# Configuring the Quality-Safety Connection With the Quality-Safety Connection, Vault supports the automatic transfer of Product Quality Complaints (PQCs) from your Safety Vault to your Quality Vault for the _Complaint Intake_ process. After an _Inbox Item_ in your Safety Vault has been identified as a potential PQC and promoted to a _Case_, Safety Vault users can select the _Transfer PQCs to Quality_ action from the _Case's_ **All Action** menu to transfer the identified PQC, along with all relevant patient and product information, via a Vault to Vault connection and initiate the _Complaint Intake_ process in their Quality Vault. Vault also supports creating _Complaints_ in your Quality Vault and sending the data to your Safety Vault to generate _Inbox Items_ for investigation. If your Quality organization receives a PQC containing a potential adverse event, Quality users can send information about the _Complaint_ record using the _Transfer to Safety_ action. Vault then creates an _Inbox Item_ record in the Safety Vault for each _Complaint_.
## Quality-Safety Connection Components The components below support the standard Quality-Safety Connection. ### Connections The following _Connection_ record is available from **Admin > Connections**: * _Quality-Safety Connection_ (`quality_safety_connection__v`) is available in your Quality Vault * _Quality-Safety Connection_ (`quality_safety_connection__v`) is available in your Safety Vault In your Safety Vault, you can update the _Connections_ object layout to include the following fields in the _Connection Stats_ section: * _Quality: Inbox Items Received_ * _Quality: PQCs Sent_ * _Quality: PQC Outcomes Received_ You must establish the Vault to Vault connection before you can use it. ### Integration & Integration Points The _Integration_ and _Integration Point_ objects enable Vault to manage 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. #### Quality Integrations & Integration Points The _Quality-Safety Connection_ (`quality_safety_connection__v`) 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| |--- |--- |--- |--- | |Quality-Safety: PQC Integration|Quality-Safety: PQC Outbound Integration Point (`qs_pqc_oip__v`)|Quality|Safety| |Quality-Safety: PQC Integration|Quality-Safety: PQC Inbound Integration Point (`qs_pqc_iip__v`)|Safety|Quality| |Quality-Safety: Inbox Item Integration|Quality-Safety: Inbox Item Outbound Integration Point (`qs_inbox_item_oip__v`)|Quality|Safety| |Quality-Safety: Inbox Item Integration|Quality-Safety: Inbox Item Inbound Integration Point (`qs_inbox_item_iip__v`)|Safety|Quality| #### Safety Integrations & Integration Points The _Quality-Safety Connection_ (`quality_safety_connection__v`)  record includes the following default _Integration_ records with standard _Integration Point_ records in your Safety Vault: |Integration Name|Integration Point Name|Sent From|Sent To| |--- |--- |--- |--- | |Quality-Safety: PQC Integration|Quality-Safety: PQC Outbound Integration Point (`qs_pqc_oip__v`)|Safety|Quality| |Quality-Safety: PQC Integration|Quality-Safety: PQC Inbound Integration Point (`qs_pqc_iip__v`)|Quality|Safety| |Quality-Safety: Inbox Item Integration|Quality-Safety: Inbox Outbound Integration Point (`qs_inbox_oip__v`)|Safety|Quality| |Quality-Safety: Inbox Item Integration|Quality-Safety: Inbox Inbound Integration Point (`qs_inbox_iip__v`)|Quality|Safety| ### Integration Rules To support the Quality-Safety Connection, it may be necessary to transform data from the source Vault's data model to fit within the target Vault's data model. Veeva delivers standard _Integration Rules_ for various connections. Navigate to **Admin > Connections > Integration Rules** for a current inventory in your Quality and Safety Vaults. #### Quality Integration Rules The standard Integration Rules for the _Quality-Safety: PQC Integration_ in a Quality Vault include: |Integration Rule|Integration Point|Primary Query Object| |--- |--- |--- | |Complaint Intake Case Assessment Integration Rule (`qs_complaint_intake_ca_ir__v`)|Quality-Safety: PQC Inbound Integration Point (`qs_pqc_iip__v`)|Case Assessment (`case_assessment__v`)| |Complaint Intake Case Contact Integration Rule (`qs_complaint_intake_cc_ir__v`)|Quality-Safety: PQC Inbound Integration Point (`qs_pqc_iip__v`)|Case Contact (`case_contact__v`)| |Reported Product Integration Rule (`qs_reported_product_ir__v`)|Quality-Safety: PQC Inbound Integration Point (`qs_pqc_iip__v`)|Case Product (`case_product__v`)| |Safety Case Assessment Integration Rule (`qs_case_assessment_ir__v`)|Quality-Safety: PQC Inbound Integration Point (`qs_pqc_iip__v`)|Case Assessment (`case_assessment__v`)| The standard Integration Rules for the _Quality-Safety: Inbox Item Integration_ in a Quality Vault include: |Integration Rule|Integration Point|Primary Query Object| |--- |--- |--- | |Inbox Item Integration Rule (`qs_complaint_inbox_item__v`)|Quality-Safety: Inbox Item Inbound Integration Point (`qs_inbox_item_iip__v`)|Inbox Item (`inbox_item__v`)| |Inbox Item Integration Rule (`qs_complaint_inbox_item__v`)|Quality-Safety: Inbox Item Outbound Integration Point (`qs_inbox_item_oip__v`)|Inbox Item (`inbox_item__v`)| #### Safety Integration Rules The standard Integration Rules for the _Quality-Safety: PQC Integration_ in a Safety Vault include: |Integration Rule|Integration Point|Primary Query Object| |--- |--- |--- | |Case Assessment Integration Rule (`qs_case_assessment_intake_ir__v`)|Quality-Safety: PQC Inbound Integration Point (`qs_pqc_iip__v`)| Complaint Intake (`complaint_intake__v`)| The standard Integration Rules for the _Quality-Safety: Inbox Item Integration_ in a Safety Vault include: |Integration Rule|Integration Point|Primary Query Object| |--- |--- |--- | |Net New Inbox Item – Complaint Integration Rule (`qs_new_complaint_ir__v`)|Quality-Safety: Inbox Inbound Integration Point (`qs_inbox_iip__v`)|Complaint (`complaint__v`)| |Net New Inbox Item – Complaint Integration Rule (`qs_new_complaint_ir__v`)|Quality-Safety: Inbox Outbound Integration Point (`qs_inbox_oip__v`)|Complaint (`complaint__v`)| |Net New Inbox Item – Quality Event Complaint Integration Rule (`qs_new_quality_event_ir__v`)|Quality-Safety: Inbox Inbound Integration Point (`qs_inbox_iip__v`)|Quality Event (`quality_event__qdm`)| |Net New Inbox Item – Quality Event Complaint Integration Rule (`qs_new_quality_event_ir__v`)|Quality-Safety: Inbox Outbound Integration Point (`qs_inbox_oip__v`)|Quality Event (`quality_event__qdm`)| |Follow-Up Inbox Item – Complaint Integration Rule (`qs_follow_up_complaint_ir__v`)|Quality-Safety: Inbox Inbound Integration Point (`qs_inbox_iip__v`)|Complaint (`complaint__v`)| |Follow-Up Inbox Item – Complaint Integration Rule (`qs_follow_up_complaint_ir__v`)|Quality-Safety: Inbox Outbound Integration Point (`qs_inbox_oip__v`)|Complaint (`complaint__v`)| |Follow-Up Inbox Item – Quality Event Complaint Integration Rule (`qs_follow_up_quality_event_ir__v`)|Quality-Safety: Inbox Inbound Integration Point (`qs_inbox_iip__v`)|Quality Event (`quality_event__qdm`)| |Follow-Up Inbox Item – Quality Event Complaint Integration Rule (`qs_follow_up_quality_event_ir__v`)|Quality-Safety: Inbox Outbound Integration Point (`qs_inbox_oip__v`)|Quality Event (`quality_event__qdm`)| |Complaint AE Code Integration Rule (`qs_complaint_ae_code_ir__v`)|Quality-Safety: Inbox Inbound Integration Point (`qs_inbox_iip__v`)|Complaint-Adverse Event Code (`complaint_ae_code__v`)| |Complaint AE Code Integration Rule (`qs_complaint_ae_code_ir__v`)|Quality-Safety: Inbox Outbound Integration Point (`qs_inbox_oip__v`)|Complaint-Adverse Event Code(`complaint_ae_code__v`)| |Complaint Batch Integration Rule (`qs_complaint_batch_ir__v`)|Quality-Safety: Inbox Inbound Integration Point (`qs_inbox_iip__v`)|Complaint Batch (`complaint_batch__v`)| |Complaint Batch Integration Rule (`qs_complaint_batch_ir__v`)|Quality-Safety: Inbox Outbound Integration Point (`qs_inbox_oip__v`)|Complaint Batch (`complaint_batch__v`)| |Quality Event AE Code Integration Rule (`qs_quality_event_ae_code_ir__v`)|Quality-Safety: Inbox Inbound Integration Point (`qs_inbox_iip__v`)|Adverse Event Problem Code (`ae_problem_code__v`)| |Quality Event AE Code Integration Rule (`qs_quality_event_ae_code_ir__v`)|Quality-Safety: Inbox Outbound Integration Point (`qs_inbox_oip__v`)|Adverse Event Problem Code (`ae_problem_code__v`)| |Quality Event Batch Integration Rule (`qs_quality_event_batch_ir__v`)|Quality-Safety: Inbox Inbound Integration Point (`qs_inbox_iip__v`)|Quality Event Batches (`quality_event_batches__v`)| |Quality Event Batch Integration Rule (`qs_quality_event_batch_ir__v`)|Quality-Safety: Inbox Outbound Integration Point (`qs_inbox_oip__v`)|Quality Event Batches (`quality_event_batches__v`)| |Product Return Integration Rule (`qs_product_return_ir__v`)|Quality-Safety: Inbox Inbound Integration Point (`qs_inbox_iip__v`)|Product Return (`product_return__v`)| |Product Return Integration Rule (`qs_product_return_ir__v`)|Quality-Safety: Inbox Outbound Integration Point (`qs_inbox_oip__v`)|Product Return (`product_return__v`)| ### Integration Field Rules Connections use Integration Field Rules to ensure specific object 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 Safety Vaults. #### Quality Integration Field Rules The _Quality-Safety: PQC Integration_ in a Quality Vault includes the following standard Field Rules: * _Complaint Intake Case Assessment Integration Rule_ (`qs_complaint_intake_ca_ir__v`) * _Complaint Intake Case Contact Integration Rule_ (`qs_complaint_intake_cc_ir__v`) * _Combination Product Product Family_ (`combination_product_product_family__v`) * _Product Family_ (`product_family__v`) * _Product Variant_ (`product_variant__v`) * _Reported Product Integration Rule_ (`qs_reported_product_ir__v`) * _Safety Case Assessment Integration Rule_ (`qs_case_assessment_ir__v`) The _Quality-Safety: Inbox Item Integration_ in a Quality Vault includes the following standard Field Rules: * _Inbox Item – Quality Event Complaint_ (`qe_inbox_item_id__v`) * _Inbox Item – Complaint_ (`complaint_inbox_item_id__v`) ##### Complaint Intake Case Assessment Integration Rule The purpose of this Field Rule is to populate target _Complaint Intake_ fields from source _Case Assessment_ fields. The table below shows how values in the source query object are copied to fields in the target object. |Target Object|Target Object Field|Target Object Field Default|Query Object|Query Field| |--- |--- |--- |--- |--- | |complaint_intake__v|awareness_date__v|N/A|case_assessment__v|case_version__vr.receiptdate_date__v| |complaint_intake__v|complaint_intake_source__v|safety__v|N/A|N/A| |complaint_intake__v|date_of_event__v|N/A|case_assessment__v|case_adverse_event__vr.onset_normalized__v| |complaint_intake__v|description__v|N/A|case_assessment__v|case_adverse_event_meddra__vr.name__v| |complaint_intake__v|initial_report_date__v|N/A| case_assessment__v|case_version__vr.receiptdate_date__v| |complaint_intake__v|link__sys|N/A| case_assessment__v |global_id__sys| |complaint_intake__v|object_type__v|complaint_intake__v|N/A|N/A| |complaint_intake__v|safety_case_assessment_id__v |N/A|case_assessment__v|id| |complaint_intake__v|safety_case_id__v|N/A|case_assessment__v|case_version__v| |complaint_intake__v|safety_title__c|N/A|case_version__vr|text_safety_title__c| |complaint_intake__v|title__v|N/A|case_assessment__v|case_adverse_event_meddra__vr.name__v|
##### Complaint Intake Case Contact Integration Rule The purpose of this Field Rule is to populate target _Complaint Intake_ fields from the appropriate source _Safety Case > Contact_ record. The table below shows how values in the source query object are copied to fields in the target object. |Target Object|Target Object Field|Target Object Field Default|Query Object|Query Field| |--- |--- |--- |--- |--- | |complaint_intake__v|initial_reporter_details__v|N/A|case_contact__v|title_value__v| |complaint_intake__v|reporter_type__v|N/A|case_contact__v|qualification__vr.api_name__v|
##### Reported Product Integration Rule The purpose of this Field Rule is to map the value in the _Product_ field on a _Safety Case Assessment_ record to the _Product_ field on a QMS _Reported Product_ record. The table below shows how values in the source query object are copied to fields in the target object. |Target Object|Target Object Field|Target Object Field Default|Query Object|Query Field| |--- |--- |--- |--- |--- | |reported_product__v|link__sys|N/A|case_product__v|global_id__sys| |reported_product__v|product__v|N/A|case_product__v|product__vr.link__sys| |reported_product__v|product_reported__v|N/A|case_product__v|product__vr.name__v| |reported_product__v|product_component_details__v|N/A|case_assessments_case_product__vr|product_component_details__v| |reported_product__v|combination_product__v|N/A|case_product__v|combination_product__v| |reported_product__v|combination_product_reported__v |N/A|case_product__v|combination_product_reported__v| The following QMS fields will be populated without a Field Rule:  * The _Reported Batch Number(s)_ (`reported_batch_numbers__v`) field is populated from the _Product_ (`case_product__v`) field on the _Case Assessment_ (`case_assessment__v`) object. * The _Safety Case Number_ (`safety_case_number__v`) field on the _Complaint Intake_ (`complaint_intake__v`) object from the _Case_ (`case_version__v`) related to the associated _Case Assessment_ (`case_assessment__v`) object. ##### Safety Case Assessment Integration Rule The purpose of this Field Rule is to collect and store Safety _Case Assessment_ data when multiple _Case Assessment_ records are used to create a single _Complaint Intake_ record. The table below shows how values in the source query object are copied to fields in the target object. |Target Object|Target Object Field|Target Object Field Default|Query Object|Query Field| |--- |--- |--- |--- |--- | |safety_case_assessment__v|case_assessment_id__v|N/A|case_assessment__v|case_assessment_id__v| |safety_case_assessment__v|case_assessment_name__v|N/A|case_assessment__v|case_assessment_name_id__v| |safety_case_assessment__v|case_id__v|N/A|case_assessment__v|case_id__v| |safety_case_assessment__v|case_name__v|N/A| case_assessment__v|case_name__v| |safety_case_assessment__v|cessation_date__v|N/A|case_assessment__v|cessation_date__v| |safety_case_assessment__v|duration__v|N/A|case_assessment__v|duration__v| |safety_case_assessment__v|expected__v|N/A|case_assessment__v|expected__v| |safety_case_assessment__v|link__sys|N/A|case_assessment__v|link__v| |safety_case_assessment__v|onset_date__v|N/A| case_assessment__v|onset_date__v| |safety_case_assessment__v|severity__v|N/A|case_assessment__v|severity__v| #### Safety Integration Field Rules The _Quality-Safety: PQC Integration_ in a Safety Vault includes the following standard Field Rule: * _Case Assessment Integration Rule_ (`qs_case_assessment_intake_ir__v`) The _Quality-Safety: Inbox Item Integration_ in a Safety Vault includes the following standard Field Rules: * _Net New Inbox Item – Quality Event Complaint_ * _Net New Inbox Item – Complaint_ * _Follow-Up Inbox Item – Quality Event Complaint_ * _Follow-Up Inbox Item – Complaint_ ##### Case Assessment Integration Rule The purpose of this Field Rule is to map the source _Case Assessment_ record in the Safety Vault to the related _Complaint Intake_ record in the Quality Vault. The table below shows how values in the source query object are copied to fields in the target object. |Target Object|Target Object Field|Target Object Field Default|Query Object|Query Field| |--- |--- |--- |--- |--- | |case_assessment__v|global_id__sys|N/A|complaint_intake__v|link__sys| |case_assessment__v|complaint_intake_id__v|N/A|complaint_intake__v|global_id__sys| ### Queues The _Quality-Safety: PQC Integration_ includes three (3) standard queues: one (1) inbound in the Safety Vault, and one (1) inbound and one (1) outbound in the Quality Vault. You can access and manage these queues from **Admin > Connections > Spark Queues**. * _Quality to Safety PQC Inbound Queue_ (`qs_pqc_inbound_queue__v`) in the Safety Vault * _Quality to Safety PQC Outbound Queue_ (`qs_pqc_outbound_queue__v`) in the Quality Vault * _Quality to Safety PQC Outbound Queue_ (`qs_pqc_outbound_queue__v`) in the Quality Vault The _Quality-Safety: Inbox Item Integration_ includes three (3) standard queues: one (1) inbound in the Safety Vault, and one (1) inbound and one (1) outbound in the Quality Vault. You can access and manage these queues from **Admin > Connections > Spark Queues**. * _Quality to Safety Inbox Item Inbound Queue_ (`qs_inbox_item_inbound_queue__v`) in the Safety Vault * _Quality to Safety Inbox Item Inbound Queue_ (`qs_inbox_item_inbound_queue__v`) in the Quality Vault * _Quality to Safety Inbox Item Outbound Queue_ (`qs_outbound_queue__v`) in the Quality Vault ### Jobs The Quality-Safety Connection deploys standard jobs into the Quality and Safety Vaults. Admins can see when a job executed and download the associated log file from **Admin > Operations > Job Status > History**. Log files can be helpful when debugging a connection error. Connections also generate exception messages when an error is encountered. Connection exception messages are available from **Admin > Connections > User Exception Messages**. ### 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 Quality-Safety Connection. If either end of your integration can't process an incoming message, Vault creates a _User Exception Message_ record to capture the failure. Vault also creates individual _User Exception Item_ records for each item that failed on the related _Integration Point_ record in the outbound Vault. _User Exception Item_ records in Quality Vaults include the originating Safety _Case ID_ for traceability. 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 update your configuration. After you update the configuration, Vault attempts to resolve any errors the next time the connection runs. You can also select the **Rerun Integration** action to run the connection and resolve errors. ### Updating Fields In order for the connection to run successfully, an Admin should update any required object fields that are not defined in the connection to either have a default value or to make values not required. Alternatively, an Admin can create custom Field Rules for any custom required fields on the _Complaint Intake_ or _Reported Product_ objects that map to appropriate object fields in the Safety Vault. ### Quality Vaults Update the following fields in your Quality Vault: 1. Activate the following standard fields on the following QMS objects for the _Quality-Safety: PQC Integration_: 1. _Safety Case Number_ (`safety_case_number__v`), _Safety Case Assessment ID_ (`safety_case_assessment_id__v`), _Complaint Intake Source_ (`complaint_intake_source__v`), _Contains Combination Product?_ (`contains_combo_product__v`), and _Type of Complaint Intake_ (`type_of_complaint_intake__v`) on the _Complaint Intake_ (`complaint_intake__v`) object 2. _Product Reported_ (`product_reported__v`), _Product Component Details_ (`product_component_details__v`), _Combination Product_ (`combination_product__v`), and _Combination Product Reported_ (`combination_product_reported__v`) on the _Reported Product_ (`reported_product__v`) object 3. _Safety Case Number_ (`safety_case_number__v`), _Contains Combination Product?_ (`contains_combo_product__v`), _Product Component Details_ (`product_component_details__v`), _Combination Product_ (`combination_product__v`), and Combination Product Reported (`combination_product_reported__v`) on the _Complaint_ (`complaint_v`) object 4. _Safety Case Number_ on the _Quality Event_ (`quality_event__qdm`) object, and add to the _Complaint_ (`complaint__qdm`) object type 5. _Contains Combination Product?_ (`contains_combo_product__v`), _Product Component Details_ (`product_component_details__v`), _Combination Product_ (`combination_product__v`), and _Combination Product Reported_ (`combination_product_reported__v`) on the _Quality Event_ (`quality_event__qdm`) object 2. Activate the following standard fields on the following QMS objects for the _Quality-Safety: Inbox Item Integration_: 1. _Safety Inbox Item ID_ (`safety_inbox_item_id__v`), _Reported Adverse Event Name_ (`reported_ae_name__v`), _Product Reported_ (`product_reported__v`), and _Last Sent to Safety Date_ (`last_sent_to_safety_date__v`) on the _Complaint_ (`complaint_v`) and _Quality Event_ (`quality_event__qdm`) objects 2. _Potential Adverse Event?_ (`adverse_event__v`) and _Reported Adverse Event Name_ (`reported_ae_name__v`) on the _Complaint Intake_ (`complaint_intake__v`) object ### Safety Vaults Update the following fields in your Safety Vault: 1. Activate the following standard fields on the _Case Assessment_ (`case_assessment__v`) object:  1. _Potential PQC_ (`potential_pqc__v`) 2. _Complaint Intake ID_ (`complaint_intake_id__v`) 2. Activate the _Type_ (`type__v`) field on the _Case Adverse Event_ (`case_adverse_event__v`) object. 3. Activate the _Potential PQC_ (`potential_pqc__v`) field on the _Case_ (`case_version__v`) object and the _Case_ (`case__v`) and _Imported Case_ (`imported_case__v`) standard object types on the _Case Product_ (`case_product__v`) object. 4. Activate the _Quality Summary & Conclusion_ and _Complaint ID_ fields on the _Inbox Item_ (`inbox_item__v`) and _Case_ (`case_version__v`) objects. ## Configuring the Quality-Safety Connection Complete the steps below to configure your Quality and Safety Vaults for this connection. ### Configuring the Quality Vault Complete the following steps to configure your Quality Vault: 1. Ensure that the connection, Integrations, Integration Points are active for your Quality Vault. 2. Ensure that the Integration Rules and their respective Field Rules are active. 3. Add the _Related Complaint Intake_ (`related_complaint_intake__v`) object as a _Related Object_ section to the _Complaint Intake_ page layout. 4. Ensure that the appropriate users have access to the _Related Complaint Intake_ object. 5. Ensure that no VQL Constraint is on the standard _Product_ (`product__v`) field in the _Reported Product_ (`reported_product__v`) object. 6. Configure the _Transfer to Safety_ action as an entry action, user action, or system action, to suit your business needs, on the _Complaint_ (`complaint_v`) and _Quality Event_ (`quality_event__qdm`) objects. 7. Optional: Ensure that the _Safety Case Assessment_ (`safety_case_assessment__v`) object is active, and add this object to the _Complaint Intake_ object page layout.
### Configuring the Safety Vault Complete the following steps to configure your Safety Vault: 1. Ensure that the connection, Integrations, and Integration Points are active for your Safety Vault. 2. Ensure that the Integration Rule and its respective Field Rule are active. 3. Configure the _Send to Quality_ action as an entry or user action on the _Case_ (`case_version__v`) object. ## Connection Limitations See Standard Connection Limitations for the limitations. ## Related Permissions You need a System Admin security profile as well as the following permissions to set up the standard Quality-Safety Connection: |Type|Permission Label|Controls| |--- |--- |--- | |Security Profile|Admin: Application: Manage Connections|Ability to set up the standard Quality to Safety 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|