Enable Automated Inbound PVA Activity Email Processing

With the 26R1 release, SafetyDocs automates the receipt and processing of inbound PVA obligation activities from partners, generating auditable documents for emails and attachments and assigning them to the appropriate PVA Activity. This automation boosts operational efficiency and compliance by ensuring faster processing, immediate status updates, and transparent communication for partners.

After you have enabled this feature, see the following articles for more information:

• Manage Pharmacovigilance Agreements
• Manage PVA Multi-Agreement Activities

Prerequisites

Before enabling this feature in your Vault, you must enable PVA Management. To enable this feature for PVA Multi-Agreement Activities, you must also enable Multi-Agreement Activities.

Overview

To configure this feature in your Vault:

• Update object layouts
• Configure PVA Activity actions
• Configure a PVA Multi-Agreement Activity action
• Update the PVA Activity Inbound workflow
• Create an Inbound Email Address
• Optional: Configure the standard Notification Templates to modify the messaging Vault uses to notify your senders and recipients in specific inbound PVA Activity scenarios
• Optional: Create Schedule records for your scheduled PVA Obligations

Update Object Layouts

To update the PV Agreement layout, add the Inbound Email Address field below the PVA Outline field.

To update the PVA Activity layout:

1. Add the Activity Inbound Email Address field below the Partner Responsible Contact field.
2. For the Inbound No Email Intake layout rule, set the Status to Active.
3. Update the existing Outbound Activity layout rule. In the Apply the following display effects section, add a new display effect as follows:
   • Effect: Select Hide
   • Type: Select Fields
   • Value: Select Activity Inbound Email Address

Configure PVA Activity Actions

Assign the following actions to the PVA Activity object:

• Send Documents Received to Partner
• Send Documents Received to Sponsor
• Send Inbound Activity Reminder
• Send Activity Rework to Partner
• Send Activity Complete to Partner

Then, add each action as a user action or entry action on the PVA Activity Lifecycle as follows:

Lifecycle State	Action Type	Action Conditions
New	User action	Condition Type: Select All conditions are met If: Select Activity Inbound Email Address > is not blank Allow the following actions: Select Send Inbound Activity Reminder Action Label: Enter Send Inbound Activity Reminder
Received from Partner	Entry action	Condition Type: Select All conditions are met If: Select Activity Inbound Email Address > is not blank perform actions: Select the following actions: Send Documents Received to Partner Send Documents Sponsor
	User action	Condition Type: Select Always Allow the following actions: Select Workflow > PVA Activity Inbound Action Label: Enter Review and Approve Partner Documents
Inbound Activity Requires Follow Up	Entry action	Condition Type: Select All conditions are met If: Select Activity Inbound Email Address > is not blank perform actions: Select Send Activity Rework to Partner
Complete	Entry action	Condition Type: Select All conditions are met If: Select Activity Inbound Email Address > is not blank perform actions: Select Send Activity Complete to Partner

Configure PVA Multi-Agreement Activity Action

To configure the Send Inbound Activity Reminders user action:

1. Assign the Send Inbound Activity Reminders action to the PVA Multi-Agreement Activity object.
2. Add the action as a user action on the In Progress state of the PVA Multi-Agreement Activity Lifecycle using the following conditions:
   • Condition Type: Select Always
   • Allow the following actions:
     • Select Send Inbound Activity Reminders
     • Action Label: Enter Send Inbound Activity Reminders

Update the PVA Activity Inbound Workflow

To update the PVA Activity Inbound workflow:

1. Navigate to Admin > Configuration > Workflows > PVA Activity Inbound.
2. Update the following workflow steps:
   • SC: Received
   • Task: Verify Received Documents
   • Decision: Complete Activity?
   • SC: Partner Follow Up
3. Activate the workflow.

Update the SC: Received Step

To update the SC: Received workflow step:

1. In the Workflow Steps section, select SC: Received.
2. Select Edit.
3. Update the Label value to SC: In Review.
4. In the Rules section, update the Lifecycle State value to Partner Documents In Review.
5. Select Save, then navigate back to the PVA Activity Inbound workflow.

Update the Task: Verify Received Documents Step

To update the Task: Verify Received Documents workflow step:

1. In the Workflow Steps section, select Task: Verify Received Documents.
2. Select Edit.
3. In the Prompts section, select the Prompt for Verdicts checkbox, then configure the following verdicts:
   • Verdict Label: Enter All Documents Received
   • Select Add Verdict, then configure the verdict as follows:
     • Verdict Label: Enter Additional Follow Up Required
       • Select Add Field Prompts:
         • Prompt for Fields: Select Partner Corrections Needed
         • Select the Required checkbox
4. In the Next Steps field:
   • Remove the SC: Complete step
   • Select Create Step
   • In the Step Name field, enter Decision: Complete Activity?
   • Select OK
5. Select Save.
6. From the Next Steps field, select Decision: Complete Activity? to navigate to the next step.

Define the Decision: Complete Activity Step

To define the Decision: Complete Activity? step:

1. From the Decision: Complete Activity? step page, select Edit.
2. For Type, select Decision.
3. In the Rules section, select Create Rule and populate the fields as follows:
   • Condition Type: Select All conditions are met
   • if: Select Task > Task: Verify Received Documents > all labels equal > All Documents Received
   • then: Select SC: Complete
4. In the then field of the Else section, select Create Step.
   • In the Create Step dialog, enter SC: Partner Follow Up
   • Select OK
5. Select Save.
6. In the Rules section, select SC: Partner Follow Up to navigate to the next step.

Define the SC: Partner Follow Up Step

To define the SC: Partner Follow Up step:

1. From the SC: Partner Follow Up step page, select Edit.
2. In the Details section, populate the fields as follows:
   • Type: Select Action
   • Next Steps: Select End
3. In the Rules section, select Create Rule and populate the fields as follows:
   • Condition Type: Select Always
   • perform actions: Select Change State
   • Lifecycle State: Select Inbound Activity Requires Follow Up
4. Select Save.

Activate the Workflow

To activate the updated PVA Activity Inbound Workflow workflow:

1. Navigate to the main page of the workflow.
2. In the Status field within the Details section, select Make configuration active.

Create an Inbound Email Address

To allow Vault to handle PVA Activity documents received via email, you must create an Inbound Email Address. When creating the Inbound Email Address, consider the following:

• Email Address: Ensure the value before the @ symbol is 42 characters or less. If this value exceeds this limit, Vault cannot generate PVA Activity documents received via email.
• Email Processor: Select Create PVA Inbound Obligation From Email.
• Send Bounce Notification: We recommend selecting this checkbox.

Configure Notification Templates

This feature introduces a number of Notification Templates, which you can configure to suit your business needs:

• PVA Inbound Activity Created
• PVA Activity Docs Received
• PVA Acknowledge Inbound Docs Received
• PVA Inbound Activity Completed
• PVA Inbound Activity Rework
• PVA Inbound Activity Generic Error
• PVA Inbound Activity Completed Error
• PVA Inbound Activity Attachment Error

To configure a Notification Template:

1. Navigate to Admin > Configuration > Notification Templates > [Notification Template].
2. Select Edit.
3. On the Create Notification Template page, modify the relevant fields as required for your business processes.
4. Select Save.