21R3 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 21R3.

With this release, we’ve added the following components to the Quality data model to support new features:

The following changes were made to support the External Collaboration Support for CAPA & SCAR Records feature:

• The SCAR (scar__v) and CAPA Action (capa_action__qdm) objects have new metadata fields:
  • The External Collaborator (external_collaborator__v) field has been made available to all object types of these objects.
• A new object has been added for use by the feature: External Collaborator Assignment (external_collaborator_assignment__v). In this release, this object is only visible to users with All Objects Read (or greater) permissions, typically Vault Owners. This object has several types used by the external collaboration feature for assignment tracking:
  • Quality Event Collaborator Assignment (quality_event_collaborator_assignment__v)
  • CAPA Action Collaborator Assignment (capa_action_collaborator_assignment__v
  • SCAR Collaborator Assignment (scar_collaborator_assignment__v)

The following changes were made to support the Generate Quality Document from Record: Batch Release Process Support feature:

• Added the Lot Disposition Record (lot_disposition_record__v) shared document field.

The following changes were made to support the Recurrence Check: Deviations feature:

• The Record Check Result (record_check_result__v) object was added along with the Deviation (deviation__v) object type
• The Record Check Match Record (record_check_match_record__v) object was added along with the Deviation (deviation__v) object type
• The following picklists were added
  • Record Check Date Unit (record_check_date_unit__v)
  • Record Check Type (record_check_type__v)
  • Recurrence Check Tier Label (recurrence_check_tier_label__v)
  • Preserve Prior Results (preserve_prior_results__v)
• The following fields were added to the Quality Event (quality_event__qdm) object
  • Record Check Result (record_check_result__v)
  • Record Check Result State (record check_result_state__v)
• The following field was added to the Related Quality Event (related_quality_event__qdm) object
  • Record Check Result (record_check_result__v)
• The following lifecycle was added Record Check Result Lifecycle (record_check_result_lifecycle__v)

The following changes were made to support the Station Manager App Update Enforcement (Vault) feature:

• The Days Left to Upgrade (days_left_to_upgrade__v) field was added to the Station Device object.

The following changes were made to support the Adverse Event Reports for TGA (Australia) feature:

• The TGA Report (DIR) # field was added to Adverse Event Report object to support reporting for TGA.

The following changes were made to support the Recurrence Check: Complaints feature:

• The Complaints object type was added to the Record Check Result and Record Check Result Match objects.

The following changes were made to support the MDCC: Change Authorization Section feature:

• Added the Change Authorization (change_authorization__v) object with the following fields:
  • Document Change Control (document_change_control__v)
  • Target Document (target_document__v)
  • Revise or Obsolete (revise_obsolete__v)
• Added the Change Authorization Lifecycle.
• Added the Change Authorization Change Control (change_authorization_change_control_v) shared document field.

The following changes were made to support the Standard Cycle Time Metrics for Quality Events feature:

• Added the Cycle Time Start (cycle_time_start__v) and Cycle Time Stop (cycle_time_stop__v) standard state types.
• Added the Quality Event Cycle Time Metric (quality_event_cycle_time_metric__v) object with the following fields:
  • Quality Event (quality_event__v)
  • Cycle Time Start Date (cycle_time_start_date__v)
  • Original Due Date (original_due_date__v)
  • Current Due Date (current_due_date__v)
  • Cycle Time Stop Date (cycle_time_stop_date__v)
  • Cycle Time (cycle_time__v)
  • Cycle Time Delta from Original Due Date (cycle_time_delta_original_due_date__v)
  • Cycle Time Delta from Current Due Date (cycle_time_delta_current_due_date__v)
  • Extensions Granted (extensions_granted__v)
• Added the following object types for the Quality Event Cycle Time Metric (quality_event_cycle_time_metric__v) object:
  • Change Control (change_control__v)
  • Complaint (complaint__v)
  • Continuous Improvement (continuous_improvement__v)
  • Deviation (deviation__v)
  • External Finding (external_finding__v)
  • Internal Finding (internal_finding__v)
  • Lab Investigation (lab_investigation__v)
  • Medtech Complaint (mt_complaint__v)
  • Nonconformance (nonconformance__v)

The following changes were made to support the Training Self-Enrollment feature:

• Added the following fields to the Training Requirement (training_requirement__v) object:
  • Available for self-enrollment? (allow_self_enrollment__v)
  • Completion Credit Given if Completed Via (completion_credit_if_completed_via__v)

The following changes were made to support the VPS: Validation Results Storage feature:

• The Adverse Event Report Validation object was added with following fields
  • Health Authority Section Number (ha_section__v)
  • Health Authority Field Name (ha_field_name__v)
  • Object Name (object_name__v)
  • Object Label (object_label__v)
  • Field Name (field_name__v)
  • Field Label (field_label__v)
  • Reason (reason__v)
  • Source Value (source_value__v)
  • Mapped Value (mapped_value__v)
  • Adverse Event Report (adverse_event_report__v)
  • Adverse Event Report Validation Type (validation_type__v)

The following changes were made to support the Multi Country Adverse Events Reporting feature:

• Added the Product Marketed (product_marketed__v) object with following fields:
  • Product Variant (product_variant__v)
  • Country (country__v)
  • Auto-name Calculation (autoname_calculation__v)
• Added the Reporting Requirement (reporting_requirement__v) field to the Reporting Decision Rules object.
• Added the following fields to the Reportability Assessment Effects object:
  • Country (country__v)
  • Severity Outcome (severity_outcome__v)
  • Is Reportable? (is_reportable__v)
  • No of Days for Initial Report (no_of_days_initial_report__v)
• Several fields were removed from Adverse Event Report object and added to the Quality Event object:
  • AE – Manufacturer Narrative (mfg_narrative__v)
  • AR Contact Person (ar_contact_person__v)
  • AR Contact Person’s Details (ar_contact_details__v)
  • Authorized Representative (authorized_representative__v)
  • CAPA Plan Summary (capa_plan_summary__v)
  • CAPA Schedule (capa_schedule__v)
  • Classification of incident (ae_classification__v)
  • Complainant (complainant__v)
  • Complainant Contact Information (complainant_contact_information__v)
  • Complainant Type (complainant_type__v)
  • Date of Death (date_of_death__v)
  • Date of Event (date_of_event__qdm)
  • Description of the Adverse Event (ae_description__v)
  • Final Comments (mfg_final_comments_cause__v)
  • Further Investigations (further_investigations__v)
  • Healthcare Facility Report Number (healthcare_facility_number__v)
  • How long device used? (how_long_device_used__v)
  • Importer (importer__v)
  • Incident – Healthcare Facility (incident_healthcare_facility__v)
  • Incident involves multiple devices? (multiple_devices__v)
  • Investigation Summary and Conclusion (investigation_summary_and_conclusion__v)
  • Latest Info Available Date (latest_info_date__v)
  • Manufacturer (manufacturer__v)
  • Manufacturer – Contact Person (manufacturer_contact_person__v)
  • Manufacturer Contact Details (mfg_contact_details__v)
  • Manufacturing Site (mfg_site__v)
  • Manufacturing Site – Contact Info (mfg_site_conatct_info__v)
  • Mfg Report # (mfg_report_number__v)
  • Non-Reportable Incident – Explanation (non_reportable_explanation__v)
  • Number of patients involved (number_of_patients__v)
  • Other Relevant History (other_history__v)
  • Outcomes Attributed to Adverse Event (adverse_event_outcomes__v)
  • Patient Consequences (patient_consequences__v)
  • Product Categorization (product_categorization)
  • Product Variant (product_variant__v)
  • Reporter – Occupation (reporter_occupation__v)
  • Reporter’s Contact Information (reporter_contact_info__v)
  • Root Cause Analysis (root_cause_analysis__v)
  • Root Cause Confirmed? (root_cause_confirmed__v)
  • Date of Event – To (date_of_event_to__v)
  • Importer Contact Details (importer_contact_details__v)
  • Role of Initial Reporter (initial_reporter_role__v)