Organizations using both a RIM Registrations Vault and a Quality QMS Vault can utilize the standard Quality to RIM Vault Connection for change control and variation management. This connection automates data sharing between the two applications, supporting change control initiation, regulatory assessment, and close out.
About the Quality to RIM Vault Connection
Often, organizations have multiple departments with disconnected systems and processes for change control and variation management. Within Vault, an organization may use a QMS Vault to ensure that a change to a product or system is introduced in a controlled and coordinated manner. The same organization may use a separate Registrations Vault to determine the impacted markets for that change and manage the filing updates and approvals for relevant Health Authorities. In such a case, separate systems can result in duplicate data entry and a lack of synchronization, which prolongs the process and results in changes occurring without a proper understanding of regulatory impact.
The Quality to RIM Vault Connection enables organizations using both a QMS Vault and a Registrations Vault to share and update data about change controls that have regulatory impact.
Connection Components
The components below support the standard Quality to RIM Vault Connection.
Connections
The following records are available from Admin > Connections:
- QMS RIM Connection (
qms_rim_connection__v) becomes available in your RIM Vault - QMS to RIM (
qms_to_rim__v) becomes available in your Quality Vault
You will still need to establish the Vault to Vault connection before you can use it.
Note: RIM Vaults also include the RIM Local Connection, which Vault uses to run source document publishing actions as the Application Owner. It must always remain active and does not require any Admin interaction.
Integration & Integration Points
The Integration and Integration Point objects enable Vault to manage the message queues and define what data the connection maps from one Vault to another. These records are read-only and are used by Vault to manage the connection and track any connection errors.
Note: The QMS RIM: Change Management integration is only available for configuration in Quality QMS Vaults and RIM Registrations Vaults. Admins can see these components in all RIM Vaults, but the integration only works for Registrations Vaults. As of 23R1, this integration will also be able to create Impacted Countries as long as all required fields are provided in the integration rule. Additionally, a new RIM-Quality: Product Integration has been added to create product-related records in Quality. These integrations can run independently or together.
The QMS RIM Connection record includes the following default Integration records with standard Integration Point records in your Quality Vault:
| Integration Name | Integration Point Name | Sent From | Sent To |
|---|---|---|---|
| QMS RIM: Change Management | New Change Event | Quality | RIM |
| QMS RIM: Change Management | Regulatory Impact Assessment Complete | RIM | Quality |
| QMS RIM: Change Management | Change Control Ready for Implementation | Quality | RIM |
| QMS RIM: Change Management | Country Filing Information Updated | RIM | Quality |
| QMS RIM: Change Management | Change Control Closed | Quality | RIM |
| QMS RIM: Change Management | Change Control Cancelled | Quality | RIM |
| RIM-Quality: Product Integration | Product Family | RIM | Quality |
| RIM-Quality: Product Integration | Product | RIM | Quality |
| RIM-Quality: Product Integration | Product Family Product | RIM | Quality |
| RIM-Quality: Product Integration | Product Variant | RIM | Quality |
| RIM-Quality: Product Integration | Complex Product Component | RIM | Quality |
The QMS RIM Connection record includes the following default Integration records with standard Integration Point records in your RIM Vault:
| Integration Name | Integration Point Name | Sent From | Sent To |
|---|---|---|---|
| QMS RIM Integration | New Change Event | Quality | RIM |
| QMS RIM Integration | Regulatory Impact Assessment Complete | RIM | Quality |
| QMS RIM Integration | Change Control Ready for Implementation | Quality | RIM |
| QMS RIM Integration | Country Filing Information Updated | RIM | Quality |
| QMS RIM Integration | Change Control Closed | Quality | RIM |
| QMS RIM Integration | Change Control Cancelled | Quality | RIM |
| RIM-Quality: Product Integration | Product Family | RIM | Quality |
| RIM-Quality: Product Integration | Product | RIM | Quality |
| RIM-Quality: Product Integration | Product Family Product | RIM | Quality |
| RIM-Quality: Product Integration | Product Variant | RIM | Quality |
| RIM-Quality: Product Integration | Complex Product Component | RIM | Quality |
Integration Rules
To support the Quality to RIM Vault Connection, it may be necessary to transform data from the source Vault’s data model to fit within the target Vault’s data model. You can use Integration Rules to incorporate configurable rules for mapping object fields between two Vaults. Learn more about creating and managing Integration Rules.
Standard Object State Types
Vault triggers updates from your Quality to RIM Vault Connection based on object lifecycle state types. When a record enters a lifecycle state associated with an object state type, Vault triggers the next step in the connection. This feature includes different object state types in both your QMS and Registrations Vaults.
QMS
The following object state types are applicable to lifecycles associated with the Quality Event (quality_event__qdm) object for change controls:
- Approved
- Cancelled
- Closed
The following object state types are applicable to lifecycles associated with the Impact Assessment (change_control_impact_assessment__v) object:
- Pending Regulatory Assessment
- Regulatory Assessment Complete
- Cancelled
Registrations
The following object state types are applicable to lifecycles associated with the Event (event__rim) object:
- Impact Assessment Complete
- Ready for Implementation
- Change Control Cancelled
- Change Control Complete
This following object state types are applicable to lifecycles associated with the Activity (activity__rim) object:
- Filing Required
- Filing Approved
- Filing Partially Approved
- Filing Rejected
- Submitted
- Implicit Approval
Lifecycle Actions
Lifecycle actions in both your QMS Vault and your Registrations Vault allow users to sync updated data between the two Vaults manually. You can set up these actions as either user actions or entry actions to fit your organization’s business processes.
| Vault | Applicable Object Lifecycle | Action Name |
|---|---|---|
| Quality | Impact Assessment | Update RIM Change Details |
| RIM | Event | Update QMS Impact Details |
| RIM | Activity | Update QMS Impacted Country Details |
Queues
This connection has six (6) standard message processing queues available: three (3) in your Quality Vault and three (3) in your RIM Vault. You can access and manage these queues from Admin > Connections > Spark Queues.
In your Quality Vault, you have:
- RIM to QMS Inbound queue (
rim_qms_inbound_queue__v) - QMS to RIM Outbound queue (
qms_rim_outbound_queue__v) - RIM to QMS Product Inbound queue (
rim_qms_product_inbound_queue__v)
In your RIM Vault, you have:
- QMS to RIM Inbound queue (
qms_rim_inbound_queue__v) - RIM to QMS Outbound queue (
rim_qms_outbound_queue__v) - RIM to QMS Product Outbound queue (
rim_qms_product_outbound_queue__v)
User Exception Objects
Vault includes the User Exception Message object and its child object, User Exception Item, to help you track and resolve any errors that occur with your connection. If either end of your integration can’t process an incoming message, Vault creates a User Exception Message record to capture the failure and individual User Exception Item records for each item that failed.
You can view and manage these messages from Admin > Connections > User Exception Messages. If you want specific users or groups to receive notifications when Vault creates User Exception Message records, you must create a custom lifecycle for the User Exception Message object and configure a notification entry action.
A User Exception Message means that you need to work with Veeva Services to update your configuration. After you update the connection configuration, you can resubmit the message that originally failed. Navigate to the User Exception Item record, open the Actions menu, and select Resubmit Message.
Configuring Quality for the Connection
Before configuring the Quality to RIM Vault Connection, you need to establish the Vault to Vault connection. To configure the standard connection, you must work with Veeva Services. The following steps need to be performed in your Quality Vault to configure the standard connection:
- Verify that the appropriate Integration records and associated Integration Points are Active in your Quality Vault. See details above on the Integrations and Integration Points available for this connection.
- Perform any additional steps to configure your Quality Vault for the QMS RIM: Change Management integration and the RIM-Quality: Product Integration.
- Add reference lookups for controlled fields within the integration scope. See details about this step below.
- Add the QMS RIM Notification User field to the object page layout of the Integration object.
Configuring Quality for Change Management
To configure the QMS RIM: Change Management integration, the following additional steps need to be performed in your Quality Vault:
- Update the Quality Event or Change Control, and Impact Assessment object lifecycles to reference the connection’s object state types. See details about this step below.
- Add the Update RIM Change Details action as a user or entry action to any relevant Impact Assessment object lifecycle states.
- Recommended: Configure atomic security on the Update RIM Change Details action so that users cannot execute this action until the change control has been approved.
- Add a Transactions related object section to the object page layout for the Change Control and Impacted Country objects.
Configuring Quality for Product Transfer
To configure the RIM-Quality: Product Integration, the following additional steps need to be performed in your Quality Vault:
- Add values to the Therapeutic Area (
therapeutic_area__v) picklist that exist for the same picklist in your RIM Vault. - Add reference lookups for the Therapeutic Area (
therapeutic_area__v) picklist. See details about this step below. - Optional: Add related object sections or fields to the object page layouts for the Product and Product Variant objects.
- Assign the Retry Transfer action to the User Exception Message object. See details on how to assign an action to an object.
Configuring RIM for the Connection
Before configuring the Quality to RIM Vault Connection, you need to establish the Vault to Vault connection. To configure the standard connection, you must work with Veeva Services. The following steps need to be performed in your RIM Vault to configure the standard connection:
- Verify that the appropriate Integration records and associated Integration Points are Active in your Quality Vault. See details above on the Integrations and Integration Points available for this connection.
- Perform any additional steps to configure your RIM Vault for the QMS RIM Integration and the RIM-Quality: Product Integration.
- Add reference lookups for controlled fields within the integration scope. See details about this step below.
- Recommended: Create a custom lifecycle for the User Exception Message object and configure an entry action to alert a specific user or group whenever Vault creates a User Exception Message record.
- Add the QMS RIM Notification User field to the object page layout of the Integration object.
Configuring RIM for Change Management
To configure the QMS RIM Integration, the following additional steps need to be performed in your RIM Vault:
- Update the Event and Activity object lifecycles to reference the connection’s object state types. See details about this step below.
- Assign the Update QMS Impact Details action to the Event object. Leave the Available in All Lifecycle States checkbox blank when setting up this action. See details on how to assign an action to an object.
- Add the Update QMS Impact Details action to only the appropriate Event object lifecycle states in your RIM Vault as a user action or an entry action. You must limit this action to the Event object types that are associated with the Quality to RIM Vault Connection.
- Assign the Update Impacted Country Details action to the Activity object. Leave the Available in All Lifecycle States checkbox blank when setting up this action.
- Add the Update Impacted Country Details action to only the appropriate Activity object lifecycle states in your RIM Vault as a user action or an entry action. You must limit this action to the Activity object types that are associated with the Quality to RIM Vault Connection.
- Enable system-managed naming for each Event join object, for example, Event Packaging. When using system-managed naming, ensure that Vault enforces a unique naming pattern or record creation may fail.
- Add a Transactions related object section to the object page layout for the Event and Activity objects.
Configuring RIM for Product Transfer
To configure the RIM-Quality: Product Integration, the following additional steps need to be performed in your Quality Vault:
- Deprecate the Abbreviation (
abbreviation__c), Generic Name (generic_name__c), and Therapeutic Area (therapeutic_area__c) custom fields on the Product Family object and the Dosage Form (dosage_form__c) picklist. These need to be replaced with standard equivalents. - Populate the new standard fields of existing Product Family records with the current values of the deprecated custom fields.
Using Object State Types
Vault triggers updates from your connection based on object lifecycle state types. When a record enters an active lifecycle state associated with one of the standard object state types, Vault triggers the next step in the connection.
Object state types must be mapped to lifecycle states for the appropriate object lifecycles. Lifecycle states must be active in order to trigger the connection to update. If your current lifecycle doesn’t have enough states, you’ll need to add new states to your lifecycle before assigning them to state types.
To assign a state to an object state type:
- Navigate to Admin > Configuration > Object Lifecycles > {Object Lifecycle} > {State Type}.
- Click Edit.
- Select a State from the drop-down. This drop-down only shows states that are not already assigned to an object state type.
- Click Save.
Configuring Reference Lookups
Reference lookups are a configuration component referenced by integration rules that allow you to map the value of a field in the target Vault indirectly from a value in the source Vault. When you configure the connection, you need to add reference lookups for controlled fields within the integration scope.
For example, you need to add reference lookups in your Quality Vault to enable the mapping of Country records and regulatory Activity lifecycle states. See Creating & Managing SDK Reference Lookups for detailed instructions.
Connection Limitations
Currently, the Quality to RIM Vault Connection supports a single Quality Event or Change Control record and a single Impact Assessment record in the QMS Vault to be linked to a single Event record in the Registrations Vault. See Standard Vault to Vault Connection Limitations for a list of limitations or errors that impact your connection.
Troubleshooting the Connection
There may be instances where you need to switch the target Vault for your Quality to RIM Vault Connection. In order for the connection to function properly, you should inactivate Transaction and Transaction Log records in your Quality Vault before resuming use of the connection.
Related Permissions
You need a System Admin security profile as well as the following permissions to set up the standard Quality to RIM Vault Connection:
| Type | Permission Label | Controls |
|---|---|---|
| Security Profile | Admin: Application: Manage Connections | Ability to set up the standard Quality to RIM Vault Connection |
| Security Profile | Object: User Exception Item, User Exception Message: Read | Ability to see User Exception Item and User Exception Message records if a connection failure occurs |