Veeva QMS lets you configure your Vault to automate and streamline the high-volume, manual complaint follow-up process, reducing effort and ensuring proper evaluation of downstream impact to minimize compliance risk. Users can create Complaint Intake Follow-Ups, optionally send requests for follow-up information from a Complaint Intake Follow-Up record, and reply to responses to these requests.
Configuration Overview
To configure Complaint Intake Follow-Up:
- Configure objects
- Optional: Configure External Notifications for the Complaint Intake Follow-Up object
- Configure object lifecycles
- Optional: Configure Auto-Retry job
- Optional: Configure email ingestion for the Complaint Intake Follow-Up object
- Optional: Configure follow-up evaluations
Configuring Objects
Make the following changes to objects in your Vault for the Complaint Intake Follow-Up feature.
Complaint Intake Object
To configure the Complaint Intake object:
- Add a Complaint Contacts related object section to the layout for all applicable object types.
- Add the Complaint Intake Follow-Up and Follow-Up Attachments application sections to the layout for the appropriate object types.
Complaint Object
To configure the Complaint or Quality Event object:
- Ensure the Complaint Intake object reference field is active and added to the relevant object types on the Complaint or Quality Event object.
- Ensure the Complaint Reporter object reference field is active. It does not need to be displayed to users.
- Add the following application sections to the layout for the appropriate object types:
- Complaint Contacts: When adding this section, you can specify which Complaint Contact object types to display. If you do not specify object types, Vault displays all types of Complaint Contacts.
- Complaint Intake Follow-Ups
- Follow-Up Attachments
Complaint Contact Object
To configure the Complaint Contact object, see Configuring Complaint Intake & Promote to Complaint.
Complaint Intake Follow-Up Object
To configure the Complaint Intake Follow-Up object:
- Optional: Activate the following fields and add them to the layout:
- Communication Language
- Latest Email Body Text
- Latest Email Response Body
- Add the following fields to the layout:
- Request Type
- Optional: CC Contacts
- Optional: Email Template
- Optional: Primary Contact
- If your configuration uses the Auto-Retry job, ensure the following fields are active and add them to the layout:
- Attempt #
- Error Message
- Remaining Retries
- Retry Due On
- Retry Frequency
- Retry Processed
- Retry?
- Source Attempt
- Optional: Add related object sections for the following objects to the layout:
- Complaint Intake Follow-Up Email
- Complaint Intake Followup Sent Notif
- Optional: Add the Send External Notification action to the Complaint Intake Follow-Up object.
- Optional: Update pre-defined values and create new values for the following picklists to support your business processes:
- Complaint Intake Contact Method: If using Auto-Retry to send emails, the Email contact method is required
- Complaint Intake Follow-Up Request Type
Note: The Complaint Intake Follow-Up object includes the Email Sent? and Send Email on Create? fields. These fields are not automatically populated or integrated into External Notification functionality, and can be configured and used per your requirements. The Complaint Intake Follow-Up object also includes the Complaint Contacts and Email Template object controls, which should not be added to any layout.
Complaint Intake Follow-Up Email Object
Optionally assign the Send Email Reply action to the Complaint Intake Follow-Up Email object. Ensure the Available in All Lifecycle States option is not selected.
Note: If you configure Atomic Security for fields on the Complaint Intake Follow-Up Email object, hidden fields and their values are still visible in the Send External Notification and Send Email Reply user action dialogs.
Configuring External Notifications
You can optionally configure External Notifications for the Complaint Intake Follow-Up object to allow users to send emails from Complaint Intake Follow-Up records.
To configure:
- If you wish to include documents in emails, create a document field referencing the Complaint Intake object and add it to the appropriate document types.
- Create a Quality External Notification configuration for the Complaint Intake Follow-Up object. Distribution groups are not available for Quality External Notification configurations for the Complaint Intake Follow-Up object.
- Create Object Messages.
- From the Notification Templates section of the Quality External Notification configuration, create Notification Templates as needed. Users can select any configured template on a Complaint Intake Follow-Up that is referenced in the Send External Notification action configuration. When creating a template for the Complaint Intake Follow-Up object, the following options are available:
- Additional Complaint Contact Types: Specify the object types of Complaint Contacts Vault will default on emails sent from Complaint Intake Follow-Up records.
- Allow users to Add/Remove Internal Recipients: Allows users to modify Persons on an external notification.
- Allow users to Add/Remove Documents: If you select this option, you must specify a Complaint Intake reference field that must be populated on documents in order to be available to select, select a download option, and set an expiry period.
- Configure the Send External Notification action.
Configuring Object Lifecycles
Make the following changes to object lifecycles in your Vault for Complaint Intake Follow-Ups. These changes are only required if your process involves sending emails from Vault.
Complaint Intake Follow-Up Lifecycle
To configure the Complaint Intake Follow-Up Lifecycle, add the Send External Notification action to the appropriate lifecycle states as a user action. The Complaint Intake Follow-Up object does not support the Send Documents as Attachment option.
Complaint Intake Follow-Up Email Lifecycle
Add the Send Email Reply action as a user action to the appropriate states of the Complaint Intake Follow-Up Email LC lifecycle.
Configuring the Auto-Retry Job
You can configure the Auto-Retry job to trigger Vault to automatically resend follow-up request emails after a defined period of time has elapsed, or to create a Complaint Intake Follow-Up record for non-email follow-up methods.
To configure the Auto-Retry job definition:
- Navigate to Admin > Operations > Job Definitions.
- Select Complaint Intake Follow-Up Auto Retry.
- Click Edit.
- Set the Status to Active.
- For Object, select Complaint Intake Follow-Up.
- Select the standard Object Type.
- Select all Included Contact Methods. You can select any active value on the Complaint Intake Follow-Up Method picklist.
- Optional: Select a Previous Attempt End State.
- Select all applicable states from the Include Complaint Intake Follow-Up Records in these States drop-down.
- Select all applicable states from the Include Complaint Intake Records in these States drop-down. For Vault to send a new follow-up attempt, the follow-up’s parent Complaint Intake must be in one of the specified states.
- Select the Auto-Send External Email checkbox if you are configuring the job to automatically generate emails.
- To use the Communication Language specified on the Complaint Intake Follow-Up record when resending follow-up attempts, select the Use Selected Communications Language to Translate Email in Subsequent Attempts checkbox.
- Click Save.
To receive a notification when retry is due for Complaint Intake Follow-Ups with Retry? set to Manual, you can configure a custom job to change the state of a Complaint Intake Follow-Up when retry is due to Retry Due, and configure a notification based on the state change.
Configuring Complaint Intake Follow-Up Email Ingestion
To configure ingestion of responses to Complaint Intake Follow-Up emails:
- Set up an email inbox for the Complaint Intake Follow-Up responses that you may receive:
- Enter the Email Address to provide to potential complainants for this type of complaint.
- For Email Processor, select Complaint Intake Follow-Up Email Processor.
- For Allowed Senders, select All Users & Persons in this Vault.
- For Email Processor User, select a user with adequate permissions.
- Create an Inbound Email Address Configuration for the Complaint Intake Follow-Up object:
- For Email Thread Detection, you must select Match on Root Message ID.
- Optional: Select the Create Complaint Contact Email Contacts from TO and CC email Addresses option to automatically create Complaint Contacts based on the contact details in follow-up response emails.
- Select the Copy Latest Response Details option to add the last-received email body text to the Latest Response Details field on a Complaint Intake Follow-Up record. If you do not select this option, Vault still populates the email body text into the Latest Email Body Text field on Complaint Intake Follow-Ups. You can restrict access to this field to support a manual redaction process, allowing users with the appropriate permissions to first review the email body before adding it to the Latest Response Details field.
- Under If match not found, create Complaint Intake with this Object Type, select a Complaint Intake object type. If Vault cannot find a matching Complaint Intake Follow-Up with which to associate a response email, Vault will instead create a Complaint Intake record of the specified object type with details of the ingested email response.
Note: Emails must be auto-forwarded to the configured email address rather than redirected.
Configuring Follow-Up Evaluations
You can configure Vault to automatically create Followup Evaluations when new information is received for a Complaint Intake Follow-Up. To do this:
- Activate the Followup Evaluation Type field on the Complaint Intake Follow-Up object and add it to the relevant Complaint Intake Follow-Up object types and layouts.
- Add a related object section for the Followup Evaluation object to the following object layouts:
- Complaint
- Complaint Intake Follow-Up
- Recommended: Complaint Intake
- Configure Quality Teams or Dynamic Access Control to define role assignments on Followup Evaluation records.
- If your organization requires a structured process for evaluating follow-ups, create and configure a follow-up evaluation workflow per your processes.
Note: Automatic creation of Followup Evaluations is not supported in Vaults that use the Complaint and Medtech Complaint object types of the Quality Event object rather than the standalone Complaint object.
Related Permissions
The Email Processor User that is utilized to perform the actions when the Complaint Intake Follow-Up Email Processor executes must have the following permissions:
- Read permission for the Complaint Intake Followup Sent Notif object
- Edit permission for the Complaint Intake Follow-Up object
- Create permission for the Complaint Intake and Complaint Intake Follow-Up Email objects
To configure Complaint Intake Follow-Up, you must have a security profile with a permission set that grants the following permissions:
| Type | Permission Label | Controls |
|---|---|---|
| Security Profile | Admin: Quality External Notifications: Read, Create, Edit, Delete | Ability to view, create, edit, or delete Quality External Notification configuration components. |
| Security Profile | Admin: Quality Inbound Email Address Configuration: Read, Create, Edit, Delete | Ability to view, create, edit, or delete Inbound Email Address Configuration components. |
| Security Profile | Admin: Inbound Email Addresses: Read, Create, Edit, Delete | Ability to view, create, edit, or delete Inbound Email Address configuration components. |