Veeva QMS provides External Collaboration Checklists that let your organization gather information about a supplier’s business, capabilities, compliance, and risk profile. Using External Collaboration and checklist functionality, you can grant an external collaborator access to a checklist in your Vault, and revoke that access when they are finished providing their responses.
You can configure External Collaboration Checklists to allow for a review process that includes the ability for reviewers and other internal stakeholders to ask follow-up questions that external collaborators must answer. You can also allow external collaborators to invite additional respondents, who can access the checklist and provide responses via an externally accessible link. This is useful in situations where an external collaborator needs input from Subject Matter Expert colleagues.
If your organization does not require a review and follow-up process for External Collaboration Checklists, you can instead follow the steps in Configuring External Collaboration for Checklists.
Supported Objects
The following objects and their respective checklists are supported for External Collaboration Checklists with Follow-Ups and Additional Respondents:
- Audit
- Organization
- Qualification
Configuration Overview
Depending on your organization’s business needs, the process to configure External Collaboration Checklists with Follow-Ups and Additional Respondents includes the following steps:
- Activate object types on the Checklist Design object and configure a layout for each object type.
- Optional: Update your Quality Teams configuration for the target object to add a Checklist Reviewer role, and configure Related Object Security for the relevant checklist object.
- Create a Quality External User Template for the external collaborator who will complete checklists. Select Application Role as the Security Model and select the External Collaborator - Checklists application role.
- Activate the Collaborate Externally? and External Collaborator fields on the target object, assign them to the relevant object types, and add them to the layout for relevant object types.
- Add roles to the target object lifecycle and target checklist object lifecycle and grant the roles appropriate lifecycle permissions.
- Configure the QMS: Activate Ext. Collaborator, Start checklist, and QMS: Inactivate Ext. Collaborator actions on the target object lifecycle. Ensure the QMS: Activate Ext. Collaborator action is configured to run before the Start checklist action. You can also optionally configure the Reassign External Collaborator action.
- Configure the appropriate workflow for the target checklist object.
- Configure user permissions.
- Create a Checklist Design record and design your checklist. Ensure you select the Allow Additional Respondents (PAL) and Allow Follow-ups checkboxes on the Checklist Design record.
- Create a Person record for the external collaborator and specify their Organization.
Configuring the Checklist Design Object
On the checklist design object, activate the following object types, as needed:
| Checklist Design Object Type | Corresponding Object and Object Type |
|---|---|
| AQ Checklist Design | Qualification: Asset Qualification |
| EO Checklist Design | Organization: External Organization |
| External Audit Checklist Design | Audit: External Audit |
| External Site Checklist Design | Organization: External Site |
| IO Checklist Design | Organization: Internal Organization |
| Inspection Checklist Design | Audit: Inspection |
| MQ Checklist Design | Qualification: Material Qualification |
| PQ Checklist Design | Qualification: Product Qualification |
| Part Qualification Checklist Design | Qualification: Part Qualification |
| SQ Checklist Design | Qualification: Service Qualification |
| Supplier Checklist Design | Organization: Supplier |
| Supplier Site Checklist Design | Organization: Supplier Site |
Once the relevant checklist design object types are active, create a layout for all relevant object types and add the following fields:
- Allow Additional Respondents (PAL): Selecting this field on a Checklist Design allows an external collaborator to send the checklist to additional external parties to provide responses.
- Allow Follow-ups: Selecting this field on a Checklist Design allows users to initiate a review and follow-up process for a checklist once an external collaborator has provided their initial responses.
Add values for all checklists you plan to use to the Checklist Type picklist. This makes the checklist type available for selection when configuring the Start checklist user or entry action.
Configuring Object Lifecycles
Add the following roles to the target object and target object checklist lifecycles (for instance, the Organization Lifecycle and Organization Checklist Lifecycle):
- Checklist Reviewer
- External Collaborator
Ensure each role has the necessary permissions in the relevant states of the target object and target object checklist lifecycles. The following table outlines the minimum permissions required in relevant lifecycle states to complete a follow-up process involving an external collaborator and additional respondents.
| Role | Target Object Lifecycle | Target Object Checklist Lifecycle |
|---|---|---|
| External Collaborator | Read permission in appropriate task state | Read and Edit permissions in the In Progress and In Follow-Up states |
| Checklist Respondent | Not required | Read and Edit permissions in the In Progress and In Follow-Up states |
| Checklist Reviewer | Read and Edit permissions in lifecycle states, as required | Read and Edit permissions in the In Review state |
| Supplier Questionnaire Respondent | Not required | Read and Edit permissions in the In Progress and In Follow-Up states |
Configuring Object Workflows
You must configure the Accepted or Pending Acceptance workflows for the relevant target checklist object to allow follow-ups and additional respondents. For instance, if the target object is Organization, configure the Organization Accepted or Organization Pending Acceptance workflows. Configure an Accepted workflow if users will initiate the Start checklist action via a user action, and configure a Pending Acceptance workflow if the Start checklist entry action will be initiated automatically via a lifecycle state change.
We recommend the following workflow configuration for this feature:
- Start Step:
- Create a Participants control, Checklist Respondents, and select Use roles as participants. Add the Checklist Respondent and External Collaborator roles.
- Create another Participants control, Checklist Reviewers, and select Use roles as participants. Add the Checklist Reviewer role.
- Add Supplier Questionnaire Respondent: Create a system action step and select the Set Supplier Questionnaire Respondent system action.
- Add Checklist Reviewer: Create a system action step and select the Set Checklist Reviewers system action.
- Add External Collaborators: For the Accepted workflow only, create a system action step and select the Set External Collaborators system action.
- Change state to In Progress: Configure an action step to set the lifecycle state to In Progress.
- Accept and Complete Checklist: Create a required task step assigned to the Checklist Respondent participant group to accept and complete the checklist, and select Make available to users in participant group and Complete task assignment without viewing under the Task Requirements section.
- Validate Checklist: Configure a system action step and select the Validate Checklist is Complete system action.
- Change state to In Review: Configure an action step to set the lifecycle state to In Review.
- Review Checklist: Configure a required task step assigned to the Checklist Reviewer participant group and select Assign to all users in participant group and Prompt for Verdicts. Add two verdicts: Follow-up Required and Checklist Complete.
- Follow-up Required?: Create a decision step with the following conditions:
Checklist Follow-Ups Required:
- Checklist follow-ups are unanswered: Configure a system action step and add the Validate Follow-up response is pending system action. This system action ensures that follow-up questions exist.
- In Follow-Up: Configure an action step to change the state of the checklist to In Follow-Up.
- Supplier Follow-Up: Create a task step assigned to the Checklist Respondent participant group and select Assign to all users in participant group.
- Checklist Follow-Up answered: Create a system action step and select the Validate all Follow-ups are answered system action. This system action ensures that all follow-up questions have been responded to. Set the next step to Change State to In Review.
Validate and Finalize Checklist:
- Validate and Finalize Checklist: Create a system action step and select the Validate checklist is Complete system action.
- Validate Follow-Ups: Create a system action step and select the Validate all Follow-ups are answered system action. This system action ensures that all follow-up questions have been responded to, or, if no follow up is required, ensures that follow-up questions have not been created.
- Set Respondent Field: Create a system action step and select the Set Respondent Field system action.
- Inactivate PAL: Create a system action step and select the Inactivate Supplier Questionnaire PAL system action.
- Set Checklist to Completed: Create an action step to change the lifecycle state of the checklist to Completed or the equivalent state.
Configuring User Permissions
External Collaborators and Reviewers must have the following permissions to complete or review checklists:
- For the Checklist Follow-up Question object: External collaborators must have Read permission, and reviewers must have Read and Edit permissions
- For the Checklist Follow-up Response object: External Collaborators must have Read and Edit permissions, and reviewers must have Read permission
- All required permissions to complete checklists
- External collaborators must have Read permission on the target object
- Under Permission Sets > Application: Participate and E-Signature permissions for Workflow, and View User Information and View User Profile permissions for User
- Under Permission Sets > Tabs: View access for the Home tab
Related Permissions
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 Lifecycles: Create, Edit | Ability to create and 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. |
| Security Profile | Objects: User Role Setup: Create, Edit, Delete | Ability to create and modify User Role Setup records. |