Organizations often need to send emails to internal and external recipients for various processes in QMS. Using Quality External Notifications, you can define distribution groups, 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 Intake and Complaint processes for medtech and pharma complaints, 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.
Tracked Emails
When using Quality External Notifications with Complaint or Complaint Intake records, Vault tracks the delivery status of sent emails and stores relevant reportable information in Email and Quality Event Sent Notification object records.
Document Packages
Quality External Notifications are capable of sending links to view pre-packaged Vault documents in a special external viewer. For example, in an Audit process, audit reports often need to be sent to external contacts such as suppliers. After sending the notification email, Vault stores a link to the externally-viewable documents in a text field on the applicable object record.
External Notification Recipients
Depending on your Vault’s configuration, Vault may either automatically populate distribution groups for an external notification when the applicable record reaches a certain lifecycle state, allow you to populate them via the Create Distribution Group Memberships user action, or allow you to manually populate distribution groups.
If a person record includes parentheses or an email address in the name, emails will not reach the external notification recipient associated with the affected person record. Ensure that you do not create any person records with parentheses or an email address in the name if you plan to use Quality External Notifications.
You must create Person records for all required recipients in distribution groups for all supported objects. This is required even if the supported object uses Complaint Contact records to store information about reporters, complainants, and additional contacts.
Complaint Contacts
If sending notifications from Complaint Intakes, you must create Complaint Contacts specific to a Complaint Intake instead of Person records to store information about reporters, complainants, and additional contacts. If your Admin’s configuration uses Complaint Contacts rather than Persons as recipients for notifications sent from Complaints (or Quality Event Complaints and Quality Event Medtech Complaints), Vault uses the Complaint Contacts related to the Complaint’s source Complaint Intake record. All other objects supported for External Notifications use Person records.
Vault displays Complaint Contacts in a section on Complaint Intakes. From the Complaint Contacts section on Complaint and Complaint Intake Follow-Up records, Vault displays the contacts associated with the source Complaint Intake. When you create new Complaint Contacts from this section on one of these records, Vault relates them to the source Complaint Intake.
When creating Complaint Contact records, consider the following:
- You can create only a single related Complaint Contact record with an object type of Initial Reporter per Complaint Intake.
- Either a First Name or Last Name is required. These are used to derive the Name field value.
- All other fields are optional by default.
You must additionally populate the following values in order to send an external notification to a contact:
- Consent to Contact: This field value must be Yes.
- Email: This field must contain a valid email address.
- Status: Must be Active.
How to Send an External Notification
In some cases, Vault sends Quality External Notifications automatically, for example, as part of an entry action. In cases where your process does not send these notifications automatically, you may need to perform the action manually:
- Navigate to the applicable record detail page in Business Admin or from a custom object tab.
- Expand the Notification Recipients section and verify that the distribution groups contain the correct Person records. You may need to perform the Create Distribution Group Memberships action to populate the distribution groups. The availability and label of this action may differ depending on your Vault’s configuration.
- If you need to change the contacts, click Manage Recipients, then select the appropriate contacts in each distribution group box. The contacts in these boxes correspond to Person object records in your Vault. Click Save when finished. Some distribution groups may not be editable.
- Perform the Send External Notification action. The label of this action may differ depending on your Vault’s configuration.
- In the dialog, choose an appropriate template from the Select Notification Template drop-down.
- Make any necessary changes to the Additional Recipients and Users associated to the following roles fields. These fields may not be editable, depending on your Vault’s configuration.
- If you are using Complaint Contacts for Complaint Intakes or Complaints, the Additional Recipients field displays as Complaint Contacts.
- If available, update the documents included with the external notification:
- If there are associated Documents to Send, you can remove them if allowed by your Admin’s configuration.
- If the Send External Notification user action is configured to allow sending the documents as attachments, the following options are available under Include documents as:
- Link in Email: Embeds a link in the external notification to open documents in a secure browser.
- Attachments to Email: Sends the documents as attachments.
- If available, you can +Select Additional Documents to add documents to the notification. Documents that reference the current record are available to select.
- If available, you can preview the notification under Preview Email. If configured for notifications from a Complaint or Complaint Intake record, the preview email displays in the Communication Language selected on the record.
- Click Send.
Note: If you specify a Reply To email address on a Complaint or Quality Event record to direct replies to external notifications to the appropriate person, some email clients may ignore it. In these cases, notification recipients may need to replace the auto-populated reply-to email address with the correct address when responding to external notifications.
Related Permissions
To view the Notification Recipients section and Manage Recipients, users require a security profile or role which grants Read and Edit permissions for the recipient object associated with the relevant quality process object. For instance, to view the Notification Recipients section and manage recipients from an Audit record, users require permissions for the Audit-Ext Notif Recipient object. Grant permissions for one or more of the following objects as needed:
- Audit-Ext Notif Recipient
- Issue Escalation-Ext Notif Recipient
- Quality Event-Ext Notif Recipient
- Complaint-Ext Notif Recipient
- Product Action-Ext Notif Recipient
- Complaint Intake-Ext Notif Recipient
In order to manage recipients on objects with external notifications enabled, users require Read permissions on the Person object. If your organization uses Complaint Contacts, users require Create permission on the Complaint Contact object and View permission for the Complaint Contacts object control on the relevant object (Complaint Intake, Complaint, or Quality Event).
In order to view the Sent Notifications section, users require Read permission for the notification object associated with the relevant quality process object. For instance, to view the Sent Notifications section on an Audit record, users require permission for the Audit Sent Notification object. Grant permission for one or more of the following objects as needed:
- Audit Sent Notification
- Issue Escalation Sent Notification
- Quality Event Sent Notification
- Complaint Sent Notification
- Product Action Sent Notification
- Complaint Intake Sent Notif