18R1 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 data model. These data model updates are automatically included in all Vaults, but Admins must make configuration changes to make them available. For information on feature functionality, see What’s New in 18R1.

As part of standardizing the configuration across all Quality applications, we’ve made the following changes to standard configuration in all QualityDocs and QMS vaults:

  • Added the following items to support Multi-Document Change Control:

    • Document Change Control (document_change_control__v) object with fields:
      • Status (status__v)
      • Lifecycle State (state__v)
      • Reason (reason__v)
      • Proposed Implementation Date (proposed_implementation_date__v)
      • Name (name__v)
      • Last Modified Date (modified_date__v)
      • Last Modified By (modified_by__v)
      • Lifecycle (lifecycle__v)
      • ID (id)
      • Description (description__v)
      • Created Date (created_date__v)
      • Created By (created_by__v)
      • Change Control (change_control__qdm)
    • Document Change Control Lifecycle (document_change_control_lifecycle__v) with items:
      • Ready for Approval (ready_for_approval__v) lifecycle state
      • Approved, Pending execution (approved__v) lifecycle state
      • Owner (owner__v) lifecycle role
      • Editor (editor__v) lifecycle role
      • Viewer (viewer__v) lifecycle role

    • Document Change Request (document_change_request__v) object with fields:

      • Created By (created_by__v)
        • Created Date (created_date__v)
        • Description (description__v)
        • Governing Change Control (governing_change_control__v)
        • ID (id)
        • Last Modified By (modified_by__v)
        • Last Modified Date (modified_date__v)
        • Lifecycle (lifecycle__v)
        • Lifecycle State (state__v)
        • Name (name__v)
        • Reason (reason__v)
        • Requested Implementation Date (requested_implementation_date__v)
        • Status (status__v)
        • Target Document (target_document__v)
        • Target Document (unbound) (target_document_unbound__v)
    • Document Change Request Lifecycle (document_change_request_lifecycle__v) object lifecycle with items:
      • Open (open__v) lifecycle state
      • Accepted (accepted__v) lifecycle state
      • Completed (completed__v) lifecycle state
      • Owner (owner__v) lifecycle role
      • Editor (editor__v) lifecycle role
      • Viewer (viewer__v) lifecycle role
    • MDCC Doc Update Failure (mdcc_doc_update_failure__v) object message template
    • Shared document fields:
      • Release Change Control (release_change_control__v)
      • Obsolete Change Control (obsolete_change_control__v)
    • Searchable Object Field records:
      • Document Change Control > name__v
      • Document Change Control > status__v
      • Document Change Request > name__v
      • Document Change Request > status__v
  • Added the following Document Message Templates to support Controlled Copy:
    • bulkControlledCopyComplete (qual_bulk_controlledcopy_delivery__v)
    • controlledCopyComplete (qual_controlledcopy_delivery__v)
    • controlledCopyFailure (qual_controlledcopy_failure__v)
  • Added the following items to support Quality Application data model alignment:
    • Department (department__v) object with fields:
      • Created By (created_by__v)
      • Created Date (created_date__v)
      • External ID (external_id__v)
      • Department Name (name__v)
      • Department Number/Code (number__v)
      • Last Modified By (modified_by__v)
      • Last Modified Date (modified_date__v)
      • Status (status__v)
      • ID (id)
    • Facility (facility__v) object with fields:
      • Created By (created_by__v)
      • Created Date (created_date__v)
      • External ID (external_id__v)
      • Facility Address (address__v)
      • Facility Name (name__v)
      • Facility Number/Code (number__v)
      • Last Modified By (modified_by__v)
      • Last Modified Date (modified_date__v)
      • Status (status__v)
      • ID (id)
    • Audit (audit__qdm) object
    • Audit (audit__qdm) object types:
      • External Audit (audit__qdm.external_audit__qdm)
      • Internal Audit (audit__qdm.internal_audit__qdm)
    • Audit (audit__qdm) object fields:
      • Actual End Date (actual_end_date__qdm)
      • Actual End Date (actual_start_date__qdm)
      • Auditee (auditee__qdm)
      • Date to Issue Audit Report (date_to_issue_audit_report__qdm)
      • Frequency (frequency__qdm)
      • Last Audit Date (last_audit_date__qdm)
      • Response Due By (response_due_by__qdm)
      • Response Received (response_received__qdm)
      • Scheduled End Date (scheduled_end_date__qdm)
      • Scheduled Start Date (scheduled_start_date__qdm)
      • Created By (created_by__v)
      • Created Date (created_date__v)
      • ID (id)
      • Last Modified By (modified_by__v)
      • Last Modified Date (modified_date__v)
      • Name (name__v)
      • Status (status__v)
    • Audit Team (qms_audit_team__qdm) object with fields:
      • Created By (created_by__v)
      • Created Date (created_date__v)
      • ID (id)
      • Last Modified By (modified_by__v)
      • Last Modified Date (modified_date__v)
      • Name (name__v)
      • Status (status__v)
    • CAPA Action (capa_action__qdm) object with fields:
      • Action Type (action_type__qdm)
      • Date Closed (date_closed__qdm)
      • Due Date (due_date__qdm)
      • Plan Approved (plan_approved__qdm)
      • Priority (priority__qdm)
      • Created By (created_by__v)
      • Created Date (created_date__v)
      • ID (id)
      • Last Modified By (modified_by__v)
      • Last Modified Date (modified_date__v)
      • Name (name__v)
      • Status (status__v)
    • CAPA-Quality Event (capaquality_event__qdm) object with fields:
      • Quality Event (quality_event__qdm)
      • CAPA Action (capa_action__qdm)
      • Created By (created_by__v)
      • Created Date (created_date__v)
      • ID (id)
      • Last Modified By (modified_by__v)
      • Last Modified Date (modified_date__v)
      • Name (name__v)
      • Status (status__v)
    • Change Action (change_action__qdm) object with fields:
      • Change Control (quality_event__qdm)
      • Context (context__qdm)
      • Date Closed (date_closed__qdm)
      • Due Date (due_date__qdm)
      • Product (product__qdm)
      • Type (type__qdm)
      • Created By (created_by__v)
      • Created Date (created_date__v)
      • ID (id)
      • Last Modified By (modified_by__v)
      • Last Modified Date (modified_date__v)
      • Name (name__v)
      • Status (status__v)
    • Context (context__qdm) object
    • Context (context__qdm) object types:
      • Asset (context__qdm.asset__qdm)
      • Batch (context__qdm.batch__qdm)
    • Context (context__qdm) object fields:
      • Expiration Date (expiration_date__qdm)
      • Manufacture Date (manufacture_date__qdm)
      • Product (product__qdm)
      • Created By (created_by__v)
      • Created Date (created_date__v)
      • ID (id)
      • Last Modified By (modified_by__v)
      • Last Modified Date (modified_date__v)
      • Name (name__v)
      • Status (status__v)
    • Context-Organization (context_organization__qdm) object with fields:
      • Context (context__qdm)
      • Organization (organization__qdm)
      • Created By (created_by__v)
      • Created Date (created_date__v)
      • ID (id)
      • Last Modified By (modified_by__v)
      • Last Modified Date (modified_date__v)
      • Name (name__v)
      • Status (status__v)
    • Context-Quality Event (contextquality_event__qdm) object with fields:
      • Context (context__qdm)
      • Quality Event (quality_event__qdm)
      • Created By (created_by__v)
      • Created Date (created_date__v)
      • ID (id)
      • Last Modified By (modified_by__v)
      • Last Modified Date (modified_date__v)
      • Name (name__v)
      • Status (status__v)
    • Effectiveness Check (effectiveness_check__qdm) objects with fields:
      • Date Closed (date_closed__qdm)
      • Due Date (due_date__qdm)
      • Outcome (outcome_qdm)
      • Quality Event (quality_event__qdm)
      • Created By (created_by__v)
      • Created Date (created_date__v)
      • ID (id)
      • Last Modified By (modified_by__v)
      • Last Modified Date (modified_date__v)
      • Name (name__v)
      • Status (status__v)
    • Extension Request (extension_request__qdm) object with fields:
      • Audit (audit__qdm)
      • CAPA (capa__qdm)
      • Change Action (change_action__qdm)
      • Date Granted (date_granted__qdm)
      • Date Requested (date_requested__qdm)
      • Investigation (investigation__qdm)
      • Quality Event (quality_event__qdm)
      • Date Closed (date_closed__qdm)
      • Due Date (due_date__qdm)
      • Outcome (outcome_qdm)
      • Quality Event (quality_event__qdm)
      • Created By (created_by__v)
      • Created Date (created_date__v)
      • ID (id)
      • Last Modified By (modified_by__v)
      • Last Modified Date (modified_date__v)
    • Investigation (investigation__qdm) object with fields:
      • Date Closed (date_closed__qdm)
      • Department (department__qdm)
      • Due Date (due_date__qdm)
      • Priority (priority__qdm)
      • Quality Event (quality_event__qdm)
      • Type (type__qdm)
      • Created By (created_by__v)
      • Created Date (created_date__v)
      • ID (id)
      • Last Modified By (modified_by__v)
      • Last Modified Date (modified_date__v)
    • Investigation Team (investigation_team__qdm) object with fields:
      • Investigation (investigation__qdm)
      • Created By (created_by__v)
      • Created Date (created_date__v)
      • ID (id)
      • Last Modified By (modified_by__v)
      • Last Modified Date (modified_date__v)
    • Organization (qms_organization__qdm) object
    • Organization (qms_organization__qdm) object type:
      • Supplier (qms_organization__qdm.supplier__qdm)
    • Organization (qms_organization__qdm) object fields: * Date Retired (date_retired__qdm) * Risk Classification (risk_classification__qdm) * Created By (created_by__v) * Created Date (created_date__v) * ID (id) * Last Modified By (modified_by__v) * Last Modified Date (modified_date__v)
      • Product-Quality Event (product_quality_event__qdm) object with fields:
        • Batch (batch__qdm)
        • Disposition (disposition__qdm)
        • Expiration Date (expiration_date1__qdm)
        • Manufacture Date (manufacture_date1__qdm)
        • Product (product__qdm)
        • Quality Event (quality_event__qdm)
        • Date Retired (date_retired__qdm)
        • Risk Classification (risk_classification__qdm)
        • Created By (created_by__v)
        • Created Date (created_date__v)
        • ID (id)
        • Last Modified By (modified_by__v)
        • Last Modified Date (modified_date__v)
      • Quality Event (quality_event__qdm) object
      • Quality Event (quality_event__qdm) object types:
        • Complaint (quality_event__qdm.complaint__qdm)
        • Change Control (quality_event__qdm.change_control__qdm)
        • Deviation (quality_event__qdm.deviation__qdm)
        • Internal Finding (quality_event__qdm.internal_finding__qdm)
        • External Finding (quality_event__qdm.external_finding__qdm)
        • Lab Investigation (quality_event__qdm.lab_investigation__qdm)
        • Proactive Initiative (quality_event__qdm.proactive_initiative__qdm)
      • Quality Event (quality_event__qdm) object fields:
        • Audit (audit__qdm)
        • Awareness Date (awareness_date__qdm)
        • CAPA Due Date (capa_due_date__qdm)
        • CAPA Recommendations (capa_recommendations__qdm)
        • Date Closed (date_closed__qdm)
        • Date Occurred (date_occurred__qdm)
        • Date of Event (date_of_event__qdm)
        • Date Received (date_received__qdm)
        • Date Return Requested (date_return_requested__qdm)
        • Department (department__qdm)
        • Due Date (due_date__qdm)
        • Impact (impact__qdm)
        • Impacted Area (impacted_area__qdm)
        • Internal Finding Owner (internal_finding_owner__qdm)
        • Justification (justification__qdm)
        • Planned Deviation (planned_deviation__qdm)
        • Potential Adverse Event (adverse_event_qdm)
        • Priority (priority__qdm)
        • Probability (probability__qdm)
        • Require Effectiveness Check (require_effectiveness_check__qdm)
        • Response Due Date (response_due_date__qdm)
        • Severity (severity__qdm)
        • Supplier CAPA Description (supplier_capa_description__qdm)
        • Temporary Change (temporary_change__qdm)
        • Created By (created_by__v)
        • Created Date (created_date__v)
        • ID (id)
        • Last Modified By (modified_by__v)
        • Last Modified Date (modified_date__v)
      • Related Audit (related_audit__qdm) object with fields:
        • Audit (parent_audit__qdm)
        • Related Audit (related_audit__qdm)
        • Created By (created_by__v)
        • Created Date (created_date__v)
        • ID (id)
        • Last Modified By (modified_by__v)
        • Last Modified Date (modified_date__v)
      • Related Quality Event (related_quality_event__qdm) object with fields:
        • Quality Event (parent_quality_event__qdm)
        • Related Quality Event (related_quality_event__qdm)
        • Created By (created_by__v)
        • Created Date (created_date__v)
        • ID (id)
        • Last Modified By (modified_by__v)
        • Last Modified Date (modified_date__v)
      • Root Cause (root_cause__qdm) object with fields:
        • Cause Detail (cause_detail__qdm)
        • Cause Type (root_cause__qdm)
        • Quality Event (quality_event__qdm)
        • Created By (created_by__v)
        • Created Date (created_date__v)
        • ID (id)
        • Last Modified By (modified_by__v)
        • Last Modified Date (modified_date__v)
  • Added the following shared document fields to support Quality Application data model alignment:
    • Effective Date (effective_date__v)
    • Owning Department (owning_department__v)
    • Impacted Departments (impacted_departments__v)
    • Owning Facility (owning_facility__v)
    • Impacted Facilities (impacted_facilities__v)