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 document and 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.
- Maintain RIM product data in Quality.
- Exchange Steady State document and field updates via CrossLinks.
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 message processing 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 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 can create Impacted Countries as long as all required fields are provided in the integration rule.
- The Product Transfer integration can create product-related records in Quality.
- The Document Exchange integration allows Steady-state CrossLinked documents and fields to be created and maintained across Quality and RIM.
These integrations can run independently or together.
Quality Integrations & Integration Points
The QMS to RIM (qms_to_rim__v) 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 |
| Quality/RIM Document Integration | RIM Documents Outbound | Quality | RIM |
| Quality/RIM Document Integration | RIM Documents Inbound | RIM | Quality |
RIM Integrations & Integration Points
The QMS RIM (qms_rim_connection__v) 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 | Regulatory Event Created | 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 |
| RIM/Quality Document Integration | Quality Documents Outbound | RIM | Quality |
| RIM/Quality Document Integration | Quality Documents Inbound | Quality | RIM |
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.
We also deliver standard Integration Rules for various Vault Connections. Navigate to Admin > Connections > Integration Rules for a current inventory in your Quality and RIM Vaults.
Integration Field Rules
Vault Connections use Integration Field Rules to ensure specific object and document fields are populated and maintained. When we deliver a standard Integration, we also include standard Integration Field Rules, however you may need to create additional custom field rules. Navigate to Admin > Connections > Integration Rules > [Integration Rule] > Field Rules for a current rule inventory for each connection in your Quality and RIM Vaults.
Integration Field Rules for Document Exchange
The Integration Rules provisioned for the document exchange integration include standard Integration Field Rules. As part of integration configuration, you’ll create additional rules to handle any additional Quality or RIM document fields the integration should populate and maintain.
To do this, add field rules to the quality_rim_inbound_documents__v (Quality) and quality_rim_inbound_documents_ir__v (RIM) Integration Rules with the below high-level requirements. Object reference fields require you to first create a Reference Lookup.
- Target Object: Document
- Target Doc Field: The document field to be populated and maintained in this Vault.
- Label and Name: The auto-populated target document field UI label and API name. We recommend maintaining the auto-populated values.
- Text fields:
- Query Object: Document
- Query Field: The outbound document field name to which the Target Doc Field (inbound document field) is mapped, for example
approved_date__c.
- Picklist fields:
- Create a Reference Lookup for the picklist field.
- Reference Lookup Type: Generic
- Reference Lookup: The reference lookup you created for this picklist.
- Query Object: Document
- Query Field: The source picklist field.
- Object fields (except Product Family, Product, and Product Variant):
- Create a Reference Lookup for the object
- Reference Lookup Type: Object
- Reference Lookup: The reference lookup you created for this object field.
- Query Object: Document
- Query Field: The source object field.
Product-Related Field Rules for Document Exchange
- Product Variant mapping:
- Query Object:
document_product_detail__vr - Query Field: Global ID (
global_id__sys)
- Query Object:
- For Product Family mapping:
- Query Object:
document_product__vr - Query Field: Global ID (
global_id__sys)
- Query Object:
Standard Document Type Groups
Vault uses Document Type Groups to determine which document types to send from one Vault to another.
Quality and RIM Vaults each include a Quality to RIM Connection Document Type Group in Admin > Business Admin > Objects > Document Type Groups. When enabling the document exchange integration, you’ll associate this group to all Quality and RIM document types, subtypes, and classifications included in the exchange.
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.
The standard object state types available in both Vaults must be mapped to active lifecycle states for the appropriate object lifecycles. If your current lifecycle doesn’t have enough states, you’ll need to add new states to your lifecycle before mapping them to state types.
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 includes standard message processing queues. You can access and manage these queues from Admin > Connections > Spark Queues.
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 below standard integrations:
- 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.
- 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 below standard integrations:
- QMS RIM Integration for Change Management
- RIM/Quality Document Integration
- 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.
- 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 RIM 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.
Configuring Quality & RIM for Document Exchange
To configure this integration, all aspects of these instructions must be considered for both your Quality and RIM Vaults.
The provided instructions assume you’ve already established the Vault to Vault connection. All remaining configuration is highly dependent upon the documents and fields your organization plans to include in the exchange, as well as document lifecycle configurations. To gather requirements:
- See About the Quality to RIM Vault Connection for the integration’s overall behavior and use cases.
- See Document Exchange Limitations for additional considerations.
- We recommend using each Vault’s configuration report as a reference point.
Configuration Overview
This configuration outline references the below variable components in your Quality and RIM Vaults:
| Component | Quality Vault Record | RIM Vault Record |
|---|---|---|
| Connection | QMS to RIM (qms_to_rim__v) |
QMS RIM Connection (qms_rim_connection__v) |
| Integration | Quality/RIM Document Integration (quality_rim_documents__v) |
RIM/Quality Document Integration (rim_quality_documents_i__v) |
| Outbound Integration Point | RIM Documents Outbound (rim_documents_outbound_ip__v) |
Quality Documents Outbound (qual_documents_outbound_oip__v) |
| Inbound Integration Point | RIM Documents Inbound (rim_documents_inbound_ip__v) |
Quality Documents Inbound (qual_documents_inbound_iip__v) |
| Integration Rules | RIM Inbound Documents (quality_rim_inbound_documents__v) |
Quality Inbound Documents (quality_rim_inbound_documents_ir__v) |
To enable your RIM and Quality Vaults for document exchange:
- Enable CrossLinks in Admin > Settings > General Settings.
- In the document lifecycle for each document type to be exchanged:
- Define or confirm the lifecycle’s Steady, Superseded, and Obsolete state types are mapped to the intended lifecycle states.
- Review the mapped Steady state to ensure it is configured with an entry action to set a new major version. See Document Exchange Limitations.
- For each of your Quality Vault’s in-scope documents, create or confirm there are Product Family and Product Variant object reference fields to ensure this information can be received from RIM.
- Activate the Vault’s Integration record in Admin > Connections > [Connection] > [Integration]. This additionally activates the integration’s outbound and inbound Integration Points. You can individually deactivate and reactivate Integration Points as required. For example, you may opt to deactivate RIM’s outbound Integration Points if the Vault will only be receiving documents.
- Confirm the related standard Integration Field Rules are active in Admin > Connections > Integration Rules > [Integration Rule]. Review all rules in the Field Rules panel to ensure their Status is Active.
- Add Reference Lookups to the connection record in Admin > Connections. You’ll add one lookup for each document type, subtype, and classification the Vault will receive in the exchange according to your organization’s requirements. See details about this step.
- Add custom Integration Field Rules to the applicable Integration Rule in Admin > Connections. Integration Field Rules are required in each Vault that will be receiving documents according to your organization’s requirements. See details about this step.
- Confirm the Quality to RIM Connection Document Type Group is active in Admin > Business Admin > Objects > Document Type Groups. Then, assign it to each relevant document in Admin > Configuration > Document Types. Select the document type, subtype, or classification’s Actions menu, then populate the Document Type Group field.
Configuring Integration Field Rules
The Integration Rules provisioned for the document exchange integration include standard Integration Field Rules. As part of integration configuration, you’ll create additional rules to handle any additional Quality or RIM document fields.
To do this, add field rules to the quality_rim_inbound_documents__v (Quality) and quality_rim_inbound_documents_ir__v (RIM) Integration Rules with the below high-level requirements. Picklist and object reference fields require you to first create a Reference Lookup.
- Target Object: Document
- Target Doc Field: The inbound document field to be populated and maintained in this Vault.
- Label and Name: The auto-populated target document field UI label and API name. We recommend maintaining the auto-populated values.
- Text fields:
- Query Object: Document
- Query Field: The outbound document field name to which the Target Doc Field (inbound document field) is mapped, for example
approved_date__c.
- Picklist fields:
- Create a Reference Lookup.
- Reference Lookup Type: Generic
- Reference Lookup: The reference lookup you created for this picklist.
- Query Object: Document
- Query Field: The source picklist field.
- Object reference field except Product, Product Family, and Product Variant (see details below):
- Create a Reference Lookup.
- Reference Lookup Type: Object
- Reference Lookup: The reference lookup you created for this object field.
- Query Object: Document
- Query Field: The source object field.
- For the Product object reference field, the connection references the standard
document_product__vIntegration Field Rule. - For Product Family and Product Variant:
- Product Family
- Query Object:
document_product__vr - Query Field: Global ID (
global_id__sys)
- Query Object:
- Product Variant
- Query Object:
document_product_detail__vr - Query Field: Global ID (
global_id__sys)
- Query Object:
- Product Family
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.
Reference Lookups for Document Exchange
For each inbound document (any document received in a Vault), you must configure one Reference Lookup in that Vault for that document type. This means, for example, a Regulatory > Correspondence > Approval Letter RIM document which will be sent to Quality and classified as Operations > Agreement requires one reference lookup in the Quality Vault.
Using your Vaults’ document and mapping inventory, add Reference Lookups to the connection record individually or in bulk with the following high-level requirements:
- Reference Lookup Type: Document Type
- Target Object: Document Type (
document_type__sys) - Source Key: The type, subtype, or classification of the document being received in this Vault, expressed as
type__c.subtype__c.classification__c. For example, RIM’s Approval Letter document classification is expressed asregulatory__c.correspondence__c.approval_letter__c. - Target Key: The type, subtype, or classification of the document that will be created in the target Vault, expressed as
type__c.subtype__c.classification__c. For example, Quality’s Agreement document subtype is expressed asoperations__c.agreement__c. - Status: Active
Additionally, in order to create related Integration Field Rules for object reference and picklist fields, you’ll need to first create Reference Lookups with the following high-level requirements:
- For object reference fields:
- Reference Lookup Type: Object
- Target Object: The object to which the inbound object data is mapped.
- Source Key: The source object record’s ID (
id). - Target Key: The target object record’s ID (
id). Alternatively, you can use this record’s External ID. - Status: Active
- For picklist fields:
- Reference Lookup Type: Generic
- Reference Lookup Name: The picklist’s API name, for example
imported_document__c - Source Key: The inbound document’s expected picklist value, for example
no__c - Target Key: The mapped picklist value in the target Vault, for example
No
Note: An object record’s ID (id) in a Production Vault is different from the same record’s ID in a Sandbox Vault. As part of your go-live strategy, ensure any Reference Lookups mapped with an ID (id) are created or updated in the Production Vault accordingly.
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.
Document Exchange Limitations
- CrossLinks are not supported across domains. The Quality and RIM Vaults configured for this integration must share the same domain.
- After this integration is enabled, the connection only initiates document and metadata transfer once the source document reaches its next Steady state. For example, if Quality document v2.0 is updated to Steady state v3.0, only v3.0 is transferred to RIM. The RIM CrossLink version history begins at v3.0, and any subsequent Steady state versions (4.0 and later) are properly reflected.
- Similarly, the integration does not create target Vault CrossLinks for source documents created in the Steady state. A source document must exit a given state (for example, Draft), then enter the Steady state in order for Vault to create a target CrossLink.
- If a document’s lifecycle is configured such that a document can reach the Steady state with a non-zero minor version, Vault does not maintain it after creating the CrossLink in the target Vault. For example, if a RIM document is in its Steady state at v1.1, Vault creates a Quality CrossLink v1.1 and takes no further action if the RIM document is subsequently updated. To avoid this, you must at minimum configure the source document’s lifecycle with a Set new major version entry action in the Steady state.
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 |