24R1 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 What’s New in 24R1.

The following updates are in support of the QRM: Periodic Risk Review feature:

Added the following objects and relationship (join) objects:

• Assessment History (assessment_history__v)
• Assessment Risk History (assessment_risk_history__v)
• Assessment Risk Mitigation History (assessment_risk_mitigation_history__v)

The following updates are in support of the QRM: Risk Builder Enhancements feature:

Added the following objects and relationship (join) objects:

• Assessment Risk Mitigation (assessment_risk_mitigation__v) (inactive by default)
• Assessment - Product (assessment_product__v)
• Deviation - Assessment Risk (deviation_assessment_risk__v)
• Nonconformance - Assessment Risk (nonconformance_assessment_risk__v)
• Complaint - Assessment Risk (complaint_assessment_risk__v)
• Quality Event - Assessment Risk (quality_event_assessment_risk__v)

The following updates are in support of the Enable Adverse Event Reportability Assessment in QMS feature:

• Reportability Assessment (reportability_assessment__v) object
• Codes (code__v) object
• Reportability Assessment Effects (reportability_assessment_effects__v) object
• Reporting Decision Rule (reporting_decision_rule__v) object

The following updates are in support of the Record Check: Capture Suggested Terms and UI Enhancements feature:

• Record Check Result (record_check_result__v) object and all types thereof have been updated with the following fields:
  • Suggested Terms (suggested_terms__v)
• Record Check Rule Detail (record_check_rule_detail__v) object and all types thereof have been updated with the following fields:
  • Suggested Terms (suggested_terms__v)

The following updates are in support of the Curriculum Prerequisites feature:

• Added the following raw (high volume) objects:
  • Curriculum Training Rule (curriculum_training_rule__v) and its object type, Prerequisite (prerequisite__v)
  • Curriculum Training Rule Set (curriculum_training_rule_set__v) and its object type, Prerequisite ( prerequisite__v)
  • Related Curriculum (related_curriculum__v)
• Added the following picklists:
  • Related Curriculum Type (related_curriculum_type__v)
  • Curriculum Prerequisite Offset Due Date (curriculum_prerequisite_offset_due_date__v)
  • Curriculum Prerequisite Duration Source (curriculum_prerequisite_duration_source__v)
  • Curriculum Prerequisite Status (curriculum_prerequisite_status__v)
  • Due Date Timing (no_due_date__v)
  • Allow Self-Registration (allow_self_registration__v)
• Added the following fields to the Training Assignment (training_assignment__v) object:
  • Curriculum Prerequisite Status (curriculum_prerequisite_status__v)
  • Due Date Timing (no_due_date__v)
• Added the Curriculum Prerequisite Expression (internal) (curriculum_prerequisite_expression_internal__v) field to the Assignment Details (assignment_details__v) object.

The following updates are in support of the Curriculum Completion Outcomes: Grant Additional Permissions feature:

• Added the Curriculum Outcome Status (curriculum_outcome_status__v) object
• Added an Outcome (outcome__v) object type to the following objects:
  • Curriculum Training Rule (curriculum_training_rule__v)
  • Curriculum Training Rule Set (curriculum_training_rule_set__v)
• Added the following fields to the Curriculum Training Rule (curriculum_training_rule__v) object:
  • Application Role (application_role__v)
  • Outcome Type (outcome_type__v)
• Added the following picklists:
  • Outcome Type (outcome_type__v)
  • Outcome Fulfillment Status (outcome_fulfillment_status__v)

The following updates are in support of the My Team Page (Manager Homepage) feature:

• Added the Nudge Detail (nudge_detail__v) object
• Added the Completed Status Picklist (completed_status_picklist__v) picklist
• Added the Completed Status (completed_status__v) field to the Training Assignment (training_assignment__v) object

The following updates are in support of the Training Requirement Impact Assessment (TRIA): Copy Training Impact from Document feature:

• Added the Training Impact (training_impact__v) document field.
• Added the Training Impact (training_impact__v) field to the Training Requirement Impact Assessment (training_requirement_impact_assessment__v) object.

The following updates to the Learner Role-Person Lifecycle (learner_role_person_lifecycle__v) are in support of the Assign, Pause, or Cancel Training Assignments Using Learner Role-Person Lifecycle feature:

• Added the following standard lifecycle states:
  • Ineligible (ineligible__v)
  • Eligible (eligible__v)
  • Retired (retired__v)
• Mapped the Initial State (initial_state__sys) state type to the Ineligible (ineligible__v) state.

The following updates are in support of the Data Model: New Fields & Objects feature:

• Added the following objects and relationship (join) objects:
  • Job Title (job_title__v)
  • Learner Role-Organization (learner_role_organization__v)
  • Learner Role-Site (learner_role_site__v)
  • Learner Role-Department (learner_role_department__v)
  • Learner Role-Sub-Department (learner_role_sub_department__v
  • Curriculum-Organization (curriculum_organization__v)
  • Curriculum-Site (curriculum_site__v)
  • Curriculum-Department (curriculum_department__v)
  • Curriculum-Sub-Department (curriculum_sub_department__v)
• Added the following picklists:
  • Working Location (working_location__v)
  • Employee Type (employee_type__v)
  • Job Level (job_level__v)
• Added the following fields to the Person (person__sys) object:
  • Job Title (job_title__v)
  • Job Level (job_level__v)
  • Employee Type (employee_type__v)
  • Working Location (working_location__v)
  • Person’s Organization (person's_organization__v)
  • Person’s Site (person's_site__v)
  • Sub-Department (sub-department__v)
• Added the following fields to the Learner Role (learner_role__v) and Curriculum (curriculum__v) objects:
  • Job Title (job_title__v)
  • Job Level (job_level__v)
  • Employee Type (employee_type__v)
  • Owning Organization (owning_organization__v)
  • Owning Site (owning_site__v)
  • Owning Department (owning_department__v)
  • Owning Sub-Department (owning_sub-department__v)
• Added the following fields to the Training Requirement (training_requirement__v) object and all of its object types:
  • Owning Organization (owning_organization__v)
  • Owning Site (owning_site__v)
  • Owning Department (owning_department__v)
  • Owning Sub-Department (owning_sub-department__v)

The following objects have been added for the Enhanced Checklists for Audit Execution feature:

• Audit Available Answer (audit_available_answer__sys)
• Audit Checklist (audit_checklist__sys)
• Audit Dependency (audit_dependency__sys)
• Audit Response (audit_response__sys)
• Audit Response-Doc (audit_response_doc__sys)
• Audit Response-Ref-Doc (audit_response_ref_doc__sys)
• Audit Section (audit_section__sys)
• Audit Sub-Checklist (audit_subchecklist__sys)

For the Enhanced Checklists for Audit Execution feature, the following fields have been added to the Finding (finding__v) object and the Internal Finding (internal_finding__v) and External Finding (external_finding__v) object types:

• Audit Checklist (audit_checklist__v)
• Audit Checklist Display Order (audit_checklist_display_order__v)
• Audit Checklist Question (audit_checklist_question__v)
• Audit Checklist Response (audit_checklist_response__v)
• Audit Checklist Section (audit_checklist_section__v)
• Audit Response (audit_response__v)

The following object has been added for the QR Code Enabled Quality Incident feature:

• Quality Incident Configuration Data (quality_incident_config_data__v)

The following fields have been added to the Quality Incident object for the QR Code Enabled Quality Incident feature::

• Organization (organization__v)
• Department (department__v)

The following field has been added to the Record Check Result and Record Check Rule Detail objects for the Record Check Enhancements: Capture Suggested Terms and UI enhancements feature:

• Suggested Terms (suggested_terms__v)

The following fields have been added to the following objects to support common customer configurations with standard fields:

• Investigation object
  • External Organization (external_organization__v)
  • Owning Organization (owning_organization__v)
• Audit object
  • Owning Organization (owning_organization__v)
  • Third Party Organization (third_party_organization__v)
• Audit Program
  • Owning Organization (owning_organization__v)
• Proposed Audit
  • Owning Organization (owning_organization__v)
• CAPA Action
  • Owning Organization (owning_organization__v)
• Change Action
  • Owning Organization (owning_organization__v)
• Change Control Impact Assessment
  • Owning Organization (owning_organization__v)
• Effectiveness Check
  • Owning Organization (owning_organization__v)
  • External Organization (external_organization__v)
• FMEA Risk Assessment
  • Owning Organization (owning_organization__v)
• FMEA Risk Event
  • Owning Organization (owning_organization__v)
• Auditor Profile
  • Owning Organization (owning_organization__v)
• Auditor Role
  • Owning Organization (owning_organization__v)
• Role Qualification Status
  • Owning Organization (owning_organization__v)
• Role Qualification Criteria Status
  • Owning Organization (owning_organization__v)
• Qualification to Complete
  • Owning Organization (owning_organization__v)

The following field has been added to the Change Plan object for the Related Events App Section feature:

• Title (title__v)

The following objects have been added in support of the Regulatory Updates for eMDR feature

• Related Adverse Event Reports (related_adverse_event_reports__v) - Raw Object

The following objects and fields have been updated in support of the Regulatory Updates for eMDR feature

• Adverse Event Report object
  • Form Code (form_code__v) has been inactivated
  • Correction Number (correction_number__v) field maximum length changed to 50 characters
• Complaint object
  • Patient Sex (patient_sex__v) picklist field added
  • Gender - Other (gender_other__v) text field added
  • Gender (gender__v) picklist values updated with new values
    • Cisgender man/boy  (cis_man__v)
    • Cisgender woman/girl (cis_woman__v)
    • Transgender man/trans man / female-to-male (FTM)  (ftm__v)
    • Transgender woman/trans woman / male-to-female (MTF)  (mtf__v)
    • Other Gender category (other__v)
    • Decline to answer (decline_to_answer__v)

The following updates are in support of the Family Validation feature in Vault Validation Management:

• Added the Validation Entity Family (val_entity_family__v) object
• Added the Validation Deliverable Entity Version (val_deliverable_entity_version__v) object
• Added the following fields to the Validation Inventory Item (val_inventory_item__v) object and made them available so they can be enabled on applicable object types:
  • Entity Family (entity_family__v)
  • Proposed Entity Family (proposed_entity_family__v)
  • Asset (asset__v)
• Added the following fields to the Validation Entity (val_entity__v) object and made them available so they can be enabled on applicable object types:
  • Entity Family (entity_family__v)
• Added the following fields to the Validation Requirement (val_requirement_svo__v) object and made them available so they can be enabled on applicable object types:
  • Entity Family (entity_family__v)
  • Entity Family Setting (entity_family_setting__v)

The following updates are in support of the Template Requirements feature in Vault Validation Management:

• Added the Template Requirement/Specification (val_template_requirement__v) object
• Added the Template Requirement Set (val_template_requirement_set__v) object
• Added the Template Req - Template Req Set (val_template_req_template_req_set__v) object
• Added the following fields to the Validation Requirement (val_requirement_svo__v) object and made them available so they can be enabled on applicable object types:
  • Template Requirement (template_requirement__v)
• Added the following standard lifecycle state type on the Template Requirement Set Lifecycle (val_template_requirement_set_lifecycle__v) and the Template Requirement Lifecycle (val_template_requirement_lifecycle__v):
  • Available for Use (val_available_for_use__v)

The following updates are in support of the DirectData API Support for Vault Validation Management feature in Vault Validation Management:

• Made the following objects available to the direct data API extracts for vaults that have a Direct Data API license
  • Validation Inventory Item (val_inventory_item__v)
  • Validation Entity (val_entity__v)
  • Validation Requirement (val_requirement_svo__v)
  • Related Validation Requirement (val_related_requirement_svo__v)
  • Validation Requirement Entity Version (val_requirement_entity_version_svo__v)
  • Validation Team Assignment (val_team_assignment__v)
  • Validation Activity (val_activity__v)
  • Validation Deliverable (val_deliverable_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 Additional Prompt (val_test_step_additional_prompt__v)
  • Test Step Change (val_test_step_change_svo__v)
  • Test Script Execution Change (val_test_script_execution_change__v)
  • Discrepancy (val_discrepancy__v)
  • Related Discrepancy (val_related_discrepancy_svo__v)
  • Requirements Traceability Matrix (val_rtm_svo__v
  • Entity Family (val_entity_family__v)
  • Val Deliverable Entity Version (val_deliverable_entity_version__v)
  • Template Requirement (val_template_requirement__v)
  • Template Requirement Set (val_template_requirement_set__v)
  • Related Template Requirement (val_related_template_requirement__v)
  • Template Req - Template Req Set (val_template_req_template_req_set__v)

The following updates have been made to remove legacy raw objects that are no longer in use in Vault Validation Management:

• Removed the following raw objects and their lifecycles from the data model for Vault Validation Management:
  • Related Discrepancy (val_related_discrepancy__v)
  • Related Validation Requirement (val_related_requirement__v)
  • Requirements Traceability Matrix (val_rtm__v)
  • Test Protocol (val_test_protocol__v)
  • Test Script (val_test_script__v)
  • Test Step (val_test_step__v)
  • Test Step Change (val_test_step_change__v)
  • Validation Deliverable (val_deliverable__v)
  • Validation Requirement (val_requirement__v)
  • Validation Requirement Entity Version (val_requirement_entity_version__v)

The following updates are in support of the Study Training: Training Matrix Automation feature:

• Added the Add to All New Studies (add_to_all_new_studies__v) field to the Training Role (learner_role__v) object and its active object type, Study Team Role (study_team_role__v).
• Added the System Aided Matrix Management (system_aided_matrix_management__v) field to the Study (study__v) object.
• Added the Training Requirement Classification (training_requirement_classification__v) object with an active object type, Study TR Classification (study_tr_classification__v).
• Added the following fields to the Training Requirement (training_requirement__v) object and all of its active object types, except where indicated:
  • Training Requirement Creation Source (training_requirement_creation_source__v)
  • Document ID (document_id__v) on the Vault Document Training Requirement (vault_document_training_requirement__v) object type only.
• Added the Training Requirement Creation Source (training_requirement_creation_source__v) picklist.

The following updates are in support of the Learn GxP ContentDirect feature:

• Added the Learn GxP Training Material (learn_gxp_training_material__v) document type
• Added the following objects:
  • LearnGxP Integration Training PAL (lgxp_integration_training_pal__v)
  • LearnGxP Users Licensed (learngxp_users_licensed__v) (raw object)
• Added the Learn GxP Training Requirement? (learngxp_training_requirement__v) field to the Training Requirement (training_requirement__v) object and its Classroom Training Requirement (classroom_training_requirement__v) object type
• Added the following picklists:
  • LearnGxP Course Type (learngxp_course_type__v)
  • LearnGxP Functional Area (learngxp_functional_area__v)
  • LearnGxP Regulatory Region (learngxp_regulatory_region__v)
  • LearnGxP Update Definition (learngxp_update_definition__v)
  • LearnGxP Update Type (learngxp_update_type__v)
• Added the following fields to the Training Requirement Impact Assessment (training_requirement_impact_assessment__v) object:
  • LearnGxP Course Type (learngxp_course_type__v)
  • Learn GxP Document? (learngxp_document__v)
  • LearnGxP Functional Area (learngxp_functional_area__v)
  • LearnGxP Regulatory Region (learngxp_regulatory_region__v)
  • LearnGxP Update Definition (learngxp_update_definition__v)
  • LearnGxP Update Type (learngxp_update_type__v)

The following updates were made to support the Family Validation feature:

• Added the following objects:
  • Validation Entity Family (val_entity_family__v)
  • Validation Deliverable Entity Version (val_deliverable_entity_version__v)
• Added the following fields to the Validation Requirement (val_requirement_svo__v) object
  • Entity Family (entity_family__v)
  • Entity Family Setting (entity_family_setting__v)
• Added the following fields to the Validation Entity (val_inventory_item__v) object:
  • Asset (asset__v)
  • Entity Family (entity_family__v)
  • Proposed Entity Family (proposed_entity_family__v)
• Added the Entity Family (entity_family_v) field to the Validation Entity Version (val_entity__v) object