Configuring Local Impact Assessments (Registration & Dossier Management)

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 and Registration Objectives 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.

After configuring your Vault for Local Impact Assessments, you can configure Global Change Impact Assessments.

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 Objective (registration_objective__v): This Registration object type represents a snapshot of a registration and the related Registration Items at a specific point in time.
  • 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.
    • Non-Registration Dossier (nonregistration_dossier__v): This Registration Item object type represents a dossier not typically meant for submission to authorities.
    • Product Registration Item (product_registration_item__v): This Registration Item object type represents a dossier intended for submission to register a product.
  • 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:

  1. Configure objects and object layouts
  2. Populate Registration Item records with the appropriate values
  3. Create Registration Attributes
  4. Create Regulated Category Attribute Impacts to define how Vault identifies matches and which matches require amendments
  5. Configure actions on the Registration Item object
  6. Define Local Impact Assessment Lifecycle Rules
  7. Configure user permissions

Configuring Local Impact Assessment Objects

You must configure several objects to support Local Impact Assessments:

  • Ensure that the Name field on the Registration object is system-managed on all object types.
  • Assign the following fields to all relevant Registration Item object types:
    • Generate Registration Data Job Status
    • Local Impact Assessment Job Status
    • Create Registration and Obj Job Status
  • Add the following fields to the Registration Item object 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 run by the associated object actions:
      • Generate Registration Data Job Status
      • Local Impact Assessment Job Status
      • Create Registration and Obj Job Status

Adding Matching Control Fields

You must add the Matching Registration and Matching Registration Objective control fields to the Registration Item object layout so that users can see relevant matches when they run the Local Impact Assessment action.

Defining an Object Mapping with Field Mappings

You can define an Object Mapping with Field Mappings to map fields from the Registration Item source object to the Registration target object and then select that Object Mapping in the Matching Registration control field. These Field Mappings appear as default filters in the Search: Registration dialog when users select an unmatched Registration. The dialog does not support mapping Long Text fields and always includes the following default filter: Type equals Registration Objective.

See Defining Object Mappings & Field Mappings for more details about how to create an Object Mapping.

Configuring Matching Control Fields

To add these fields:

  1. Navigate to Admin > Configuration > Objects > Registration Item > Layouts.
  2. Open the applicable layout.
  3. Select the Matching Registration control field with the slider (Slider Icon) icon.
    1. Optional: Enter Help text to customize the label and tooltip text that appears to users for this field.
    2. Optional: For Registration Grid Columns, select up to ten (10) active supported Registration object fields to display to users in the Search Registration dialog. The Name field always displays as the first column, so you do not have to add it. Drag and drop the fields to determine the order the columns display to users.
    3. Optional: Select Lifecycle States to Ignore to exclude Registrations in certain lifecycle states from appearing to users in the Search: Registration dialog to select an unmatched record for a Registration Item. This drop-down includes all active lifecycles on the Registration object.
    4. Optional: Select Object Mapping for Default Registration Filtering. This drop-down includes all active Object Mappings that map the Registration Item source object to the Registration target object to allow users to filter search results in the Search: Registration dialog based on the selected mapping.
    5. Click Done.
  4. Add the Matching Registration Objective control field with the slider (Slider Icon) icon. You can define Local Impact Assessment Lifecycle Rules to specify certain lifecycle states Vault ignores when populating this field with matching records.
    1. Optional: Enter Help text that displays to users for this field.
    2. Click Done.
  5. Click Save.

Supported Fields & Field Types

Vault supports the Lifecycle State (state__v) field and the following object field types in the Registration Grid Columns field:

  • Date
  • Name
  • Number
  • Object (excluding references to the Document and User objects)
  • Picklist
  • Text
  • Yes/No
  • Lookup (so long as the type is a supported type listed above)

Configuring Registration Object Types

If you set up object types for the Registration object, you must assign the fields you include in the Registration Grid Columns field for the Matching Registration control field to the applicable Registration object types. Vault does not display field values to users for any fields you do not assign to the applicable object types.

Configuring the Regulated Category Object Layout

You can insert 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 run 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 runs. See Defining Registration Attributes for more details.

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 Business Admin > Objects > Regulated Category Attribute Impacts.
  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:

To configure these actions, you must first assign them to the Registration Item object. 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 blank 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 specified fields with no existing values on the source Registration Item record based on Relational Token resolution. Vault only populates blank fields. If any specified field is already populated, Vault preserves the existing value. 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 and Registration Objectives 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.

You can define Local Impact Assessment Lifecycle Rules so that Vault ignores matching Registration records in specified lifecycle states when populating the Matching Registration Objective control field.

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. 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 rerun 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 you configure the action as a user action on Registration lifecycle states, you can optionally define which types of records Vault generates when users run the action.

You can define Local Impact Assessment Lifecycle Rules so that Vault ignores matching Registration records in specified lifecycle states when populating the Matching Registration Objective control field.

When the Create Registration and Objective action runs, Vault does the following:

  • Updates the Create Registration and Obj Job Status field to the current status of the job.
  • If the Regulatory Process Type is New, Vault searches for an active Registration Item in the applicable lifecycle states with the same Regulated Category and attributes. When applicable, Vault assigns the same Registration Objective. If multiple Registration Items exist with the same attributes, Vault assigns the Registration Objective with the highest Objective Number. If multiple records have the same Objective Number, Vault assigns the most recently created record.
  • If there are no matching Registration Objectives, Vault creates and relates the applicable Registration records based on the Registration Request records created when the Local Impact Assessment job ran. If the action runs as a user action and you’ve configured object types for the user action, Vault generates records of the specified Registration object type. 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 Registration Objective record and relates the source Registration Item to the Registration Objective.
[Registration] Blank Vault creates a new child Registration Objective 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 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 run 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.

How to Configure the Create Registration and Objective User Action

When configuring the Create Registration and Objective user action on a Registration Item lifecycle state, you can specify which Registration object types Vault generates when the action runs, allowing users to differentiate between generated registrations. To do this, select values for the following optional fields when configuring the action on specific Registration Item lifecycle states:

  • Registration Object Type: Select the name of an active object type to specify which object type of Registrations Vault generates when the action runs.
  • Registration Objective Object Type: Select the name of an active object type to specify which object type of Registrations Vault generates when the action runs.

For the selected object types, ensure you assign all relevant fields, including the Type field. For Registration Objectives, this also includes the Registration and Version fields.

If you do not want Vault to assign a specific object type to generated Registrations, leave the applicable field blank. Vault will generate those records in the default Registration object type.

Define Local Impact Assessment Lifecycle Rules

You can define Local Impact Assessment Lifecycle Rules component types to specify which Registration lifecycle states Vault ignores when populating the Matching Registration Objective control field when users run the Local Impact Assessment and Create Registration and Objective actions. For example, you can create a rule that specifies Vault ignores matching Registration Objectives in Cancelled state since the work on those objectives is complete.

To define these lifecycle rules:

  1. Navigate to Admin > Configuration > Local Impact Assessment Lifecycle Rule.
  2. On the All Local Impact Assessment Lifecycle Rules page, click Create.
  3. Enter a unique Name. Vault adds the __c suffix to the Name you enter.
  4. Select a Lifecycle. This drop-down displays active lifecycles on the Registration object.
  5. Select a Lifecycle State. This drop-down displays active lifecycle states for the specified Lifecycle.
  6. Click Save.
  7. Repeat these steps for each lifecycle state you want Vault to ignore.

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. Users must also have Read permission on the fields you added as Registration Grid Columns on the Matching Registration control field. If any of the Registration Grid Column fields are object references, users must also have Read permission on those objects.
  • For the Registration Item object:
    • Edit permission on the Create Registration and Obj Job Status, Generate Registration Data Job Status, and Local Impact Assessment Job Status fields.
    • Read permission on all fields specified in Registration Attribute components.
    • To run the Create Registration and Objective action, users must also have Read permission on the Regulated Category field.
  • For the Registration Request object: Edit permission, including Edit permission on the Is Selected field.
  • If your Vault utilizes DAC for objects or Atomic Security on the Registration object, users can only see Registration matches and Registration fields 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: Object Workflows: Create, Edit Ability to create and modify new object workflows.
Security Profile Admin: Configuration: Objects: Create, Edit Ability to create and modify Vault objects.
Security Profile Admin: Security: Permission Sets: Edit Ability to modify permission sets for users.
Security Profile Application: Vault Owner Actions: Vault Owner Actions: Vault Loader Ability to view and use the Loader tab.
Security Profile Application: Vault Owner Actions: Vault Owner Actions: Record Migration Ability to load object records (through Vault Loader or API only) in a lifecycle state other than Starting State.