# Enable PVA Management

With the 23R1 release, SafetyDocs supports the <a href="/en/gr/01242/">management of Pharmacovigilance Agreements (PVAs)</a>, sometimes known as Safety Data Exchange Agreements (SDEAs). This feature promotes regulatory compliance through centralized document storage, making it easy to review and reconcile partner obligations across agreements. In addition, contact management capabilities increase the efficiency of tracking reconciliation activities and managing follow-up agreements.

## Updates {#updates}
We have added the following updates to this feature:

* <a id="r261">**PVA: Defer Contact Entry**</a>: With the 26R1 release, SafetyDocs allows you to configure the _Partner Contact_ and _Sponsor Contact_ fields on the _PVA Obligation_ object as optional on initial record creation, enabling users to create _PVA Obligations_ when sponsor or partner contact information is not yet known. See [Configure PVA: Defer Contact Entry][6] to configure your Vault for this feature.
* <a id="r253">**Product Family Support for PV Agreements**</a>: With the 25R3 release, SafetyDocs introduces the ability to classify _PV Agreements_ at the _Product Family_ level, enabling more efficient agreement management and improving scalability across product portfolios. See [Configure Product Family Support for PV Agreements][5]  to configure your Vault for this feature.
* <a id="r251">**PVA Scheduling**</a>: With the 25R1 release, SafetyDocs supports PVA Scheduling. Scheduling defines when and how often Vault creates _PVA Activity_ records and documents for a given _PVA Obligation_ record. This is useful in situations where a PVA has obligations with recurring activities, such as circulating a weekly summary of literature articles. For more information, see <a href="/en/gr/832416/">Enable PVA Scheduling</a>.
* <a id ="r243">**Pharmacovigilance Agreements Usability Improvements**</a>: With the 24R3 release, SafetyDocs displays more meaningful values when a PVA object is referenced in an object field rather than the auto-generated name for improved usability of PVA-related records. See [Configure Pharmacovigilance Agreements Usability Improvements][1] for details. In addition to the configuration updates described on this page, you must configure the _PVA Activity Outbound Workflow_ as described in <a href="/en/gr/682082/#update-the-pva-activity-outbound-workflow">Enable PVA Document Distribution via Vault Task</a>.

## Overview

To configure this feature:
* [Configure object layouts][7]
* [Configure document types][10]
* [Configure security][13]
* [Configure custom sharing rules][16]
* [Configure the _PV Agreement Lifecycle_ object lifecycle][17]
* [Configure the _PVA Lifecycle_ document lifecycle][23]
* [Configure object workflows][38]
* [Configure document workflows][43]
* [Configure tabs][49]

## Configure Object Layouts {#layouts}

Configure the following object layouts:
* [_PVA Relationship_][8]
* [_PV Agreement_][9]

### Configure the PVA Relationship Object Layout {#pva-relationship-object-layout}

To configure the _PVA Relationship_ object layout:

1. Navigate to **Admin > Configuration > Objects > PVA Relationship > Layouts > Relationship Detail Page Layout**.
2. Select **Edit**.
3. Configure the layout as follows:
    * Ensure the _Details_ section contains the following fields in the following order:
        * _Name_
        * _Partner_
        * _Description_
    * Ensure the _PV Agreements_ section contains the following default columns in the following order:
        * _Name_
        * _Agreement Title_
        * _PVA Scope_
        * _Agreement Effective Date_
        * _Agreement End Date_
        * _Agreement Owner_
    * Ensure there is a _Workflow Timeline_ section
4. Select **Save**.

### Configure the PV Agreement Object Layout {#pv-agreement-object-layout}

To configure the _PV Agreement_ object layout:

1. Navigate to **Admin > Configuration > Objects > PV Agreement > Layouts > PV Agreement Detail Page Layout**.
2. Select **Edit**.
3. Configure the layout as follows:
    * Ensure the _Details_ section contains the following fields in the following order:
        * _Relationship_
        * _Agreement Title_
        * _Agreement Effective Date_
        * _Agreement End Date_
        * _PVA Scope_
        * _Agreement Owner_
        * _Agreement Notes_
    * Ensure the following <a href="/en/gr/26387/#related-object">related object sections</a> appear in the following order, with the specified default columns:
        * _Covered Products_
            * _Product Name_
            * _Product Type_
            * _Abbreviation_
        * _Covered Studies_
            * _Study Number_
            * _Study Name_
            * _Protocol Title_ 
            * _Study Type_
            * _Masking_
        * _Agreement Countries_
            * _Name_ 
            * _Code (2-letter)_
            * _Code (3-letter)_
            * _Agency_
        * _Contacts_
            * _Name_
            * _Person_
            * _Vault User_
            * _Contract Party_
            * _Communication Method_
        * _Action Items_
            * _Name_
            * _Assigned To_
            * _Agreement Contact_
            * _Due Date_
            * _Completion Date_
            * _Description_
        * _Obligations_
            * _Name_
            * _Obligation Category_
            * _Clause Title_
            * _Partner Contact_
            * _Sponsor Contact_
        * _Activities_
            * _Name_
            * _Obligation Title_
            * _Due Date_
            * _Completion Date_
            * _Partner Responsible Contact_
            * _Sponsor Responsible Contact_
        * _Reconciliations_
            * _Name_
            * _Assigned To_
            * _Obligation Name_
            * _Activity_
            * _Due Date_
            * _Evaluation_
        * _Agreement Documents_
            * _Name_
            * _Title_
            * _Status_
    * Ensure there is a _Workflow Timeline_ section
    * Ensure there is a _Signatures_ section with the following columns:
        * Name
        * Signature Name
        * Signature Meaning
        * Signature Status
4. Select **Save**.

## Configure Document Types {#document-types}

To configure document types:
* [Create a _Document Type Group_][11]
* [Add the _Document Type Group_ to the _Pharmacovigilance Agreements_ document type][12]

### Create the PVA Documents Document Type Group {#create-document-type-group}

To create a _Document Type Group_:

1. Navigate to **Business Admin > Objects > Document Type Groups**.
2. Select **Create**. 
3. In the **Name** field, enter `PVA Documents`.
4. Select **Save**.

### Add the PVA Document Type Group to the PVA Document Type {#add-document-type-group}

To add your new _Document Type Group_, <a href="/en/gr/618/#EditingDocTypes">edit the _Pharmacovigilance Agreements_ document type</a>. In the _General_ tab, select **PVA Documents** in the **Document Type Groups** field.

## Configure Security {#security}

Configure security settings to grant access to the PVA management features. Use the following settings as a starting point, but configure access according to your business process:
* Create a <a href="/en/gr/22824/">permission set</a> with the label `PVA Actions`
* Create a <a href="/en/gr/23647/#how-to-create-new-profiles">security profile</a> with the label `PVA Management` and assign to it the _PVA Actions_ permission set
* [Create PVA _Groups_ ][14]
* [Grant permissions on the _PVA Actions_ permission set][15]

### Create PVA Groups {#pva-groups}

<a href="/en/gr/3200/#how-to-create-custom-groups">Create groups</a> with the following labels, then add the **PVA Management** security profile to the **Included Security Profiles** field for each new group:
* _PVA Users_
* _PVA Viewers_
* _PVA Consumers_

### Grant Permissions {#grant-permissions}

To grant permissions to the _PVA Actions_ permission set:

1. Grant _Vault Actions_ <a href="/en/gr/22824/#applicationpermissions">application permissions</a> as follows:

    <table>
        <thead>
            <tr>
                <th>Vault Action</th>
                <th>Permissions</th>
            </tr>
        </thead>
        <tbody>
            <tr>
                <td><em>Dashboards and Reports</em></td>
                <td><ul>
                    <li><em>Create Dashboards</em></li>
                    <li><em>Delete Dashboards</em></li>
                    <li><em>Share Dashboards</em></li>
                    <li><em>Schedule Reports</em></li>
                    <li><em>Read Group Membership</em></li>
                    </ul></td>
            </tr>
            <tr>
                <td><em>Workflows</em></td>
                <td><ul>
                    <li><em>Start</em></li>
                    <li><em>Read and Understand</em></li>
                    <li><em>eSignature</em></li>
                    </ul></td>
            </tr>
            <tr>
                <td><em>CrossLink</em></td>
                <td><ul>
                    <li><em>Create CrossLink</em></li>
                    </ul></td>
            </tr>
            <tr>
                <td><em>Viewer Administration</em></td>
                <td><ul>
                    <li><em>Manage Tags</em></li>
                    </ul></td>
            </tr>
            <tr>
                <td><em>Document</em></td>
                <td><ul>
                    <li><em>Cancel Checkout</em></li>
                    <li><em>Download Document</em></li>
                    <li><em>Download Rendition</em></li>
                    </ul></td>
            </tr>
            <tr>
                <td><em>User</em></td>
                <td><ul>
                    <li><em>Allow As A Delegate</em></li>
                    <li><em>View User Information</em></li>
                    <li><em>View User Profile</em></li>
                    </ul></td>
            </tr>
            <tr>
                <td><em>Search</em></td>
                <td><ul>
                    <li><em>User Filters</em></li>
                    </ul></td>
            </tr>
            <tr>
                <td><em>Views</em></td>
                <td><ul>
                    <li><em>Share Views</em></li>
                    </ul></td>
            </tr>
            <tr>
                <td><em>Audit Trail</em></td>
                <td><ul>
                    <li><em>View</em></li>
                    </ul></td>
            </tr>
        </tbody>
    </table>
2. Grant <a href="/en/gr/22824/#objectpermissions">object permissions</a> as follows:
    <table>
        <thead>
            <tr>
                <th>Objects</th>
                <th>Permissions</th>
            </tr>
        </thead>
        <tbody>
            <tr>
                <td><ul>
                    <li><em>Application Role</em></li>
                    <li><em>Country</em></li>
                    <li><em>Document Stages</em></li>
                    <li><em>Document Type Group</em></li>
                    <li><em>Language</em></li>
                    <li><em>Language (ISO)</em></li>
                    <li><em>Object Stages</em></li>
                    <li><em>Person</em></li>
                    <li><em>Product</em></li>
                    <li><em>Product Alias</em></li>
                    <li><em>Product Constituent</em></li>
                    <li><em>Product Family</em></li>
                    <li><em>Product Registration</em></li>
                    <li><em>Product Substance</em></li>
                    <li><em>Study</em></li>
                    <li><em>Study Registration</em></li>
                    <li><em>Study Product</em></li>
                    <li><em>Study Site</em></li>
                    <li><em>Substance</em></li>
                    <li><em>Substance Alias</em></li>
                    </ul></td>
                <td><em>Read</em></td>
            </tr>
            <tr>
                <td><ul>
                    <li><em>Organization</em></li>
                    <li><em>PV Agreement</em></li>
                    <li><em>PVA Action Item</em></li>
                    <li><em>PVA Activity</em></li>
                    <li><em>PVA Contact</em></li>
                    <li><em>PVA Obligation</em></li>
                    <li><em>PVA Reconciliation</em></li>
                    <li><em>PVA-Country</em></li>
                    <li><em>PVA-Product</em></li>
                    <li><em>PVA-Study</em></li>
                    <li><em>PVA Relationship</em></li>
                    </ul></td>
                <td><em>Create</em></td>
            </tr>
            <tr>
                <td><ul>
                    <li><em>Organization</em></li>
                    <li><em>PV Agreement</em></li>
                    <li><em>PVA Action Item</em></li>
                    <li><em>PVA Activity</em></li>
                    <li><em>PVA Contact</em></li>
                    <li><em>PVA Obligation</em></li>
                    <li><em>PVA Reconciliation</em></li>
                    <li><em>PVA-Country</em></li>
                    <li><em>PVA-Product</em></li>
                    <li><em>PVA-Study</em></li>
                    <li><em>PVA Relationship</em></li>
                    </ul></td>
                <td><em>Edit</em></td>
            </tr>
            <tr>
                <td><ul>
                    <li><em>PV Agreement</em></li>
                    <li><em>PVA Action Item</em></li>
                    <li><em>PVA Activity</em></li>
                    <li><em>PVA Contact</em></li>
                    <li><em>PVA Obligation</em></li>
                    <li><em>PVA Reconciliation</em></li>
                    <li><em>PVA-Country</em></li>
                    <li><em>PVA-Product</em></li>
                    <li><em>PVA-Study</em></li>
                    <li><em>PVA Relationship</em></li>
                    </ul></td>
                <td><em>Delete</em></td>
            </tr>
        </tbody>
    </table>
3. Grant _View_ <a href="/en/gr/22824/#tab-permissions">tab permissions</a> for the following _Tabs_:
    * _Home_
    * _Library_
    * _PVAs_
      * _PVA Relationships_
      * _PV Agreements_
      * _Open PVA Actions_
    * _Analytics_
      * _Reports_
      * _Dashboards_

## Configure Custom Sharing Rules for PVA Objects {#custom-sharing-rules}

To configure custom sharing rules: 
1. <a href="/en/gr/25494/#configuration-overview">Enable custom sharing rules</a> for the following objects:
    * _PV Agreement_
    * _PVA Action Item_
    * _PVA Activity_
    * _PVA Contact_
    * _PVA Obligation_
    * _PVA Reconciliation_
    * _PVA Relationship_
2. For each object, <a href="/en/gr/25494/#how-to-create-sharing-rules">create a custom sharing rule</a>  and <a href="/en/gr/61279/#how-to-manually-assign-users">add manual assignments</a> as follows:
    <table>
        <thead>
            <tr>
                <th>Role</th>
                <th>Users & Groups</th>
            </tr>
        </thead>
        <tbody>
            <tr>
                <td><em>Viewer</em></td>
                <td><em>PVA Consumers</em></td>
            </tr>
            <tr>
                <td><em>Owner</em></td>
                <td><em>PVA Users</em></td>
            </tr>
            <tr>
                <td><em>Editor</em></td>
                <td><em>PVA Users</em></td>
            </tr>
            <tr>
                <td><em>Viewer</em></td>
                <td><em>PVA Viewers</em></td>
            </tr>
        </tbody>
    </table>

## Configure the PV Agreement Object Lifecycle {#pv-agreement-lifecycle}

To configure the _PV Agreement Lifecycle_ <a href="/en/gr/30683/">object lifecycle</a>:
* [Add roles][18]
* [Edit role permissions][19]
* [Configure atomic security on relationships][20]
* [Create entry criteria][21]
* [Configure a lifecycle stage group][22]

### Add Lifecycle Roles {#pv-agreement-lifecycle-roles}

<a href="/en/gr/36440/#how-to-add-roles">Add</a> the following roles to the _PV Agreement Lifecycle_:
* _Approver_
* _Reviewer_
* _Safety Operations_

### Edit Role Permissions {#pv-agreement-lifecycle-role-permissions}

<a href="/en/gr/36440/#edit-role-lifecycle-state-permissions">Edit role permissions</a> on the specified states of the _PV Agreement Lifecycle_ as follows:

<table>
    <thead>
        <tr>
            <th>Role</th>
            <th>Permissions</th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td><em>Approver</em></td>
            <td>All states: <em>Read</em></td>
        </tr>
        <tr>
            <td><em>Editor</em></td>
            <td>
                <ul>
                    <li><em>Drafting</em>: <em>Edit</em></li>
                    <li><em>Scoping</em>: <em>Edit</em></li>
                    <li><em>Initiated</em>: <em>Delete</em></li>
                </ul>
            </td>
        </tr>
        <tr>
            <td><em>Owner</em></td>
            <td>
                <ul>
                    <li><em>Drafting</em>: <em>Edit</em></li>
                    <li><em>Scoping</em>: <em>Edit</em></li>
                    <li><em>Initiated</em>: <em>Delete</em></li>
                </ul>
            </td>
        </tr>
        <tr>
            <td><em>Reviewer</em></td>
            <td>All states: <em>Read</em></td>
        </tr>
        <tr>
            <td><em>Safety Operations</em></td>
            <td>All states: <em>Read</em></td>
        </tr>
    </tbody>
</table>

### Configure Atomic Security on Relationships {#pv-agreement-lifecycle-atomic-security}

<a href="/en/gr/47850/#secure_inbound_relationships">Configure atomic security on relationships</a> on the _Effective_ and _Terminated_ states of the _PV Agreement Lifecycle_ as follows:

<table>
    <thead>
        <tr>
            <th>Lifecycle State</th>
            <th>Relationship Label</th>
            <th>Default</th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td rowspan="8"><em>Effective</em></td>
            <td><em>PVA Action Items</em></td>
            <td><em>Edit</em></td>
        </tr>
        <tr>
            <td><em>PVA Activities</em></td>
            <td><em>Edit</em></td>
        </tr>
        <tr>
            <td><em>PVA Contacts</em></td>
            <td><em>Read</em></td>
        </tr>
        <tr>
            <td><em>PVA Obligations</em></td>
            <td><em>Read</em></td>
        </tr>
        <tr>
            <td><em>PVA Reconciliations</em></td>
            <td><em>Edit</em></td>
        </tr>
        <tr>
            <td><em>PVA-Countries</em></td>
            <td><em>Read</em></td>
        </tr>
        <tr>
            <td><em>PVA-Products</em></td>
            <td><em>Read</em></td>
        </tr>
        <tr>
            <td><em>PVA-Studies</em></td>
            <td><em>Read</em></td>
        </tr>
        <tr>
            <td rowspan="8"><em>Terminated</em></td>
            <td><em>PVA Action Items</em></td>
            <td><em>Read</em></td>
        </tr>
        <tr>
            <td><em>PVA Activities</em></td>
            <td><em>Read</em></td>
        </tr>
        <tr>
            <td><em>PVA Contacts</em></td>
            <td><em>Read</em></td>
        </tr>
        <tr>
            <td><em>PVA Obligations</em></td>
            <td><em>Read</em></td>
        </tr>
        <tr>
            <td><em>PVA Reconciliations</em></td>
            <td><em>Edit</em></td>
        </tr>
        <tr>
            <td><em>PVA-Countries</em></td>
            <td><em>Read</em></td>
        </tr>
        <tr>
            <td><em>PVA-Products</em></td>
            <td><em>Read</em></td>
        </tr>
        <tr>
            <td><em>PVA-Studies</em></td>
            <td><em>Read</em></td>
        </tr>
    </tbody>
</table>

### Create Entry Criteria {#pv-agreement-lifecycle-entry-criteria}

<a href="/en/gr/59885/#how-to-define-entry-criteria">Create entry criteria</a> on the following states of the _PV Agreement Lifecycle_:

* On the _Terminated_ state, create an entry criteria to **Always** validate:
    * **State of Related Record**
    * **PVA Activities**
    * **No records Include**
    * **Received from Partner**, **New**, **In Progress**
* On the _Effective_ state, create an entry criteria to **Always** validate:
    * **Field** > **Agreement Effective Date** > **is not blank**
    * **Field** > **Agreement End Date** > **is not blank**
    * **Field** > **Agreement Owner** > **is not blank**
    * **Field** > **PVA Scope** > **is not blank**

### Configure the PVA Lifecycle Stage Group {#pv-agreement-lifecycle-lifecycle-stage-group}

Create an <a href="/en/gr/52053/#how-to-create-object-lifecycle-stage-groups">object lifecycle stage group</a> with the following settings:
* **Stage Group Label**: Enter `PVA Stages`
* **Object Lifecycle**: Select **PV Agreement Lifecycle**
* **Object Type**: Select **Base PV Agreement**

Then, create <a href="/en/gr/52053/#how-to-create-stages">stages</a> and define their states as follows:
* Create the **New** stage, then add the **Initiated** state
* Create the **Pending** stage, then add the following states:
    * **Scoping**
    * **Drafting**
    * **In Approval**
* Create the **Effective** stage, then add the **Effective** state
* Create the **Terminated** stage, then add the **Terminated** state

## Configure the PVA Lifecycle Document Lifecycle {#pva-lifecycle-document-lifecycle}

To configure the _PVA Lifecycle_ document lifecycle:
* <a href="/en/gr/2306/">Create a document lifecycle</a> with the label **PVA Lifecycle**
* [Create lifecycle states][24]
* [Update lifecycle state security settings][25]
* [Create entry actions on the _Approved_ state][33]
* [Define state types][34]
* [Define allowed and default users on roles][35]
* [Add the _PVA Lifecycle_ to the _Pharmacovigilance Agreements_ document type][36]
* [Configure a lifecycle stage group][37]

### Create Lifecycle States {#pva-lifecycle-states}

<a href="/en/gr/2357/">Create</a> the following lifecycle states on the _PVA Lifecycle_:
* _Draft_
* _In Review_
* _In Approval_
* _In Authoring_
* _Approved_
* _Obsolete_
* _Superseded_
* _Ready for Review_
* _Ready for Approval_
* _Planned_

### Update Lifecycle State Security Settings {#pva-lifecycle-state-security-settings}

Update <a href="/en/gr/2572/#view">document lifecycle state security settings</a> for the following states on the _PVA Lifecycle_:
* [_Draft_][26]
* [_In Review_][27]
* [_In Approval_][28]
* [_Approved_][29]
* [_Obsolete_][30]
* [_Superseded_][31]
* [_Planned_][32]

#### Update Draft State Security Settings {#draft-state-security-settings}

Update lifecycle state security settings on the _Draft_ state of the _PVA Lifecycle_ as follows:

<table>
    <thead>
        <tr>
            <th>Role</th>
            <th>Security Settings</th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td><em>Owner</em></td>
            <td>
                <ul>
                    <li><em>View Document</em></li>
                    <li><em>View Content</em></li>
                    <li><em>Edit Fields</em></li>
                    <li><em>Edit Relationships</em></li>
                    <li><em>Edit Sharing Settings</em></li>
                    <li><em>Annotate</em></li>
                    <li><em>Download Source</em></li>
                    <li><em>Edit Document</em></li>
                    <li><em>Manage Viewable Rendition</em></li>
                    <li><em>Reclassify</em></li>
                    <li><em>Change Owner</em></li>
                    <li><em>Change Coordinator</em></li>
                    <li><em>Delete</em></li>
                </ul>
            </td>
        </tr>
        <tr>
            <td><em>Coordinator</em></td>
            <td>
                <ul>
                    <li><em>View Document</em></li>
                    <li><em>View Content</em></li>
                    <li><em>Edit Fields</em></li>
                    <li><em>Edit Relationships</em></li>
                    <li><em>Edit Sharing Settings</em></li>
                    <li><em>Annotate</em></li>
                    <li><em>Download Source</em></li>
                    <li><em>Edit Document</em></li>
                    <li><em>Change Owner</em></li>
                    <li><em>Change Coordinator</em></li>
                </ul>
            </td>
        </tr>
        <tr>
            <td><em>Editor</em></td>
            <td>
                <ul>
                    <li><em>View Document</em></li>
                    <li><em>View Content</em></li>
                    <li><em>Edit Fields</em></li>
                    <li><em>Edit Relationships</em></li>
                    <li><em>Edit Sharing Settings</em></li>
                    <li><em>Annotate</em></li>
                    <li><em>Download Source</em></li>
                    <li><em>Edit Document</em></li>
                </ul>
            </td>
        </tr>
        <tr>
            <td><em>Viewer</em></td>
            <td>
                <ul>
                    <li><em>View Document</em></li>
                    <li><em>View Content</em></li>
                </ul>
            </td>
        </tr>
        <tr>
            <td><em>Consumer</em></td>
            <td>No permissions</td>
        </tr>
        <tr>
            <td><em>Reviewer</em></td>
            <td>
                <ul>
                    <li><em>View Document</em></li>
                    <li><em>View Content</em></li>
                    <li><em>Edit Fields</em></li>
                    <li><em>Annotate</em></li>
                    <li><em>Download Source</em></li>
                    <li><em>Edit Document</em></li>
                </ul>
            </td>
        </tr>
        <tr>
            <td><em>Approver</em></td>
            <td>
                <ul>
                    <li><em>View Document</em></li>
                    <li><em>View Content</em></li>
                    <li><em>Edit Fields</em></li>
                    <li><em>Annotate</em></li>
                    <li><em>Download Source</em></li>
                    <li><em>Edit Document</em></li>
                </ul>
            </td>
        </tr>
    </tbody>
</table>

#### Update In Review State Security Settings {#in-review-state-security-settings}

Update lifecycle state security settings on the _In Review_ state of the _PVA Lifecycle_ as follows:

<table>
    <thead>
        <tr>
            <th>Role</th>
            <th>Security Settings</th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td><em>Owner</em></td>
            <td>
                <ul>
                    <li><em>View Document</em></li>
                    <li><em>View Content</em></li>
                    <li><em>Edit Fields</em></li>
                    <li><em>Edit Relationships</em></li>
                    <li><em>Edit Sharing Settings</em></li>
                    <li><em>Annotate</em></li>
                    <li><em>Change Owner</em></li>
                    <li><em>Change Coordinator</em></li>
                </ul>
            </td>
        </tr>
        <tr>
            <td><em>Coordinator</em></td>
            <td>
                <ul>
                    <li><em>View Document</em></li>
                    <li><em>View Content</em></li>
                    <li><em>Edit Fields</em></li>
                    <li><em>Edit Relationships</em></li>
                    <li><em>Edit Sharing Settings</em></li>
                    <li><em>Annotate</em></li>
                    <li><em>Change Owner</em></li>
                    <li><em>Change Coordinator</em></li>
                </ul>
            </td>
        </tr>
        <tr>
            <td><em>Editor</em></td>
            <td>
                <ul>
                    <li><em>View Document</em></li>
                    <li><em>View Content</em></li>
                    <li><em>Edit Fields</em></li>
                    <li><em>Edit Relationships</em></li>
                    <li><em>Edit Sharing Settings</em></li>
                    <li><em>Annotate</em></li>
                </ul>
            </td>
        </tr>
        <tr>
            <td><em>Viewer</em></td>
            <td>
                <ul>
                    <li><em>View Document</em></li>
                    <li><em>View Content</em></li>
                </ul>
            </td>
        </tr>
        <tr>
            <td><em>Consumer</em></td>
            <td>No permissions</td>
        </tr>
        <tr>
            <td><em>Reviewer</em></td>
            <td>
                <ul>
                    <li><em>View Document</em></li>
                    <li><em>View Content</em></li>
                    <li><em>Annotate</em></li>
                </ul>
            </td>
        </tr>
        <tr>
            <td><em>Approver</em></td>
            <td>
                <ul>
                    <li><em>View Document</em></li>
                    <li><em>View Content</em></li>
                    <li><em>Annotate</em></li>
                </ul>
            </td>
        </tr>
    </tbody>
</table>

#### Update In Approval State Security Settings {#in-approval-state-security-settings}

Update lifecycle state security settings on the _In Approval_ state of the _PVA Lifecycle_ as follows:

<table>
    <thead>
        <tr>
            <th>Role</th>
            <th>Security Settings</th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td><em>Owner</em></td>
            <td>
                <ul>
                    <li><em>View Document</em></li>
                    <li><em>View Content</em></li>
                    <li><em>Edit Sharing Settings</em></li>
                    <li><em>Download Source</em></li>
                    <li><em>Change Owner</em></li>
                    <li><em>Change Coordinator</em></li>
                </ul>
            </td>
        </tr>
        <tr>
            <td><em>Coordinator</em></td>
            <td>
                <ul>
                    <li><em>View Document</em></li>
                    <li><em>View Content</em></li>
                    <li><em>Edit Sharing Settings</em></li>
                    <li><em>Download Source</em></li>
                    <li><em>Change Owner</em></li>
                    <li><em>Change Coordinator</em></li>
                </ul>
            </td>
        </tr>
        <tr>
            <td><em>Editor</em></td>
            <td>
                <ul>
                    <li><em>View Document</em></li>
                    <li><em>View Content</em></li>
                </ul>
            </td>
        </tr>
        <tr>
            <td><em>Viewer</em></td>
            <td>
                <ul>
                    <li><em>View Document</em></li>
                    <li><em>View Content</em></li>
                </ul>
            </td>
        </tr>
        <tr>
            <td><em>Consumer</em></td>
            <td>No permissions</td>
        </tr>
        <tr>
            <td><em>Reviewer</em></td>
            <td>
                <ul>
                    <li><em>View Document</em></li>
                    <li><em>View Content</em></li>
                    <li><em>Download Source</em></li>
                </ul>
            </td>
        </tr>
        <tr>
            <td><em>Approver</em></td>
            <td>
                <ul>
                    <li><em>View Document</em></li>
                    <li><em>View Content</em></li>
                    <li><em>Download Source</em></li>
                </ul>
            </td>
        </tr>
    </tbody>
</table>

#### Update Approved State Security Settings {#approved-state-security-settings}

Update lifecycle state security settings on the _Approved_ state of the _PVA Lifecycle_ as follows:

<table>
    <thead>
        <tr>
            <th>Role</th>
            <th>Security Settings</th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td><em>Owner</em></td>
            <td>
                <ul>
                    <li><em>View Document</em></li>
                    <li><em>View Content</em></li>
                    <li><em>Edit Sharing Settings</em></li>
                    <li><em>Version</em></li>
                    <li><em>Download Source</em></li>
                    <li><em>Change Owner</em></li>
                    <li><em>Change Coordinator</em></li>
                </ul>
            </td>
        </tr>
        <tr>
            <td><em>Coordinator</em></td>
            <td>
                <ul>
                    <li><em>View Document</em></li>
                    <li><em>View Content</em></li>
                    <li><em>Edit Sharing Settings</em></li>
                    <li><em>Version</em></li>
                    <li><em>Download Source</em></li>
                    <li><em>Change Owner</em></li>
                    <li><em>Change Coordinator</em></li>
                </ul>
            </td>
        </tr>
        <tr>
            <td><em>Editor</em></td>
            <td>
                <ul>
                    <li><em>View Document</em></li>
                    <li><em>View Content</em></li>
                    <li><em>Edit Sharing Settings</em></li>
                    <li><em>Version</em></li>
                    <li><em>Download Source</em></li>
                </ul>
            </td>
        </tr>
        <tr>
            <td><em>Viewer</em></td>
            <td>
                <ul>
                    <li><em>View Document</em></li>
                    <li><em>View Content</em></li>
                    <li><em>Download Source</em></li>
                </ul>
            </td>
        </tr>
        <tr>
            <td><em>Consumer</em></td>
            <td>
                <ul>
                    <li><em>View Document</em></li>
                    <li><em>View Content</em></li>
                    <li><em>Download Source</em></li>
                </ul>
            </td>
        </tr>
        <tr>
            <td><em>Reviewer</em></td>
            <td>
                <ul>
                    <li><em>View Document</em></li>
                    <li><em>View Content</em></li>
                    <li><em>Download Source</em></li>
                </ul>
            </td>
        </tr>
        <tr>
            <td><em>Approver</em></td>
            <td>
                <ul>
                    <li><em>View Document</em></li>
                    <li><em>View Content</em></li>
                    <li><em>Download Source</em></li>
                </ul>
            </td>
        </tr>
    </tbody>
</table>

#### Update Obsolete State Security Settings {#obsolete-state-security-settings}

Update lifecycle state security settings on the _Obsolete_ state of the _PVA Lifecycle_ as follows:

<table>
    <thead>
        <tr>
            <th>Role</th>
            <th>Security Settings</th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td><em>Owner</em></td>
            <td>
                <ul>
                    <li><em>View Document</em></li>
                    <li><em>View Content</em></li>
                    <li><em>Edit Sharing Settings</em></li>
                    <li><em>Download Source</em></li>
                    <li><em>Change Owner</em></li>
                    <li><em>Change Coordinator</em></li>
                </ul>
            </td>
        </tr>
        <tr>
            <td><em>Coordinator</em></td>
            <td>
                <ul>
                    <li><em>View Document</em></li>
                    <li><em>View Content</em></li>
                    <li><em>Edit Sharing Settings</em></li>
                    <li><em>Download Source</em></li>
                    <li><em>Change Owner</em></li>
                    <li><em>Change Coordinator</em></li>
                </ul>
            </td>
        </tr>
        <tr>
            <td><em>Editor</em></td>
            <td>
                <ul>
                    <li><em>View Document</em></li>
                    <li><em>View Content</em></li>
                </ul>
            </td>
        </tr>
        <tr>
            <td><em>Viewer</em></td>
            <td>No permissions</td>
        </tr>
        <tr>
            <td><em>Consumer</em></td>
            <td>No permissions</td>
        </tr>
        <tr>
            <td><em>Reviewer</em></td>
            <td>No permissions</td>
        </tr>
        <tr>
            <td><em>Approver</em></td>
            <td>No permissions</td>
        </tr>
    </tbody>
</table>

#### Update Superseded State Security Settings {#superseded-state-security-settings}

Update lifecycle state security settings on the _Superseded_ state of the _PVA Lifecycle_ as follows:

<table>
    <thead>
        <tr>
            <th>Role</th>
            <th>Security Settings</th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td><em>Owner</em></td>
            <td>
                <ul>
                    <li><em>View Document</em></li>
                    <li><em>View Content</em></li>
                    <li><em>Edit Sharing Settings</em></li>
                    <li><em>Download Source</em></li>
                    <li><em>Change Owner</em></li>
                    <li><em>Change Coordinator</em></li>
                </ul>
            </td>
        </tr>
        <tr>
            <td><em>Coordinator</em></td>
            <td>
                <ul>
                    <li><em>View Document</em></li>
                    <li><em>View Content</em></li>
                    <li><em>Edit Sharing Settings</em></li>
                    <li><em>Download Source</em></li>
                    <li><em>Change Owner</em></li>
                    <li><em>Change Coordinator</em></li>
                </ul>
            </td>
        </tr>
        <tr>
            <td><em>Editor</em></td>
            <td>
                <ul>
                    <li><em>View Document</em></li>
                    <li><em>View Content</em></li>
                    <li><em>Download Source</em></li>
                </ul>
            </td>
        </tr>
        <tr>
            <td><em>Viewer</em></td>
            <td>
                <ul>
                    <li><em>View Document</em></li>
                    <li><em>View Content</em></li>
                </ul>
            </td>
        </tr>
        <tr>
            <td><em>Consumer</em></td>
            <td>No permissions</td>
        </tr>
        <tr>
            <td><em>Reviewer</em></td>
            <td>
                <ul>
                    <li><em>View Document</em></li>
                    <li><em>View Content</em></li>
                </ul>
            </td>
        </tr>
        <tr>
            <td><em>Approver</em></td>
            <td>
                <ul>
                    <li><em>View Document</em></li>
                    <li><em>View Content</em></li>
                </ul>
            </td>
        </tr>
    </tbody>
</table>

#### Update Planned State Security Settings {#planned-state-security-settings}

Update lifecycle state security settings on the _Planned_ state of the _PVA Lifecycle_ as follows:

<table>
    <thead>
        <tr>
            <th>Role</th>
            <th>Security Settings</th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td><em>Owner</em></td>
            <td>
                <ul>
                    <li><em>View Document</em></li>
                    <li><em>View Content</em></li>
                    <li><em>Edit Fields</em></li>
                    <li><em>Edit Relationships</em></li>
                    <li><em>Edit Sharing Settings</em></li>
                    <li><em>Download Source</em></li>
                    <li><em>Edit Document</em></li>
                    <li><em>Change Owner</em></li>
                    <li><em>Change Coordinator</em></li>
                </ul>
            </td>
        </tr>
        <tr>
            <td><em>Coordinator</em></td>
            <td>
                <ul>
                    <li><em>View Document</em></li>
                    <li><em>View Content</em></li>
                    <li><em>Edit Fields</em></li>
                    <li><em>Edit Relationships</em></li>
                    <li><em>Edit Sharing Settings</em></li>
                    <li><em>Download Source</em></li>
                    <li><em>Edit Document</em></li>
                    <li><em>Change Owner</em></li>
                    <li><em>Change Coordinator</em></li>
                </ul>
            </td>
        </tr>
        <tr>
            <td><em>Editor</em></td>
            <td>
                <ul>
                    <li><em>View Document</em></li>
                    <li><em>View Content</em></li>
                    <li><em>Edit Fields</em></li>
                    <li><em>Edit Relationships</em></li>
                    <li><em>Edit Sharing Settings</em></li>
                    <li><em>Download Source</em></li>
                    <li><em>Edit Document</em></li>
                </ul>
            </td>
        </tr>
        <tr>
            <td><em>Viewer</em></td>
            <td>No permissions</td>
        </tr>
        <tr>
            <td><em>Consumer</em></td>
            <td>No permissions</td>
        </tr>
        <tr>
            <td><em>Reviewer</em></td>
            <td>
                <ul>
                    <li><em>View Document</em></li>
                    <li><em>View Content</em></li>
                    <li><em>Edit Fields</em></li>
                </ul>
            </td>
        </tr>
        <tr>
            <td><em>Approver</em></td>
            <td>
                <ul>
                    <li><em>View Document</em></li>
                    <li><em>View Content</em></li>
                    <li><em>Edit Fields</em></li>
                </ul>
            </td>
        </tr>
    </tbody>
</table>

### Create Entry Actions on the Approved State {#pva-lifecycle-entry-actions}

<a href="/en/gr/12399/#create">Create entry actions</a>  on the _Approved_ state of the _PVA Lifecycle_ to **Always** perform the following actions:
* **Set new major version**
* **Set previous steady state to superseded**

### Define Lifecycle State Types {#pva-lifecycle-state-types}

To <a href="/en/gr/14560/#how-to-define-state-types">define state types</a> on the _PVA Lifecycle_, map the previously created states to state types as follows:

<table>
    <thead>
        <tr>
            <th>State Type</th>
            <th>State</th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td><em>Starting State</em></td>
            <td><em>Draft</em></td>
        </tr>
        <tr>
            <td><em>Steady State</em></td>
            <td><em>Approved</em></td>
        </tr>
        <tr>
            <td><em>Superseded State</em></td>
            <td><em>Superseded</em></td>
        </tr>
        <tr>
            <td><em>Obsolete State</em></td>
            <td><em>Obsolete</em></td>
        </tr>
        <tr>
            <td><em>Document Workflow: Pre-Approval</em></td>
            <td><em>Ready for Approval</em></td>
        </tr>
        <tr>
            <td><em>Document Workflow: Approved</em></td>
            <td><em>Approved</em></td>
        </tr>
        <tr>
            <td><em>Document Workflow: Rejected</em></td>
            <td><em>Draft</em></td>
        </tr>
        <tr>
            <td><em>In Review</em></td>
            <td><em>In Review</em></td>
        </tr>
        <tr>
            <td><em>Rejected</em></td>
            <td><em>Draft</em></td>
        </tr>
    </tbody>
</table>

### Define Allowed and Default Users for PVA Lifecycle Roles {#pva-lifecycle-allowed-users}

<a href="/en/gr/6572/#defineAllowed">Define allowed and default users</a> for the specified roles on the _PVA Lifecycle_ as follows:

<table>
    <thead>
        <tr>
            <th>Role</th>
            <th>Allowed User/Group</th>
            <th>Default User</th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td><em>Consumer</em></td>
            <td>
                <ul>
                    <li><em>All Users and Groups</em></li>
                    <li><em>PVA Consumers</em></li>
                </ul>
            </td>
            <td><em>PVA Consumers</em></td>
        </tr>
        <tr>
            <td><em>Viewer</em></td>
            <td>
                <ul>
                    <li><em>All Users and Groups</em></li>
                    <li><em>PVA Viewers</em></li>
                </ul>
            </td>
            <td><em>PVA Viewers</em></td>
        </tr>
        <tr>
            <td><em>Editor</em></td>
            <td>
                <ul>
                    <li><em>All Users and Groups</em></li>
                    <li><em>PVA Users</em></li>
                </ul>
            </td>
            <td><em>PVA Users</em></td>
        </tr>
    </tbody>
</table>

### Add the PVA Lifecycle to the Pharmacovigilance Agreements Document Type {#pva-lifecycle-document-type}

To add the _PVA Lifecycle_ to the _Pharmacovigilance Agreements_ <a href="/en/gr/618/">_Document Type_</a>:

1. Navigate to **Admin > Configuration > Document Types > Pharmacovigilance Agreements**.
2. In the **Actions** menu, select **Edit Details**.
3. On the _General_ tab, in the **Available Lifecycles** field, select **PVA Lifecycle**.
4. Select **Save**.

### Configure the PVA Document Stages Lifecycle Stage Group {#pva-document-lifecycle-stage-group}

Create an <a href="/en/gr/52053/#how-to-create-document-lifecycle-stage-groups">document lifecycle stage group</a> with the following settings:
* **Stage Group Label**: Enter `PVA Document Stages`
* **Document Lifecycle**: Select **PVA Lifecycle**

Then, create <a href="/en/gr/52053/#how-to-create-stages">stages</a> and define their states as follows:
* Create the **New** stage, then add the following states:
    * **Draft**
    * **Planned**
* Create the **Authoring** stage, then add the following states:
    * **In Authoring**
    * **Ready for Review**
* Create the **Review & Approval** stage, then add the following states:
    * **In Review**
    * **Ready for Approval**
    * **In Approval**
* Create the **Approved** stage, then add the **Approved** state

## Configure Object Workflows {#object-workflows}

Configure the following PVA management <a href="/en/gr/33498/">object workflows</a>. Use these steps as a starting point, but configure your workflows according to your business processes:
* Create the [_PVA Creation Workflow_][39]
* Create the [_PVA Close-Out Workflow_][40]
* Create the [_PVA Activity Outbound Workflow_][41]
* Create the [_PVA Activity Inbound Workflow_][42]
* [Configure user actions on the _PV Agreement Lifecycle_ and the _PVA Activity Lifecycle_][43]

### Create the PVA Creation Workflow {#pva-creation-workflow}

Create the following workflow to manage PVA creation:

1. Navigate to **Admin > Configuration > Workflows**.
2. Select **Create**.
3. In the _Create Workflow_ window, select **Object Workflow**.
4. Select **Continue**.
5. On the _Create Workflow_ page, populate the fields as follows:
    * **Label**: Enter `PVA Creation Workflow`
    * **Lifecycle**: Select **PV Agreement Lifecycle**
6. Select **Save**.
7. In the _Workflow Steps_ section, configure the workflow to include the following steps:
    * _Start_ <a href="/en/gr/33550/#start">Start step</a>
    * _SC: Scoping_ state change <a href="/en/gr/33550/#how-to-define-an-action-step">action step</a>
    * _Task: Search for Articles_ <a href="/en/gr/33550/#wftaskstep">task step</a>
    * _Update Sharing_ <a href="/en/gr/33550/#how-to-define-an-update-sharing-settings-step">update sharing settings step</a>
    * _Update Sharing: Approver_ <a href="/en/gr/33550/#how-to-define-an-update-sharing-settings-step">update sharing settings step</a>
    * _Task: Scope PVA_ <a href="/en/gr/33550/#wftaskstep">task step</a>
    * _SC: Drafting_ state change <a href="/en/gr/33550/#how-to-define-an-action-step">action step</a>
    * _Task: Draft_ <a href="/en/gr/33550/#wftaskstep">task step</a>
    * _SC: In Approval_ state change <a href="/en/gr/33550/#how-to-define-an-action-step">action step</a>
    * _Task: Approve & Effective_ <a href="/en/gr/33550/#wftaskstep">task step</a>
    * _SC: Effective_ state change <a href="/en/gr/33550/#how-to-define-an-action-step">action step</a>
    * _End_ <a href="/en/gr/33550/#how-to-define-an-end-workflow-step">end step</a>
8. In the **Status** field, select **Make configuration active**.

<a href="https://platform.veevavault.help/assets/images/saf-pva-creation-workflow.png" data-lightbox="saf-pva-creation-workflow.png" data-title="PVA Creation workflow" data-alt="PVA Creation workflow">
  <img class="docimage" src="https://platform.veevavault.help/assets/images/saf-pva-creation-workflow.png" alt="PVA Creation workflow" style=""  />
</a>

### Create the PVA Close-Out Workflow {#pva-close-out-workflow}

Create the following workflow to manage PVA close-out or termination:

1. Navigate to **Admin > Configuration > Workflows**.
2. Select **Create**.
3. In the _Create Workflow_ window, select **Object Workflow**.
4. Select **Continue**.
5. On the _Create Workflow_ page, populate the fields as follows:
    * **Label**: Enter `PVA Close-Out Workflow`
    * **Lifecycle**: Select **PV Agreement Lifecycle**
6. Select **Save**.
7. In the _Workflow Steps_ section, configure the workflow to include the following steps:
    * _Start_ <a href="/en/gr/33550/#start">Start step</a>
    * _Task: Closeout_ <a href="/en/gr/33550/#wftaskstep">task step</a>
    * _SC: Terminated_ state change <a href="/en/gr/33550/#how-to-define-an-action-step">action step</a>
    * _End_ <a href="/en/gr/33550/#how-to-define-an-end-workflow-step">end step</a>
8. In the **Status** field, select **Make configuration active**.

<a href="https://platform.veevavault.help/assets/images/saf-pva-closeout-workflow.png" data-lightbox="saf-pva-closeout-workflow.png" data-title="PVA Close-Out Workflow" data-alt="PVA Close-Out Workflow">
  <img class="docimage" src="https://platform.veevavault.help/assets/images/saf-pva-closeout-workflow.png" alt="PVA Close-Out Workflow" style=""  />
</a>

### Create the PVA Activity Outbound Workflow {#pva-activity-outbound-workflow}

Create a workflow to manage PVA outbound activities (activities completed by your organization and sent to partner organizations for review):

1. Navigate to **Admin > Configuration > Workflows**.
2. Select **Create**. 
3. In the _Create Workflow_ window, select **Object Workflow**.
4. Select **Continue**.
5. On the _Create Workflow_ page, populate the fields as follows:
    * **Label**: Enter `PVA Activity Outbound Workflow`
    * **Lifecycle**: Select **PVA Activity Lifecycle**
6. Select **Save**.
7. In the _Workflow Steps_ section, configure the workflow to include the following steps:
    * _Start_ <a href="/en/gr/33550/#start">Start step</a>
    * _SC: In Progress_ state change <a href="/en/gr/33550/#how-to-define-an-action-step">action step</a>
    * _Update Sharing Settings_ <a href="/en/gr/33550/#how-to-define-an-update-sharing-settings-step">update sharing settings step</a>
    * _Task: Prepare Activity_ <a href="/en/gr/33550/#wftaskstep">task step</a>
    * _SC: Sent_ state change <a href="/en/gr/33550/#how-to-define-an-action-step">action step</a>
    * _Task: Confirm Receipt_ <a href="/en/gr/33550/#wftaskstep">task step</a>
    * _Decision: Complete?_ <a href="/en/gr/33550/#decision">decision step</a>
    * _SC: Complete_ state change <a href="/en/gr/33550/#how-to-define-an-action-step">action step</a>
    * _SC: Cancelled_ state change <a href="/en/gr/33550/#how-to-define-an-action-step">action step</a>
    * _End_ <a href="/en/gr/33550/#how-to-define-an-end-workflow-step">end step</a>
8. In the **Status** field, select **Make configuration active**.

<a href="https://platform.veevavault.help/assets/images/saf-pva-activity-outbound-workflow.png" data-lightbox="saf-pva-activity-outbound-workflow.png" data-title="PVA Activity Outbound workflow" data-alt="PVA Activity Outbound workflow">
  <img class="docimage" src="https://platform.veevavault.help/assets/images/saf-pva-activity-outbound-workflow.png" alt="PVA Activity Outbound workflow" style=""  />
</a> 

### Create the PVA Activity Inbound Workflow {#pva-activity-inbound-workflow}

Create a workflow to manage PVA inbound activities (activities completed by a partner organization and sent to your organization for review):

1. Navigate to **Admin > Configuration > Workflows**.
2. Select **Create**. 
3. In the _Create Workflow_ window, select **Object Workflow**.
4. Select **Continue**.
5. On the _Create Workflow_ page, populate the fields as follows:
    * **Label**: Enter `PVA Activity Inbound Workflow`
    * **Lifecycle**: Select **PVA Activity Lifecycle**
6. Select **Save**.
7. In the _Workflow Steps_ section, configure the workflow to include the following steps:
    * _Start_ <a href="/en/gr/33550/#start">Start step</a>
    * _SC: Received_ state change <a href="/en/gr/33550/#how-to-define-an-action-step">action step</a>
    * _Update Sharing_ <a href="/en/gr/33550/#how-to-define-an-update-sharing-settings-step">update sharing settings step</a>
    * _Task: Verify Received Documents_ <a href="/en/gr/33550/#wftaskstep">task step</a>
    * _SC: Complete_ state change <a href="/en/gr/33550/#how-to-define-an-action-step">action step</a>
    * _End_ <a href="/en/gr/33550/#how-to-define-an-end-workflow-step">end step</a>
8. In the **Status** field, select **Make configuration active**.

<a href="https://platform.veevavault.help/assets/images/saf-pva-activity-inbound-workflow.png" data-lightbox="saf-pva-activity-inbound-workflow.png" data-title="PVA Activity Inbound workflow" data-alt="PVA Activity Inbound workflow">
  <img class="docimage" src="https://platform.veevavault.help/assets/images/saf-pva-activity-inbound-workflow.png" alt="PVA Activity Inbound workflow" style=""  />
</a> 

### Configure User Actions {#object-workflow-user-actions}

Add <a href="/en/gr/59885/#user-actions">user actions</a> to the following states of the specified lifecycles:

* To the _PV Agreement Lifecycle_:
    * _Initiated_ state:
      * **Always**: Start the _PVA Creation Workflow_
          * **Action Label**: Enter `Start PVA Authoring`
    * _Effective_ state: 
      * **Always**: Start the _PVA Close-Out Workflow_
          * **Action Label**: Enter `Close out PVA`
* To the _New_ state of the _PVA Activity Lifecycle_:
    * **Always**: Start the _PVA Activity Outbound Workflow_
        * **Action Label**: Enter `Start Outbound Activity`
    * **Always**: Start the _PVA Activity Inbound Workflow_
        * **Action Label**: Enter `Start Inbound Activity`

## Configure Document Workflows {#document-workflows}

Configure the following PVA management <a href="/en/gr/50498/">document workflows</a>. Use these steps as a starting point, but configure your workflows according to your business processes:
* Create the [_PVA Authoring Workflow_][45]
* Create the [_PVA Review Workflow_][46]
* Create the [_PVA Approval Workflow_][47]
* [Configure user actions on the _PVA Lifecycle_ document lifecycle][48]

### Create the PVA Authoring Workflow {#pva-authoring-workflow}

To create a PVA authoring workflow:

1. Navigate to **Admin > Configuration > Workflows**.
2. Select **Create**. 
3. In the _Create Workflow_ window, select **Document Workflow**.
4. Select **Continue**.
5. On the _Create Workflow_ page, populate the fields as follows:
    * **Label**: Enter `PVA Authoring Workflow`
    * **Lifecycle**: Select **PVA Lifecycle**
6. Select **Save**.
7. In the _Workflow Steps_ section, configure the workflow to include the following steps:
    * _Start_ <a href="/en/gr/50498/#start">start step</a>
    * _SC: In Authoring_ state change <a href="/en/gr/50498/#how-to-define-an-action-step">action step</a>
    * _Task: Author_ <a href="/en/gr/50498/#document_task_steps">task step</a>
    * _SC: Ready for Review or Draft_ state change <a href="/en/gr/50498/#how-to-define-an-action-step">action step</a>
    * _End_ <a href="/en/gr/50498/#how-to-define-an-end-workflow-step">end step</a>
8. In the **Status** field, select **Make configuration active**.

<a href="https://platform.veevavault.help/assets/images/saf-pva-authoring-workflow.png" data-lightbox="saf-pva-authoring-workflow.png" data-title="PVA Authoring workflow" data-alt="PVA Authoring workflow">
  <img class="docimage" src="https://platform.veevavault.help/assets/images/saf-pva-authoring-workflow.png" alt="PVA Authoring workflow" style=""  />
</a> 

### Create the PVA Review Workflow {#pva-review-workflow}

To create a PVA review workflow:

1. Navigate to **Admin > Configuration > Workflows**.
2. Select **Create**. 
3. In the _Create Workflow_ window, select **Document Workflow**.
4. Select **Continue**.
5. On the _Create Workflow_ page, populate the fields as follows:
    * **Label**: Enter `PVA Review Workflow`
    * **Lifecycle**: Select **PVA Lifecycle**
6. Select **Save**.
7. In the _Workflow Steps_ section, configure the workflow to include the following steps:
    * _Start_ <a href="/en/gr/50498/#start">start step</a>
    * _SC: In Review_ state change <a href="/en/gr/50498/#how-to-define-an-action-step">action step</a>
    * _Task: Review_ <a href="/en/gr/50498/#document_task_steps">task step</a>
    * _SC: Ready for Approval or Draft_ state change <a href="/en/gr/50498/#how-to-define-an-action-step">action step</a>
    * _End_ <a href="/en/gr/50498/#how-to-define-an-end-workflow-step">end step</a>
8. In the **Status** field, select **Make configuration active**.

<a href="https://platform.veevavault.help/assets/images/saf-pva-review-workflow.png" data-lightbox="saf-pva-review-workflow.png" data-title="PVA Review workflow" data-alt="PVA Review workflow">
  <img class="docimage" src="https://platform.veevavault.help/assets/images/saf-pva-review-workflow.png" alt="PVA Review workflow" style=""  />
</a> 

### Create the PVA Approval Workflow {#pva-approval-workflow}

To create a PVA approval workflow:

1. Navigate to **Admin > Configuration > Workflows**.
2. Select **Create**. 
3. In the _Create Workflow_ window, select **Document Workflow**.
4. Select **Continue**.
5. On the _Create Workflow_ page, populate the fields as follows:
    * **Label**: Enter `PVA Approval Workflow`
    * **Lifecycle**: Select **PVA Lifecycle**
6. Select **Save**.
7. In the _Workflow Steps_ section, configure the workflow to include the following steps:
    * _Start_ <a href="/en/gr/50498/#start">start step</a>
    * _SC: In Approval_ state change <a href="/en/gr/50498/#how-to-define-an-action-step">action step</a>
    * _Task: Approve_ <a href="/en/gr/50498/#document_task_steps">task step</a>, configured to include the following settings:
        * In the _Prompts_ section:
            * Select the **Prompt for Verdicts** checkbox
            * Select the **Multiple Verdicts: One verdict for each item** option
        * In the _Verdicts_ section, create the following verdicts:
            * **Approved**:
              * Select **Add eSignature**
              * For **Instructions**, enter `Please provide an eSignature for Document Approval`
              * Select the **Manifest eSignature on document** checkbox
            * **Reviewed, Back to Draft**:
              * Select **Add Comments**
              * For **Prompt for comments**, enter `Comments`
              * Select the **Required** checkbox
    * _SC: Approved or Draft_ state change <a href="/en/gr/50498/#how-to-define-an-action-step">action step</a>
    * _End_ <a href="/en/gr/50498/#how-to-define-an-end-workflow-step">end step</a>
8. On the _PVA Approval Workflow_ page, in the **Status** field, select **Make configuration active**.

<a href="https://platform.veevavault.help/assets/images/saf-pva-approval-workflow.png" data-lightbox="saf-pva-approval-workflow.png" data-title="PVA Approval workflow" data-alt="PVA Approval workflow">
  <img class="docimage" src="https://platform.veevavault.help/assets/images/saf-pva-approval-workflow.png" alt="PVA Approval workflow" style=""  />
</a> 

### Create User Actions on the PVA Lifecycle {#document-workflow-user-actions}

Create <a href="/en/gr/12339/#create">user actions</a> on the following states of the _PVA Lifecycle_ document lifecycle:

* On the _Draft_ state:
    * **Always**: Start the _PVA Authoring Workflow_
        * **Action Label**: Enter `Start Authoring`
    * **Always**: Start the _PVA Review Workflow_
        * **Action Label**: Enter `Start Review`
* On the _Ready for Review_ state:
    * **Always**: Start the _PVA Review Workflow_
        * **Action Label**: Enter `Start Review`
* On the _Ready for Approval_ state:
    * **Always**: Start the _PVA Approval Workflow_
        * **Action Label**: Enter `Start Approval`

## Manage Tabs {#tabs}
For easy user access to PVA management features:
* <a href="/en/gr/23516/#access-control">Set the tab status to _Active_</a> for the following tabs:
    * _PVA Relationships_
    * _PV Agreements_
    * _Open PVA Action_
* Create an active _PVAs_ <a href="/en/gr/542174/#Create_Tab_Collection">tab collection</a> and add the following tabs:
    * _Home_
    * _PVAs_
    * _Library_
    * _Analytics_

## (26R1) Configure PVA: Defer Contact Entry {#r261-configure}
To configure the _Partner Contact_ and _Sponsor Contact_ fields on the _PVA Obligation_ object as optional during initial _PVA Obligation_ creation:
1. Navigate to **Admin > Configuration > Objects > PVA Obligation > Fields**.
2. Select the relevant field.
3. Select **Edit**.
4. Under the _Options_ section, clear the **User must always enter a value (required)** attribute.
5. Select **Save**.

## (25R3) Configure Product Family Support for PV Agreements {#r253-configure}

To allow users to classify _PV Agreements_ at the _Product Family_ level, you can <a href="/en/gr/26387/#copy-a-layout">copy</a> the standard _PV Agreement Detail Page_ object layout, <a href="/en/gr/26387/#set-a-default-layout">set the copied layout as the default</a>, and <a href="/en/gr/26387/#delete-a-layout">delete</a> any other existing custom _PV Agreement_ layouts. Alternatively, you can update the applicable _PV Agreement_ object layouts to:
* <a href="/en/gr/26387/#how-to-remove-sections-and-pages">Remove</a> the _Covered Products_ section
* Insert the **Covered Product Families** <a href="/en/gr/26387/#how-to-add-sections">related object section</a> below the _Details_ section:
   * **Related Object**: Select **PVA-Product Family > Product Family**
   * **Section Label**: Enter `Covered Product Families`
   * **Creation Options**: Select **Create record in pop-up dialog**
   * <a href="/en/gr/26387/#how-to-edit-related-object-columns">Edit the default columns</a> to display the following fields:
      * _Name_
      * _Generic Name_
      * _Therapeutic Area_

## (24R3) Configure Pharmacovigilance Agreements Usability Improvements {#r243}

To display meaningful values for PVA-related object references in records, you must update your custom <a href="/en/gr/26387/">object layouts</a> to include the applicable control fields. Alternatively, you can <a href="/en/gr/26387/#copy-a-layout">copy the standard layouts</a> and replace the custom layout versions in your Vault.

### Update Object Layout Fields {#r243-layouts}

Update the following object layouts by <a href="/en/gr/26387/#show-hide-move">replacing the listed fields</a>  with the control field versions with the **Slider** (<img class="inline" src="https://platform.veevavault.help/assets/images/saf-app-control.png" alt="Slider" style="" />) icon in each object layout's _Details_ section: 

<table>
  <tr>
    <th>Object</th>
    <th>Field to Remove</th>
    <th>Control Field to Add</th>
  </tr>
  <tr>
   <td rowspan="4" ><em>PVA Action Item</em></td>
   <td><em>Agreement Contact</em></td>
   <td><em>Agreement Contact</em></td>
  </tr>
  <tr>
   <td><em>PV Agreement</em></td>
   <td><em>PV Agreement</em></td>
  </tr>
  <tr>
   <td><em>Related PVA Activity</em></td>
   <td><em>Related Activity</em></td>
  </tr>
  <tr>
   <td><em>Related PVA Obligation</em></td>
   <td><em>PVA Obligation</em></td>
  </tr>
  <tr>
   <td rowspan="4" ><em>PVA Activity</em></td>
   <td><em>Partner Responsible Contact</em></td>
   <td><em>Partner Responsible Contact </em></td>
  </tr>
  <tr>
   <td><em>PV Agreement</em></td>
   <td><em>PV Agreement</em></td>
  </tr>
  <tr>
   <td><em>PVA Obligation</em></td>
   <td><em>Related Obligation </em></td>
  </tr>
  <tr>
   <td><em>Sponsor Responsible User</em></td>
   <td><em>Sponsor Responsible User</em></td>
  </tr>
  <tr>
   <td><em>PVA Contact</em></td>
   <td><em>PV Agreement</em></td>
   <td><em>PV Agreement</em></td>
  </tr>
  <tr>
   <td rowspan="2" ><em>PVA Document Distribution Event</em></td>
   <td><em>PVA Activity</em></td>
   <td><em>Activity </em></td>
  </tr>
  <tr>
   <td><em>Recipient</em></td>
   <td><em>Recipient</em></td>
  </tr>
  <tr>
   <td><em>PVA Document for Distribution</em></td>
   <td><em>PVA Activity</em></td>
   <td><em>Activity </em></td>
  </tr>
  <tr>
   <td rowspan="2" ><em>PVA Obligation</em></td>
   <td><em>Partner Contact</em></td>
   <td><em>Partner Contact </em></td>
  </tr>
  <tr>
   <td><em>Sponsor Contact</em></td>
   <td><em>Sponsor Contact</em></td>
  </tr>
  <tr>
   <td rowspan="2" ><em>PVA Reconciliation</em></td>
   <td><em>Activity</em></td>
   <td><em>Activity</em></td>
  </tr>
  <tr>
   <td><em>Obligation</em></td>
   <td><em>Obligation</em></td>
  </tr>
</table>

### Edit Object Layout Default Columns {#r243-columns}

<a href="/en/gr/26387/#how-to-edit-related-object-columns">Edit the default columns</a> for the following object layout sections to include the applicable control fields and make any additional changes for your business processes as needed:

<table>
  <tr>
    <th>Object</th>
    <th>Section</th>
    <th>Fields to Add</th>
  </tr>
  <tr>
   <td rowspan="5" ><em>PV Agreement</em></td>
   <td><em>Contacts</em></td>
   <td><em>PV Agreement</em></td>
  </tr>
  <tr>
   <td><em>Action Items</em></td>
   <td><ul><li><em>Agreement Contact</em></li>
        <li><em>PV Agreement</em></li>
        <li><em>PVA Obligation</em></li>
        <li><em>Related Activity</em></li></ul></td>
  </tr>
  <tr>
   <td><ul><li><em>Obligations</em></li>
        <li><em>ICSR Reporting Obligations</em></li></ul></td>
   <td><ul><li><em>Partner Contact</em></li>
        <li><em>PV Agreement</em></li>
        <li><em>Sponsor Contact</em></li></ul></td>
  </tr>
  <tr>
   <td><ul><li><em>Case Processing Activities</em></li>
        <li><em>ICSR Reporting Activities</em></li></ul></td>
   <td><ul><li><em>Partner Responsible Contact</em></li>
        <li><em>PV Agreement</em></li>
        <li><em>Related Obligation</em></li>
        <li><em>Sponsor Responsible User</em></li></ul></td>
  </tr>
  <tr>
   <td><em>PVA Reconciliations</em></td>
   <td><ul><li><em>Activity</em></li>
        <li><em>Obligation</em></li></ul></td>
  </tr>
  <tr>
   <td rowspan="2" ><em>PVA Action Item</em></td>
   <td><em>Document Distribution Events</em></td>
   <td>
        <ul><li><em>Activity</em></li>
        <li><em>Recipient</em></li></ul></td>
  </tr>
  <tr>
   <td><em>Documents for Distribution</em></td>
   <td><em>Activity</em></td>
  </tr>
  <tr>
   <td rowspan="3" ><em>PVA Activity</em></td>
   <td><em>Related Action Items</em></td>
   <td><ul><li><em>Agreement Contact</em></li>
        <li><em>PV Agreement</em></li>
        <li><em>Related Activity</em></li>
        <li><em>PVA Obligation</em></li></ul></td>
  </tr>
  <tr>
   <td><em>Document Distribution Events</em></td>
   <td><ul><li><em>Activity</em></li>
        <li><em>Recipient</em></li></ul></td>
  </tr>
  <tr>
   <td><em>Documents for Distribution</em></td>
   <td><em>Activity</em></td>
  </tr>
  <tr>
   <td rowspan="3" ><em>PVA Obligation</em></td>
   <td><ul><li><em>Outbound Activities</em></li>
        <li><em>Inbound Activities</em></li></ul></td>
   <td><ul><li><em>Partner Responsible Contact</em></li>
        <li><em>PV Agreement</em></li>
        <li><em>Related Obligation</em></li>
        <li><em>Sponsor Responsible User</em></li></ul></td>
  </tr>
  <tr>
   <td><em>Action Items</em></td>
   <td><ul><li><em>Agreement Contact</em></li>
        <li><em>PV Agreement</em></li>
        <li><em>PVA Obligation</em></li>
        <li><em>Related Activity</em></li></ul></td>
  </tr>
  <tr>
   <td><em>Reconciliations</em></td>
   <td><ul><li><em>Activity</em></li>
        <li><em>Obligation</em></li></ul></td>
</tr>
</table>


[1]: #r243
[2]: #r243-layouts
[3]: #r243-columns
[4]: #r253
[5]: #r253-configure
[6]: #r261-configure
[7]: #layouts
[8]: #pva-relationship-object-layout
[9]: #pv-agreement-object-layout
[10]: #document-types
[11]: #create-document-type-group
[12]: #add-document-type-group
[13]: #security
[14]: #pva-groups
[15]: #grant-permissions
[16]: #custom-sharing-rules
[17]: #pv-agreement-lifecycle
[18]: #pv-agreement-lifecycle-roles
[19]: #pv-agreement-lifecycle-role-permissions
[20]: #pv-agreement-lifecycle-atomic-security
[21]: #pv-agreement-lifecycle-entry-criteria
[22]: #pv-agreement-lifecycle-lifecycle-stage-group
[23]: #pva-lifecycle-document-lifecycle
[24]: #pva-lifecycle-states
[25]: #pva-lifecycle-state-security-settings
[26]: #draft-state-security-settings
[27]: #in-review-state-security-settings
[28]: #in-approval-state-security-settings
[29]: #approved-state-security-settings
[30]: #obsolete-state-security-settings
[31]: #superseded-state-security-settings
[32]: #planned-state-security-settings
[33]: #pva-lifecycle-entry-actions
[34]: #pva-lifecycle-state-types
[35]: #pva-lifecycle-allowed-users
[36]: #pva-lifecycle-document-type
[37]: #pva-document-lifecycle-stage-group
[38]: #object-workflows
[39]: #pva-creation-workflow
[40]: #pva-close-out-workflow
[41]: #pva-activity-outbound-workflow
[42]: #pva-activity-inbound-workflow
[43]: #object-workflow-user-actions
[44]: #document-workflows
[45]: #pva-authoring-workflow
[46]: #pva-review-workflow
[47]: #pva-approval-workflow
[48]: #document-workflow-user-actions
[49]: #tabs