Configuring Formulation Questionnaire Import (Compliance Management)

Compliance Management provides users with the ability to automate the creation of Qualitative Assessment records by importing formulation questionnaire data into Qualitative Assessments. Users can review responses from completed questionnaires (FQ Checklists) with automatically-assigned regulated categories and statuses, then select which responses to convert into Qualitative Assessments for the related Formulation. Users can view generated Qualitative Assessments in the Formulation Composition Viewer.

You must configure formulation questionnaires, set up checklists for formulation questionnaires, and configure the Formulation Composition Viewer before completing the steps in this article.

Formulation Questionnaire Import Objects

Compliance Management uses the following core objects and object types to support importing formulation questionnaires:

Formulation Questionnaire (formulation_questionnaire__v): This object represents a Formulation that requires a questionnaire and can target a location and industry, specifying how Vault identifies which Checklist Design record to instantiate for each Formulation record.
FQ Checklist (fq_checklist__sys): This type of checklist targets the Formulation Questionnaire object. Each record is an individual formulation questionnaire and represents an instantiated Checklist Design related to a target Formulation Questionnaire record.
Qualitative Assessment (compliance assessment__v): This object represents the compliance status of a formulation’s regulated category.
Response Mapping Strategy (response_mapping_strategy__v): This object represents a mapping strategy for questionnaire responses and identifies responses respondents can submit for a questionnaire.
FQ Regulated Category Mapping (fq_regulated_category_mapping__v): This object maps Response Mapping Strategies to Regulated Categories and Compliance Assessment Statuses.

Note: In Vaults created prior to 22R3, the Qualitative Assessment object may be labeled Compliance Assessment.

Configuration Overview

Configuring your Vault to import formulation questionnaires involves the following steps:

Configure objects
Define response mappings to determine how Vault creates Qualitative Assessments for imported formulation questionnaire data
Review how Vault imports questionnaire data to determine your Vault’s import behavior for matching records
Configure the Import Questionnaire action
Configure user permissions

Note: Depending on your Vault’s creation date and which features are currently enabled and configured, some of the steps described in this article may be unavailable or already complete in your Vault.

Configuring Formulation Questionnaire Import Objects

You must make the following changes to object fields and layouts:

Enable system-managed naming for the Qualitative Assessment object.
Add the Name field to the Qualitative Assessment object layout.
Add the Imported field to the FQ Checklist object layout.

We also recommend adding the Question Text field as a lookup field from the Question Design object to the FQ Regulated Category Mapping object.

Defining Response Mappings

You must create Response Mapping Strategies and FQ Regulated Category Mappings to instruct Vault how to generate Qualitative Assessments from formulation questionnaire responses. First, create Response Mapping Strategies that identify expected responses. Second, link those strategies to FQ Regulated Category Mappings to define how Vault creates and populates Qualitative Assessment records based on specific responses in FQ Checklists.

You do not have to create Response Mapping Strategies for each response and Regulated Category combination. Instead, you can link the same Response Mapping Strategy to multiple FQ Regulated Category Mappings.

Example Use Case

Configure a checklist with the question “Is your product listed on the Toxic Substance Control Act (TSCA)?” with possible responses “Listed”, “Not Listed”, and “Exempt”. For this response, you only want to create Qualitative Assessments for the “TSCA” Regulated Category for “Listed” responses. To do this, create the following records to define response mapping:

A Response Mapping Strategy for the Multiple Choice Question question type with the following values:
- Name: “Listed”
- Answer Text: “Listed”
An FQ Regulated Category Mapping with the following values:
- Regulated Category: “TSCA”
- Response Mapping Strategy: “Listed”
- Compliance Assessment Status: “Y”
- Mapping Priority: “1”

When a user imports a completed questionnaire to review for Formulation “HEXACRON-DOS” with a response of “Listed” for the “Is your product listed on the Toxic Substance Control Act (TSCA)?” question, Vault assigns that response the Regulated Category value of “TSCA” and the Compliance Assessment Status value of “Y”. If the user then selects that response to import, Vault will create a new Qualitative Assessment with the assigned values for the “HEXACRON-DOS” Formulation.

If the questionnaire had a response of “Not Listed” or “Exempt” for that question, Vault would not create a Qualitative Assessment for that response when the user imported the questionnaire.

Creating Response Mapping Strategies

Response Mapping Strategies define expected responses for multiple choice and number types of Question Designs included in questionnaires. You must create Response Mapping Strategies for all multiple choice and number types of responses you want to allow users to import and convert to Qualitative Assessments. You can only create mapping strategies for responses to multiple choice and number types of Question Designs.

To create a Response Mapping Strategy:

Navigate to Business Admin > Objects > Response Mapping Strategies.
Click Create.
In the Create Response Mapping Strategy dialog, select Multiple Choice Question or Number Question to specify the type of question this response defines.
Click Continue.
Enter a Name.
Define the response depending on the type of question:
- For Multiple Choice Questions, enter the Answer Text you want to map. This text must exactly match the Answer Text in the applicable Available Answer Design.
- For Number Questions, define the numeric range (0 - 100) of responses to map to by entering values in the Greater than or equal and Less than or equal fields. You must enter a value for at least one (1) of the fields.
Click Save, or to create another Response Mapping Strategy for the same type of question, click Save + Create.

Creating FQ Regulated Category Mapping

FQ Regulated Category Mappings map a specific response defined in a Response Mapping Strategy to a Regulated Category and a Compliance Assessment Status. You can also map the response to a specific Question Design in addition to the category and status. When users import questionnaires on completed FQ Checklists, Vault populates the Regulated Category and Compliance Assessment Status fields on generated Qualitative Assessments based on these mappings. You must have already created Response Mapping Strategies to be able to create FQ Regulated Category Mappings.

To create an FQ Regulated Category Mapping:

Navigate to Business Admin > Objects > FQ Regulated Category Mappings.
Click Create.
Optional: Limit this mapping to a response to a specific question:
- Select a Checklist Design to filter the list of sections and questions you can select.
- Optional: Select a Section Design to filter the list of questions you can select.
- Select an active Question Design to which apply this mapping. Selecting a value for this field automatically populates the Question Text field.
Select a Regulated Category to define how Vault will populate this value on generated Qualitative Assessments when a questionnaire response is equal to the specified Response Mapping Strategy.
Select a Response Mapping Strategy to identify the response you are mapping.
Select a Compliance Assessment Status to define how Vault will populate this value on generated Qualitative Assessments when a questionnaire response is equal to the specified Response Mapping Strategy. You can select any value included in the Compliance Assessment Status picklist.
Enter a Mapping Priority to define how Vault handles multiple mapped values to a single multiple choice question and multiple mapped value ranges for a single response to a number question. In these scenarios, Vault only considers the FQ Regulated Category Mapping with the highest priority, with “1” being the highest priority.
Click Save, or to create another FQ Regulated Category Mapping, click Save + Create.

How Vault Imports Questionnaire Data

The Import Questionnaire action on the FQ Checklist object allows users to import questionnaire data and convert responses into Qualitative Assessments based on active FQ Regulated Category Mappings. Vault creates new Qualitative Assessments and inactivates or updates matching Qualitative Assessments depending on your Vault’s import behavior for matching records. Vault automatically populates the following fields on generated records:

Formulation: The Formulation of the related Formulation Questionnaire.
Regulated Category: Based on FQ Regulated Category Mappings.
Compliance Assessment Status: Based on FQ Regulated Category Mappings.

After users finish importing a questionnaire, Vault updates the Imported field to “Yes” on the FQ Checklist record so users can easily determine which questionnaires they’ve already imported.

Import Behavior for Matching Records

When generating new records based on questionnaire import, Vault does not create duplicate Qualitative Assessment records for a given Formulation and Regulated Category. By default, Vault inactivates any existing matching Qualitative Assessment records and replaces them with new Qualitative Assessment records based on imported response data.

Note: You can change the import behavior of your Vault to update matching Qualitative Assessment records based on imported response data rather than inactivating and replacing them. Contact your Veeva Representative for more details.

Inactivate & Replace Matching Records

By default, Vault creates new Qualitative Assessment records and replaces any matching Qualitative Assessments based on imported response data. When users finish importing a questionnaire, Vault:

Creates new Qualitative Assessments for all user-selected responses.
Inactivates all matching Qualitative Assessments and clears the Regulated Category (Internal Name) field so the records will not appear in the Formulation Composition Viewer.

Note: Formulation questionnaire import will fail if you use a lifecycle on the Qualitative Assessment object and your Vault inactivates and replaces matching records based on imported response data.

Update Matching Records

If you have enabled the update existing records behavior in your Vault, Vault creates new Qualitative Assessment records and updates any matching Qualitative Assessments based on imported response data. When users finish importing a questionnaire, Vault does the following:

Creates new Qualitative Assessments for any user-selected responses that do not match active Qualitative Assessments.
Updates the Compliance Assessment Status field on any active matching records based on FQ Regulated Category Mappings.
Deletes any inactive matching records.

Configuring the Import Questionnaire Action

You must configure the Import Questionnaire action as a record action on the FQ Checklist object. The action only displays in the All Actions menu of an FQ Checklist (formulation questionnaire) when it is in a lifecycle state associated with the Complete State state type.

When users run the Import Questionnaire action on a completed questionnaire, Vault lists all mapped responses on the Import Questionnaire page and displays the Regulated Categories and Compliance Assessment Statuses, which are automatically assigned based on your response mappings. Users can review responses with the assigned category and status, then select which responses to import and convert into Qualitative Assessments.

Review the following behavior regarding the process of how Vault displays details on the Import Questionnaire page when users run the Import Questionnaire action:

Regulated Category and Compliance Assessment Status columns display values based on active response mappings.
All responses are displayed, including unmapped responses that you cannot convert into Qualitative Assessments. Unmapped responses are not assigned Regulated Category or Compliance Assessment Status values.
If a question has multiple mapped responses, Vault displays only the response with the higher priority.
If a question has multiple responses, none of which are mapped, Vault displays a single response and does not assign Regulated Category or Compliance Assessment Status values.

Limitations

Formulation questionnaire import does not support lifecycle enablement on the Qualitative Assessment object.

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 permissions outlined below:

For the Qualitative Assessment object: Create permission
For the FQ Checklist object: Read permission
Pages: Import Questionnaire: View

You can complete all 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 Lifecycle: Edit	Ability to modify object lifecycles.
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.