20R3 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 20R3.

QMS: Organization Object Standard Field Updates

The Organization object of Quality Suite Vaults has been updated with standard address fields. These fields are being added to support future feature enhancements to Organization management. Many Quality implementations already have custom address fields within the object and, after this release, Admins may see the new standard fields next to their custom fields on the Admin pages. The new standard fields are not mandatory to use today, unless you are intending to use Vault Product Surveillance, a new Quality application available for Medtech / Medical Device and Diagnostics customers.

The following changes were made to support the Audit Finding External Collaboration feature:

  • Added following fields to the Person (person__sys) object:
    • Organization (organization__v)
  • Added following fields to the User (user__sys) object:
    • Managed by QMS Automation (managed_by_qms_automation__v)
  • Added following fields to the Quality Event (quality_event__qdm) object for use on the External Finding object-type:
    • External Collaborator (external_collaborator__v)
  • Added the Quality Event Collaborator Assignment (quality_event_collaborator_assignment__v) object to the Vault
    • This object is a system managed object. It is not intended for end-user or administrator interaction.

The following changes were made to support the Vault Product Surveillance application and features:

  • Added following fields to the Quality Event (quality_event__qdm) object for use on the Medtech Complaint object-type:
    • Reporter (reportable__v)
    • Is Reportable? (reportable__v)
    • Adverse Event Severity (ae_severity__v)
    • Days for Initial Report Due Date (days_initial_report_due__v)
  • Added following standard address fields to the Organization (organization__qdm) object:
    • Address Line 1 (address__v)
    • Address Line 2 (address2__v)
    • City (city__v)
    • State Code (state_address__v
    • Zipcode (zip__v)
    • Zip Extension (zip_extension__v)
    • Country (country__v)
    • Postal Code (postal_code__v)
    • Organization Email (organization_email__v)
    • Fax Number (fax__v)
    • Phone Number (phone__v)
    • Contact (vps_contact__v)
  • Added following standard address fields to the Product (product__v) object:
    • Product Code (vps_product_code__v)
    • Common Device Name (vps_common_name__v)
  • Added the following objects for use with Vault Product Surveillance
    • Reportable Event (reportable_event__v)
    • Reporting Decision Rules (reporting_decision_rules__v)
    • Relevant Tests (relevant_tests__v)
    • Concomitant Products and Therapy Dates (concomitant_therapy __v)
    • Reporter (reporter__v)
    • Code (code__v)
    • Reportable Event Problem Code (reportable_event_problem_code__v)
    • Country Report Type (country_report_type__v)
    • Contact (contact__v)
    • Transmission (transmission__v)
    • Transmission Profile (transmission_profile__v)
    • Transmission Message (transmission_message__v)
  • Added the following standard document types:
    • VPS Reportable Event Document (reportable_event_document__v) with subtypes
      • eMDR (emdr__v)
      • XML (classification_xml__v)

The following changes were made to support the Issue Escalation & Notification feature:

  • Added the Issue Escalation (issue_escalation__v) object with the following fields:
    • Closed Date (closed_date__v)
    • Date of Occurrence (occurrence_date__v)
    • Department (department__v)
    • Health Authority Notification? (requires_ha_notification__v)
    • Notification Error Reason (notification_error_reason__v)
    • Organization (organization__v)
    • Product Impacted? (is_product_impacted__v)
    • Product On Hold? (is_product_onhold__v)
    • Related External Event (related_external_event__v)
    • Source (issue_source__v)
    • Sub-Type (issue_subtype__v)
    • Title (title__v)
    • Triggering Audit (triggering_audit__v)
    • Triggering Quality Event (triggering_quality_event__v)
    • Type (issue_type__v)
  • Added the Issue Escalation Impacted Country object with the following fields:
    • Country (country__v)
    • Issue Escalation (issue_escalation__v)
  • Added the Issue Escalation Impacted Organization object with the following fields:
    • Organization (organization__v)
    • Issue Escalation (issue_escalation__v)
  • Added the Issue Escalation Impacted Product object with the following fields:
    • Product (product__v)
    • Issue Escalation (issue_escalation__v)
  • Added the Issue Escalation Notification object with the following fields:
    • Notification Purpose (notification_purpose__v)
    • Recipients (recipients__v)
    • Related Issue Escalation (related_issue_escalation__v)
    • Sender (sender__v)
    • Sent Date (sent_date__v)
  • Added the following field to the Quality Event (quality_event__qdm) object
    • Related Issue Escalation (related_issue_escalation__v)

The following changes were made to support the Audit Program Planning feature:

  • Added the Audit Program (audit_program __v) object with the following fields:
    • Planned End Date (planned_end_date__v)
    • Planned Start Date (planned_start_date__v)
  • Added the Proposed Audit (proposed_audit__v) object with the following fields:
    • Auditee (auditee__v)
    • Create Audit Error Reason (create_audit_error_reason__v)
    • Planned End Date (planned_end_date__v)
    • Planned Start Date (planned_start_date__v)
    • Proposed Audit Type (object_type__v)
    • Related Audit Program (related_audit_program__v)
  • Added the following object types to the Proposed Audit (proposed_audit__v) object
    • Base Proposed Audit (base__v)
    • External Audit (external_audit__v)
    • Internal Audit (internal_audit__v)
  • Added the following fields to the Audit (audit__qdm) object
    • Related Audit Program (related_audit_program__v)
    • Related Proposed Audit (related_proposed_audit__v)

The following page components were added to support the Mobile Training Task Completion feature:

  • Vault Training Mobile: Document Information Page (training_mobile_document_info_page__v)
  • Vault Training Mobile: Interstitial (training_mobile_interstitial_page__v)
  • Vault Training Mobile: Learner Task Page (training_mobile_learner_task_page__v)
  • Vault Training Mobile: Success Page (training_mobile_success_page__v)

The following changes were made to support the Learner Homepage feature:

  • Updated the Training Assignment (training_assignment__v) object with the following fields:
    • Completion Date (completion_date__v)
    • Description (description__v)
    • Learner Homepage Card Image (learner_homepage_card_image__v)
  • Updated the Assignment Details (assignment_details__v) object with the following fields:
    • Completion Date (completion_date__v)
  • Updated the Training Requirement (training_requirement__v) object with the following fields:
    • Learner Homepage Card Image (learner_homepage_card_image__v)
  • Added the tab My Learning (training_my_learning_tab__v)
  • Added the page component Vault Training Learner Homepage: My Learning Page (training_my_learning_page__v)