Enable PVA Periodic Review

With the 26R2 release, SafetyDocs introduces periodic reviews for Pharmacovigilance Agreements documents, automating review scheduling and task management for PV Agreement evaluations. Vault identifies documents due for review and creates PVA Periodic Review tasks for assigned reviewers, eliminating the need for manual oversight.

Prerequisite

To enable this feature in your Vault, you must first enable PVA Management.

Overview

To enable this feature in your Vault:

• Assign shared document fields to Pharmacovigilance Agreements documents
• Update the PVA Periodic Review object layout
• Configure custom sharing rules for PVA Periodic Reviews
• Update permissions on the custom PVA Actions permission set
• Create a user action on the PVA Periodic Review Lifecycle object lifecycle
• Create entry actions on the PVA Lifecycle document lifecycle
• Set the tab status to Active for the Periodic Reviews sub-tab on the PVAs tab
• Set the Safety Scheduler Job to active
• Optional: Create custom Schedules for use in PVA Periodic Reviews

Assign Shared Fields to Pharmacovigilance Agreements Documents

Assign the following shared fields to the relevant Pharmacovigilance Agreements document subtypes and classifications, as required by your business processes:

• PVA Last Review Date
• PVA Next Review Due Date
• PVA Review Timeline (Days)
• PVA Schedule

Update the PVA Periodic Review Object Layout

To update the PVA Periodic Review object layout:

1. Copy the standard layout and ensure it is active.
2. Set the copied layout as the default.
3. Delete any other existing custom layouts.

Configure Custom Sharing Rules for PVA Periodic Reviews

To configure custom sharing rules for the PVA Periodic Review object:

1. Enable custom sharing rules.
2. Create custom sharing rules with the following labels, then add manual assignments for the specified roles, users, and groups as follows:

Label	Roles	Users and Groups
PVA Consumers	Viewer	PVA Consumers
PVA Users	Owner Editor Assigned To	PVA Users
PVA Viewers	Viewer	PVA Viewers

Update PVA Actions Permissions

To update permissions on the custom PVA Actions permission set:

1. Grant object permissions as follows:
   • On the PVA Periodic Review object, grant the following permissions:
     • Read
     • Create
     • Edit
     • Delete
   • On the PVA Periodic Review type of Schedule Recurrence object, grant Read permissions
2. Grant tab permissions on the Periodic Reviews sub-tab of the PVAs tab.

Create a User Action on the PVA Periodic Review Lifecycle

Create a user action on the Open state of the PVA Periodic Review Lifecycle object lifecycle as follows:

• Condition Type: Select Always
• Allow the following actions:
  • Select Change State to
  • Select Complete
  • Action Label: Enter Change State to Complete

Create Entry Actions on the PVA Lifecycle Document Lifecycle

Create entry actions on the following states of the PVA Lifecycle document lifecycle:

• Effective state
  • Condition Type: Select Always
  • perform actions: Select Schedule Periodic Reviews
• Terminated state
  • Condition Type: Select Always
  • perform actions: Select Cancel Scheduled Periodic Reviews