Veeva QMS provides automation and tools to streamline the high-volume complaint follow-up process, reducing manual effort and ensuring proper evaluation of downstream impact to minimize compliance risk. Initial reports of complaints often require follow-up attempts to gather more information to determine if the complaint is valid. After creating a Complaint Intake in Vault for an initial report, you can track follow-up attempts and optionally send follow-up request emails from related Complaint Intake Follow-Up records. When a reporter, complainant, or other external contact replies to a follow-up email, Vault stores the reply, lets you email back and forth to request additional information, and initiates an evaluation process for any new information received. Upon promotion of a Complaint Intake to a Complaint, information about follow-up attempts displays on all Complaints created from the Complaint Intake, allowing you to continue the follow-up process until you have gathered all relevant information.

Depending on your Admin’s configuration, object, field, and section labels may appear differently than the labels mentioned in this article.

Creating Complaint Contacts

To send follow-up requests from a Complaint Intake Follow-Up record, the parent Complaint Intake must have related Complaint Contact records to store information about the recipients of follow-up emails. Vault may create Complaint Contacts automatically when creating a Complaint Intake from an email or via an integration, or you can manually create them from the corresponding section on Complaint Intake and Complaint records. When sending a follow-up request email from a Complaint Intake Follow-Up, or when replying to a response, you can modify the Complaint Contacts that receive the email.

Creating Complaint Intake Follow-Ups

You can create Complaint Intake Follow-Up records from the corresponding section on Complaint Intake and Complaint records. All Complaint Intake Follow-Ups are related to the source Complaint Intake, including those created from a Complaint. If creating Complaint Intake Follow-Ups from a Complaint, the Complaint must have the Complaint Intake reference field populated. The fields available may vary, but you must select a Request Type and Contact Method. If configured by your Admin, you may also be able to select a Communication Language which determines the language of the email when sending a follow-up request from the Complaint Intake Follow-Up.

Sending Follow-Up Requests & Replies

To send an initial follow-up request, navigate to a Complaint Intake Follow-Up record and select the Send External Notification action from the All Actions menu. After selecting the action, you may be able to modify the following values in the resulting dialog:

  • To: Defaults to the Primary Contact on the Complaint Intake Follow-Up. If no primary contact is selected, Vault populates the Initial Reporter type Complaint Contact associated with the follow-up’s Complaint Intake. This is the primary recipient of the notification. If you update this field when sending a notification, Vault updates the Primary Contact on the Complaint Intake Follow-Up record.
  • CC: Complaint Contacts: Populates based on your Admin’s configuration and the Complaint Contacts specified in the CC Contacts field of the Complaint Intake Follow-Up. These are the CC recipients on an external notification. If you update this field when sending a notification, Vault updates the CC Contacts field on the Complaint Intake Follow-Up record.
  • Internal Recipients: You can select any active Person record you have permission to view. You can choose to include these recipients in the BCC field instead of the CC field.
  • Users associated to the following Complaint Intake roles: Defaults to users in the Complaint Intake roles specified by your Admin. You can select additional roles and their associated users who will receive the notification, and choose to include role recipients in the BCC field instead of the CC field.
  • Documents to Send: You can select documents that reference the Complaint Intake Follow-Up’s related Complaint Intake.

All recipients must have the Consent to Contact? field set to Yes on their corresponding Complaint Contact record.

When the action completes, Vault creates an outbound Complaint Intake Follow-Up Email record for each email you send.

Replying to a Follow-Up Response

You can reply to any responses to a follow-up request by navigating to the Complaint Intake Follow-Up Email section on a Complaint Intake Follow-Up, selecting an inbound email, and selecting the Send Email Reply action from the email record’s All Actions menu. After selecting the action, you can modify the recipients, add your response text, and add documents in the resulting dialog. Vault derives the default recipients from the most recent outbound Complaint Intake Follow-Up Email matching on the same primary contact, and updates the role recipients to match the current role assignments on the Complaint Intake Follow-Up record.

About Follow-Up Response Email Processing

Vault creates Complaint Intake Follow-Up Email records for each sent and received email in a thread and associates them with the originating Complaint Intake Follow-Up. If you receive multiple responses for a single follow-up request, Vault captures each response in a separate Complaint Intake Follow-Up Email record.

For inbound emails, Vault populates the following data on Complaint Intake Follow-Up Email records and their corresponding Complaint Intake Follow-Up:

Field on Created Complaint Intake Follow-Up Email Record Updated Field on Complaint Intake Follow-Up Record Populated Value
Complaint Intake Follow-Up N/A Originating Complaint Intake Follow-Up
Email N/A Name of email received
Direction N/A Inbound
Subject N/A Plain text of the email subject
Email Body Text Latest Email Body Text and, if configured, Latest Response Details Plain text of the email body
Email Body Latest Email Body Displays email in HTML format. You can select View Email to display a dialog with the HTML-formatted email.
Received Date Latest Response Date The date on which Vault received the email
Original Sender Email N/A The email address of the original sender

Upon receiving a new response to a follow-up request, Vault also sets the following field values on the Complaint Intake Follow-Up record to end the Auto-Retry process for the follow-up request:

  • Retry Rule: None
  • Retry Due On: Blank

Attachments

Vault adds attachments from received emails to the Attachments section of the associated Complaint Intake Follow-Up record, and also displays them in the Follow-Up Attachments section on the related Complaint Intake and any Complaints.

About Auto-Retry

Your Admin can configure Vault to automatically send additional follow-up requests after you send an initial request. Each time Vault makes a new follow-up attempt, Vault creates a Complaint Intake Follow-Up record with the same details as the previous attempt. If Vault cannot send a follow-up email for any reason, Vault sets the next Complaint Intake Follow-Up record to an Error state and captures details about the error in the Error Message field.

For Vault to automatically process follow-up requests, you must populate the following values on a Complaint Intake Follow-Up:

  • Retry?: Must be Auto.
  • Retry Due On: Select a date by which the retry must be processed.
  • Retry Frequency: The cadence of retry attempts in days.
  • Remaining Retries: The number of subsequent attempts to be processed by Auto-Retry.

The following limitations apply to Auto-Retry:

  • Document attachments are not supported; you must send documents as links in emails.
  • Auto-Retry only supports CC for Internal Recipients and Role Recipients. If you sent the initial email using BCC, these recipients will be included in the email as CC recipients.

About Email Tracking

Vault tracks the delivery status of sent emails and captures information about warnings and errors in the Sent Notifications section of Complaint Intake Follow-Ups.

About Email Processing Failure

If Vault cannot find the originating Complaint Intake Follow-Up record upon receiving a reply to a follow-up request, Vault instead creates a new Complaint Intake record with details about the email and sets its state to Error. If Complaint Intake creation fails, Vault sets the Email record’s state to Failure. Vault sets the Email record to a Bounced state if the inbound email address is invalid. We recommend creating a flash report to track Email records that are in Failure or Bounced states.

Evaluating Follow-Up Responses

You can perform an evaluation for follow-up information received from complaint contacts such as reporters and complainants. Vault creates Followup Evaluation records when a Complaint Intake Follow-Up record meets the following conditions:

  • The Latest Response Details field is populated upon record creation, or updated or populated on an existing record.
  • The Followup Evaluation Type field is set to Followup Evaluation Needed upon record creation, or upon updating an existing record.
  • The parent Complaint Intake has one or more related Complaints.

Vault does not create Followup Evaluations for cancelled or inactive Complaints, or for Complaint Intake Follow-Ups related to a Complaint Intake that has not been promoted to a Complaint.

When the above conditions are met, Vault:

  • Creates a Followup Evaluation record for each Complaint related to the Complaint Intake Follow-Up’s parent Complaint Intake, even if the Complaint is closed.
  • Sets the following field values on the created Followup Evaluation records:
    • Complaint: The Followup Evaluation’s parent Complaint
    • Complaint Intake: The parent Complaint’s originating Complaint Intake
    • Complaint Intake Follow-Up: The Complaint Intake Follow-Up for which evaluation is needed
    • Response Date: The value of the Latest Response Date field on the evaluation’s originating Complaint Intake Follow-Up, if available
    • Response Details: The value of the Latest Response Details field on the evaluation’s originating Complaint Intake Follow-Up
  • Begins a workflow that assigns tasks and sends notifications for relevant users to review the newly received information. This process may vary depending on your Admin’s configuration and your organization’s requirements.

Related Permissions

To use Complaint Intake Follow-Up, you must have a security profile with a permission set that grants the following permissions:

  • Execute permission for the Send External Notification and Send Email Reply actions: Only required if sending emails from Complaint Intake Follow-Ups
  • Read, Edit, or Create permissions as required for the following objects:
    • Complaint, or the Complaint and Medtech Complaint object types on the Quality Event object
    • Complaint Contact: Only required if sending emails from Complaint Intake Follow-Ups
    • Complaint Intake
    • Complaint Intake Follow-Up
    • Optional: Followup Evaluation
  • View permission for the following object controls on the Complaint Intake and Complaint or Quality Event objects:
    • Complaint Contacts
    • Complaint Intake Follow-Ups
    • Follow-Up Attachments
  • If sending emails from Complaint Intake Follow-Up records, Read permission for the following objects:
    • Complaint Intake Follow-Up Email
    • Complaint Intake Followup Sent Notif
    • Email
    • Person: For the ability to include Persons as CC recipients on an email