Distribute PVA Documents via Email

Learn how to share documents with partner organizations and track their progress.

About Distributing PVA Documents via Email

SafetyDocs provides a centralized process for sharing documents with partner organizations and tracking their activity directly from your Vault. Depending on the terms set out in your Pharmacovigilance Agreement (PVA), you can distribute documents from a PVA Action Item or PVA Activity. This prompts Vault to send an email to the assigned recipient with a link that they can use to view the documents.

You can leverage this functionality to share various documents managed in SafetyDocs, including but not limited to:

• Pharmacovigilance System Master Files (PSMFs)
• Aggregate reports
• Literature reviews
• Signal reports
• Risk management plans
• Workbench Reports

Once the documents have been sent, Vault tracks when the email has been delivered and, if possible, opened. These records enable you to closely track the progress of Activities and Action Items to ensure your organization is properly managing regulatory timelines and meeting PVA mandates.

Prerequisite

To use this feature, your Admin must enable PVA Document Distribution via Email.

Overview

To distribute documents to users via email from a PVA Action Item or PVA Activity, you must:

1. Create PVA Documents for Distribution.
2. Grant users access to the relevant PVA Action Item or PVA Activity.
3. Distribute PVA documents.

Create PVA Documents for Distribution

For each document that you want to distribute via email, create a PVA Document for Distribution record:

1. Navigate to PVAs > PV Agreements.
2. Select the PV Agreement under which you want to add a document for distribution.
3. In the PVA Documents for Distribution section, select Create.
4. On the Create PVA Document for Distribution page, complete the following fields then select Save:

Field	Description
Document for Distribution	Select the document you want to distribute from the picklist or select the Advanced Search () icon to use filters and refine your search.
Version	Select the version of the document you want to distribute from the picklist. The selected version must be in a steady state to be eligible for distribution.
PVA Activity	If there is only one (1) PVA Activity on the selected PV Agreement, Vault sets it by default. Otherwise, select the PVA Activity related to the document from the picklist or select the Advanced Search icon to use filters and refine your search.
PVA Action Item	If there is only one (1) PVA Action Item on the selected PV Agreement, Vault sets it by default. Otherwise, select the PVA Action Item related to the document from the picklist or select the Advanced Search icon to use filters and refine your search.

Vault populates the following fields:

Field	Description
PV Agreement	Populated with the PV Agreement on which you create the PVA Document for Distribution.
Sent Date	Populated with the date on which you run the Distribute PVA Document(s) action and send out the documents.
Link Expiry Date	Populated with the date on which the link to access the documents will expire, which is always 30 days after the Sent Date.

Automated Creation of PVA Documents for Distribution

If your Admin has configured Automated Distribution of PVA Reports, Vault can automatically create PVA Document for Distribution records and distribute documents from a PVA Activity, provided the PVA Activity meets the following criteria:

• The PVA Activity was created from a Scheduled-type PVA Obligation
• The parent PVA Obligation has an Auto-Send Generated Document value of Send After Generation
• The PVA Activity contains a document generated from either a Vault Report or a Workbench Report Set

When these criteria are met, Vault distributes documents from the PVA Activity at the intervals defined by the parent PVA Obligation’s Schedule, using the same dispatch logic as the manual Distribute PVA Document(s) action.

Grant User Access

To grant user access to a PVA Action Item or PVA Activity and its related documents and to run the Distribute PVA Document(s) action, you must populate the relevant PVA Action Item or PVA Activity fields with distribution information.

PVA Action Item Fields

To allow for distributing PVA documents to a user from a PVA Action Item, populate the following fields with the specified values:

Object	Field	Value
PVA Contact record of the User to whom you are granting access	Communication Method	Email
PVA Action Item	Agreement Contact	The PVA Contact to whom you are granting access
	Partner Access	Access Granted

PVA Activity Fields

In addition to the primary recipient specified in the Partner Responsible Contact field of the PVA Activity, Vault can distribute documents and Vault tasks to up to 19 additional recipients.

To allow for distributing PVA documents to selected users from a PVA Activity, populate the following fields with the specified values:

Object	Field	Value
PVA Contact record of the User to whom you are granting access	Communication Method	Email
PVA Obligation related to the PVA Activity	Partner Contact	The PVA Contact1 to whom you are granting access
	Up to 19 PVA Contacts specified in the Additional Recipients section	Additional PVA Contacts1 to whom you are granting access
PVA Activity	Partner Responsible Contact	The User to whom you are granting access
	Delivery Method	Email
	Partner Access	Access Granted
1. For Vault to generate emails from a PVA Activity, the Partner Contact and all additional PVA Contacts must have the same Communication Method value.

Distribute PVA Documents

Once you have created PVA Documents for Distribution and granted access to all applicable recipients, distribute the documents:

1. Navigate to the PVA Action Item or PVA Activity from which you want to distribute the documents.
2. From the Workflow State Change menu (), select Distribute PVA Document(s).

Result

Vault sends an email to the following recipients, depending on the object on which you ran the Distribute PVA Document(s) action:

• PVA Action Item: The Agreement Contact on the PVA Action Item
• PVA Activity:
  • The Partner Responsible Contact on the PVA Activity in the email’s “To” field
  • The Partner Contact on the parent PVA Obligation of the initiating PVA Activity, added to the email’s “CC” field
  • Up to 19 PVA Contacts specified in the Additional Recipients section of the parent PVA Obligation, added to the email’s “CC” field

The email is made up of:

• A subject line mapped from the Message Subject value of the related PVA Action Item or PVA Activity.
• An email body mapped from the Message Body value of the related PVA Action Item or PVA Activity.
• A link to view and download all the PVA Documents for Distribution associated with the PVA Action Item or PVA Activity. This link expires 30 days after the email is sent.

You can send up to 1,000 documents via email at a time.

Track PVA Document Distribution Events

Once the email has been sent, Vault creates a PVA Document Distribution Event on the PV Agreement to track each interaction each recipient has with the email. Vault creates separate PVA Document Distribution Events per recipient for each of the following events:

• When the email is dispatched
• When the email is delivered
• When the email is opened, if the recipient’s system allows
• If any errors have been detected

Each PVA Document Distribution Event contains details such as its related PVA Activity or PVA Action Item, as well as the exact time and type of the event.