# Configuring the Safety-RIM Connection Configure the Safety-RIM Connection to sync product and registration data between Regulatory and Pharmacovigilance systems. With this feature, you can automatically transfer product and registration data from your Regulatory Submissions Vault to your Safety Vault. ## Prerequisites To use this connection, you must: * Establish the Vault to Vault Connection * Enable the Safety-RIM Connection ## Safety-RIM Connection Components The components below support the standard Safety-RIM Connection. ### Connections The following connection records are available in **Admin > Connections**: * _Safety to RIM_ connection (`safety_to_rim__v`) is available in your Safety Vault. * _Safety RIM_ connection (`safety_rim_connection__v`) is available in your RIM Submissions Vault. In your Safety Vault, you can update the _Connections_ object layout to include the following fields in the _Connection Stats_ section: * _RIM: Product Families Created_ * _RIM: Registrations Created_ ### Integration & Integration Points {#integration} The _Integration_ and _Integration Point_ objects enable Safety to manage the message queues and define what data the connection maps from RIM to Safety. These records are read-only and are used by Safety to manage the connection and track any connection errors. The _Safety to RIM_ connection record in each Vault includes the default _RIM-Safety: Product Integration_ record with the following standard _Integration Point_ records: * Safety Vaults * _RIM-Safety: Organization_ * _RIM-Safety: Product_ * _RIM-Safety: Product Alias_ * _RIM-Safety: Product Constituent_ * _RIM-Safety: Product Dose Form_ * _RIM-Safety: Product Family_ * _RIM-Safety: Product Family Product_ * _RIM-Safety: Product Family Substance_ * _RIM-Safety: Product Registration_ * _RIM-Safety: Product Variant_ * _RIM-Safety: Substance_ * RIM Vaults * _RIM-Safety: Co-Packaged Product Constituents_ * _RIM-Safety: Organization_ * _RIM-Safety: Product_ * _RIM-Safety: Product Alias_ * _RIM-Safety: Product Constituent_ * _RIM-Safety: Product Family_ * _RIM-Safety: Product Family Active Substance_ * _RIM-Safety: Product Family Product_ * _RIM-Safety: Product Manufactured Dose Form_ * _RIM-Safety: Product Registration_ * _RIM-Safety: Product Substance_ * _RIM-Safety: Product Variant_ #### Integration Rules {#rules} To support the Safety-RIM connection, it may be necessary to transform data from the source RIM Vault's data model to fit within the target Safety Vault's data model. You can use _Integration Rules_ to incorporate configurable rules for mapping object and document fields between two Vaults. The Safety-RIM connection includes the following _Integration Rules_, which transfer, create, and update the following records in your Safety Vault based on updates made to corresponding records in your RIM Vault: | Integration Rule | Source RIM Object | Target Safety Object | | --- | --- | --- | | _1.0 Organization_ | _Organization_ (`organization__rim`) | _Organization_ (`organization__v`) of type _Registration Holder_ (`registration_holder__v`) | | _2.0 Product Family_ | _Product Family_ (`product__v`) | _Product Family_ (`product_family__v`) | | _3.0 Product_ | _Product_ (`drug_product__v`) | [_Product_][3] (`product__v`) | | _3.1 Product - FDA Product Code Update_ | _Product Nomenclature Code_ (`product_classification__v`) | [_Product_][3] (`product__v`) | | _3.2 Combo Product (Packaging)_ | _Packaging_ (`packaging__rim`) | [_Product_][3] (`product__v`) | | _4.0 Product Family Product_ | _Product Family Product_ (`product_pharmaceutical_product__rim`) | _Product Family Product_ (`product_family_product__v`) | | _5.0 Product Variant_ | _Product Variant_ (`product_detail__v`) | _Product Variant_ (`product_variant__v`) | | _6.0 Product Constituent_ | _Product Component_ (`product_component__rim`) | _Product Constituent_ (`product_constituent__v`) | | _6.1 Product Constituent (Packaging)_ | _Product Packaging Variant_ (`packaging_product_detail__rim`) | _Product Constituent_ (`product_constituent__v`) | | _7.0 Substance_ | _Active Substance_ (`drug_substance__v`) | _Substance_ (`substance__v`) | | _8.0 Product Family Substance_ | _Product Family Active Substance_ (`product_active_substance__rim`) | _Product Family Substance_ (`product_family_substance__v`) | | _9.0 Product Registration_ | _Registration_ (`registration__rim`) | _Product Registration_ (`product_registration__v`) | | _9.1 Registration (Packaging)_ | _Registered Packaging_ (`registration_packaging__rim`) | _Product Registration_ (`product_registration__v`) | | _9.2 Product Reg - Med Product Update_ | _Medicinal Product Registration_ (`medicinal_product_registration__v`) | _Product Registration_ (`product_registration__v`) | | _10.0 Product Alias_ | _Registered Regulatory Text_ (`registered_regulatory_text__v`) | Product Alias (`product_alias__v`) | | _11.0 Product Dose Form_ | _Product Manufactured Dosage Form_ (`product_manufactured_dosage_form__v`) | _Manufactured Dosage Form_ (`manufactured_dosage_form__v`) | ### Query Object Rules With query object rules, you can use Criteria VQL to determine which records get created, updated, and deleted in your Safety Vault. For example, you can configure a rule in your Safety Vault to prevent Organization records from being sent to Safety if they do not meet certain criteria. To ensure the connection transfers only approved _Registrations_ from RIM to Safety, we recommend the following query object rule for the _9.0 Product Registration_ (`rs_product_registration__v`) [rule][2]: * **Query Object**: `registration__rim` * **Label**: Registrations * **Name**: `registrations__c` * **Filter Clause**: `state__v = 'approved_state1__c` If you would like Registrations in all lifecycle states (for example, Inactive, Withdrawn, or Expired) to transfer, you can ignore this query object rule. ### Queues This feature includes two standard message processing queues. You can access and manage these queues from **Admin > Connections > Spark Queues**. * In your Safety Vault: _RIM to Safety Product Inbound Queue_ (`rim_safety_product_inbound_queue__v`) * In your RIM Vault: _RIM to Safety Product Outbound Queue_ (`rim_safety_product_outbound_queue__v`) ### User Exception Objects Safety 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 Safety to RIM connection. If the Safety side of the integration can't process an incoming message, Safety creates a _User Exception Message_ to capture the failure. You can view and manage these messages from **Admin > Connections > User Exception Messages**. Safety also creates individual _User Exception Items_ for each item that failed on the related _Integration Point_ in your Safety Vault. The _User Exception Item's Error Message_ field contains the reason for the error. A _User Exception Message_ means you need to update your configuration. After you update the configuration, Safety attempts to resolve any errors the next time the connection runs. You can also select the _Reprocess Request_ action on the _User Exception Message_ to run the connection and resolve errors. When the connection job runs, Safety processes all active _User Exception Messages_. Any new errors result in new active _User Exception Messages_. Once the connections on both the Safety and RIM side run, Vault inactivates any _User Exception Messages_. ## Configuring Co-Packaged Product Constituents {#combo} For complex products in your RIM Vault, including products with shared packaging, the connection generates _Combination Product_ types of _Products_ in your Safety Vault for the following _Products_ in your RIM Vault: * All _Complex Product_ types of _Products_ * All co-packaged _Products_ associated with the _Primary Product Family_ specified in a _Packaging_ record To configure your RIM Vault to transfer co-packaged product constituent details: 1. Add the _Primary Product Family_ field to the _Packaging_ object layouts for the _Device Packaging_, _Drug Packaging_, and _Multiform Packaging_ object types. 2. Populate the field of the applicable _Packaging_ records. 3. Activate the _RIM-Safety: Co-Packaged Product Constituents_ [point][1]. ## Configuring PSMF Annex H Support {#psmf-annex-h} You can use the standard _Annex H_ report to generate the PSMF Annex H document in your SafetyDocs Vault using product registration data received from your RIM Vault. To include Annex H data in PSMF documents generated from Vault reports, follow the steps below to configure your Safety Vault: 1. Add the following fields to the _Product Registration_ object layout: * _Additional Monitoring_ * _Application Lead Market_ * _Application Number_ * _Non-Standard Aggregate Periodicity_ * _Procedure Type_ * _Procedure Number_ 2. Ensure all _Country_ records referenced in _Product Registrations_ follow the standard ISO naming convention. The standard _Annex H_ report excludes any European Union (EU) Countries that do not follow the naming convention. 3. Optional: Go to **Analytics > Reports** and open the **Annex H** report to review the fields included in the report. 4. Configure your Safety Vault to automatically generate PSMF documents from Vault reports. You can copy the _Annex H_ report to create a new report based on the standard report and then customize the columns and filters on the new report. [1]: #integration [2]: #rules [3]: #combo