23R2 Data Model Changes: Quality | Vault Release Notes

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 What’s New in 23R2.

The following changes were made to support the SmartMatch Curricula feature:

Added the Smartmatch Enabled (smartmatch_enabled__v) and Smartmatch Configuration (smartmatch_configuration__v) fields to the Learner Role (learner_role__v) object
Added the Always Assign? (always_assign__v) field to the Curriculum (curriculum__v) object

The following changes were made to support the Assign Curriculum to a Learner’s Training Matrix feature:

Added the following objects:
- Individual Assignment Request (individual_assignment_request__v)
- Individual Request-Person (individual_request_person__v)
Added the Individual Learner Role (individual_learner_role__v) object type to the Learner Role (learner_role__v) object
Added the Requires Approval (requires_approval__v) field to the Curriculum (curriculum__v) object.
Added the Individual Assignment Request Lifecycle (individual_assignment_request_lc__v) and the VT: Individual Assignment Request (vt_individual_assignment_request__v) standard workflow

The following changes were made to support the Dynamic Enrollment: Automatically Assign Learner Roles to Person feature:

Added the Allow Dynamic Enrollment? (allow_dynamic_enrollment__v) and Dynamic Enrollment Configuration (dynamic_enrollment_configuration__v) fields to the Learner Role (learner_role__v) object.
Added the following fields to the Learner Role-Person (learner_role_person__v) object:
- Creation Source (creation_source__v)
- Latest Automation Update (latest_automation_update__v)
Added Learner Role-Person Creation Source (learner_role_person_creation_source__v) standard picklist

The following changes were made to support the Study Training: Auto Create User Role Setup Security Records feature:

Added the Learner Role Dependency (learner_role_dependency__v) object
Added the Learner Role Dep-User Role Setup (learner_role_dep_user_role_setup__v) join object

The following changes were made to support the External Collaboration: External Review & Approval of Documents feature:

Added the Collaborate Externally (collaborate_externally__v) and External Collaborators (external_collaborators__v) shared document fields
Added the Document Collaborator Assignment (document_collaborator_assignment__v) object type and the Target Document (target_document__v) field to the External Collaborator Assignment (external_collaborator_assignment__v) object

The following changes were made to support the QMS: 5 Whys Root Cause Record Creation Enhancements feature:

Changed the name of the Cause Type (cause_type__v) field on the Root Cause Analysis Item (root_cause_analysis_item__v) object to Root Cause Type (root_cause_type__v)
Added the Root Cause Object Type (root_cause_object_type__v) field to the Root Cause Analysis Item (root_cause_analysis_item__v) object

The following changes were made to support the External Notification Usability Enhancements feature:

Enabled the Secure relationship field attribute for the Ext Notification Enabled Record (enr_enabled_record__v) field on the following objects if they are associated with a lifecycle:
- Audit-Ext Notif Recipient (audit_external_ext_notif_recipient__v)
- Complaint-Ext Notif Recipient (complaint_external_ext_notif_recipient__v)
- Issue Escalation-Ext Notif Recipient (issue_escalation_ext_notif_recipient__v)
- Quality Event-Ext Notif Recipient (quality_event_ext_notif_recipient__v)
Added the Distribution Group Label (distribution_group_label__v) field to the following objects:
- Audit-Ext Notif Recipient (audit_external_ext_notif_recipient__v)
- Complaint-Ext Notif Recipient (complaint_external_ext_notif_recipient__v)
- Issue Escalation-Ext Notif Recipient (issue_escalation_ext_notif_recipient__v)
- Quality Event-Ext Notif Recipient (quality_event_ext_notif_recipient__v)

The following changes were made to support the Create Change Actions from Template Records feature:

Added the Change Action Template (change_action_template__v) object and associated Change Action Template Lifecycle (change_action_template_lifecycle__v)
Added the Template Record (template_record__v) field on the Change Action (change_action__qdm) object

The following changes were made to support the External Collaboration: Support for Investigation, Effectiveness Check, & Supplier Change Notifications feature:

Added the External Collaborator (external_collaborator__v) and Collaborate Externally (collaborate_externally__v) fields to the following objects:
- Investigation (investigation__qdm)
- Effectiveness Check (effectiveness_check__qdm)
- Supplier Change Notification (supplier_change_notification__v)
Added the following standard object types and fields for the External Collaborator Assignment object:
- Investigation Collaborator Assignment (investigation_collaborator_assignment__v)
  - Added the Investigation (investigation__v) field
- Effectiveness Check Collaborator Assignment (eff_check_collaborator_assignment__v)
  - Added the Effectiveness Check (effectiveness_check__v) field
- SCN Collaborator Assignment (scn_collaborator_assignment__v)
  - Added the Supplier Change Notification (supplier_change_notification__v) field

The following changes were made to support the Quality/ClinOps: Study Data Connection feature:

Added the Study (study__v), Study Country (study_country__v), and Study Site (study_site__v) fields to the following objects:
- Quality Event (quality_event__qdm)
  - Fields were provisioned as inactive. Will need to be set to active before use
- Audit (audit__qdm)
  - Fields were provisioned as inactive. Will need to be set to active before use
- Proposed Audit (proposed_audit__v)
  - Fields were provisioned as inactive. Will need to be set to active before use
- Qualification (qms_org_qualification__v)
  - Fields were provisioned as inactive. Will need to be set to active before use
- Deviation (deviation__v)
- Finding (finding__v)
Added the following standard join objects and associated lifecycles:
- Quality Event * Study (quality_event_studies__v)
- Audit * Study (audit_studies__v)
- Organization * Study (org_studies__v)
Added the following object type to the Qualification (qualification__v) object:
- Study Site (study_site__v)
  - Object type was provisioned as inactive. Will need to be set to active before use
Added the following fields to the Study (study__v) object:
- Protocol Title (protocol_title__v)
- Study Type (study_type__v)
Added the IRB/EC Type (ec_type__v) field to the Study Country (study_country__v) object

The following changes were made to the Root Cause Analysis Item (root_cause_analysis_item__v) object to support the 5 Whys Root Cause Record Creation Enhancements feature:

Cause Type (cause_type__v) field on the was renamed to Root Cause Type (root_cause_type__v)
Added the Root Cause Object Type (root_cause_object_type__v) field
Category, Cause Type and Subcategory fields are now able to be set to Inactive in order to prevent them from appearing in the UI

Added the following to support the Pause, Resume, and Terminate Test feature:

Test Script Execution Change (val_test_script_execution_change__v) object

The following change was made to support future Quality integration functionality:

Field attributes on the External Batch (external_batch_id__v) field on the Batch object have been updated as follows:
- User must enter a value = false
- Value must be unique = true
- Do not copy this field in Copy Record = true
Field attributes on the External ID (external_id__v) field on the Material object have been updated as follows:
- User must enter a value = false
- Value must be unique = true
- Do not copy this field in Copy Record = true

The following changes were made to support the Standalone Quality Events Data Model & Feature Parity feature:

New data model components:

Introduced new Change Control object along with the following attributes:
- Object has the following standard types: GMP Change Control, IT Change Control, and Temporary Change Control
- Associated Change Control Lifecycle
- Associated join objects to align with existing Quality Event-Change Control join objects
- Associated Change Control Sent Notification object and lifecycle and Change Control * Ext Notif Recipient object required for External Notification feature support
- Object reference field added to Change Action and Document Change Control objects
Introduced new Change Plan object with the following attributes:
- Object has types enabled
- Associated Change Plan Lifecycle
- Object reference field added to Change Action and Document Change Control objects
Introduced new Continuous Improvement object with the following attributes:
- Object has types enabled
- Associated Continuous Improvement Lifecycle
- Associated join object records to align with existing Quality Event-Continuous Improvement join objects
- Associated Continuous Improvement Sent Notification object and lifecycle and Cont. Improvement - Ext Notif Recipient object required for External Notification feature support
Introduced new Deviation object with the following attributes:
- Object has the following standard types: GMP Deviation, GCP Deviation, GLP Deviation, and IT Deviation
- Associated Deviation Lifecycle
- Associated join object records to align with existing Quality Event-Deviation join objects
- Associated Deviation Sent Notification object and lifecycle and Deviation - Ext Notif Recipient object required for External Notification feature support
Introduced new Finding object with the following attributes:
Object has the following standard types: Internal Finding and External Finding
- Associated Finding Lifecycle
- Associated join object records to align with existing Quality Event-Finding and Audit-Quality Event join objects
- Associated Finding Sent Notification object and lifecycle and Finding - Ext Notif Recipient object required for External Notification feature support
Introduced new Lab Investigation object with the following attributes:
- Object has the following standard types: Out-of Specification, Out-of-Tolerance, and Out of Trend
- Associated Lab Investigation Lifecycle
- Associated join object records to align with existing Quality Event-Lab Investigation join objects
- Associated Lab Investigation Sent Notification object and lifecycle and Lab Investigation - Ext Notif Recipient object required for External Notification feature support
- Associated Test Plan object and lifecycle
- Associated Related Lab Deviation object and lifecycle

Updates to existing objects in the QMS data model:

Related Event (related_event__v) object
- Added the following object reference fields:
  - Source Finding
  - Related Finding
  - Source Change Control
  - Related Change Control
  - Source Continuous Improvement
  - Related Continuous Improvement
  - Source Deviation
  - Related Deviation
  - Source Lab Investigation
  - Related Lab Investigation
  - Source Change Plan
  - Related Change Plan
- Updated existing standard layout rules to reference new fields
- Added new standard layout rules for new fields
- Added the following values to the Related Event Type picklist (related_event_type__v):
  - Finding (finding__v)
  - Change Control (change_control__v)
  - Deviation (deviation__v)
  - Continuous Improvement (continuous_improvement__v)
  - Lab Investigation (lab_investigation__v)
  - Change Plan (change_plan__v)
Extension Request (extension_request__qdm) object
- Added the following object reference fields:
  - Deviation
  - Change Control
  - Change Plan
  - Continuous Improvement
  - Lab Investigation
  - Finding
Issue Escalation (issue_escalation__v) object
- Added the following object reference field:
  - Triggering Deviation
CAPA Action (capa_action__qdm) object
- Added the following object reference fields:
  - Deviation
  - Continuous Improvement
  - Finding
Effectiveness Check (effectiveness_check__qdm) object
- Added the following object reference fields:
  - Deviation
  - Continuous Improvement
  - Finding
  - Change Control
  - Change Plan
Impact Assessment (change_control_impact_assessment__v) object
- Added the following object reference fields:
  - Deviation
  - Continuous Improvement
  - Change Control
  - Change Plan
- Added the following Yes/No fields:
  - Deviation in Impact Assessment?
  - Cont. Improvement in Impact Assessment?
  - Change Control in Impact Assessment?
  - Change Plan in Impact Assessment?
Investigation (investigation__qdm) object
- Added the following object reference fields:
  - Deviation
  - Lab Investigation
Root Cause Analysis (root_cause_analysis__v) object
- Added the following object reference fields:
  - Deviation
  - Lab Investigation
  - Finding
Root Cause (root_cause__qdm) object
- Added the following object reference fields:
  - Deviation
  - Lab Investigation
  - Finding
SCAR (qms_scar__v) object
- Added the following object reference fields:
  - Deviation
  - Continuous Improvement
  - Finding
Quality Event Cycle Time Metric (quality_event_cycle_time_metric__v) object
- Added the following object reference fields:
  - Deviation
  - Change Control
  - Change Plan
  - Continuous Improvement
  - Finding
  - Complaint
  - Lab Investigation
External Collaborator Assignment (external_collaborator_assignment__v) object
- Added the following standard object types:
  - Deviation Collaborator Assignment
  - Change Control Collaborator Assignment
  - Finding Collaborator Assignment
  - Change Plan Collaborator Assignment
- Added the following object reference fields:
  - Deviation
  - Change Control
  - Change Plan
  - Finding
Record Check Result (record_check_result__v) object
- Added the following standard object types:
  - Change Plan
  - Finding
- Added the following object reference fields:
  - Deviation
  - Change Control
  - Change Plan
  - Continuous Improvement
  - Finding
  - Lab Investigation
Record Check Match Record (record_check_match_record__v) object
- Added the following standard object types:
  - Change Plan
  - Finding
- Added the following object reference fields:
  - Related Deviation
  - Related Change Control
  - Related Change Plan
  - Related Continuous Improvement
  - Related Finding
  - Related Lab Investigation

The following changes were made to support the QualityOne Training Connector: eLearning Data Model Provisioning feature:

Added the following document fields:
- Source Document Number (source_document_number_elearn__v)
- Source Document Version (source_document_version_elearn__v)
- Source Link (source_link_elearn__v)
- Source Vault Name (source_vault_name_elearn__v)
Added the QualityOne Training E-learning Integration (qone_training_elearning_integration__v) integration.
Added the QualityOne E-learning Documents (qualityone_elearning_documents__v) integration rule.
Added the E-learning Inbound Integration Point (elearning_inbound_integration_point__v) integration point.

See 23R2 Data Model Changes: QualityOne for more details.

The following changes were made to support the Deliverable Reference Document Automation Enhancements feature:

Added the Validation Deliverable Closure Check (val_deliverable_closure_check__v) shared document field
Added the field Vault Document (Latest) (vault_document_latest__v) on the Validation Deliverable object (val_deliverable_svo__v)

The following changes were made to support the Validation Team feature:

Added the following objects:
- Validation Team Role (val_team_role__v)
- Role Dependency (val_role_dependency__v)
- Validation Team Assignment (val_team_assignment__v)
Added the following fields:
- Activity Owner (activity_owner__v) on the Validation Activity (val_activity__v) object
- Author (author__v) on the Test Step (val_test_step_svo__v) object
- Deliverable Owner (deliverable_owner__v) on the Validation Deliverable (val_deliverable_svo__v) object
- Discrepancy Owner (discrepancy_owner__v) on the Validation Discrepancy (val_discrepancy__v) object
- Requirement Owner (requirement_owner__v) on the Validation Requirement (val_requirement_svo__v) object
- Validation Inventory Item (validation_inventory_item__v) on the following objects:
  - Requirements Traceability Matrix (val_rtm_svo__v)
  - Test Protocol (val_test_protocol_svo__v)
  - Test Script (val_test_script_svo__v)
  - Test Step (val_test_step_svo__v)
  - Test Step Change (val_test_step_change_svo__v)
  - Validation Deliverable (val_deliverable_svo__v)
  - Validation Activity (val_activity__v)
  - Discrepancy (val_discrepancy__v)
Added the validation rule Required Validation Inventory Item (required_validation_inventory_item__v) on the following objects:
- Validation Activity (val_activity__v)
- Validation Deliverable (val_deliverable_svo__v)
- Validation Discrepancy (val_discrepancy__v)
- Requirements Traceability Matrix (val_rtm_svo__v)
- Test Protocol (val_test_protocol_svo__v)
- Test Script (val_test_script_svo__v)
- Test Step (val_test_step_svo__v)
- Test Step Change (val_test_step_change_svo__v)
Added the validation rule Required Deliverable or Test Protocol (required_deliverable_or_test_protocol__v) on the Validation Test Script (val_test_script_svo__v) object
Updated the following default values:
- On the Deliverable field (deliverable__v) to test_protocol__vr.deliverable__v on the Validation Test Script object (val_test_script_svo__v)
- On the Validation Inventory Item field (validation_inventory_item__v) to deliverable__vr.validation_inventory_item__v on the Validation Test Script object object (val_test_script_svo__v)
Validation RTM Lifecycle (val_rtm_lifecycle__v) was added to the Requirements Traceability Matrix (val_rtm_svo__v) object

The following changes were made to support the Pause, Resume, and Terminate Test feature:

Added the Test Script Execution Change object (val_test_script_execution_change__v)
New lifecycle state types were added: Execution Paused (val_execution_paused__v), In Execution (val_in_execution__v), and Execution Terminated (val_execution_terminated__v) on the Validation Test Script Lifecycle (val_test_script_svo_lifecycle__v)

To support the Vault Validation Management application, the following previously existing high volume objects that were replaced by standard volume have been locked in 23R2:

(OBS-HVO) Related Discrepancy (val_related_discrepancy__v)
(OBS-HVO) Related Val Requirements (val_related_requirement__v)
(OBS-HVO) Reqs Traceability Matrix (val_rtm__v)
(OBS-HVO) Test Step Change (val_test_step_change__v)
(OBS-HVO) Test Step (val_test_step__v)
(OBS-HVO) Test Script (val_test_script__v)
(OBS-HVO) Test Protocol (val_test_protocol__v)
(OBS-HVO) Val Deliverable (val_deliverable__v)
(OBS-HVO) Val Req Entity Version (val_requirement_entity_version__v)
(OBS-HVO) Val Requirement (val_requirement__v)

The following new fields were added to the Assessment Risk (fmea_risk_event__v) object to support the QRM: Risk Builder Enhancements feature. These fields will appear on the page layout for the pFMEA object type by default. If you are using the Risk Builder feature, you do not need to take any action. The new features (Risk Flagging and Insert Row Above/Below) are available to the users by default. If you are not using the Risk Builder feature, you can remove them from the object page layout:

Assessment Risk Flag (assessment_risk_flag__v)
Assessment Risk Order (assessment_risk_order__v)