Organizations using both a RIM Vault and a Quality Vault can utilize the standard Quality-RIM Connection for Enhanced Change Control, Document Exchange, and Product Transfer.
About the Quality-RIM Connection
The Quality-RIM Connection enables organizations using both a Quality Vault and a RIM Vault to use the following features:
- Product Transfer: Maintain RIM product data in Quality. This Connection automates the creation of Product-related records in Quality. This connection also checks for records with matching External IDs between RIM and Quality Product records and links the records when Vault finds a match, rather than creating a new Product record. See additional details about this feature.
- Enhanced Change Control: Share and update data about change controls that have regulatory impact. This connection automates the transfer of Regulatory Change Items and Regulatory Activity Items from a Quality Vault with QMS enabled to a RIM Vault with Registrations enabled, triggering the creation of groupings of change items in RIM when Change Items are linked to an Event in a RIM Vault. See additional details about this feature.
- Document Exchange: Exchange Steady State document and field updates via CrossLinks between a RIM Vault with Submissions enabled and a Quality Vault with QualityDocs enabled. Document Exchange can work independently or with Product Transfer. See additional details about this feature.
In most cases, these integrations can run independently or together. The Product Transfer integration must be enabled in order to use Enhanced Change Control.
Note: As of 25R1, Variation Management, formerly known as Change Management, is superseded by the Enhanced Change Control feature. Existing customers may still use Variation Management, but new implementations of the Quality-RIM Connection must use the Enhanced Change Control feature instead.
Related Articles & Resources
The Quality-RIM Connection is one of many Veeva-provided standard connections that support and automate business processes between separate Vaults. See About Veeva Connections for general information about how a connection can work for your organization.
Veeva Connections leverage Veeva Vault Platform’s Connection feature, and as such many of the concepts described on this page are covered in greater detail by the below configuration articles for Vault Admins:
- Creating & Managing Connections
- Creating & Managing Spark Queues
- Creating & Managing Vault to Vault Integrations
We also recommend visiting a Veeva Connect community to learn about best practices and interact with the Veeva Vault Product Team:
- Quality: QMS or QualityDocs
- RIM: Submissions, Publishing and Archive or Registrations
Configuration Overview
Generally, Vault Admins configuring a connection must first establish the Vault to Vault connection. Once the connection is established, the Vault Admin enables some or all of the currently-supported features, including:
- Product Transfer
- Enhanced Change Control
- Document Exchange
To support this process, Veeva delivers standard Integration Points and Integration Rules for organizations to update per their specific requirements. This configuration may include Query Object Rules and Field Rules (with or without reference lookups).
About Product Transfer Configuration
In addition to configuring your Quality and RIM Vaults, implementing Product Transfer involves requirements analysis and planning, including reconciling any existing records in Quality and RIM. Contact your Veeva Representative to learn more about the specific configuration steps required to enable this integration.
About Enhanced Change Control Configuration
In addition to configuring your Quality and RIM Vaults, implementing Enhanced Change Control involves requirements analysis and planning, including change management and education around business processes for RIM and Quality users. Contact your Veeva Representative to learn more about the specific configuration steps required to enable this integration.
About Document Exchange Configuration
Implementing Document Exchange involves requirements analysis and planning, including mapping source documents between your RIM and Quality Vaults. Contact your Veeva representative to learn more about the specific configuration steps required to enable this integration.
Connection Components
The components below support the standard Quality-RIM 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.
Integration & Integration Point Records
The QMS to RIM (qms_to_rim__v) connection record in your Quality Vault and the QMS RIM (qms_rim_connection__v) connection record in your RIM Vault include the following standard Integration and Integration Point records.
Product Transfer uses the RIM-Quality: Product Integration record and the following Integration Point records:
| Quality Integration Point Record | RIM Integration Point Record |
|---|---|
| Product Family | Product Family |
| Product | Product |
| Product Family Product | Product Family Product |
| Product Variant | Product Variant |
| Complex Product Component | Complex Product Component |
| Material Packaging | Packaging |
| Material Product (PKG PRD) | Packaging |
| Material Product (PKG PV) | Packaging |
| Material Active Substance | Active Substance |
| Material Active Substance Alias | Active Substance |
| Material Inactive Ingredient | Inactive Ingredient |
| Material Inactive Ingredient Alias | Inactive Ingredient |
| Material Container | Container |
| Related Material Packaged Container | Container |
Enhanced Change Control uses the Quality-RIM: Enhanced Change Control record and the following Integration Point records:
| Quality Integration Point Record | RIM Integration Point Record |
|---|---|
| Quality-RIM: Regulatory Change Item to Change Item (Outbound) |
Quality-RIM: Regulatory Change Item to Change Item (Product) (Inbound) If your Quality Vault uses the Quality Event object rather than standalone quality process objects, the connection instead uses the following Integration Point record: Quality-RIM: Regulatory Change Item to Change Item (Product Legacy) (Inbound) |
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Quality-RIM: Regulatory Change Item to Change Item (Packaging) If your Quality Vault uses the Quality Event object rather than standalone quality process objects, the connection instead uses the following Integration Point record: Quality-RIM: Regulatory Change Item to Change Item (Packaging Legacy) |
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Quality-RIM: Regulatory Change Item to Change Item (Container) If your Quality Vault uses the Quality Event object rather than standalone quality process objects, the connection instead uses the following Integration Point record: Quality-RIM: Regulatory Change Item to Change Item (Container Legacy) |
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Quality-RIM: Regulatory Change Item to Change Item (Active Substance) If your Quality Vault uses the Quality Event object rather than standalone quality process objects, the connection instead uses the following Integration Point record: Quality-RIM: Regulatory Change Item to Change Item (Active Substance Legacy) |
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Quality-RIM: Regulatory Change Item to Change Item (Inactive Ingredient) If your Quality Vault uses the Quality Event object rather than standalone quality process objects, the connection instead uses the following Integration Point record: Quality-RIM: Regulatory Change Item to Change Item (Inactive Ingredient Legacy) |
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| Quality-RIM: Change Item to Event and Event Change Item (Inbound) | |
| Quality-RIM: Change Item to Event and Event Change Item by Product Family (Inbound) | |
| Quality-RIM: Activity Change Item to Regulatory Activity Item (Inbound) | Quality-RIM: Activity Change Item to Regulatory Activity Item (Outbound) |
| Quality-RIM: Change Item to Regulatory Change Item (Inbound) | Quality-RIM: Change Item to Regulatory Change Item (Outbound) |
Document Exchange uses the Quality/RIM Document Integration record in Quality Vaults and the RIM/Quality Document Integration record in RIM Vaults, in addition to the following Integration Point records:
| Quality Integration Point Record | RIM Integration Point Record |
|---|---|
| RIM Documents Outbound | Quality Documents Inbound |
| RIM Documents Inbound | Quality Documents Outbound |
Variation Management uses the QMS-RIM: Change Management record in Quality Vaults and the QMS RIM Integration record in RIM Vaults, in addition to the following Integration Point records:
| Quality Integration Point Record | RIM Integration Point Record |
|---|---|
| New Change Event | New Change Event |
Integration Rules
To support the Quality-RIM 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 connections. Navigate to Admin > Connections > Integration Rules for a current inventory in your Quality and RIM Vaults.
Integration Field Rules
Connections use Integration Field Rules to ensure that 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.
Standard Document Type Groups for Document Exchange
For the Document Exchange integration, 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 will associate this group to all Quality and RIM document types, subtypes, and classifications included in the exchange.
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.
Connection Limitations
For a list of limitations or errors that affect your connection, 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-RIM 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-RIM Connection:
| Type | Permission Label | Controls |
|---|---|---|
| Security Profile | Admin: Application: Manage Connections | Ability to set up the standard Quality-RIM 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 |