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.
Note: The Quality to Safety Connection is only available for organizations with both a Safety Vault and a Quality Vault. Product Quality Complaint (PQC) functionality is only available for organizations with the Vault QMS application.
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
You will 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 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 |
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 |
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 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) |
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) - Reported Product Integration Rule (
qs_reported_product_ir__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 |
Note: The Safety Case Number (safety_case_number__v) field on the Complaint Intake record will be automatically populated by this Connection without a Field Rule.
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 |
Note: Due to Case Contact logic, custom field rules are not supported.
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 |
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 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)
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
This feature 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
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.
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 field in your Quality Vault:
- Activate the following standard fields on the following QMS objects:
- Safety Case Number (
safety_case_number__v), Safety Case Assessment ID (safety_case_assessment_id__v), and Complaint Intake Source (complaint_intake_source__v) on the Complaint Intake (complaint_intake__v) object - Product Reported (
product_reported__v) on the Reported Product (reported_product__v) object - Safety Case Number (
safety_case_number__v) on the Complaint (complaint_v) object - Safety Case Number on the Quality Event (
quality_event__qdm) object, and add to the Complaint (complaint__qdm) object type
- Safety Case Number (
Safety Vaults
Update the following fields in your Safety Vault:
- Activate the following standard fields on the Case Assessment (
case_assessment__v) object:- Potential PQC (
potential_pqc__v) - Complaint Intake ID (
complaint_intake_id__v)
- Potential PQC (
- Activate the Type (
type__v) field on the Case Adverse Event (case_adverse_event__v) object. - 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.
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:
- Ensure that the connection, Integrations, Integration Points are active for your Quality Vault.
- Ensure that the Integration Rules and their respective Field Rules are active.
- Add the Related Complaint Intake (
related_complaint_intake__v) object as a Related Object section to the Complaint Intake page layout. - Ensure that the appropriate users have access to the Related Complaint Intake object.
- Ensure that no VQL Constraint is on the standard Product (
product__v) field in the Reported Product (reported_product__v) object.
Note: If a VQL Constraint is on the Product (product__v) field, and users create Reported Product records, removing the VQL Constraint means that users will select from an unfiltered list of Product records. In order to maintain a filtered list of Products after deploying this Connection, consider adding a configuration that conditionally enforces the VQL Constraint. Consult your Veeva Services team for guidance if needed.
Configuring the Safety Vault
Complete the following steps to configure your Safety Vault:
- Ensure that the connection, Integrations, and Integration Points are active for your Safety Vault.
- Ensure that the Integration Rule and its respective Field Rule are active.
- Configure the Send to Quality action as an entry or user action on the Case (
case_version__v) object.
Connection Limitations
Safety users can only send a Product Quality Complaint (PQC) from their Safety Vault to their Quality Vault once per Case version.
See Standard Connection Limitations for additional 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 |