Regulatory Request Management (Compliance Management)

Compliance Management provides you with the ability to mitigate non-compliance risks by accessing accurate, up-to-date, and consistent information to include in responses to requests for information related to the regulatory compliance of a product or formulation. For each request, you can quickly create a request from predefined types and include relevant details, and then submit for review. You can provide responses, associate related documents, view similar requests to ensure consistency in responses, and create any required secondary requests.

Depending on your Admin’s configuration, object, field, and section labels may appear differently than the labels mentioned in this article. In addition, the available fields, order of fields, and required fields may vary based on your Vault.

Creating Regulatory Requests

When you create a Regulatory Request, you first select the request type that is most appropriate. When you’re providing information for some types of requests, you can associate one (1) or more related Formulations. You can only see and select Formulations that you have permission to view based on Admin-defined criteria.

The request types you can select include the following:

  • Certificate
  • Declaration
  • Other
  • Raw Material Questionnaire
  • Registration
  • Regulatory Data Sheet
  • Safety Data Sheet
  • Technical Data Sheet

How to Create a Regulatory Request

To create a Regulatory Request:

  1. Navigate to Compliance > Regulatory Requests.
  2. Click Create.
  3. In the dialog, select the appropriate regulatory request type and click Continue.
  4. Authority Question types only: You can optionally select the Registration Objective.
  5. Optional: Enter any details about the Request.
  6. Select a Priority.
  7. For all types except Authority Question, you can specify the following:
    • Optional: Select a Confidentiality type.
    • Optional: Select a Source.
    • Optional: Select the appropriate Organization. Selecting a value here automatically populates the Organization Type field.
    • Optional: Select the Organization Contact.
    • Optional: Select one (1) or more Formulations to associate with this request.
    • Optional: Select the Country of origin.
  8. Safety Data Sheet types only: You can optionally select the Language.
  9. When you are finished entering all relevant details, click Save.

Using the Formulation Composition Viewer

Depending on your Admin’s configuration, you may be able to see the Formulation Composition Viewer on Formulation records associated with the Regulatory Request. The viewer allows you to visualize and interact with a formula’s hierarchical composition and quickly assess its compliance in a specific market before approving it for use by your organization.

To access the Formulation Composition Viewer:

  1. Navigate to the appropriate Regulatory Request record.
  2. In the Formulations section, click on the appropriate Formulation record.
  3. Navigate to the Formulation Composition Viewer section in the Formulation record.

Reviewing & Responding to Regulatory Requests

After a Regulatory Request is created, you may be notified that your review and response is needed. You can select a response, provide response comments (if applicable), add related documents, and create any required secondary requests, if needed, to obtain missing information required to fulfill the original request.

How to Review & Respond to a Regulatory Request

To review & respond to a regulatory request:

  1. When notified, navigate to the appropriate Regulatory Request record.
  2. Click Edit.
  3. In the Response Details section, select the appropriate Response.
  4. Optional: If you select Other as the Response, enter any Response Comments.
  5. Optional: Enter the Closed Date.
  6. Optional: In the Response Documents section, click Add to search for, and select, related documents.
  7. Optional: In the Secondary Requests section, click Create to create a secondary request for missing or additional information, then:
    • In the Create Regulatory Request dialog, select the applicable request type and click Continue.
    • In the dialog, provide the details for any required requests to obtain missing or additional information.
  8. When you are finished reviewing and responding, click Save.

Depending on your Admin’s configuration, you may need to select a workflow action from the Workflow Actions menu after reviewing and responding to a request.

Viewing Similar Requests

Depending on your Admin’s configuration and your permissions, you may be able to review Similar Requests on the detail page for a Regulatory Request. Similar requests that appear in the list are other Regulatory Request records with similar characteristics; you can review the details of these requests to help provide a consistent and correct response to the current request.

To view similar requests:

  1. Navigate to the appropriate Regulatory Request record.
  2. In the Similar Requests section, review the available requests.
  3. To view the details of a particular request, click the request’s Name.

Regulatory Request Lifecycle

Depending on your Admin’s configuration, Regulatory Requests might use an object lifecycle and include at least the following states:

  • Open: The initial state of the request.
  • In Review: The request is being reviewed and responded to.
  • Closed: All information (including documents) has been provided and responses completed.

Regulatory Request Workflow

Depending on your Admin’s configuration, Regulatory Requests might use an object workflow to suit your team’s needs to manage requests from an Open state to a Closed state by assigning tasks to users. You can initiate a workflow from the Workflow Actions menu. Depending on your Admin’s configuration, this action may be in the All Actions menu.