Configuring the Identify Impacted Materials Action (QMS)

Veeva QMS allows you to configure an action to simplify the identification of downstream materials impacted by a change control. When the Identify Impacted Materials action runs on a Change Control record, Vault creates Downstream Change Control Material and Regulatory Change Item records for impacted materials and products, and relates the created records to the Change Control. This allows users to easily view and manage impacted materials directly from a Change Control, eliminating the time-consuming process of manually identifying downstream materials impacted by a change control.

The Identify Impacted Materials action is supported for the standalone Change Control object and the Change Control object type of the Quality Event object.

Adopting this feature automates Regulatory Change Item creation. For Vaults using the Quality-RIM Connection, this may result in increased data transfer from your Quality Vault to your RIM Vault.

Configuration Overview

To configure impacted material identification, complete the following steps:

  1. Configure objects for use with the Identify Impacted Materials action.
  2. Configure the Identify Impacted Materials action on a state in the Change Control Lifecycle or on a system action step in a Change Control workflow.
  3. Configure user permissions.

Configuring Objects

Configuring the Downstream Change Control Material Object

To configure the Downstream Change Control Material object:

  1. Activate the Downstream Change Control Material object.
  2. Activate the Change Control or Quality Event field, depending on if you use a standalone Change Control or Change Control object type of the Quality Event object.
  3. Add the following fields to the layout:
    • Change Control (or Quality Event if your Vault uses the Change Control object type of the Quality Event object)
    • Material
    • Material Type
    • Product
    • Product Family
    • Product Variant

Configuring the Regulatory Change Item Object

To configure the Regulatory Change Item object:

  • Ensure the Material field and Material Change object type are active.
  • Add the following fields to the layout for the appropriate object type:
    • Material
    • Product
    • Product Family
    • Product Variant

Configuring the Change Control Object

To configure the Change Control object:

  1. Ensure a related object section for the Change Control - Material object is present on the layouts for the relevant object types.
  2. Add a related object section to the appropriate object layouts for the Downstream Change Control Material object and set the following fields as default columns:
    • Material
    • Material Type
    • Product
    • Product Family
    • Product Variant
    • Regulatory Change Item
  3. Add a related object section to the appropriate object layouts for the Regulatory Change Item object and set the following fields as default columns:
    • Material
    • Product
    • Product Family
    • Product Variant
    • Regulatory Change Item Type
  4. Add the Identify Impacted Materials action to the Change Control object. This step is only necessary if you plan to configure the action as a user action.

Configuring the Material Object

To configure the Material object, ensure that related object sections for the Related Material and Material - Product objects are present on the layout for each relevant Material object type.

  • Related Material: This object relates a primary material (for instance, a Raw Material) to a downstream material (for instance, an Intermediate Material).
  • Material - Product: This object relates a Material (for instance, a Finished Material) to a Product.

Configuring the Identify Impacted Materials Action

You can configure the Identify Impacted Materials action as an entry action or user action on a state in the Change Control Lifecycle, or as a system action step in a Change Control workflow. When configuring the action, you can specify the Material object types for which Vault creates Regulatory Change Item records. A typical configuration may narrow the scope of Regulatory Change Items to the Finished Material object type, but this may vary depending on your business processes.

If configuring the action as an entry or user action for the Quality Event object, add a condition to ensure the entry action only executes, or the user action only displays, if the Quality Event record is of the Change Control type.

Configuring User Permissions

To run the Identify Impacted Materials action, users must have a security profile with a permission set that grants Execute permission for the Identify Impacted Materials action on the Change Control object.

To manage Downstream Change Control Material and Regulatory Change Item records created by the action, Change Control Owners must have Read, Create, and Delete permissions for the Downstream Change Control Material and Regulatory Change Item objects.