Veeva QMS allows you to identify the 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 you to easily view and manage impacted materials and products directly from a Change Control, eliminating the time-consuming process of manually identifying downstream materials impacted by a change control.
Depending on your Admin’s configuration, object, field, and section labels may appear differently than the labels mentioned in this article.
Best Practices for Material & Product Data
Before running the Identify Impacted Materials action on a Change Control, we recommend ensuring that the product and material data in your Vault is up-to-date and accurate. If you rerun the action after updating relevant data, Vault creates records to reflect the new data but does not delete any existing records, even if downstream materials and products were removed. For instance, if an impacted Material had a related Product that was removed since the action last ran, running the action again does not delete the previously-created Regulatory Change Item record for that product.
This feature assumes your organization is using the following Material object types and product hierarchy objects to store the following information:
- Raw Material: An unprocessed ingredient used to make a product.
- Intermediate Material: A blend of raw materials or processed materials.
- Finished Material: A material in its final iteration. Finished Materials are typically associated with Product Families, Products, and Product Variants, but this may vary depending on your organization’s processes.
- Product Family: A general category of products.
- Product: A product formulation.
- Product Variant: The variation of a product, such as size or region.
You can manage the relationship between Materials and Products from a Material record by:
- Adding a material to the Related Materials section.
- Adding a product to the Material - Products section.
Material Data Example
Consider the following example. A manufacturing process for Cholecarb Tablets includes the following materials:
| Material | Related Material |
|---|---|
| Raw Material: Carbolin | Intermediate Material: Trihydrate Granulated Blend |
| Intermediate Material: Trihydrate Granulated Blend | Intermediate Material: Multihydrate Granulated Blend |
| Intermediate Material: Multihydrate Granulated Blend | Intermediate Material: Multihydrate Final Blend |
| Intermediate Material: Multihydrate Final Blend | Finished Material: Cholecarb Tablet 1 mg 10 Pack US Finished Material: Cholecarb Tablet 1 mg 10 Pack CA |
The Finished Materials above are related to Products through the following Material - Product records:
| Finished Material | Material - Product |
|---|---|
| Cholecarb Tablet 1 mg 10 Pack US | Product: Cholecarb Tablets Product Variant: Cholecarb Tablet 1mg |
| Cholecarb Tablet 1 mg 10 Pack CA | Product: Cholecarb Tablets Product Variant: Cholecarb Tablet 1mg |
Identifying Impacted Materials
Depending on your Admin’s configuration, you may be able to trigger Vault to search for impacted materials in the following ways:
- From the All Actions menu of the relevant Change Control, select the Identify Impacted Materials action.
- Move a Change Control record to a lifecycle state or workflow step configured to automatically identify impacted materials.
Vault identifies impacted Materials by first looking for Related Material records associated with the records in the Materials section of a Change Control. The Materials specified in those Related Material records are considered impacted materials. If the impacted materials have Related Materials, Vault also identifies them as impacted materials. Vault continues this process, identifying Materials that are up to 10 relationship levels removed from the Materials directly related to a Change Control.
Downstream Change Control Material & Regulatory Change Item Record Creation
After identifying the impacted materials, Vault creates a Downstream Change Control Material for each impacted material. If multiple impacted materials share the same downstream material, Vault creates one Downstream Change Control Material for that downstream material.
Additionally, Vault uses Product and Product Variant information from Material - Product records related to the impacted Materials to determine the Regulatory Change Item records to create:
- If an impacted Material has both a Product and a Product Variant, Vault creates a Product Change Regulatory Change Item for the Product Variant.
- If multiple impacted Materials have the same Product or Product Variant, Vault creates a Product Change Regulatory Change Item per unique Product or Product Variant.
- If an impacted Material does not have a Product or Product Variant, Vault creates a Material Change Regulatory Change Item for the impacted Material.
- If an impacted Material has multiple Products or Product Variants, Vault creates a Product Change Regulatory Change Item per unique Product or Product Variant.
Vault creates Downstream Change Control records for each impacted Material, regardless of the impacted Material’s object type. Vault only creates Regulatory Change Item records for Materials and their related Products and Product Variants if the impacted material is of an object type specified in the action’s configuration.
When this process concludes, Vault sends the initiating user a notification with a CSV file containing details of successfully created records and any failures. Vault also notes any records that were skipped to avoid creating duplicates.
In a Vault with material and product data set up as in the example above, Carbolin is listed as a material on a Change Control. In a Vault configured to create Regulatory Change Items for Finished Materials only, the Identify Impacted Materials action creates the following records:
| Created Downstream Change Control Materials | Created Regulatory Change Items |
|---|---|
| DCCM-000001 Material Type: Intermediate Material Material: Trihydrate Granulated Blend |
N/A |
| DCCM-000002 Material Type: Intermediate Material Material: Multihydrate Granulated Blend |
N/A |
| DCCM-000003 Material Type: Intermediate Material Material: Multihydrate Final Blend |
N/A |
| DCCM-000004 Material: Cholecarb Tablet 1 mg 10 Pack US Material Type: Finished Material Product: Cholecarb Tablets Product Variant: Cholecarb Tablets 1mg DCCM-000005 Material: Cholecarb Tablet 1 mg 10 Pack CA Material Type: Finished Material Product: Cholecarb Tablets Product Variant: Cholecarb Tablets 1mg |
RCI-000001 Regulatory Change Item Type: Product Change Product: Cholecarb Tablets Product Variant: Cholecarb Tablet 1mg |
Reporting on Change Control Products
The Identify Impacted Materials action does not populate the Products section on a Change Control. If your process requires reporting on Change Controls by product, you can update your reports to use Regulatory Change Items to capture product information for Change Controls.
Related Permissions
To run the Identify Impacted Materials action, you 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, you must have Read, Create, and Delete permissions for the Downstream Change Control Material and Regulatory Change Item objects.