24R3 Data Model Changes: Quality

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 24R3 Limited Release.

The following updates are in support of the Instructor-Led Training: Maximum Attendees & Waitlisting feature:

  • Added the Manually Manage Waitlist? field (manually_manage_waitlist__v) to the Class Schedule object (class_schedule__v).
  • Added the Classroom Waitlist object (classroom_waitlist__v)
  • Added the following picklists:
  • Waitlist Source (waitlist_source__v)
  • Waitlist Status (waitlist_status__v)
  • Waitlist Removal Reason (waitlist_removal_reason__v)

The following updates are in support of the Complaints Email Processor Update: Support for Complaint Intake feature:

  • Added the following fields to the Complaint Intake standard object type on the Complaint Intake (complaint_intake__v) standard object:
    • Sender Email Address (sender_email_address__v)
    • Email Body (email_body__v)
    • Email Text (email_text__v)
    • Vault Email Inbox Address (vault_email_inbox_ address__v)
    • Message ID (message_id__v)
    • Root Message ID (root_message_id__v)
    • Type of Complaint (type_of_complaint__v)
    • Promote to Complaint Required? (promote_to_complaint_required__v)
    • Triage Assessment (triage_assessment__v)
  • Added the following standard picklist values to the Type of Complaint (type_of_complaint__v) standard picklist:
    • Pharma Complaint (pharma_complaint__v)
    • MedTech Complaint (medtech_complaint__v)
  • Added the Complaint Intake Emails (complaint_intake_email__v) standard object to join the Email (email__sys) and Complaint Intake (complaint_intake__v) standard objects with the following fields:
    • Complaint Intake (complaint_intake__v)
    • Email (email__v)

The following updates are in support of the Action Paths: Support Change Action Templates feature:

  • Added the following fields to the Change Action Template (change_action_template__v) standard object:
    • Action Path ID (action_path_id__v)
    • Action Step ID (action_step_id__v)

The following are in support of the 24R3 Standard App Enhancements for Vault Validation Management feature:

  • DAC has been locked and can no longer be modified by admins for the below objects. It is critical that DAC is disabled (unchecked) by admins for all of these objects prior to 24R3 if they were enabled at some point prior to 24R3:
    • val_team_assignment__v
    • val_team_role__v
    • val_role_dependency__v
    • val_inventory_item__v
    • val_entity__v
    • val_entity_family__v
    • val_requirement_svo__v
    • val_related_requirement_svo__v
    • val_requirement_entity_version_svo__v
    • val_activity__v
    • val_deliverable_svo__v
    • val_deliverable_entity_version__v
    • val_test_protocol_svo__v
    • val_test_script_svo__v
    • val_test_script_execution_change__v
    • val_test_step_svo__v
    • val_test_step_change_svo__v
    • val_test_step_additional_prompt__v
    • val_discrepancy__v
    • val_related_discrepancy_svo__v
    • val_rtm_svo__v
    • val_template_requirement__v
    • val_template_requirement_set__v
    • val_template_req_template_req_set__v
    • val_test_co_author__v
    • val_requirement_suffix__v
  • Added standard lifecycle states to the Validation Entity Lifecycle (val_inventory_lifecycle__v):
    • Obsolete (obsolete_state__v)
    • In Entity Family Review (in_entity_family_review_state__v)
  • Custom fields can no longer be added by admins on the following simple join objects. If a custom field exists, please remove the custom field prior to the 24R3 release:
    • Validation Requirement Entity Version (val_requirement_entity_version_svo__v)
    • Validation Deliverable Entity Version (val_deliverable_entity_version__v)
    • Related Discrepancy (val_related_discrepancy_svo__v)
    • Template Req - Template Req Set (val_template_req_template_req_set__v)
    • Test Co-Author (val_test_co_author__v)
  • Modified the Test Structure (val_deliverable_test_structure__v) picklist so that the standard picklist status values can be modified from Active to Inactive and from Inactive to Active by an admin from the Vault UI.
  • Added new fields on the Validation Entity Version (val_entity__v) object:
    • Asset (asset__v)
    • Cancellation Date (cancellation_date__v)
    • Cancellation Justification (cancellation_justification__v)
  • Added new fields on the Validation Activity (val_activity__v) object:
    • External Change Control ID (external_chnage_control_id__v)
    • Activity Due Date (activity_due_date__v)
    • Amendment Date (amendment_date__v)
    • Cancellation Date (cancellation_date__v)
    • Cancellation Justification (cancellation_justification__v)
  • Added the following standard picklist values on the Activity Type (val_activity_type__v) picklist and made those values inactive by default:
    • Commissioning (commissioning__v)
    • Initial Qualification (initial_qualification__v)
    • Monitoring (monitoring__v)
    • Requalification (requalification__v)
  • Added the following fields on the Validation Deliverable (val_deliverable_svo__v) object:
    • Cancellation Date (cancellation_date__v)
    • Cancellation Justification (cancellation_justification__v)
    • Completion Status (completion_status__v)
  • Added the following fields on the Validation Deliverable (val_deliverable_svo__v) object:
    • Cancellation Date (cancellation_date__v)
    • Cancellation Justification (cancellation_justification__v)
    • Completion Status (completion_status__v)
  • Added the following fields on the Validation Test Script (val_test_script_svo__v) object:
    • Date Authoring Started (date_authoring_started__v)
    • Date Execution Started (date_execution_started__v)
    • Date Post-Approved (date_postapproved__v)
    • Date Pre-Approved (date_preapproved__v)
    • Cancellation Date (cancellation_date__v)
    • Cancellation Justification (cancellation_justification__v)
  • Added the following standard picklist values on the Test Type (val_test_type__v) picklist and made those values inactive by default:
    • DQ (dq__v)
    • PPQ (ppq__v)
  • Added the following fields on the Validation Test Protocol (val_test_protocol_svo__v) object:
    • Date Authoring Started (date_authoring_started__v)
    • Date Execution Started (date_execution_started__v)
    • Date Post-Approved (date_postapproved__v)
    • Date Pre-Approved (date_preapproved__v)
    • Cancellation Date (cancellation_date__v)
    • Cancellation Justification (cancellation_justification__v)
    • Test Type (test_type__v)
  • Added the following fields on the Validation Requirement (val_requirement_svo__v) object:
    • Cancellation Date (cancellation_date__v)
    • Cancellation Justification (cancellation_justification__v)
    • Workflow Status (workflow_status__v)
    • Backlog (backlog__v)
  • Added a new object type Configuration Specification (configuration_specification__v) with a status of inactive on the Validation Requirement (val_requirement_svo__v) object.
  • Added the External Trace (external_trace__v) field on the Traceability Matrix (val_rtm_svo__v) object.

The following updates are in support of the External Collaboration: Supplier Questionnaires feature:

  • Added the new Audit Collaborator Assignment (audit_collaborator_assignment__v) object type to the External Assignment Collaborator (external_collaborator_assignment__v) object. This object type contains only the Audit (audit__v) field.
  • Added the new External Collaborator (external_collaborator__v) field to the Audit (audit__v) object.
  • Added the following new notification templates:
    • Welcome: qms_extcollab_welcome_audit__v
    • Goodbye: qms_extcollab_goodbye_audit__v
    • Welcome back: qms_extcollab_welcomeback_audit__v