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
Vault 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 Activity or PVA Action Item record. This prompts the system 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 Vault SafetyDocs, including but not limited to the following:
- Pharmacovigilance System Master Files (PSMFs)
- Aggregate reports
- Literature reviews
- Signal reports
- Risk management plans
Once the documents have been sent, the system 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.
The following sections provide more details about document distribution and tracking.
Prerequisites
Your Admin must fully configure this feature before it can be used. See Enable PVA Document Distribution via Email for more information.
Create PVA Documents for Distribution
For each document that you want to distribute via email, complete the following steps to create a PVA Document for Distribution record under the related PV Agreement record.
- Go to PVAs and 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 and 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 record, the system picks it as the default. If not, 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 record, the system picks it as the default. If not, 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. |
The following fields are populated by the system:
| Field | Description |
|---|---|
| PV Agreement | Populated based on the PV Agreement record 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. |
Distribute PVA Documents
Once you have created PVA Documents for Distribution records, you can initiate an action to distribute the documents. Complete the following steps to initiate this action:
- Go to the PVA Activity or PVA Action Item from which you want to distribute the documents.
- From the Workflow State Change menu (
) on the Action Bar, select Distribute PVA Document(s).
Result
The system sends an email to the partner contact with a link to view and download the documents. You can send up to 1,000 documents via email at a time.
The recipient of the email is set to the contact entered in the Partner Responsible Contact field of the PVA Activity or the Agreement Contact field of the PVA Action Item, depending on where the action is initiated.
The email is composed of the following:
- A subject, mapped from the value in the Message Subject field of the related PVA Activity or PVA Action Item.
- A body, mapped from the value in the Message Body field of the related PVA Activity or PVA Action Item.
- A link to access all the PVA Documents for Distribution associated with this particular PVA Activity or PVA Action Item. This link expires 30 days after the email is sent.
Track PVA Document Distribution Events
Once the email has been sent, Vault tracks the recipient’s interactions with it, including events such as:
- When the email is delivered
- When the email is opened, if the recipient’s system allows
- If any errors have been detected
For each event, the system creates a PVA Document Distribution Event on the related PV Agreement record. Each PVA Document Distribution Event record contains details such as the PV Agreement and PVA Activity and/or PVA Action Item to which it is related, 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.