Regulatory Request Management provides users with the ability to mitigate non-compliance risks by accessing accurate, up-to-date, and consistent information to include in responses. For each request, users can quickly create a request from predefined types and include relevant details, and then submit for review. Regulatory users can provide responses, associate related documents, view similar requests to ensure consistency in responses, and create any required secondary requests. You can configure your Vault to ensure users can respond to regulatory requests quickly and easily.

Regulatory Request Management Objects

Compliance Management uses the following core objects and object types to support Regulatory Request Management:

  • Regulatory Request (regulatory_request__v): This object represents a regulatory request including the request type, priority, source, organization information, country, language, and response details.
  • Regulatory Request Formulation (regulatory_request_formulation__v): This object joins the Regulatory Request and Formulation objects.
  • Formulation (formulation__v): This object represents a formulation and contains information about version.
  • Organization (organization__v): This object represents an external organization and contains information about address, location, and contact details.
  • Organization Person (organization_person__v): This object represents a person associated with a particular organization.

Configuration Overview

Configuring your Vault to use Regulatory Request Management involves the following steps:

Configuring Object Page Layouts

You must modify the Regulatory Request object page layout so that users can access functionality.

Detail Form Sections

You must configure multiple detail form sections on the Regulatory Request object so users can capture request and response details.

Request Details Section

Configure a Detail Form section. This section allows users to provide request details. We recommend labeling this section “Request Details”. Ensure you include the following fields:

  • Confidentiality
  • Country
  • Language
  • Organization
  • Organization Contact
  • Organization Type
  • Priority
  • Request
  • Source

You must also add the Formulation field so users can select the appropriate Formulation for a Regulatory Request:

  1. In the “Request Details” section, Add the Formulation control field with the slider (Slider Icon) icon.
  2. Optional: In the Add Formulation dialog, change the Name of the field.
  3. Optional: Select the Specify different Label and Help Content checkbox to customize the Label and tooltip text that appears to users.
  4. Enter the Maximum number of suggestions displayed to users.
  5. Optional: Add VQL Criteria to restrict the Formulation records that users can see and select for this field.
  6. Click Done.

Response Details Section

Configure a Detail Form section that includes the following fields: Closed Date, Response, and Response Comments fields. We recommend labeling this section “Response Details”. This section allows users to provide response details in a section other than the Request Details section.

Configure a Related Object section for the Regulatory Request Formulation > Formulation object. We recommend using the section label “Formulations”. This allows users to modify the Formulations related to the Regulatory Request after creation.

Configure a Related Object section for the Regulatory Request object. We recommend using the section label “Secondary Requests”. This uses a self-reference on the Regulatory Request object so that users can create required requests for missing or additional information as part of the request.

Configure a Related Document section that uses the Related Regulatory Requests field as the Referencing Document Field. We recommend using the section label “Response Documents”. In the Criteria VQL field, add criteria to filter on the appropriate Document Types or Formulations. This allows users to select from relevant documents when they search for, and add, related documents to the request. For example, to display all documents related to the Formulation FORM-00000001, you could use the following criteria: document_formulation__cr.name__v=FORM-00000001

Similar Requests Section

Configure the Similar Requests section so that users can view requests with similar characteristics from a Regulatory Request. You can configure Matching Fields to ensure the requests that display in this section share the same characteristics such as Regulatory Request Type, Organization Type, and Formulation. You can also configure the Regulatory Request object fields to display as column headers for users in the section.

The following object field types are supported:

  • Component (for lifecycle states)
  • Date
  • Formula (where Return Type is Text, Number, Yes/No, or Date)
  • ID
  • Lookup (where type is Text, Number, Date, or Yes/No)
  • Number
  • Object and Parent Object
  • Text (excluding Long Text and Rich Text fields)
  • Yes/No

To configure the Similar Requests section:

  1. In the Regulatory Request object page editor, click Add Section.
  2. Select the Similar Request control section with the slider (Slider Icon) icon.
  3. Enter a Section Label.
  4. Optional: In the Show the section only in these lifecycle states field, select one (1) or more lifecycle states.
  5. Optional: Enter the Section Help content to provide the user with any relevant information. Help content appears below the section label.
  6. Select the active fields you want to use as Matching Fields.
  7. Select up to 30 active Regulatory Request fields to display as Request Grid Columns headers in the section.
  8. Specify the Number of Records per Page to display to the user using an integer from 20 to 100.
  9. Click Done.

Adding Values to Picklists

Regulatory Request Management contains the following picklists:

  • Confidentiality: This picklist contains values for the type of confidentiality required for the request and is used when users create Regulatory Request records.
  • Country: This picklist contains values for the country of origin for the request and is used when users create Regulatory Request records.
  • Language: This picklist contains values for the language in which the request was made and is used when users create Regulatory Request records.
  • Organization Type: This picklist contains values for the different types of organizations and is used when users create Regulatory Request records.
  • Priority: This picklist contains values for the level or priority for the request and is used when users create Regulatory Request records.
  • Response: This picklist contains values for the type of response and is used when responding to a request.
  • Source: This picklist contains values for the source of the request and is used when users create Regulatory Request records.

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

Regulatory Request Lifecycle

You can create a custom lifecycle for the Regulatory Request object and add custom lifecycle states to suit your organization’s needs. We recommend creating, at minimum, custom lifecycle states for Open, In Review, and Closed.

Regulatory Request Workflow

You can create a custom workflow for the Regulatory Request object to suit your organization’s needs. Ensure you have a custom lifecycle already created before configuring a workflow. We recommend optionally creating a separate custom workflow for Secondary Requests so that secondary requests don’t have to be closed before parent requests are closed.

Configuring the Formulation Composition Viewer

You can add the Formulation Composition Viewer to Formulation records, allowing users to easily visualize the hierarchical composition and compliance status of the constituent chemicals in the Formulation related object section on a Regulatory Request record. See Configuring the Formulation Composition Viewer for more details.

Configuring User Permissions

You must ensure users have the appropriate read and create permissions to access the appropriate objects and object fields in addition to the permissions outlined below:

For users to be able to select Formulations while creating a Regulatory Request:

  • For the Regulatory Request object: Read permission on the Title object field and Edit permission on the Create Detail JSON object field.
  • For the Formulation object: Read permission, including Read permission on any fields you added to the VQL Criteria applied to the Formulation field in the Request Details Section of the Regulatory Request object. Vault hides the Formulation field from users that do not have Read permission on all fields specified in the VQL Criteria.

For users to be able to view Similar Requests on the Regulatory Request records, they must have the appropriate field-level object permissions on the fields you configured as matching fields as well as field-level object permissions on the fields on the Regulatory Request object. If a user does not have field-level object permissions on some fields, those columns will not display for the user when they view the list of Similar Requests.

We also recommend enabling DAC on the Regulatory Request object on fields by lifecycle state and role, as well as Atomic Security on related objects and documents.

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 Admin: Permission Sets: Read, Create, Edit Ability to make changes to permission sets for users.
Security Profile Admin: Configuration: Object Lifecycles: Create, Edit Ability to create and modify object lifecycles.