Learn how to share documents with partner organizations and track their progress.
Note: Depending on your Admin’s configuration, object, field, and section labels, lifecycle states, and workflows may differ from the general information on this page. Refer to your organization’s business processes for guidance.
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.
Note: If your Admin has enabled Multi-Recipient PVA Document Distribution, you can distribute documents to up to 20 recipients from a PVA Activity.
Overview
To distribute documents to users via email from a PVA Action Item or PVA Activity, you must:
- Create PVA Documents for Distribution.
- Grant users access to the relevant PVA Action Item or PVA Activity.
- 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:
- Navigate to PVAs > PV Agreements.
- Select the PV Agreement under which you want to add a document for distribution.
- In the PVA Documents for Distribution section, select Create.
- 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 (![]() |
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.
Note: Vault supports multi-recipient document distribution from PVA Activities only. This functionality does not extend to PVA Action Items, which support only a single recipient.
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 | |
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 | |
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 | ||
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:
- Navigate to the PVA Action Item or PVA Activity from which you want to distribute the documents.
- 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
Note: If the email fails to send from a PVA Activity, Vault sends an email to the Sponsor Responsible User on the PVA Activity to notify them of the error.
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.
Note: Depending on your Admin’s configuration, Vault can send emails from a custom email domain and from address.
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.
Note: The creation of PVA Document Distribution Events may be delayed for up to one (1) hour after they occur.
Use Custom Outbound Domains and Emails
By default, Vault sends outbound emails using the standard @veevavault.com domain. Your Admin can configure custom outbound email domains and a custom From Email Person.
To use this feature, your Admin must first add the Originating Email field to the PV Agreement object.
Configure Custom Outbound Email Domains
Follow the instructions in Configuring Outbound Email Addresses to create custom domains that are more relevant to your organization. Next, proceed with creating a From Email Person using the custom outbound domain.
Create a From Email Person
After configuring custom outbound email domains, your Admin can create a custom From Email Person:
- Navigate to Business Admin > Objects > Persons.
- Select Create.
- In the Create Person dialog, select From Email Person and then select Continue.
- Complete the following information:
- First Name: Enter the first name of the person.
- Last Name: Enter the last name of the person.
- Email: Enter the email address, using a custom outbound email domain.
- Language: Select a language from the dropdown.
- Select Save.
- Navigate to the new Person record and from the All Actions menu, select Verify Outbound Email.
Result
Vault creates the new Person record of the From Email Person object type. After you verify the outbound email, the Outbound Email Status updates from Inactive to Active.
Next, see the following section to add this From Email Person to a PV Agreement.
Add the From Email Person to the PV Agreement
For more information about creating a PV Agreement, see Manage Pharmacovigilance Agreements.
Add the From Email Person you created to the PV Agreement Email type:
- Navigate to Business Admin > Objects > PV Agreements > [PV Agreement].
- Select Edit.
- In the Details section, in the Originating Email field, select a From Email Person.
- Select Save.
Result
After adding the From Email Person to the PV Agreement record, Vault sends emails using the From email address associated with the Person record.