24R2 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 24R2.

The attached document contains the data model updates in support of the Standard Layout & Data Model Updates feature.

The following updates are in support of the Complaint Intake & Promote to Complaint feature:

  • Added the following fields to the Medtech Complaint (medtech_complaint__v) and Pharma Complaint (pharma_complaint__v) object types on the Complaint (complaint__v) object:
    • Complaint Intake (complaint_intake__v)
    • Product Family (product_family__v)
  • Added the following fields to the Medtech Complaint (mt_complaint_v) and Complaint (complaint_qdm) object types on the Quality Event (quality_event__qdm) object:
    • Complaint Intake (complaint_intake__v)
    • Product Family (product_family__v)
  • Added the Complaint Intake (complaint_intake__v) object with the Base (base__v) and Complaint Intake (complaint_intake__v) object types and the following fields:
    • Name (name__v)
    • Product Quality Complaint Name (pqc_name__v)
    • Case Number (case_number__v)
    • Case State (case_state__v)
    • Product Quality Complaint State (pqc_state__v)
    • Title (title__v)
    • Description (description__v)
    • Initial Reporter (initial_reporter_details__v)
    • Reporter Type (reporter_type__v)
    • Initial Contact Method (initial_contact_method__v)
    • Date of Event (date_of_event__v)
    • Initial Report Date (initial_report_date__v)
    • Type (type__v)
    • Awareness Date (awareness_date__v)
    • Comments (comments__v)
    • Country of Incident (country_of_incident__v)
    • Promote to Complaint Run? (promote_to_complaint__v)
  • Added the Complaint Intake Complaint (complaint_intake_complaints__v) object with the following fields:
    • Name (name__v)
    • Complaint Intake (complaint_intake__v)
    • Complaint (complaint__v)
    • Reported Product (reported_product__v)
    • Relationship Type (relationship_type__v)
    • Comments (comments__v)
  • Added the Complaint Intake Quality Event Complaint (complaint_intake_qe_complaints__v) object with the following fields:
    • Name (name__v)
    • Complaint Intake (complaint_intake__v)
    • QE Complaint (quality_event_complaint__v)
    • Reported Product (reported_product__v)
    • Relationship Type (relationship_type__v)
    • Comments (comments__v)
  • Added the Reported Product (reported_product__v) object with the following fields:
    • Name (name__v)
    • Complaint Intake (complaint_intake__v)
    • Product Quality Complaint Name (product_quality_complaint_name__v)
    • Reported Batch Number(s) (reported_batch_numbers__v)
    • Product Family (product_family__v)
    • Product (product__v)
    • Product Variant (product_variant__v)
  • Added the Reported Product Batch (reported_product_batch__v) object with the following fields:
    • Name (name__v)
    • Reported Product (reported_product__v)
    • Batch (quality_batch__v)

The following updates are in support of the Recurrence Check: Refresh Results from Comparison Page feature:

  • Added the following field to all object types for the Record Check Result (record_check_result__v) object:
    • Allow Match Term Override (allow_match_term_override__v)

The following updates are in support of the Action Paths & Steps for Change Control feature:

  • Added the Action Step (action_step__v) object
  • Added the Action Step (action_step__v) field to the Change Action (change_action__qdm) object
  • Added the following fields to the Quality Event (quality_event__qdm) object and its Change Control (change_control__qdm) object type:
    • Action Path ID (action_path_id__v)
    • Action Path Name (action_path_name__v)
  • Added the following fields to the Change Control (change_control__v) object and its object types:
    • Action Path ID (action_path_id__v)
    • Action Path Name (action_path_name__v)
  • Added the following fields to the Change Plan (change_plan__v) object and its object types:
    • Action Path ID (action_path_id__v)
    • Action Path Name (action_path_name__v)

The following updates are in support of the Supplier Change Notifications: Extract Entities from Attachment feature:

  • Added the SCN - Qualification (scn_qualification__v) object with the following fields:
    • Attachment Name (attachment_name__v)
    • Material (material__v)
    • Qualification (qualification__v)
    • Supplier Change Notification (supplier_change_notification__v)

The following objects were added in support of the Quality Recurrence Check Insights feature:

  • Related Record Check Summary Data (rc_insights_summary_data__v)
  • Related Record Check Field Data (rc_insights_field_suggestions_data__v)

The following updates are in support of the MedTech Standard Layouts and Data Model feature:

  • Added the following fields to the VPS: Reportability Assessment (reportability_assessment__v) object and its object types:
    • Public Health Threat (public_health_threat__v)
    • Death (death__v)
    • Product Malfunction (product_malfunction__v)
    • Serious Injury (serious_injury__v)
    • Did We Manufacture? (did_we_manufacture__v)
  • Added the Owner (owner__v) field to the MedTech CAPA (medtech_capa__v) object.
  • Added the Owner (owner__v) field to the Nonconformance (nonconformance__v) object.

The following updates are in support of the External & On-the-Job Training (OJT): Support Document-Based Training feature:

  • Added the In Use Training Content Set field (in_use_training_content_set__v) and In Use Training Content Set Is Trainable field (in_use_tcs_contains_is_trainable__v) to the following Training Requirement object types (training_requirment__v):
    • Evaluation Training Requirement (evaluation_training_requirement__v)
    • External Training Requirement (external_training_requirement__v)

The following updates are in support of the On-the-Job Training (OJT): Learner Selects Evaluator feature:

  • Added the Learner Selects Evaluators (learner_selects_evaluators__v) field to the following objects:
    • Evaluation Training Requirement (evaluation_training_requirement__v), an object type of Training Requirement (training_requirement__v)
    • Evaluation Training Assignment (evaluation_training_assignment__v), an object type of Training Assignment (training_assignment__v)
  • Added the Select Evaluator state (select_evaluator__v) to the Training Assignment object lifecycle (training_assignment_lifecycle__v).

The following updates are in support of the Study Training: Responsibility-Based Training feature:

  • Added the following picklists:
    • Role Type (role_type__v)
    • Training Type (training_type__v)
  • Added the following fields to the Study Team Role object (study_learner_role__v), an object type of Learner Role (learner_role__v)
    • Role Type (role_type__v)
    • Training Type (training_type__v)
    • System ID (system_id__v)
  • Added or updated the following within the study_team_role__v object:
    • Updated the object label to Clinical Mapping (previously labeled Clinical Study Team Role)
    • Updated the name__v field label to Clinical Responsibility (previously labeled Clinical Study Team Role)
    • Added the following fields:
      • Role Type (role_type__v)
      • Training Type (training_type__v)
      • System ID (system_id__v)
      • Target Key Field (target_key_field__v)
      • Source Key (source_key__v)
      • Target Key (target_key__v)

The following field was added to the Assessment History (assessment_history__v) and Assessment Risk History (assessment_risk_history__v) objects:

  • Owning Organization (owning_organization__v)

APIs are being released to only allow CDMS Vaults to communicate with Vault Training. While the following new components are visible in Training Vaults, they are meant for this purpose only and are not useful in the Training application on their own:

  • Objects:
    • CDMS Training: Public Access Links (PAL) (cdms_training_pal__v)
    • Training Connection (training_connection__v)
    • Training Connection-Person (training_connection_person__v)
  • Jobs:
    • Training: Export Training Matrix (export_training_matrix_job__v)
    • Training: Export Training Completion (export_training_completion_job__v)
    • Training: Create User Accounts (training_create_user_accounts_job__v)

The data model changes made in support of the Standard Layout & Data Model Updates feature will be documented in the 24R2 General Release Notes.

The following updates are in support of the Instructor-Led Training: Learner Self-Attendance & Learner E-Signature feature:

  • Added the Learner E-Signature Required? (learner_signature_required__v) field to the following objects and object types:
    • Training Requirement (training_requirement__v)
    • Classroom Training Requirement (classroom_training_requirement__v)
    • Class Schedule (class_schedule__v)
  • Added the Classroom Learner E-Signature Captured? (classroom_learner_signature_captured__v) field to the Classroom Training Assignment (classroom_training_assignment__v) object type.
  • Added the Attendance Capture Method (attendance_capture_method_v) field to the Session Roster (session_roster_v) object.

Vault Validation Management Data Model Changes

The following updates are in support of the Requirement, Test Script, and Test Protocol Naming Schemes feature:

  • Added the Validation Requirement Suffix (val_requirement_suffix__v) object
  • Added the following field and made available to be added to all object types for the Validation Entity (val_inventory_item__v) object:
    • Entity Acronym (entity_acronym__v)
  • Added the following fields and made available to all object types for the Validation Requirement (val_requirement_svo__v) object:
    • Legacy Requirement ID (legacy_requirement_id__v)
    • Requirement Suffix (requirement_suffix__v)
    • Requirement Type Acronym (requirement_type_acronym__v)
    • Uniqueness Key (System Managed) (uniqueness_key__v)
  • Added or updated the following on the Test Protocol (val_test_protocol_svo__v) object:
    • Added the following fields
      • Legacy Test Protocol ID (legacy_test_protocol_id__v)
      • Run Number (run_number__v)
      • Uniqueness Key (System Managed) (uniqueness_key__v)
    • Changed the Run Number (run_number__v) data type from text to number
    • Updated component security for the Record Number (name__v) field:
      • System manages field value (read-only) option editable 
      • Values must be unique option editable
      • Do not copy option editable
  • Added or updated the following on the Test Script (val_test_script_svo__v) object:
    • Added the following fields
      • Legacy Test Script ID (legacy_test_script_id__v)
      • Uniqueness Key (System Managed) (uniqueness_key__v)
    • Updated component security for the Record Number (name__v) field:
      • System manages field value (read-only) option editable 
      • Values must be unique option editable
      • Do not copy option editable
  • Added the Requirement Suffix (requirement_suffix__v) field on the Validation Template Requirement (val_template_requirement__v) object:

The following updates are in support of the Multiple Test Script Authors feature:

Added the Test Co-Author (val_test_co_author__v) object