Generating Requirements (Registration & Dossier Management)

Registration & Dossier Management provides you with the ability to define and track what needs to be completed for a registration objective or registration item so that you can register a product or amend an existing registration. Regulatory Affairs users can also create internal non-registration dossiers not usually meant for submission to authorities. For each registration objective or registration item, you can generate and regenerate requirements with expected document lists and items based on an Admin-defined dynamic template for the product or based on an existing root Requirement. You can then create Dossier Binders for the generated top-level Requirement.

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

About Requirement Generation

Requirement Libraries are a hierarchical structure containing levels of parent requirements and child requirements, including some requirements that may act as section groupings. A Requirement is a Requirement Library for a specific Registration Item. The Generate Requirements action lets you automatically generate all Requirements for Registration Objectives and Registration Items. The Update Requirements action lets you automatically regenerate Requirements to reflect changes since you last generated Requirements.

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. If your Admin has configured your Vault to create multiple requirements for each instance of a specific product hierarchy relationship, some 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 Requirements for each Raw Material Formulation record associated with the Product on the Registration Item.

Copy & Amend Dossier

You can copy and amend an existing dossier by selecting it as the source before generating Requirements. Before you run the action, you can specify a source root Requirement in the Source Dossier field from which to reuse shared requirements and matched documents. Specifying a source root Requirement allows you to generate Requirements based on that Requirement and reuse the shared requirements and expected documents. This may be helpful if you need to make a small change to a previously submitted dossier. When you later generate a Dossier Binder from the parent Requirement created from the Generate Requirements action, Vault automatically includes those shared documents unless you specify not to use the source documents by running the Customize action.

Example Use Case: Reusing Shared Requirements

Your organization previously submitted a dossier called “Bellor Lipstick Registration: EU” to register a product in the European Union (EU) and now needs to register the same product in Spain. Since many of the requirements to register the product in Spain are the same requirements used to register the product in the EU, you want to copy and amend the “Bellor Lipstick Registration: EU” dossier to only reuse the applicable shared requirements. To do this, you create a new Registration Objective and name it “Bellor Lipstick Registration: Spain”.

To reuse shared requirements included in the previously submitted dossier, you select the “Bellor Lipstick Registration: EU” Requirement in the Source Dossier field and then run the Generate Requirements action. Vault generates new Requirements for every Requirement Library in the hierarchy that is required to register the product in Spain.

Vault identifies which of the Requirements in the “Bellor Lipstick Registration: EU” dossier can be shared with the new Requirements in the “Bellor Lipstick Registration: Spain” objective. Vault populates the Source fields on the generated records with the names of the “Bellor Lipstick Registration: EU” source Requirements records with which “Bellor Lipstick Registration: Spain” is sharing the requirement so that you can access the relevant EDL Items. Vault does not generate EDLs or EDL Items for shared requirements because the existing EDL Items associated with the source records are also applicable for registering the product in Spain.

When you create a “Bellor Lipstick Registration: Spain” Dosser Binder from the top-level Requirements generated for the Registration Objective for Spain, you can specify if each Requirement record in the hierarchy will reuse the shared source documents. If you do use the shared documents, any updates you make to shared documents are automatically reflected each time you create binders for either of the “Bellor Lipstick Registration: EU” and “Bellor Lipstick Registration: Spain” dossiers.

Living Dossiers

You can use the Update Requirements action to regenerate a global or core dossier’s Requirements to reflect new information and changes to documentation requirements over time. This may be helpful when a company develops new variations of a product with new information and documentation requirements. For example, if your organization maintains an Ingredient List Number (ILN) dossier that includes requirements for the products that reference the ILN, you must add the documentation for new products to the ILN’s dossier, such as a new shade of an existing product.

Defining Referenced Items

Before generating Requirements, you can define Regulated Categories, EDLs, EDL Items, and Requirement Libraries by creating new records or updating existing records.

Regulated Categories

You can define Regulated Categories to relate each Requirement Library to a Location. Regulated categories help to organize regulations into logical groupings, such as “cosmetics” or “over the counter (OTC)”.

EDLs & EDL Items

You can define EDLs and EDL Items to link to the applicable Requirement Libraries.

Requirement Libraries

You can define Requirement Libraries from which you’ll generate Requirements. For each Requirement Library, you can define the following as needed:

  • To generate an EDL and EDL Item when generating Requirements, select the EDL checkbox.
  • To associate the Requirement Library with a Location, select the appropriate Regulated Category.
  • To specify the default order of generated Requirements in the dossier, populate or update the Default Order field. You can adjust the order of generated Requirements in the Requirement Hierarchy Viewer before generating Dossier Binders.

Generating Requirements

Depending on your Admin’s configuration, you may be able to generate Requirements for Registration Objectives and Registration Items by running the Generate Requirements action, which creates requirements for dossiers depending on if you plan to submit them for registration:

  • Registration Objectives: Creates requirements for typical dossiers that you plan to submit to authorities, such as country-level dossiers for products.
  • Registration Items: Creates requirements for internal non-registration dossiers not usually meant for product registration that you will not submit to authorities, such as global product dossiers.

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

  • Creates a Requirement of an Admin-defined type for either:
    • Specific root Requirement Libraries you manually select.
    • Every active Requirement Library in the hierarchy (including child requirements) that matches an Admin-defined filter.
  • Relates each new Requirement to the Requirement Library record and to the record on which you ran the action.
  • Sorts the generated Requirements in the dossier based on the Default Order values of the related Requirement Libraries. If the action creates multiple records from Requirement Libraries in the same section with the same Default Order, Vault orders them based on the related Requirement Library’s name, created date, and ID and then by the Requirement’s name.
  • If you selected the EDL checkbox on a Requirement Library, Vault creates EDLs and EDL Items to capture the associated required documents for the registration and associates the EDL and EDL Items to the Requirement. Each Requirement can link to one (1) EDL and one (1) EDL Item.
  • If configured by your Admin, Vault automatically populates any Admin-mapped fields on all generated Requirement, EDL, and EDL Item records.
  • If you specify a root Requirement from which you want to reuse shared requirements and documents, Vault also does the following:
    • Identifies requirements matched to the source root record, including its child Requirements.
    • Links them to the generated Requirements.
    • Populates the Source field on these records so you can trace the source requirements.
    • Selects the Use Source checkbox on all generated records.

How to Generate Requirements

To generate Requirements:

  1. Navigate to the appropriate Registration or Registration Item.
  2. Optional: Click Edit to modify the record:
    • Optional: Set the Select Root Requirement field to Yes if you want to select specific root requirements. If you select No or leave this field blank, Vault selects requirements based on the Admin-defined dynamic template.
    • Optional: Select an active root Requirement in the Source Dossier field to reuse applicable shared requirements associated with the specified record. The source root record must have the same Requirement Library as the record for which you generate Requirements. If you leave this field blank, Vault will not reuse any shared requirements for this Requirement.
    • Click Save.
  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 root Requirement Libraries, which may be filtered based on Admin-defined criteria and your permissions. You can apply Filters to refine the list. Select up to 100 root Requirement Libraries and click Continue.

When notified that Requirement generation is complete, navigate to the record on which you ran the action to review the newly-created requirements. If applicable, you can:

Vault automatically adds relevant EDL Items to the Expected Documents section based on your Admin’s configuration. If you selected an existing Requirement in the Source Dossier field before running the Generate Requirements action, Vault selects the Use Source checkbox on generated Requirements and does not add EDL Items for any Requirement linked to a source. This is because the EDL Items related to the source Requirement are shared with the generated Requirement.

Automatic Requirement Creation

Depending on your Admin’s configurations, your Vault may automatically generate all requirements based on Admin-defined criteria when the Registration or Registration Item 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 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.

Limitations

The Generate Requirements action supports the creation of up to 4,000 Requirements, up to ten (10) levels deep. If you select a source root Requirement in the Source Dossier field from which to reuse shared requirements, Vault supports up to six (6) hierarchical levels from a primary source root.

Updating Requirements

When configured by your Admin, you can regenerate Requirements by running the Update Requirements action. This action creates new Requirements from the Admin-defined dynamic template or the specified Source Dossier and reflects all changes to applicable Requirement Libraries since you last generated Requirements. When you run the Update Requirements action, Vault creates records similar to how it creates records when you run the Generate Requirements action, but excludes root Requirements based on Admin-defined criteria. For example, your Admin may have configured the action to exclude root Requirements in completed or canceled states. When you run this action, you cannot select root Requirements, even if you selected “Yes” for the Select Root Requirement field.

To update Requirements:

  1. Navigate to the appropriate Registration Objective or Registration Item.
  2. If the Source Dossier field is populated, ensure it references an active record.
  3. From the All Actions menu, select Update Requirements.

When notified that Requirement generation is complete, navigate to the record on which you ran the action to review the newly-created requirements. If applicable, you can:

Automatic Requirement Updates

Depending on your Admin’s configurations, your Vault may automatically update requirements based on Admin-defined criteria when the Registration or Registration Item 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 action.

Notifications

When Vault finishes updating 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.

Limitations

The Update Requirements action supports the creation of up to 4,000 Requirements, up to ten (10) levels deep. If you select a source root Requirement in the Source Dossier field from which to reuse shared requirements, Vault supports up to six (6) hierarchical levels from a primary source root.

Customizing Matched Documents for Shared Requirements

If you don’t want to reuse the documents associated with any shared requirements, you can unlink a Requirement from the shared source EDLs and EDL Items by running the Customize action. When you run the Customize action on a generated Requirement, Vault creates new EDLs and EDL Items for each EDL and EDL Item associated with the source Requirement. Vault adds the new EDL Items to the Expected Document section of the applicable Registration or Registration Item and automatically populates certain fields on the new records copied from the source records or based on Admin-defined mappings.

Depending on your Admin’s configuration, the Customize action may carry over documents matched to the source EDL Items to the generated EDL Items. When this happens, the new EDL Items are matched to the same documents matched to the source EDL Item. Vault automatically sets the Batch Update field to No on generated EDLs to prevent continuous matching on the EDL Items related to each EDL.

You can run the Customize action on active Requirements that meet the following criteria:

  • There are no associated active EDLs or EDL Items.
  • The Use Source checkbox is selected.
  • The Source field is populated with a Requirement with associated EDLs and EDL Items, none of which reference other Requirements.
  • The shared Requirement Library is active, has the EDL checkbox selected, and is shared with the source Requirement.

How to Customize Matched Documents

To customize matched documents for shared requirements:

  1. Navigate to the Requirement section of the Registration or Registration Item on which you generated Requirements.
  2. Find the active Requirement record you want to unlink from the shared EDLs and EDL Items and select Customize from the record’s Actions menu.
  3. When notified that the action is complete, navigate to the Expected Documents section of the Registration or Registration Item to review the newly-created EDL Items. Certain fields may be automatically populated based on your Admins configuration.
  4. Optional: Open the new EDL Items and manually match the appropriate documents.

Vault clears the Use Source checkbox on the Requirement after you run the Customize action since that record is no longer linked to documents matched to the source EDL Items. You cannot select the Use Source checkbox on any Requirement linked to an active EDL or EDL Item.

Notifications

When Vault finishes generating EDLs and EDL Items, you’ll receive a Vault notification. The notification lets you know if the action was successful or if there were any errors. When the action is successful, the notification includes details about which fields Vault populated on the new records, including any Admin-mapped fields.

Limitations

The Customize action fails if the source Requirement is related to more than 100 EDLs or 100 EDL Items or if any of the source EDL Items are matched to more than 500 documents.

Creating & Updating Requirements

You can manually create and update Requirements:

  1. Open an existing Requirement record or navigate to Registrations > Requirement to create a new record.
    • To create a new record:
      1. Click Create.
      2. Select the type.
      3. Click Continue.
      4. Enter a Name.
  2. Add or update the applicable details. You must select either a Registration Item or Registration Objective.
    • Selecting a Registration Objective automatically populates the Requirement field. If you are creating a root Requirement, this field must reference a root Requirement Library record.
  3. Click Save.

Deleting Requirements

You can delete a Requirement by selecting Delete from the record’s All Actions menu, which also deletes all Requirement child records and any related EDL and EDL Item records.

Automatically Creating Dossier Documents from Templates

After generating Requirements, you can use the Auto create document from template action to generate documents from templates. See Creating Dossier Documents from Templates Automatically for more details.

Using the Requirement Hierarchy Viewer

If configured by your Admin, you can access the Requirement Hierarchy Viewer on Registration Objective and Registration Item records. The viewer displays all active related Requirements in a hierarchical structure, allowing you to review and adjust records, nested order, and matched documents before generating a Dossier Binder. See Using the Requirement Hierarchy Viewer for more details.

Creating Dossier Binders

After generating Requirements, you can create a Dossier Binder for the top-level Requirement. See Working with Dossier Binders for more details.