Enable Automatic Generation of PSMF Documents from Vault Reports

With the 23R2 release, SafetyDocs supports automatically generating PSMF documents from Vault reports. You can configure these reports to run whenever information is updated, and Vault will create a new version of the relevant document.

23R3 Update: Add the PSMF Annex Field to the PSMF Generated Report Classification

The PSMF Annex field can be used to specify which annex of the PSMF is being uploaded. To add the PSMF Annex field to the PSMF Generated Report document classification:

  1. Navigate to Admin > Configuration > Document Fields > Pharmacovigilance System Master File > PSMF Generated Document > PSMF Generated Report.
  2. Select Add > Existing Shared Field.
  3. In the Use Shared Field window, select PSMF Annex from the picklist and then select OK.

Add Document Fields

To add related document fields to the PSMF Details section of the Document Information page:

  1. Navigate to Admin > Configuration > Document Fields > Pharmacovigilance System Master File > PSMF Generated Document > PSMF Generated Report > Report Generation Type.
  2. Select Edit.
  3. In the Display Section field, select PSMF Details from the picklist, then select Save.
  4. Navigate back to the Document Fields page and select Shared Fields.
  5. Complete steps 2 and 3 for the following fields:
    • PSMF Jurisdiction
    • Report Format
    • Source Report
    • Source Report Prompt

Configure User Actions on the PSMF Generated Document Lifecycle

Navigate to Admin > Configuration > Document Lifecycles > PSMF Generated Document Lifecycle > States > [State] > User Actions and configure the Upversion from Report action as a user action on the following states:

  • Generated
  • Final
  • Planned

Create user actions on the specified lifecycle states using the following criteria:

  • Condition Type: Select All conditions are met
  • If: Select Classification > equals > Pharmacovigilance System Master File > PSMF Generated Document > PSMF Generated Report
  • Allow the following actions:
    • Select Upversion from Report
    • Action Label: Enter a value depending on the lifecycle state:
      • Generated: Enter Update Content from Report
      • Final: Enter Create Draft from Report
      • Planned: Enter Generate from Report