Configuring External Notifications (QMS)

Organizations often need to send emails to internal and external recipients for various processes in QMS. Using the Quality External Notifications configuration component, you can define distribution groups and notification templates, send emails, and share documents. This addresses several scenarios that your organization may encounter:

  • When an Audit report is completed, that report often needs to be sent to an external recipient, such as the supplier contact, as well as persons associated with the Audit or supplier.
  • In Complaint and Medtech Complaint processes, customers often need to send correspondence letters and forms to the complainant or the reporter associated with the complaint at various times during the event lifecycle.
  • If a serious issue is encountered, such as a critical deviation, and an Issue Escalation process is initiated, upper management external to Vault may need to be notified of the serious event.
  • In Field Corrective Action processes, external parties may need to be notified of Product Action developments.

This article provides basic configuration information to get started using Quality External Notifications in your Vault. The External Notifications feature supports standard and custom object types on the Quality Event, Complaint, Audit, and Issue Escalations objects, as well as the Change Control, Change Plan, Deviation, Finding, Lab Investigation, Continuous Improvement, Nonconformance, Product Action, and MedTech CAPA objects. These are collectively referred to as the “supported object” in this article.

Configuration Overview

Setting Up Objects for External Notifications

To enable external notification functionality you must update object configurations.

Add the Send External Notification Action to a Supported Object

To add this action to a supported object:

  1. Navigate to the object that you want to enable for External Notifications.
  2. Navigate to Actions > Create.
  3. Select Send External Notification.
  4. Click Continue. Review the action’s details and make any adjustments, however do not select the Available in All Lifecycle States option. The action does not properly function with this configuration. If the action is configured with this option, delete the action and repeat the steps above.
  5. Click Save.

Once created, you can configure the Send External Notification action in the object’s corresponding object lifecycle.

Add the Create Distribution Group Memberships Action to a Supported Object

The Create Distribution Group Memberships action can automatically populate distribution groups based on matching field data. To add this action to a supported object:

  1. Navigate to the object that you want to enable for External Notifications.
  2. Navigate to Actions > Create.
  3. Select Create Distribution Group Memberships.
  4. Click Continue. This will enable you to configure the Create Distribution Group Memberships action in the object’s corresponding object lifecycle.

Supported Object

Make the following changes to the supported object for which you are setting up external notifications:

  • Add the Notification Recipients object control section on the supported object page layout. Adding this section to a non-supported object results in a non-functional section.
  • If your external notifications will include documents, you must add Document object reference fields to the supported object. You must also add a Text field to the supported object to contain the external link URL for use by your notification template. The external link URL must have a text field length of at least 320.
  • Optional: Add the Sent Notification object as a related object to the page layout of the object you are configuring for external notifications. This will allow you to see the notifications that were sent out for the record in this object. For example, for Audits, you can add the Audit Sent Notifications object to the Audit page layout.

Make the following changes to the Complaint or Medtech Complaint object types on the Quality Event object, or the Complaint object, for which you are setting up external notifications:

  • Optional: Add the Reply To field to the page layout of the object you are configuring for external notification. The person in this field will receive email replies from the recipient of the external notification.
  • Optional: Add the From field to the page layout of the object you are configuring for external notification. The person in this field will appear as the sender of the external notification. To use this feature, you must ensure that you have configured and verified Outbound Email Domains and From Email Address Persons appropriate for your organization.

Creating Object Message Templates for External Notifications

You can create message templates for external notifications like standard object message templates except as follows:

  • After selecting the token, replace the Object prefix manually in each token with Custom. For example, update the token ${Object.name_v} to ${Custom.name_v}.
  • Formula fields are not supported for external notifications.
  • Text tokens in external notifications are always displayed as rich text.

Creating Quality External Notifications

The core component of external notification setup is the Quality External Notification configuration component. You must create one, then add Distribution Groups and Notification Templates for each supported object you wish to use.

To create Quality External Notifications:

  1. Navigate to Admin > Configuration > Quality External Notifications.
  2. Click Create.
  3. Fill in the required details.
  4. Select the supported object from the Object drop-down. For the Quality Event object, Vault only supports external notifications for the Complaint and Medtech Complaint object types.
  5. If necessary, select an Object Type.
  6. Optional: If you selected the Complaint or Medtech Complaint object type, you can select the Do Not Include Headers and Footers checkbox if you do not want the notification email to include the standard Vault header or footer.
  7. Click Save.

Adding Distribution Groups

To add a Distribution Group:

  1. From a Quality External Notification configuration, click Add Distribution Group.
  2. Fill in the required details.
  3. Select a value for Maximum Recipients, up to 50. You can optionally select a value for Minimum Recipients.
  4. If you want Vault to automatically populate the distribution group via either an entry or user action, select the Populated by Distribution Group Management action checkbox.
  5. If you do not want users to be able to make modifications to the distribution group in the Notification Recipients section of the applicable object record, select the Prevent users from adding persons to distribution group checkbox.
  6. Optional: You can limit the Persons available for inclusion in the distribution group via Person record data. In the Match Persons on the Following Fields section, click Add Filter Field and select an External Notification Enabled Object and a corresponding Person Field. This option only supports fields with a data type of Object or Picklist, and Vault automatically filters Person fields based on the data type of the External Notification-enabled object field. Whether the group is automatically or manually populated, Vault only includes Persons whose field values match. To add additional filters, click the plus (+) icon. You can configure up to 10 matching pairs.
  7. Click Save.

Distribution Groups appear in the Notification Recipients section on the supported object details page, and in the Distribution Groups Label field on any resulting external notification records.

Adding Notification Templates

Notification Templates defined in a Quality External Notification configuration have several options to suit your processes.

To add a Notification Template:

  1. From a Quality External Notification configuration, click Add Notification Template.
  2. Fill in the required details.
  3. Select Person object reference fields on the supported object in the Recipients drop-down. These will be the default recipients when the Send External Notification action is triggered or performed by a user.
  4. Optional: Add one or more defined groups from the Included Distribution Groups drop-down. These will be the default groups when the Send External Notification action is triggered or performed by a user.
  5. Optional: Select Include users associated to application roles on object lifecycle if you additionally want the notification sent to Vault users in specified roles. If checked, select one or more Application Roles from the drop-down.
  6. Optional: Select Include Documents in Notification if you want your notification to include links to view Vault documents in a special external viewer. If checked:
    1. Select at least one (1) Document Reference Field on this Object. Vault includes all referenced documents in a single package, accessible via a single URL linked in the notification.
    2. Optional: Select at least one (1) Field on Document Referencing this Object if you want to add a document from the library that references the record in the notification. Populating this field allows an end user to manually select a document from the library that is associated to the record.
    3. Select a value from the Allow Download drop-down. You can optionally make the document URL time-limited to a number of days selected in the Expiry Period (days) field. When Download Source Document is enabled, recipients can download the source file even if a viewable rendition does not exist.
    4. Select a Text field on the supported object to contain the URL to the document package.
  7. Optional: Select Allow user to Add/Remove Recipients to allow users to change recipients when performing the Send External Notification user action.  With this release, users will only be able to remove recipients if this is selected.
  8. Optional: Select Allow user to Add/Remove Documents to allow users to add or remove documents from the notification before it is sent.
  9. Select an object message template in the Object Message drop-down. See this article for information on creating object messages.

Configuring Object Lifecycles & Workflows for External Notifications

Send External Notification Action

Add the Send External Notification user action or entry action to a state in the supported object lifecycle in which external contacts need to be notified. When configuring the entry action, you must select one External Notification Template defined in the Quality External Notification component for the action to use. When configuring the user action, you can select one or more of the External Notification Templates, and the user can choose from these when executing the action.

If configured as an event action, you should include the Create Distribution Group Memberships action to execute before the Send External Notification action, as the Send External Notification action may fail if no recipients are identified when sending the notification.

Create Distribution Group Memberships Action

Add the Create Distribution Group Memberships user action, entry action, or event action to a state in the supported object lifecycle in which you want to populate distribution groups.

Limitations

  • You can define up to five (5) distribution groups per Quality External Notification configuration, and up to 50 persons per distribution group.
  • Up to 400 recipients can receive a notification.
  • For Complaints and Medtech Complaints, delivery is only tracked for the Recipient, not the additional recipients (bcc).
  • For Complaints and Medtech Complaints, delivery tracking is “best effort”, based on the responses received from the receiving email server configuration. For example, some email servers are configured to always send back “Delivered” status events, even if the email address doesn’t exist. In this case, the status of the email will be set to Delivered and not Email Bounced.
  • If you include lifecycle roles in the external notification template, only users that are manually assigned will receive a notification.
  • Object message templates created for External Notifications have additional limitations.

You must have a security profile with the following permissions to configure Quality External Notifications:

Type Permission Label Controls
Security Profile Admin: Quality External Notifications Ability to view, create, edit, or delete Quality External Notifications configuration components.