22R3 Vault SafetyDocs Data Model Changes

Learn about the changes to the Vault SafetyDocs Data Model in 22R3.

Last Updated

Note Beginning with 23R3 content and for all subsequent releases, Vault Release Notes is the official site for Vault Safety release notes.

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 SafetyDocs data model. These data model updates are automatically included in all SafetyDocs Vaults, but Admins must make configuration changes to make them available. For information on feature functionality, see About the Release.

Data Model Updates

The following changes were made to support the PSMF Automatic Logbook Generation feature:

  • Added the PSMF Logbook (psmf_logbook__v) object.
  • Added the PSMF Logbook Lifecycle (psmf_logbook_lifecycle__v) object lifecycle.
  • Added the PSMF Logbook Entry (psmf_logbook_entry__v) object.
  • Added the PSMF Logbook Entry Lifecycle (psmf_log_entry_lifecycle__v) object lifecycle.
  • Added the PSMF Binder Lifecycle (psmf_binder_lifecycle__v).
  • Added the PSMF Content Lifecycle (psmf_content_lifecycle__v).
  • Added the PSMF Generated Document Lifecycle (psmf_generated_document_lifecycle__v).
  • Added the Pharmacovigilance System Master File (pharmacovigilance_system_master_file__v) document type.
    • Added the document subtype PSMF Content (psmf_content__v) under Pharmacovigilance System Master File.
      • Added the following document classifications under Pharmacovigilance System Master File > PSMF Content:
        • PSMF Title Page (psmf_title_page__v).
        • PSMF Core Document (psmf_core_document__v).
        • PSMF Annex (psmf_annex__v).
    • Added the document subtype PSMF Generated Document (psmf_generated_document__v) under Pharmacovigilance System Master File.
      • Added the following document classifications under Pharmacovigilance System Master File > PSMF Generated Document:
        • PSMF Table of Contents (psmf_table_of_contents__v).
        • PSMF Logbook (psmf_logbook__v).
        • PSMF eSignature Page (psmf_esignature_page__v).
        • PSMF Generated PDF (psmf_generated_pdf__v).
    • Added the document subtype PSMF Binder (psmf_binder__v) under Pharmacovigilance System Master File.
      • Added the following document classifications under Pharmacovigilance System Master File > PSMF Binder:
        • PSMF Global Binder (psmf_global_binder__v).
        • PSMF Local Binder (psmf_local_binder__v).
  • Added the PSMF Details field layout, along with the following fields:
    • Added the PSMF Section (psmf_section__v) field.
    • Added the PSMF Annex (psmf_annex__v) field.
    • Added the PSMF Jurisdiction (psmf_jurisdiction__v) field.
  • Added the following relationship types:
    • Under Pharmacovigilance System Master File > PSMF Binder, added the Generated PSMF (generated_psmf__v) relationship type.
    • Under Pharmacovigilance System Master File > PSMF Generated Document, added the PSMF Binder (psmf_binder__v) relationship type.
  • Added the following tabs under the PSMF tab:
    • PSMF Binders (psmf_binders__v).
    • PSMF Logbooks (psmf_logbooks__v).
  • Added the following notification templates:
    • PSMF Merge Succeeded (psmf_merge_success__v).
    • PSMF Merge Warning (psmf_merge_warning__v).
    • PSMF Merge Failure (psmf_merge_failure__v).
  • Added the following components to support PSMF logbook report generation:
    • Added the PSMF Logbook with Documents and PSMF Logbook Entry (psmf_logbook_with_documents_and_psmf__v) report type.
    • Added the PSMF Content Documents in Binder (psmf_content_documents_in_binder__v) report view.
    • Added the Logbook with Logbook Final Entries and Documents (logbook_with_logbook_entries_and_docs__v) report view.
    • Added the PSMF Binder Logbook (psmf_binder_logbook__v) multi-pass report type.
    • Added the PSMF Binder Logbook (psmf_binder_logbook__v) standard report.
  • Added the Generate PSMF PDF (generate_psmf_pdf__v) document action.