Registration & Dossier Management provides users with the ability to assess if a new registration objective can be accomplished by amending an existing registration or if a new registration is required for a location’s specific regulations. Users can search existing registrations for matches and Vault identifies which of the matching registrations can be used to register the product or if any matches must be amended before they can be used to register the product. Users can then select the most appropriate registration, initiating the appropriate registration process.

Vault uses Regulated Category Impacts to match Registrations (including registration objective types of Registrations) to a source Registration Item based on fields in that record matching to fields in existing Registration Items. Vault then identifies the Registrations related to those matching Registration Items. If the Regulated Category Impacts reference optional Relational Tokens that are linked to Object Mappings with Field Mappings for those fields, Vault automatically populates the fields on the source Registration Item based on Relational Token resolution.

Local Impact Assessment Objects

Registration & Dossier Management uses the following core objects to support local impact assessments:

  • Registration (registration__v): This object represents proof that validates clearance in a state, country, region, and by Third-Party Certification or Retailer.
  • Registration Item (request__v): This object represents a request to identify or scope out what needs to be done to market or sell a product in a jurisdiction.
  • Registration Request (registration_request__v): This object joins the Registration and Registration Item objects and represents existing Registration matches that users can select in order to create and relate the appropriate new Registration records.
  • Regulated Category (regulated_category__v): This object represents a category for regulation and contains information about location.
  • Regulated Category Attribute Impact (regulated_category_attribute_impact__v): This object links Regulated Categories to Admin-defined Registration Attributes and specifies how Vault identifies Registration matches and optionally populates fields on Registration Items based on Relational Token resolution.

Configuration Overview

Configuring your Vault to use local impact assessments involves the following steps:

Configuring Local Impact Assessment Objects

You must configure several objects to support Local Impact Assessments.

Configuring the Registration Object

Ensure that the Name field on the Registration object is system-managed on all object types.

Configuring the Registration Item Page Layout

Add the following fields to the Registration Item object page layout for all applicable object types:

  • Eligible for Impact Assessment
  • Registration (parent_registration__v)
  • Regulated Category (regulated_category__v)
  • Regulatory Process Type
  • Optional: Add the following fields to allow users to track the status of relevant jobs triggered by the associated object actions:
    • Generate Registration Data Job Status
    • Local Impact Assessment Job Status
    • Generate Registration and Obj Job Status

You must also add the Matching Registration and Matching Registration Objective control fields so that users can see any matches when they trigger the Local Impact Assessment action. To add these fields:

  1. Navigate to Admin > Configuration > Objects > Registration Item > Page Layouts.
  2. Open the applicable page layout.
  3. In the Details section of the layout, click Add.
  4. Select the Matching Registration control field with the slider (Slider Icon) icon.
  5. Optional: In the Add Matching Registration dialog, select the Specify different Label and Help Content checkbox to customize the label and tooltip text that appears to users.
  6. Click Done.
  7. In the Details section of the layout, click Add. Select the Matching Registration Objective control field with the slider (Slider Icon) icon.
  8. Optional: In the Add Matching Registration Objective dialog, select the Specify different Label and Help Content checkbox to customize the label and tooltip text that appears to users.
  9. Click Done.
  10. Click Save.

Configuring the Regulated Category Object Page Layout

You can add a related object section to the Regulated Category object for the Regulated Category Attribute Impact object so users can see all Regulated Category Attribute Impacts related to each Regulated Category.

Populating Registration Item Records

You must ensure that the Eligible for Local Impact Assessment field is populated appropriately on all relevant Registration Items in your Vault. When users trigger actions on a source Registration Item to conduct a Local Impact Assessment, Vault compares that record to existing Registration Items and identifies matches based on Regulated Category Attribute Impacts. Vault only evaluates existing Registration Items if the Eligible for Local Impact Assessment value is Yes.

In addition, the following fields must be populated on all Registration Item records in your Vault in order for the Local Impact Assessment feature to perform correctly:

  • Registration (parent_registration__v): When Vault matches a source Registration Item to an existing Registration Item, it identifies its parent Registration as a potential match to the source Registration Item.
  • Regulated Category (regulated_category__v): When identifying matches, Vault evaluates all Registration Items with the same Regulated Category.

Bulk Updating Registration Item Records

To bulk update all Registration Items in your Vault, we recommend either of the following options:

  • Use Vault Loader to update the fields on all Registration Item records.
  • Configure a temporary workflow to update the fields on all Registration Items, then inactivate the workflow.

Creating Registration Attribute Components

You must create Registration Attribute components and link them to Regulated Category Attribute Impacts, which determine how Vault identifies Registration matches when the Local Impact Assessment action runs. If you link a Registration Attribute to a Relational Token with a defined Object Mapping, Vault automatically populates the mapped fields on the source Registration Item record based on token resolution when the Generate Registration Data action. See About RegulatoryOne Component Types for more details about how to create Registration Attributes in MDL.

Creating Regulated Category Attribute Impacts

You must create Regulated Category Attribute Impact records and relate them to pre-defined Registration Attributes to determine which fields Vault evaluates when matching a source Registration Item to existing Registration Items. Vault evaluates existing Registration Items with an Eligible for Local Impact Assessment value of Yes and the same Regulated Category as the Regulated Category Attribute Impact.

To create a Regulated Category Attribute Impact:

  1. Navigate to Admin > Business Admin > Regulated Category Attribute Impact.
  2. Click Create.
  3. Enter a Name such as “Canada - Formulation” for an impact that applies to formulation changes in Canada.
  4. Select a Regulated Category Attribute Impact Type. Select Amendable if this attribute requires an amendment to an existing registration. Select Unique if this attribute requires a new registration. If you have configured custom values for this picklist and select a custom value for this field, Vault will ignore this Regulated Category Attribute Impact record when running the Local Impact Assessment job.
  5. For Registration Attribute, enter the label of a Registration Attribute to identify the Registration Item field this Regulated Category Attribute Impact applies to.
  6. Select a Regulated Category to restrict this Regulated Category Attribute Impact to evaluate only Registration Items with the same Regulated Category.
  7. Click Save.

Configuring Registration Item Object Actions

Registration and Dossier Management Vaults include several asynchronous actions on the Registration Item object to support Local Impact Assessments, which users trigger in the following order:

  1. Generate Registration Data
  2. Local Impact Assessment
  3. Create Registration and Objective

Depending on your business needs, you can configure these actions as:

When performing these actions, Vault only evaluates existing Registration Items with an Eligible for Local Impact Assessment field value of Yes.

Configuring the Generate Registration Data Action

The Generate Registration Data action allows users to automatically populate fields on a Registration Item based on Relational Tokens linked to the applicable Regulated Category Attribute Impacts. When the Generate Registration Data action runs, Vault automatically populates the specified fields on the source Registration Item record based on Relational Token resolution. Vault also updates the Generate Registration Data Job Status field to the current status of the job.

If Vault finds more than one (1) applicable field value based on Relational Token resolution for all Registration Attributes, the job fails and does not populate any fields on the source record.

Configuring the Local Impact Assessment Action

The Local Impact Assessment action allows users to identify any existing Registrations (including registration objective types of Registrations) that match a source Registration Item and determine if those matching Registrations require an amendment. To do this, Vault identifies all Registration Items in your Vault with Eligible for Impact Assessment values of Yes and matches fields based on the applicable Regulated Category Attribute Impacts to identify incomplete parent Registration matches. Vault also identifies any amendment requirements based on the Regulated Category Attribute Impact Type values (Unique or Amendable) of the fields specified in the relevant Regulated Category Attribute Impacts.

When the Local Impact Assessment action runs, Vault does the following:

  • Populates the Matching Registration and Matching Registration Objective fields on the source Registration Item based on the applicable scenario:
    • Blank: No matching Registration record.
    • [Registration]: The label of the matching Registration. Users can click on this hyperlink to view the record’s details.
    • [Registration Objective]: The label of the matching registration objective type of Registration. Users can click on this hyperlink to view the record’s details.
    • Matching Registrations Found: There are multiple existing matching Registrations. Users must click on this hyperlink value to see the Search Registrations dialog, which lists all matches (each representing a Registration Request record).
  • Populates the Regulatory Process Type field on the source Registration Item based on the applicable scenario:
    • New: No existing parent Registrations match, and a new registration is required. There are zero (0) existing Registration Items with matching Unique or Amendable fields.
    • Amendment: One (1) or more matching parent Registration exists and requires an amendment. There is one (1) or more existing Registration Items with at least one (1) matching field equal to Amendable.
    • No Action Required: One (1) or more matching Registrations exists and does not require an amendment. There is one (1) existing Registration Item with all matching fields equal to Unique and Amendable fields.
  • Creates Registration Request records for every matching Registration record. These records are represented in the Search Registration dialog that users see when clicking on the Matching Registrations Found hyperlink populated in the Matching Registrations field. If Vault creates only one (1) Registration Request record, it automatically sets the Is Selected field on that record to Yes. If there are multiple Registration Requests, Vault does not populate that field until the user selects a Registration. If users re-trigger the Local Impact Assessment on a Registration Item, Vault first deletes any Registration Requests previously created for the source Registration Item before creating new records.
  • Updates the Local Impact Assessment Job Status field to the current status of the job.

Configuring the Create Registration and Objective Action

The Create Registration and Objective action allows users to begin the appropriate registration process for the source Registration Item. When the Create Registration and Objective action runs, Vault does the following:

  • Validates that the outcome of the previously run Local Impact Assessment action is still applicable. If the values of the Matching Registration and Matching Registration Objective fields are no longer valid, Vault does not create or relate any new records and instead instructs users to re-trigger the Local Impact Assessment action.
  • Updates the Generate Registration and Obj Job Status field to the current status of the job.
  • Creates and relates the applicable Registration records based on the Registration Request records created when the Local Impact Assessment job ran. Records are created and related based on the values in the Matching Registration and Matching Registration Objective fields on the Registration Item record:
If Matching Registration is… And Matching Registration Objective is… Outcome
Blank Blank Vault creates and relates a new parent Registration record to a new child registration objective type of Registration record and relates the source Registration Item to the registration objective.
[Registration] Blank Vault creates a new child registration objective type of Registration and relates it to the matching parent Registration record and the source Registration Item. The existing Registration record is up-versioned.
[Registration] [Registration Objective] Vault relates the source Registration Item to the matching parent Registration and child registration objective type of Registration records. The existing Registration records are up-versioned.
Matching Registrations Found Any No records are created. Because multiple matching Registrations were found, users must first select an applicable Registration.

If the user did not previously trigger the Local Impact Assessment job to populate the Matching Registrations and Matching Registration Objective fields for the Registration Item, Vault creates and relates new Registration records.

Limitations

When the Local Impact Assessment action runs, Vault creates a maximum of 20 Registration Requests to match a source Registration Item to 20 Registrations. If there are more than 20 matches, the job fails.

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 following permissions:

  • For the Registration object: Create permission.
  • For the Registration Item object:
    • Edit permission on the Generate Registration and Obj Job Status, Generate Registration Data Job Status, and Local Impact Assessment Job Status fields.
    • Read permission on all fields defined in Registration Attribute components.
  • For the Registration Request object: Edit permission, including Edit permission on the Is Selected field.
  • If your Vault utilizes DAC for objects, users can only see Registration matches they have permission to Read.

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: Create, Edit Ability to make changes to permission sets for users.
Security Profile Object Workflows: Create, Edit Ability to create and modify new object workflows.
Security Profile Application: Vault Owner Actions: Vault Loader Ability to view and use the Loader tab.
Security Profile Application: Vault Owner Actions: Record Migration Ability to load object records (through Vault Loader or API only) in a lifecycle state other than Starting State.