In Vaults using Veeva AI for Quality, Veeva QMS provides a Complaint Agent that can generate a narrative summary of the investigation or CAPA plan for a Complaint. The summary includes information from key related records, such as Investigations and Root Causes for an investigation summary, and CAPA Actions for a CAPA plan summary. The Complaint Agent can also answer questions about a Complaint record and its related records via Veeva AI Chat.

Supported Objects & Object Types

The Complaint Agent supports the following objects and object types:

  • Complaint: Pharma Complaint object type
  • Quality Event: Complaint object type

The Complaint Agent does not support custom objects and object types.

Your Vault may process complaints using either a standalone Complaint object or a Quality Event object of a Complaint object type. In this article, these objects are collectively referred to as Complaints.

How to Generate a Narrative Summary

To generate a narrative summary:

  1. Navigate to a Complaint record with a supported object type.
  2. Click Edit.
  3. Next to the Investigation Summary & Conclusion or CAPA Plan Summary field, click the Generate Summary (Narrative Summary Generation Icon) icon to invoke the Agent for summary generation.
  4. Review the generated summary.
  5. Click Save.

When you click Save, the narrative summary is saved to the field from which you generated it.

For the best results, we recommend generating a narrative summary only when a record is in its later lifecycle states, and when the data is expected to be most complete.

Using the Ask Questions Action

You can ask questions about a Complaint record using Veeva AI Chat. Click the Veeva AI (Global AI Chat Icon) icon in the upper right of the Vault interface while viewing a record, and begin typing your question into the text box. You can ask questions about the record you are currently viewing, as well as the records related to the primary record.

To interact with the Complaint Agent, you must have the following permissions:

Type Permission Label Controls
Security Profile Agents: Complaint Agent: Execute Ability to generate a narrative summary using the Complaint Agent.
Security Profile Agents: Super Agent: Execute Ability to ask questions via Veeva AI Chat about a Complaint record.
Security Profile Application: Vault Actions: Veeva AI Chat: Use Chat Ability to view and interact with Veeva AI Chat.
Security Profile Objects: Complaint: Pharma Complaint: Edit Ability to edit Pharma Complaint records.
Security Profile Objects: Complaint: Object Field Permissions: CAPA Plan Summary, Investigation Summary & Conclusion: Edit Ability to edit relevant fields on Complaint records.
Atomic Security Complaint Lifecycle: [state]: Atomic Security: Fields: CAPA Plan Summary, Investigation Summary & Conclusion: Edit Ability to edit relevant fields in applicable lifecycle states of the Complaint Lifecycle.