v)
    • Link (link__sys)
    • Name (name__v)
    • Status (status__v)
    • User (user__v)
  • Added the following new field to the Change Action (change_action__qdm) object:
    • External Collaborator (external_collaborator__v)
  • Added the following new field to the Impact Assessment (change_control_impact_assessment__v) object:
    • External Collaborator (external_collaborator__v)
  • Added the following new standard notification template configurations:
    • Welcome (qms_extcollab_welcome_change_action__v)
    • Goodbye (qms_extcollab_goodbye_change_action__v)
    • Welcome Back (qms_extcollab_welcomeback_change_action__v)
    • Welcome (qms_extcollab_welcome_impact_assessment__v)
    • Goodbye (qms_extcollab_goodbye_impact_assessment__v)
    • Welcome Back (qms_extcollab_welcomeback_impact_assessment__v)

In support of the VPS: Regulatory Updates Enhancements feature, the following data model changes were made:

  • Added the following object type to the Adverse Event Report (adverse_event_report__v) object:
    • Other (other__v)
  • Added the following field to the Adverse Event Report (adverse_event_report__v) object:
    • Report Type (ae_report_type__v)
  • Added the following entries to the Report Type (ae_report_type__v) picklist:
    • Number of Reports (number_of_reports__v
    • Withdrawal Report (withdrawal_report__v)

In support of the Execute Root Cause Analysis from Investigation feature, the following data model changes were made:

  • Added the following field to the Root Cause (root_cause__v) object:
    • Investigation (investigation__v)
  • Added the following field to the Root Cause Analysis (root_cause_analysis__v) object:
    • Investigation (investigation__v)

In support of the Audit Room: Auto Assignment feature, the following data model changes were made:

  • Added the Inspection Request Auto Assignments (inspection_request_assignment__v) object.

In support of the Field Actions: Related Event Automation feature, the following data model changes were made:

  • Added the following fields to the Related Event (related_event__v) object:
    • Related Field Corrective Action (related_field_corrective_action__v)
    • Source Field Corrective Action (source_field_corrective_action__v)
    • Related Health Hazard Evaluation (related_health_hazard_event__v)
    • Source Health Hazard Evaluation (source_health_hazard_event__v)
  • Added the following entries to the Related Event Type (related_event_type__v) picklist:
    • Field Corrective Action (field_corrective_action__v)
    • Health Hazard Evaluation (health_hazard_evaluation__v)