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 Complaint Intake processes for medtech and pharma complaints, customers often need to send correspondence letters and forms to the reporter or complainant 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, Complaint Intake (standard object types only), 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 user 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.
  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.

Complaint & Complaint Intake Objects

Make the following additional changes if you are configuring external notifications for the standalone Complaint Intake and Complaint objects, or the Complaint and Medtech Complaint object types of the Quality Event object:

  • Add a Complaint Contacts related object section to the Complaint Intake object layout.
  • Optional: Add the Complaint Contacts object control section to the Complaint object layout, or to the relevant Quality Event object layout. If your organization uses the Complaint Contact object, this step is required.
  • If using Complaint Contacts for Complaints, activate the Complaint Reporter field on the Complaint object. This field identifies the Complaint Reporter associated with the related Complaint Intake. This is a system-managed field, and should not be added to the page layout.
  • Optional: If your process requires users to communicate with reporters in their local language, activate the Communication Language field on the Complaint and Complaint Intake objects. If using this option, you must create object message templates in all relevant languages and select the relevant option when configuring the Send External Notification action.
  • 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.

About Complaint Contacts & Persons

Depending on the object for which you are configuring external notifications, the Person object or the Complaint Contact object may be used to store information about reporters, complainants, and additional contacts. Person records must be used to store information about any members of distribution groups for all supported objects.

If you are configuring external notifications for the Complaint Intake object, you must use the related Complaint Contact object to capture information about reporters and complainants. This object can also optionally be used by the Complaint or Quality Event object for external notifications and for consistency across intakes and their respective promoted complaints. Complaint Intake Follow-Ups will require the use of Complaint Contacts when this object is supported for external notifications in a future release.

Supported objects using the Person object must have a Person object reference field to specify the recipient(s) of a notification, referenced in the notification template configuration. For Complaint Intakes, and Complaints (or Quality Event Complaints and Quality Event Medtech Complaints) using Complaint Contacts, Vault derives the recipients from the source Complaint Intake’s related Complaint Contact records of the object types specified in the notification template configuration.

The following table outlines the use of Complaint Contacts and Persons across complaints objects supported for External Notifications:

Supported Object Persons Complaint Contacts
Complaint Intakes Not Supported Required
Complaints, or Quality Event Complaints and Quality Event Medtech Complaints Optional Optional
Complaint Intake Follow-Ups (supported in a future release) Not Supported Required (future release)
All other objects supported for External Notifications Required Not supported

To simplify the creation of Complaint Contacts, you can configure Action Triggers to populate Complaint Contact records with values from a selected Master Complaint Contact record.

Limitation for Complaint Contacts

If the Send External Notification action is configured as an entry or event action, and a recipient is skipped because a Complaint Contact record is missing an email, is inactive, or has Consent to Contact set to blank or No, then the action continues processing for the remaining recipients, but Vault does not create sent notification records for the skipped recipients.

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.

If your process requires sending notifications in the reporter or complainant’s communication language, you can configure notification templates for all supported languages by navigating to Admin > Settings > Language & Region Settings > Bulk Translation, selecting Notification Messages as the items to translate, and using bulk translation to export and import the translated templates.

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.
    • If you are configuring a notification template for the Complaint Intake object, you must instead use Complaint Contact Types to select one or more object types from the Complaint Contact object instead of the Person object.
    • If you are configuring a notification template for the Complaint object (or Quality Event object for Complaint and Medtech Complaint object types), a Recipients Option drop-down is displayed, from which you can select Recipients (Persons) if your configuration uses the Person object, or Complaint Contact Types if your configuration uses the Complaint Contact object.
  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 documents. Documents may be sent as attachments or as links to view Vault documents in a special external viewer, depending on the Send External Notification action’s configuration. 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.

Enabling Application Setting for Document Attachments

If your process requires sending documents as attachments on external notifications, you must enable the Enable Document Attachments on External Notifications application setting. If this setting is enabled and if the notification template referenced in the Quality External Notification’s configuration has the Include Documents in Notification option selected:

  • You can configure the Send External Notification user action to allow users to choose whether to include documents as email attachments or as embedded links when sending an external notification.
  • You can configure the Send External Notification entry and event actions to automatically include any documents referenced by the originating record as email attachments on the external notification.

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.

When configuring the action, the following options may also be available:

  • Send Documents as Attachment (for event and entry actions) or Allow send Documents as Attachments (for user actions): Include documents referenced in the originating record’s document reference field as attachments in the sent notification. This option is available if:
  • Use Communications Language to translate notifications: Sends external notifications in the language specified in the Communication Language field on a Complaint Intake or Complaint record, or a Complaint or Medtech Complaint type of Quality Event record.
  • Allow user to preview email?: Lets users preview an external notification email before sending it. This option is only available to select when configuring the Send External Notification action as a user action.

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.
  • Delivery tracking is not supported for custom object types.
  • For Complaints and Complaint Intakes, delivery is only tracked for the Recipient, not the additional recipients (bcc).
  • For Complaints and Complaint Intakes, 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.
  • While Preview Email displays the URL for reference documents, the preview display does not remove the URL when changing to send as attachment. Preview also does not populate the value for the document link token used in the notification template. In both of these cases, the sent email will display correctly.
  • Object message templates created for External Notifications have additional limitations.
  • Complaint Contacts have an additional limitation.

Related Permissions

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.