Veeva QMS lets you configure your Vault to automate and streamline the high-volume, manual complaint process for known, recurring complaints. Leveraging a set of predefined Known Complaint records, Vault automatically links risks, investigations, codes, CAPAs, and root causes to Complaint records, significantly reducing cycle times for recurring complaints.
Supported Objects
Known Complaint Profiles are supported for the Medtech Complaint and Pharma Complaint object types of the standalone Complaint (complaint__v) object, and for the Complaint and Medtech Complaint object types of the Quality Event (quality_event__qdm) object. In this article, these objects are collectively referred to as the Complaint object.
If your Vault uses a standalone Complaint object, Vault creates the following object records when copying related records between Known Complaints and Complaints:
- Complaint - Adverse Event Code (
complaint_ae_code__v): Relates Codes to Complaints. - Complaint - Assessment Risk (
complaint_assessment_risk__v): Relates Assessment Risks to Complaints. - Complaint - CAPA (
complaint_capa__v): For Pharma Complaints only; relates CAPA Actions to Complaints. - MedTech Complaint - MedTech CAPA (
medtechcomplaint_medtechcapa__v): For Medtech Complaints only; relates Medtech CAPAs to Complaints. - Investigation - Complaint (
investigation_complaint__v): Relates Investigations to Complaints. - Root Cause (
root_cause__qdm): Vault copies related Root Causes directly.
If your Vault uses the Complaint and Medtech Complaint object types of the Quality Event object, Vault instead creates the following object records when copying related records between Known Complaints and Complaints:
- Adverse Event Problem Code (
ae_problem_code__v): Relates Codes to Complaints. - Quality Event - Assessment Risk (
quality_event_assessment_risk__v): Relates Assessment Risks to Complaints. - CAPA-Quality Event (
capaquality_event__qdm): For the Complaint object type only; relates CAPA Actions to Complaints. - MedTech Complaint (QE) - MedTech CAPA (
medtechcomplaintqe_medtechcapa__v): For the Medtech Complaint object type only; relates Medtech CAPAs to Medtech Complaints. - Investigation - Quality Event (
investigation_quality_event__v): Relates Investigations to Complaints. - Root Cause (
root_cause__qdm): Vault copies related Root Causes directly.
Configuration Overview
To configure Known Complaint Profiles:
- Configure objects
- Create a QMS Known Complaint Profile configuration
- Configure the Complaint Lifecycle
- Configure user permissions
- Optional: Update your Quality Teams configuration for the MedTech Known Complaint and Pharma Known Complaint object types
- Recommended: Configure a review and approval workflow for MedTech and Pharma Known Complaints
Configuring Objects
Make the following changes to the Complaint Intake (complaint_intake__v) object, and the Complaint (complaint__v) or Quality Event (quality_event__qdm) object.
Complaint Intake Object
To configure the Complaint Intake object, activate the following fields and add them to the appropriate layouts:
- For Vaults using a standalone Complaint object: Associated Known Complaint
- For Vaults using the Complaint and Medtech Complaint object types of the Quality Event object: Associated Known Complaint (QE)
- Optional: Material
Complaint Object
To configure the Complaint object:
- Add the following record actions to the Complaint object and ensure the Available in All Lifecycle States checkbox is not selected:
- Associate Known Complaint Profile
- Promote to Known Complaint Profile
- Update Known Complaint Profile
- Activate the Pharma Known Complaint and MedTech Known Complaint object types and assign any fields to these object types to copy between Known Complaints and processing or source Complaints.
- Create layouts for the Pharma Known Complaint and MedTech Known Complaint object types.
- Activate and add the appropriate fields to the following layouts:
- Medtech Complaint and Pharma Complaint object types: Add the Associated Known Complaint field and, optionally, the Material field.
- Medtech Known Complaint and Pharma Known Complaint object types: Add the Source Complaint field.
- Ensure the Product and Product Variant fields are present on the layouts you will use for processing complaints and known complaints.
- Add related object sections for any related objects you wish to copy between Known Complaints and Complaints. The sections you add should correspond to the Related Objects to Copy in your QMS Known Complaint Profile Configuration. For instance, if copying CAPA Actions, add a section for the Complaint - CAPA object. Ensure that you add each related object section to the processing Complaint object type as well as the corresponding Known Complaint object type. For instance, the related object sections on the Pharma Complaint layout should correspond to those on the Pharma Known Complaint layout.
Creating QMS Known Complaint Profile Configurations
When Known Complaint Profile actions run, Vault uses QMS Known Complaint Profile Configurations to determine the records to create and the fields to populate on Known Complaint and processing Complaint records, as well as lifecycle state changes for a processing Complaint based on the state of the Known Complaint upon association.
To create a QMS Known Complaint Profile Configuration:
- Navigate to Admin > Configuration > QMS Known Complaint Profile Configurations.
- Click Create.
- Enter a Label.
- Optional: Enter a Description.
- Select an Object depending on if your Vault uses a standalone Complaint object or object types on the Quality Event object.
- Select an Object Type. Only Medtech Complaint and Pharma Complaint are valid selections.
- Optional: Select one or more Related Objects to Copy. Vault copies the relationships to these records when copying related record data between Known Complaints and Complaints.
- In the Fields to Copy: Promote to Profile and Update Profile section, select Fields to Copy from Complaints to Known Complaints when promoting a complaint to a known complaint or updating a Known Complaint with the latest data from its source Complaint. These fields must be active and available on the selected Object Type and its corresponding Known Complaint object type. See details.
- Optional: In the Fields to Copy: Associate Profile and Update Associated Records section, select Fields from Known Complaints to Complaints when associating a Known Complaint with a Complaint or updating a Complaint with the latest data from its associated Known Complaint. These fields must be active and available on the selected Object Type and its corresponding Known Complaint object type. See details.
- Under Processing Complaint Lifecycle State Changes, select lifecycle states from Lifecycle States of Known Complaint. When users associate a processing Complaint with a Known Complaint in one of the selected states, the processing Complaint moves into a state that corresponds to the Known Complaint Closed state type. Otherwise, Complaints move into a state that corresponds to the Known Complaint Open state type.
- Click Save.
Best Practices for Fields to Copy from Source Complaints to Known Complaints
When determining the fields to copy from source Complaints to Known Complaints, we recommend not including any fields specific to the source Complaint, such as Reporter Information or Contact Method. The fields you select should be fields that can then be copied to processing Complaints from a Known Complaint.
Best Practices for Fields to Copy from Known Complaints to Processing Complaints
Though this is optional, we recommend defining fields to copy from Known Complaints to processing Complaints. Consider which fields on Known Complaints would contain valuable, reusable data, such as Investigation Summary & Conclusion, Initial Risk Analysis, and CAPA Plan Summary. If your configuration involves copying CAPAs and investigations from source Complaints, we recommend setting the CAPA Required and Investigation Required fields to No on Known Complaints and copying those field values to processing Complaints. Since neither Known Complaints nor processing Complaints require the creation of new CAPAs or investigations, this allows the processing Complaint to bypass those steps.
Limitations
The following limitations apply to QMS Known Complaint Profile Configurations:
- You can create only one QMS Known Complaint Profile Configuration per object and object type combination.
- Only standard object types are supported.
- You can configure up to 20 fields per Fields to Copy input.
- You can select up to five lifecycle states in the Lifecycle States of Known Complaint field.
- You cannot select custom objects as Related Objects to Copy.
Configuring the Complaint Lifecycle
To configure the Complaint Lifecycle for Known Complaint Profiles:
- Configure lifecycle state types
- Configure the Promote to Known Complaint Profile action
- Configure the Update Known Complaint Profile action
- Configure the Associate Known Complaint Profile action
- Configure the Update Associated Records from Profile action
The Known Complaint Profile actions are not supported as event actions.
Configure Lifecycle State Types
Associate the following state types with relevant states in the Complaint Lifecycle:
- Known Complaint Open
- Known Complaint Closed
When a processing Complaint is associated with a Known Complaint, Vault moves the Complaint to the associated state depending on if the Known Complaint is open or in a terminal state. This happens only if the processing Complaint is in a state specified in the Lifecycle States of Known Complaint field of the governing QMS Known Complaint Profile Configuration.
Configure the Promote to Known Complaint Profile Action
The Promote to Known Complaint Profile user action promotes a source Complaint to a Known Complaint Profile that users can then associate with additional similar processing Complaints.
When the Promote to Known Complaint action runs, Vault:
- Creates a Complaint record of the Medtech or Pharma Known Complaint object type and populates it with field data from the source Complaint, determined by the Fields to Copy: Promote to Profile and Update Profile in the relevant QMS Known Complaint Profile Configuration. The new record serves as a Known Complaint Profile.
- Associates records related to the source Complaint with the created Known Complaint. These records depend on the Related Objects to Copy specified in the relevant QMS Known Complaint Profile Configuration and may include:
- Assessment Risks
- CAPA Actions or Medtech CAPAs
- Codes
- Investigations
- Root Causes
- Populates the Source Complaint field on the newly created Known Complaint with the source Complaint.
You can configure this action as a user action on any Complaint lifecycle state. This action would typically be used after investigations are complete or when a Complaint is in a terminal state, but this may vary depending on your processes.
We recommend configuring a condition to display this action only on the Pharma Complaint and Medtech Complaint object types on the Complaint object, or the Complaint and Medtech Complaint object types on the Quality Event object.
Configure the Update Known Complaint Profile Action
The Update Known Complaint Profile action allows users to populate a Known Complaint with the latest information from the source Complaint.
When this action runs, Vault:
- Deletes and recreates all related records created by the Promote to Known Complaint Profile action from the source Complaint to the Known Complaint.
- Populates any updated data in fields to copy from the source Complaint.
Configure this action as a user action or an entry action on a lifecycle state corresponding to a terminal or closed state in the Complaint Lifecycle.
We recommend configuring a condition to display or run this action only on the Pharma Complaint and Medtech Complaint object types on the Complaint object, or the Complaint and Medtech Complaint object types on the Quality Event object.
Configure the Associate Known Complaint Profile Action
The Associate Known Complaint Profile action:
- Associates a processing Complaint with a Known Complaint and populates the Associated Known Complaint field on the processing Complaint.
- Populates the processing Complaint with field data from the Known Complaint, determined by the Fields to Copy: Associate Profile and Update Associated Records in the relevant QMS Known Complaint Profile Configuration.
- Copies any related records and field values from the Known Complaint to the processing Complaint, per your QMS Known Complaint Profile Configuration.
- Moves the processing Complaint to a lifecycle state depending on the state of the associated Known Complaint, per your QMS Known Complaint Profile Configuration.
We recommend configuring this action on the earlier states of the Complaint Lifecycle in the following ways:
- As a user action for a state in which the Associated Known Complaint field would be blank.
- As an entry action if the Complaint’s associated Complaint Intake will have an Associated Known Complaint value populated. This ensures that when the Complaint Intake is promoted to a Complaint, Vault can associate key fields and related records from the Known Complaint. When configured as an entry action, the action does not change the lifecycle state of processing Complaints.
We recommend configuring a condition to display or run this action only on the Pharma Complaint and Medtech Complaint object types on the Complaint object, or the Complaint and Medtech Complaint object types on the Quality Event object.
Update Associated Records from Profile Action
The Update Associated Records from Profile entry action updates field data and related records on all Complaints associated with a Known Complaint and moves the Complaints to a configured destination state. When the action completes, Vault sends a notification with links to Known Complaint Profile Log and Known Complaint Profile Log Details records to view successes and details of any failures.
Configure this action as an entry action on a terminal or approved state for MedTech and Pharma Known Complaints. When configuring the action, you can select lifecycle states in which processing Complaints must be for Vault to update them with data from their associated known complaint.
We recommend configuring a condition to run this action only on the Pharma Known Complaint and MedTech Known Complaint object types on the Complaint object, or the Pharma Known Complaint and MedTech Known Complaint object types on the Quality Event object.
Configuring User Permissions
To use Known Complaint Profiles, users must have a permission set and Atomic Security settings that grant the following permissions:
- To run the Promote to Known Complaint Profile user action:
- Execute permission for the Promote to Known Complaint action on the Complaint object
- Create permission for the Complaint object, including the MedTech Known Complaint and Pharma Known Complaint object types
- Edit permission for all fields to copy on the Complaint object
- Create permission for related objects as needed
- Edit permission for any fields that will be populated on related objects
- Atomic Security permissions granting Edit permission for the relevant relationships and fields on the lifecycle state associated with the Initial state type of the Complaint Lifecycle
- To run the Update Known Complaint Profile user action:
- Execute permission for the Update Known Complaint Profile action on the Complaint object
- Edit permission for the Complaint object, including the MedTech Known Complaint and Pharma Known Complaint object types
- Edit permission for all fields to copy on the Complaint object
- Create permission for the same related objects as specified for the Promote to Known Complaint Profile action, as needed
- Edit permission for any fields that will be populated on related objects
- Atomic Security permissions granting Edit permission for the relevant relationships and fields on the relevant states of the Complaint Lifecycle
- To run the Associate Known Complaint Profile user action:
- Execute permission for the Associate Known Complaint Profile action on the Complaint object
- Edit permission for the Complaint object, including the Medtech Complaint and Pharma Complaint object types
- Read permission for the MedTech Known Complaint and Pharma Known Complaint object types of the Complaint object
- Edit permission for all fields to copy on the Complaint object
- Edit permission for the Associated Known Complaint field on the Complaint object
- Create permission for the same related objects as specified for the Promote to Known Complaint Profile action, as needed
- Edit permission for any fields that will be populated on related objects
- Atomic Security permissions granting Edit permission for the relevant relationships and fields on the relevant states of the Complaint Lifecycle
- To view Known Complaint Profile Log and Known Complaint Profile Log Detail records created from the Update Associated Records from Profile action, users require Read permission for the Known Complaint Profile Log and Known Complaint Profile Log Detail objects.
Related Permissions
To create QMS Known Complaint Profile Configurations, you must have a security profile with a permission set that grants the following permission:
| Type | Permission | Controls |
|---|---|---|
| Security Profile | Admin: QMS Known Complaint Profile Configuration: Create, Edit, Delete | Ability to manage QMS Known Complaint Profile Configurations. |