23R1 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 23R1.

Added the Exclude Quiz for Doc Revision Training (exclude_quiz_for_doc_revision_training__v) field to the Training Assignment (training_assignment__v) object.

Made the following changes to support the Standalone MedTech Objects Data Model feature:

• Added the Complaint (vps_complaint__v) field to the following objects:
  • VPS: Reportability Assessment (reportability_assessment__v)
  • Adverse Event Report (adverse_event_report__v)
  • Adverse Event Problem Code (ae_problem_code__v)
  • Relevant Test (relevant_test__v)
  • Concomitant Product and Therapy Date (concomitant_therapy__v)
• Added the Complaint (complaint__v) field to the following objects:
  • MedTech Complaint Details (mt_complaint_details__v)
  • Product Returns (product_return__v)
  • SCAR (qms_scar__v)
• Added the Nonconformance (nonconformance__v) object and added the Nonconformance (nonconformance__v) object reference field to the following objects:
  • Containment (containment__v)
  • Corrections (correction__v)
  • Investigations (investigation__qdm)
  • Root Cause (root_cause__qdm)
  • Related Event (related_event__v)
  • Extension Request (extension_request__qdm)

Added the following fields to the Test Step object to support the Test Steps for Test Execution feature:

• Evaluate to Proceed (evaluate_to_proceed__v)
• Completed (completed__v)

The following changes were made to support the 5 Whys Analysis feature:

• Added the Root Cause Analysis (root_cause_analysis__v) object and Root Cause Analysis Lifecycle (root_cause_analysis_lifecycle__v)
• Added the Root Cause Analysis Item (root_cause_analysis_item__v) object
• Added the Related Root Cause Analysis Item (related_rca_item__v) field to the Root Cause object

The following changes were made to support the Standalone MedTech CAPA & Nonconformance Objects feature:

• Added the MedTech CAPA (medtech_capa__v) object

The following changes were made to support the Supplier Change Notifications feature:

• Added the Supplier Chan_ge Notification (supplier_change_notification__v) object and Supplier Change Notification Lifecycle (supplier_change_notification_lifecycle__v)
• Added the Supplier Change Notification Email (supplier_change_notif_email__v) object
• Added the SCN - Impacted Sites (scn_impacted_site__v) object and SCN-Impacted Site Lifecycle (scn_impacted_site_lifecycle__v)
• Added the SCN Impact Assessment (scn_impact_assessment__v) and SCN Impact Assessment Lifecycle (scn_impact_assessment_lifecycle__v)
• Added the following fields to the Quality Event object:
  • Supplier Change Notification (supplier_change_notification__v)
  • Supplier Change Impact Assessment (scn_impact_assessment__v)

The following changes were made to support the Tag Reason for Training Assignment Creation feature:

• Added the Creation Reason (creation_reason__v) field to the Training Assignment object.
• Added the standard picklist Creation Reason (creation_reason__v)

The following changes were made to support the Extend Recurrence Check to Support Custom Quality Event Object Types feature:

• Added the Custom (custom__v) object type to the Record Check Result and Record Check Match Record objects

The following changes were made to support the QualityOne & Training Vault Connection feature:

• Added the following connections:
  • Local App Owner Connection (local_app_owner_connection__v)
  • QualityOne to Training (qualityone_to_training__v)
• Added the QualityOne Training Documents Integration (qualityone_training_docs_integration__v) integration
• Added the Documents Inbound Integration Point (documents_inbound_integration_point__v) integration point
• Added the QualityOne Training Documents (qualityone_training_documents__v) integration rule
• Added the QualityOne to Training Inbound Queue (qualityone_to_training_inbound_queue__v) queue

See 23R1 Data Model Changes: QualityOne for more details.

The following changes were made to support the Study Training: Vault Connections with Clinical Operations feature:

• Added the ISO 3166 3-letter Country Code (iso_3166_3_letter_country_code__v) field to the Country (country__v) object
• Added the Link (link__sys) field to the Organization (qms_organization__qdm) object
• Added the Link (link__sys) field to the Person (person__sys) object
• Added the following fields to the Study (study__v) and Study Country (study_country__v), and Study Site (study_site__v) objects:
  • Source Record Status (source_record_status__v)
  • Source Lifecycle State (source_lifecycle_state__v)
  • Clinical Study Link (clinical_study_link__v)
  • Link (link__sys)
• Added the following fields to the Learner Role-Person (learner_role_person__v) object:
  • Source Record Status (source_record_status__v)
  • Source Lifecycle State (source_lifecycle_state__v)
  • Link (link__sys)

Converted the following standard objects for Validation Management application from high volume data store to standard data store:

• Validation Deliverable (val_deliverable__v to val_deliverable_svo__v)
• Validation Requirement (val_requirement__v to val_requirement_svo__v)
• Validation Requirement Entity Version (val_requirement_entity_version__v to val_requirement_entity_version_svo__v)
• Related Validation Requirement (val_related_requirement__v to val_related_requirement_svo__v)
• Test Protocol (val_test_protocol__v to val_test_protocol_svo__v)
• Test Script (val_test_script__v to val_test_script_svo__v)
• Test Step (val_test_step__v to val_test_step_svo__v)
• Test Step Change (val_test_step_change__v to val_test_step_change_svo__v)
• Requirements Traceability Matrix (val_rtm__v to val_rtm_svo__v)
• Related Discrepancy (val_related_discrepancy__v to val_related_discrepancy_svo__v)

Added the following objects to support the QMS <> RIM: Processing Enhancements feature:

• QMS-RIM Transaction (qms_rim_transaction__v) object
• QMS-RIM Transaction Log (qms_rim_transaction_log__v) object

Added the following components to support the RIM/Quality: Registered Product for Change Control feature:

• Added the RIM Status (rim_status__v) picklist
• Added the following objects:
  • Product Family Product (product_family_product__v)
  • Product Component (product_component__v)
• Added the following fields to the Product Family (product_family__v) object:
  • RIM Status (rim_status__v)
  • Deleted in RIM? (deleted_in_rim__v)
• Added the following fields to the Product (product__v) object:
  • RIM Product Type (rim_product_type__v)
  • RIM Status (rim_status__v)
  • Deleted in RIM? (deleted_in_rim__v)
• Added the following fields to the Product Variant (product_variant__v) object:
  • RIM Product Variant Type (rim_product_variant_type__v)
  • RIM Status (rim_status__v)
  • Deleted in RIM? (deleted_in_rim__v)
• Added the RIM-Quality: Product Integration (standard_product_integration_v) to the QMS to RIM (qms_to_rim__v) Connection
• Added the following integration points and integration rules to the RIM-Quality: Product Integration (standard_product_integration__v):
  • RIM-Quality: Product Family (product_family_int_point__v) Integration Point
    • 1.0 Product Family (rim_qual_product_family__v) Integration Rule
  • RIM-Quality: Product (product_int_point__v) Integration Point
    • 2.0 Product (rim_qual_product__v) Integration Rule
    • 2.1 Product - FDA Product Code Update (rim_qual_product_fda_code_update__v) Integration Rule
  • RIM-Quality: Product Family Product (product_family_product_int_point__v) Integration Point
    • 3.0 Product Family Product (rim_qual_product_family_product__v) Integration Rule

Added the following components to support the Tracking Curriculum Completions feature:

• Added the Curriculum Completion Status (curriculum_completion_status__v) object.
• Added the Training Requirement (training_requirement__v) lookup field to the Assignment Details object.

Added the following components to support the Curriculum Sequencing on Learner Homepage feature:

• Added the Learner Role-Curriculum Order (learner_role_curriculum_order__v) object.
• Added the Learner Homepage Card Image (learner_homepage_card_image__v) field to the Learner Role (learner_role__v) object.