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.
Note: These components are available for configuration in Quality QMS Vaults and RIM Registrations Vaults. Admins can see these components in all RIM Vaults, but the connection only works for Registrations Vaults.
Connections
The following records are available from Admin > Connections:
- QMS RIM Connection (
qms_rim_connection__v) becomes available in your Registrations Vault - QMS to RIM (
qms_to_rim__v) becomes available in your QMS Vault
Note that you’ll still need to establish the Vault to Vault connection before you can use it.
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.
The QMS RIM Connection includes a default Integration (integration_sys) record. This is labelled QMS RIM Integration (qms_rim_integration__v) in your Registrations Vault and QMS-RIM: Change Management (qms_rim_change_management__v) in your QMS Vault.
This integration includes the following standard Integration Point records:
| Name | Sent From | Sent To | Included Data |
|---|---|---|---|
| New Change Event | QMS | Registrations | Quality Event ID, Impact Assessment ID |
| Regulatory Event Created | Registrations | QMS | Event ID, Impact Assessment ID |
| Regulatory Impact Assessment Complete | Registrations | QMS | Event ID, Country-specific Activity IDs |
| Change Control Ready for Implementation | QMS | Registrations | Quality Event ID |
| Country Filing Information Updated | Registrations | QMS | Country-specific Activity ID |
| Change Control Closed | QMS | Registrations | Quality Event ID |
| Change Control Cancelled | QMS | Registrations | Quality Event ID |
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 Spark Integration Rules to incorporate configurable rules for mapping object fields between two Vaults. Learn more about creating and managing Spark 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
This 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 |
|---|---|---|
| QMS | Impact Assessment | Update RIM Change Details |
| Registrations | Event | Update QMS Impact Details |
Queues
This feature includes four (4) standard message processing queues: two (2) in your QMS Vault and two (2) in your Registrations Vault. You can access and manage these queues from Admin > Configuration > Queues.
In your QMS Vault, you have:
- RIM to QMS Inbound queue (
rim_qms_inbound_queue__v) - QMS to RIM Outbound queue (
qms_rim_outbound_queue__v)
In your Registrations Vault, you have:
- QMS to RIM Inbound queue (
qms_rim_inbound_queue__v) - RIM to QMS Outbound queue (
rim_qms_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 created 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 the Quality to RIM Vault Connection
Note: This section discusses the configuration required for the standard Quality to RIM Vault Connection. To configure any additional data mapping outside of the standard connection, you must work with your Customer Success Manager or Veeva Services.
You must complete the following steps in both your QMS Vault and your Registrations Vault to configure the connection:
- Establish the Vault to Vault connection between your QMS Vault and your Registrations Vault. See Creating & Managing Connections for detailed instructions.
- Ensure the QMS RIM Integration record and related Integration Point records are Active.
- Update your object lifecycles to reference the connection’s object state types. See details about this step below.
- Add the Update RIM Change Details action to any relevant Impact Assessment object lifecycle states in your QMS Vault. You can configure this action as a user action or an entry action. We recommend that you don’t make this action available to users after the change control has been approved.
- Assign the Update QMS Impact Details to the Event object. Leave the Available in All Lifecycle States checkbox blank when setting up this action. Next, add the Update QMS Impact Details action to only the appropriate Event object lifecycle states in your Registrations 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.
- Enable system-managed naming for each Event join object, for example, Event Packaging. Alternatively, you could configure an integration rule on the Name field for each object, but we recommend system-managed naming. When using system-managed naming, ensure that Vault enforces a unique naming pattern or record creation may fail.
- Add reference lookups for controlled fields within the integration scope. See details about this step below.
- We recommend creating 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 Integration object page layout.
If you don’t complete these steps in both Vaults, the connection will not work.
Using Object State Types
Vault triggers updates from your connection based on object lifecycle state types. When a record enters a lifecycle state associated with one of the standard object state types, Vault triggers the next step in the connection.
Examine your object lifecycles for the Quality Event and Change Control Impact Assessment objects in your QMS Vault and the Event and Activity objects in your Registrations Vault. You should map the standard object state types must be mapped to states in those objects’ lifecycles. If your current lifecycle contains enough states to assign one state to each object state type, you are ready to assign object state types. If your current lifecycle doesn’t have enough states, you’ll need to add new states to your lifecycle first.
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, in order for Vault to transfer records from one Vault to the other, you need to create object type reference lookups to map the Change Control type or the Impact Assessment type to the target regulatory Event object type. You need to add additional reference lookups in the QMS 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 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.
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 |