Registration & Dossier Management provides you with the ability to define and track what needs to be completed for a registration item or all registration items in a registration objective so that you can register a product or amend an existing registration. For each registration item or registration objective, you can generate a set of Admin-defined requirements that is dynamic depending on the product, and also generate any expected document lists and items.

Depending on your Admin’s configuration, object, field, and section labels may appear differently than the labels mentioned in this article.

About Requirement Creation

Requirements are a hierarchical structure containing levels of parent requirements and child requirements, including some requirements that may act as section groupings. When configured by your Admin, your Vault includes the Generate Requirements action, which lets you automatically generate all Registration Item Requirements for a Registration Item or registration objective type of Registration.

When you trigger the Generate Requirements action, Vault does the following:

  • Creates a Registration Item Requirement for either:
    • Specific root Requirements you manually select.
    • Every Requirement in the hierarchy, including child requirements, that match an Admin-defined filter.
  • Relates each new Registration Item Requirement to the Requirement record and:
    • When you trigger the action on a Registration Item record, Vault relates each new Registration Item Requirement to the Registration Item record.
    • When you trigger the action on a registration objective type of Registration record, Vault relates each new Registration Item Requirement to the Registration record.
  • If you selected the EDL checkbox on a Requirement, Vault creates EDLs and EDL Items to capture the associated required documents for the registration, and associates the EDL and EDL Items to the Registration Item Requirement.
  • If configured by your Admin, Vault automatically populates any object field mappings on all generated Registration Item Requirement, EDL, and EDL Item records.

When you generate requirements, Vault can leverage the various relationships that exist between the Product record associated with the root Registration Item or Registration and other object records in the product hierarchy.

When you generate requirements for a Registration Item and your Requirements are set up using tokens, some Registration Item Requirements will repeat for each instance of a specific relationship. For example, a “Raw Material Information” parent requirement could result in the creation of multiple child registration item requirements for each Raw Material Formulation record associated with the Product on the Registration Item.

Creating Regulated Categories

Before generating requirements, you can create Regulated Categories so that you can relate a Requirement to a Location. Regulated categories help to organize regulations into logical groupings, such as “cosmetics” or “over the counter (OTC)”.

To create a regulated category:

  1. Navigate to Regulated Categories.
  2. Click Create.
  3. Enter the Name for the category.
  4. Click Save. To create another regulated category, click Save + Create.

Defining Requirements

Before generating requirements, you can specify whether you want the Generate Requirements action to create any EDLs. You can also associate any of the Requirements in the structure with the appropriate Regulated Category.

For each Requirement, you can define the following as needed:

  • To generate an EDL and EDL Item when running the Generate Requirements action, select the EDL checkbox.
  • To associate the Requirement with a Location, select the appropriate Regulated Category.

To define requirements:

  1. Navigate to the appropriate Requirement.
  2. Click Edit.
  3. Optional: Select the EDL checkbox.
  4. Optional: Select the Regulated Categories.
  5. Click Save.
  6. Repeat as needed for each Requirement record.

Generating Requirements

The options available to you to generate requirements depend on your Admin’s configuration. Your Admin has configured your Vault to generate requirements for either a Registration Item or a Registration. You may be able to generate requirements by selecting an action from the All Actions menu of a Registration Item or Registration record, or your Vault might automatically generate requirements when you move that record to a particular lifecycle state. If you don’t see the Generate Requirements option in the All Actions menu, the action may be part of an entry action. See Automatic Requirement Creation for more details.

Before being able to generate requirements, you must have already created a Registration Item.

How to Generate Requirements

To generate requirements:

  1. Navigate to the appropriate Registration Item or Registration.
  2. Optional: To select specific root requirements, click Edit and set the Select Root Requirement field to Yes. If you select No or leave this field blank, Vault selects requirements based on Admin-defined criteria.
  3. From the All Actions menu, select Generate Requirements.
  4. If you selected Yes for the Select Root Requirement field, Vault displays the Select Requirement dialog listing non-child requirements. This list may be filtered based on Admin-defined criteria and your permissions. After selecting the applicable root requirements, click Continue.
  5. When notified that requirement generation is complete, navigate to the detail page of the Registration Item or Registration to review the newly-created requirements.

Automatic Requirement Creation

Depending on your Admin’s configurations, your Vault may automatically generate all requirements based on Admin-defined criteria when the Registration Item or Registration record enters a specific lifecycle state rather than, or in addition to, the action being available to you in the All Actions menu.

Change the state of the record from the Workflow Actions menu to trigger the entry action.

Notifications

When Vault finishes generating requirements, you’ll receive an email and a Vault notification. The notification lets you know if the generation was successful or if there were any errors.

Deleting Registration Item Requirements

You can delete a Registration Item Requirement which also deletes all Registration Item Requirement child records. Any EDL and EDL Item records associated with the Registration Item Requirement are also deleted.

To delete a request requirement and all of its children:

  1. Navigate to the appropriate Registration Item Requirement record.
  2. From the All Actions menu, select Delete.