Enable Combination Products

Learn how to update your Vault’s configuration to enable Combination Products.

About the Feature

Support for Combination Products was added in 20R2. Vaults created in 20R2 or later include this functionality by default, while Vaults created in 20R1 or earlier must have the configuration upgrades described on this page to enable this feature.

Once you enable this feature, Manage Combination Products describes how to set up and use Combination Products.

25R3 Update: Combination Product Type Identification

With the 25R3 release, Safety includes the Combination Product Type field on the Product object, which Vault populates based on the product type of related active Product Constituents and their Product Registrations. To use this feature, you must configure your Vault.

After configuring this feature, see Manage Combination Products for more information.

Vaccine Combination Products

You must perform additional configuration to use combination products with a vaccine constituent. The vaccine feature enablement instructions provide more information.

Mandatory Configuration

The following configuration is required to enable Combination Products.

Add the Combination Product Layout

1. Navigate to Admin > Configuration > Objects > Product.
2. On the Layouts tab, open the Combination Product Detail Page Layout. If this layout does not exist, create a new layout with this name for the Combination Product object type.
3. Update the Details section to include the following fields:
   • Organization
   • Product Name
   • Combination Type
   • Abbreviation
   • Generic Name
   • Manufacturer
   • Core Datasheet
4. Insert a Product Constituents Related Object section with the following details:
   • Related Object: Product Constituent
   • Section Label: Product Constituents
   • Creation Option: Create record in new page
   • Columns:
     • Name
     • Product Type
     • Constituent Product
5. Insert a Product Registrations Related Object section with the following settings:
   • Related Object: Registration
   • Section Label: Product Registrations
   • Creation Option: Create record in new page
   • Columns:
     • Name
     • Registration Type
     • Product Constituent
     • PMOA
     • Country
     • Agency

Update the Case Layout

1. Navigate to Admin > Configuration > Objects > Case.
2. On the Layouts tab, open the Case Page Layout.
3. Insert a Device Details section with the following fields:
   • Device Report Type
   • Malfunction-Only
   • Device Follow-Up Type
   • Remedial Action
   • Remedial Action - Other

Update the Device Case Product Layout

1. Navigate to Admin > Configuration > Objects > Case Product.
2. On the Layouts tab, open the Device Detail Page Layout.
3. Edit the Device Information section to add the following fields:
   • Device Evaluated
   • Manufacture Date (combined control)
   • Device Usage Type
   • Device Age (combined control)
4. Insert a Device Problem and Evaluation Codes section with the following fields:
   • Device Problem
   • Evaluation Method
   • Evaluation Result
   • Evaluation Conclusion

Update the Submission Layout

1. Navigate to Admin > Configuration > Objects > Transmission.
2. On the Layouts tab, open the Submission Detail Page Layout.
3. Add the FDA Report Type field to the Details section.

Configure Tabs

1. Navigate to Admin > Configuration > Tabs.
2. Expand Business Admin (Quick Access) and select Product Library.
3. Add a new Product Library tab with all of the original object types, with the addition of Combination Products.
4. Remove the previously used Product Library tab.

Update Permissions

You must update permission sets to make the Combination Products feature available to users.

Grant Read Access to Combination Product Components

Navigate to Admin > Users & Groups > Permission Sets and update the following permission sets:

• Administration Actions
• Case Distribution Actions
• Case Entry Actions
• Case Intake Actions
• Safety Operations Actions
• Safety Writer
• Submission Actions

Ensure each of the above permission sets has Read access to the following components:

• Combination Product object type under Product
• Product Constituent object
• Each field within the Product Constituent object
• Device Follow-Up Type object type under Controlled Vocabulary
• Device Usage Type object type under Controlled Vocabulary
• Remedial Action object type under Controlled Vocabulary
• Device Problem object type under Device Code
• Evaluation Conclusion object type under Device Code
• Evaluation Method object type under Device Code
• Evaluation Result object type under Device Code

Grant Full Combination Product Management Access to Admins

For the Administration Action permission set, grant Create, Edit, and Delete permissions to the following components:

• Combination Product object type under Product
• Product Constituent object

Recommended Configuration

The following configuration is optional but recommended for the best user experience.

Add Combination Products to the Organization Layout for Sponsors

1. Navigate to Admin > Configuration > Objects > Organization.
2. On the Layouts tab, open the Sponsor Detail Page Layout.
3. Edit the Product related object section to add the following filter:
   Product Type | is not equal to | Combination Product
4. Insert a Combination Products related object section with the following filter:
   Product Type | is equal to | Combination Product
5. In the Combination Products section, add the following columns:
   • Product Name
   • Combination Type

Add Combination Products to Product Layouts

Make the changes described in this section to the following layouts:

• Device Detail
• Biologic
• Drug

1. Navigate to Admin > Configuration > Objects > Product > Layouts.
2. Select a layout.
3. Edit the Registrations section to add the PMOA field.
4. Insert a new related object section with the following details:
   • Related Object: Product Constituent
   • Section Label: Combination Products
   • Columns:
     • Name
     • Combination Product

Update the Product Registration Layout

1. Navigate to Admin > Configuration > Objects > Product Registration.
2. On the Layouts tab, open the Product Registration Detail Page Layout.
3. Edit the Details section to add the following fields:
   • Product Constituent
   • Product Type
   • PMOA

Update Case Product Layouts

Make the changes described in this section to the following layouts:

• Device Detail
• Biologic
• Drug

1. Navigate to Admin > Configuration > Objects > Case Product > Layouts.
2. Select a layout.
3. Edit the Details section to add the following fields:
   • Combination Product
   • Combination Product Registration

Optional Template Updates for Combination Products

The following configuration was a 20R3 Template Revision and is included by default in Vaults configured in 20R3 or later.

For legacy Vaults, this configuration is optional but may improve user experience.

Update the Case Layout Rules with Device Details

1. Navigate to Admin > Configuration > Objects > Case > Layouts > Case Page Layout > Layout Rules.
2. Select Create.
3. Create the layout rule with the following details:
   • Label: Device Details
   • Name: device_details__c
   • Hide the following Page Layout Items:
     • Type: Sections
     • Values: Device Details
   • IF this Layout Rule Expression is TRUE: product_type__vr.name__v != "Combination Product"
4. Select Save.

Update the Constituent Product Field on Product Constituent Object

1. Navigate to Admin > Configuration > Objects > Product Constituent > Fields > Constituent Product.
2. Select Edit.
3. Update the Criteria VQL field to:
   organization_v = this.organizationv AND object_typevr.api_namev != 'combination_product_v'
4. Select Save.

(25R3) Configure Combination Product Type Identification

To configure your Vault to identify the product type of Combination Products based on Product Constituents and their Product Registrations, add the Combination Product Type field to the Combination Product Detail Page Layout of the Product object.