Configuring Quantitative Assessments (Compliance Management)

Compliance Management provides users with the ability to use quantitative assessments to quickly compare the total concentration of substances in a formulation to substance restrictions in a given market, allowing them to determine if that formulation is compliant early in the product development lifecycle. This allows your organization to derisk product launches by assessing the right-to-sell in certain markets before initiating testing and commercialization.

If you have integrated your Compliance Management Vault with a third-party application such as a PLM system, you can configure your Vault to import data to Formulation Concentration and Regulatory Restriction records and automatically populate certain fields on Quantitative Assessment records with those same values.

Quantitative Assessment Objects

Compliance Management uses the following core objects to support Quantitative Assessments:

Quantitative Assessment (quantitative_assessment__v): This object represents the assessment status of a substance’s concentration in relation to its intended use in a given location.
Formulation Concentration (formulation_concentration__v): This object represents the concentration of a substance in a specific formula.
Regulated Category (regulated_category__v): This object represents a registration category for a location, such as “Cosmetic” or “OTC”.
Regulatory Restriction (regulatory_restriction__v): This object represents the restriction for a substance of concern. We recommend creating a single Regulatory Restriction for the Intended Use of each Substance and Regulated Category’s specific Location combination.

Configuration Overview

Configuring your Vault to use Quantitative Assessments involves the following steps:

Optional: Set up an external connection to integrate data from a third-party application to pull data into Quantitative Assessment records
Configure object layouts
Add values to picklists
Create the appropriate Formulation Concentration and Regulatory Restriction records
Populate Regulated Category records with the appropriate Location values
Optional: Configure your Vault to automatically create Quantitative Assessments
Optional: Configure reports so users can easily track and compare assessment and concentration data

Note: Depending on your Vault’s creation date and which features are currently enabled and configured, some of the steps described in this article may be unavailable or already complete in your Vault.

Setting Up External Connection Integration

You can set up an external connection to a third-party application, such as a PLM system, to pull concentration and restriction data into Formulation Concentration and Regulatory Restriction records. Vault automatically populates certain fields on Quantitative Assessment records with the same values in the related Formulation Concentrations and Regulatory Restrictions.

Configuring Object Layouts

You must make the following changes to object layout to support Quantitative Assessments:

Add the Location field to the Regulated Category object layout.
Insert the Formulation Concentration and Quantitative Assessment related object sections to the Formulation object layout.

Adding Values to Picklists

Compliance Management Vaults include the following picklists to support Quantitative Assessments, which users populate when they create Quantitative Assessment records:

Intended Use
Restriction Type
Quantitative Assessment Status
Unit

You can add values to these picklists to suit your organization’s needs.

Creating Formulation Concentration & Regulatory Restriction Records

You must create the appropriate Formulation Concentration and Regulatory Restriction records in your Vault. You can automatically populate these records with values from an integrated third-party application or use Vault Loader to bulk create and populate these records.

Note: If you configure Automatic Quantitative Assessments, the Create Quantitative Assessments action will fail if any applicable Regulatory Restrictions have a Restriction Type value that is not “Max”.

The Quantitative Assessment object includes Formulation Concentration and Regulatory Restriction object reference fields, which Vault automatically populates on Quantitative Assessment records based on the user’s Formula and Regulated Category selections. When users create new Quantitative Assessment records, Vault utilizes a Vault Java SDK trigger to automatically populate the following fields based on the user-selected Formulation Concentration and Regulatory Restriction values on that record:

Target Field	Source Record	Source Field
Formula Concentration	Formulation Concentration	Total Concentration
Formula Unit	Formulation Concentration	Concentration Unit
Intended Use	Regulatory Restriction	Intended Use
Restriction Type	Regulatory Restriction	Restriction Type
Restriction Amount	Regulatory Restriction	Amount
Restriction Unit	Regulatory Restriction	Restriction Unit

Populating Regulated Category Records

You must ensure that the Location field is populated appropriately on all relevant Regulated Categories in your Vault so that users can track Quantitative Assessments for specific market locations of interest. You can use Vault Loader to update this field on all applicable records.

Note: In Vaults created prior to 23R3, the Regulated Category object in your Vault may be configured with the custom Location (location__c) field. If this is the case in your Vault, you must populate the standard Location (location__v) field on all Regulated Category records.

Configuring Automatic Quantitative Assessments

You can configure your Vault to automatically create Quantitative Assessments for substances of concern in a Formulation. See Configuring Automatic Quantitative Assessments for more details.

Configuring Reports

We recommend configuring the following types of Multi-pass reports so users can easily track and compare assessment and concentration data in relation to the relevant objects:

Formulation Quantitative Assessments
Formulation Qualitative Assessments
Formulation Total Concentrations
Substance Quantitative Assessments

You can complete all the steps in this article with the standard System Administrator or Vault Owner security profile. If your Vault uses custom security profiles, your profile must grant the following permissions:

Type	Permission	Controls
Security Profile	Admin: Configuration: Objects: Create, Edit	Ability to create and modify Vault objects.
Security Profile	Application: Vault Actions: Connections: Manage Connections	Ability to view and manage Vault connections.
Security Profile	Application: Vault Owner Actions: Vault Owner Actions: Vault Loader	Ability to view and use the Loader tab.
Security Profile	Application: Vault Owner Actions: Vault Owner Actions: Record Migration	Ability to load object records (through Vault Loader or API only) in a lifecycle state other than Starting State.