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 using the Transfer to Safety action. Vault then creates an Inbox Item in your Safety Vault for each Complaint.
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 Quality-Safety Connection.
Connections
The following Connection is available from Admin > Connections:
- Quality-Safety Connection is available in your Quality Vault
- Quality-Safety Connection 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 used by Vault to manage the connection and track any connection errors.
Quality Integrations & Integration Points
The Quality-Safety Connection includes the following default Integration with Integration Points in your Quality Vault:
| Integration Name | Integration Point Name | Sent From | Sent To |
|---|---|---|---|
| Quality-Safety: PQC Integration | Quality-Safety: PQC Outbound Integration Point | Quality | Safety |
| Quality-Safety: PQC Integration | Quality-Safety: PQC Inbound Integration Point | Safety | Quality |
| Quality-Safety: Inbox Item Integration | Quality-Safety: Inbox Item Outbound Integration Point | Quality | Safety |
| Quality-Safety: Inbox Item Integration | Quality-Safety: Inbox Item Inbound Integration Point | Safety | Quality |
Safety Integrations & Integration Points
The Quality-Safety Connection includes the following default Integration with Integration Points in your Safety Vault:
| Integration Name | Integration Point Name | Sent From | Sent To |
|---|---|---|---|
| Quality-Safety: PQC Integration | Quality-Safety: PQC Outbound Integration Point | Safety | Quality |
| Quality-Safety: PQC Integration | Quality-Safety: PQC Inbound Integration Point | Quality | Safety |
| Quality-Safety: Inbox Item Integration | Quality-Safety: Inbox Outbound Integration Point | Safety | Quality |
| Quality-Safety: Inbox Item Integration | Quality-Safety: Inbox Inbound Integration Point | 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 provides 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 your Quality Vault include:
| Integration Rule | Integration Point | Primary Query Object |
|---|---|---|
| Complaint Intake Case Assessment Integration Rule | Quality-Safety: PQC Inbound Integration Point | Case Assessment |
| Complaint Intake Case Contact Integration Rule | Quality-Safety: PQC Inbound Integration Point | Case Contact |
| Reported Product Integration Rule | Quality-Safety: PQC Inbound Integration Point | Case Product |
| Safety Case Assessment Integration Rule | Quality-Safety: PQC Inbound Integration Point | Case Assessment |
| Safety Case Complaint Integration Rule | Quality-Safety: PQC Inbound Integration Point | Inbox Item |
| Safety QE Complaint Integration Rule | Quality-Safety: PQC Inbound Integration Point | Inbox Item |
The standard Integration Rules for the Quality-Safety: Inbox Item Integration in your Quality Vault include:
| Integration Rule | Integration Point | Primary Query Object |
|---|---|---|
| Inbox Item Integration Rule | Quality-Safety: Inbox Item Inbound Integration Point | Inbox Item |
| Inbox Item Integration Rule | Quality-Safety: Inbox Item Outbound Integration Point | Inbox Item |
Safety Integration Rules
The standard Integration Rules for the Quality-Safety: PQC Integration in your Safety Vault include:
| Integration Rule | Integration Point | Primary Query Object |
|---|---|---|
| Case Assessment Integration Rule | Quality-Safety: PQC Inbound Integration Point | Complaint Intake |
The standard Integration Rules for the Quality-Safety: Inbox Item Integration in your Safety Vault include:
| Integration Rule | Integration Point | Primary Query Object |
|---|---|---|
| Net New Inbox Item – Complaint Integration Rule | Quality-Safety: Inbox Inbound Integration Point | Complaint |
| Net New Inbox Item – Complaint Integration Rule | Quality-Safety: Inbox Outbound Integration Point | Complaint |
| Net New Inbox Item – Quality Event Complaint Integration Rule | Quality-Safety: Inbox Inbound Integration Point | Quality Event |
| Net New Inbox Item – Quality Event Complaint Integration Rule | Quality-Safety: Inbox Outbound Integration Point | Quality Event |
| Follow-Up Inbox Item – Complaint Integration Rule | Quality-Safety: Inbox Inbound Integration Point | Complaint |
| Follow-Up Inbox Item – Complaint Integration Rule | Quality-Safety: Inbox Outbound Integration Point | Complaint |
| Follow-Up Inbox Item – Quality Event Complaint Integration Rule | Quality-Safety: Inbox Inbound Integration Point | Quality Event |
| Follow-Up Inbox Item – Quality Event Complaint Integration Rule | Quality-Safety: Inbox Outbound Integration Point | Quality Event |
| Complaint AE Code Integration Rule | Quality-Safety: Inbox Inbound Integration Point | Complaint-Adverse Event Code |
| Complaint AE Code Integration Rule | Quality-Safety: Inbox Outbound Integration Point | Complaint-Adverse Event Code |
| Complaint Batch Integration Rule | Quality-Safety: Inbox Inbound Integration Point | Complaint Batch |
| Complaint Batch Integration Rule | Quality-Safety: Inbox Outbound Integration Point | Complaint Batch |
| Quality Event AE Code Integration Rule | Quality-Safety: Inbox Inbound Integration Point | Adverse Event Problem Code |
| Quality Event AE Code Integration Rule | Quality-Safety: Inbox Outbound Integration Point | Adverse Event Problem Code |
| Quality Event Batch Integration Rule | Quality-Safety: Inbox Inbound Integration Point | Quality Event Batches |
| Quality Event Batch Integration Rule | Quality-Safety: Inbox Outbound Integration Point | Quality Event Batches |
| Product Return Integration Rule | Quality-Safety: Inbox Inbound Integration Point | Product Return |
| Product Return Integration Rule | Quality-Safety: Inbox Outbound Integration Point | Product Return |
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 your Quality Vault includes the following standard Field Rules:
- Complaint Intake Case Assessment Integration Rule
- Complaint Intake Case Contact Integration Rule
- Combination Product Product Family
- Product Family
- Product Variant
- Reported Product Integration Rule
- Safety Case Assessment Integration Rule
The Quality-Safety: Inbox Item Integration in your Quality Vault includes the following standard Field Rules:
- Inbox Item – Quality Event Complaint
- Inbox Item – Complaint
Complaint Intake Case Assessment Integration Rule
This Field Rule populates target Complaint Intake fields from source Case Assessment fields. The table below shows how Vault copies values in the source query object 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: Vault automatically populates the Safety Case Number field on the Complaint Intake without a Field Rule.
Complaint Intake Case Contact Integration Rule
This Field Rule populates target Complaint Intake fields from the applicable source Safety Case > Contact. The table below shows how Vault copies values in the source query object 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: The connection does not support custom Field Rules due to Case Contact logic.
Reported Product Integration Rule
This Field Rule maps the Product field on a Safety Case Assessment to the Product field on a QMS Reported Product. The table below shows how Vault copies values in the source query object 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 |
Vault populates the following QMS fields without a Field Rule:
- Vault populates the Reported Batch Number(s) field from the Product field on the Case Assessment.
- Vault populates the Safety Case Number field on the Complaint Intake from the Case related to the associated Case Assessment.
Safety Case Assessment Integration Rule
This Field Rule collects and stores Safety Case Assessment data for Complaint Intakes generated from multiple Case Assessments. The table below shows how Vault copies values in the source query object 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 your Safety Vault includes the following standard Field Rule:
- Case Assessment Integration Rule
The Quality-Safety: Inbox Item Integration in your 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
This Field Rule maps the source Case Assessment in your Safety Vault to the related Complaint Intake in your 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 the following standard queues: one inbound in your Safety Vault, and one inbound and one outbound in your Quality Vault. You can access and manage these queues from Admin > Connections > Spark Queues.
- Quality to Safety PQC Inbound Queue in your Safety Vault
- Quality to Safety PQC Outbound Queue in your Quality Vault
- Quality to Safety PQC Outbound Queue in your Quality Vault
The Quality-Safety: Inbox Item Integration includes the following standard queues: one inbound in your Safety Vault, and one inbound and one outbound in your Quality Vault. You can access and manage these queues from Admin > Connections > Spark Queues.
- Quality to Safety Inbox Item Inbound Queue in your Safety Vault
- Quality to Safety Inbox Item Inbound Queue in your Quality Vault
- Quality to Safety Inbox Item Outbound Queue in your Quality Vault
Jobs
The Quality-Safety Connection deploys standard jobs into the Quality and Safety Vaults. You 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 to capture the failure. Vault also creates individual User Exception Items for each item that failed on the related Integration Point in the outbound Vault. User Exception Items 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 Messages, 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 run the Rerun Integration action to resolve errors.
Updating Fields
In order for the connection to run successfully, you 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, you 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 your Safety Vault.
Quality Vaults
Update the following fields in your Quality Vault:
- Activate the following fields on the following QMS objects for the Quality-Safety: PQC Integration:
- Safety Case Number, Safety Case Assessment ID, Complaint Intake Source, Contains Combination Product?, and Type of Complaint Intake on the Complaint Intake object
- Product Reported, Product Component Details, Combination Product, and Combination Product Reported on the Reported Product object
- Safety Case Number, Contains Combination Product?, Product Component Details, Combination Product, and Combination Product Reported on the Complaint object
- Safety Case Number on the Quality Event object, and add to the Complaint object type
- Contains Combination Product?, Product Component Details, Combination Product, and Combination Product Reported on the Quality Event object
- Activate the following fields on the following QMS objects for the Quality-Safety: Inbox Item Integration:
- Safety Inbox Item ID, Reported Adverse Event Name, Product Reported, and Last Sent to Safety Date on the Complaint and Quality Event objects
- Potential Adverse Event? and Reported Adverse Event Name on the Complaint Intake object
Safety Vaults
Update the following fields in your Safety Vault:
- Activate the following fields on the Case Assessment object:
- Potential PQC
- Complaint Intake ID
- Activate the Type field on the Case Adverse Event object.
- Activate the Potential PQC field on the Case object and the Case and Imported Case object types on the Case Product object.
- Activate the Quality Summary & Conclusion and Complaint ID fields on the Inbox Item and Case objects.
Configuring the Quality-Safety Connection
Complete the steps below to configure your Quality and Safety Vaults for this connection.
Configuring Your 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 object as a Related Object section to the Complaint Intake object layout.
- Ensure that the appropriate users have permissions to access the Related Complaint Intake object.
- Ensure that no VQL Constraint is on the Product field in the Reported Product object.
- Configure the Transfer to Safety action as an entry action, user action, or system action, according to your business needs, on the Complaint and Quality Event objects.
- Optional: Ensure that the Safety Case Assessment object is active, and add this object to the Complaint Intake object layout.
- To allow users to track the status of Inbox Items generated in the Safety Vault by the connection:
- Activate the Safety Case Complaint Integration Rule and Safety QE Complaint Integration Rule, and their respective Field Rules.
- Add the following fields to the Complaint object layout:
- Safety Inbox Item Status
- Safety Case State
- Safety Case ID
Note: If the Product field includes a VQL constraint and users create Reported Products, removing the constraint means that users select from an unfiltered list of Products. To maintain a filtered list of Products after deploying the connection, consider adding a configuration that conditionally enforces the constraint. Consult your Veeva Services team for guidance, if needed.
Configuring Your 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 object.
- To track quality complaints transferred to your Quality Vault by the connection, add a related object section for the Quality Complaint Information object to the Case layout.
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 a connection:
| Type | Permission Label | Controls |
|---|---|---|
| Security Profile | Admin: Application: Manage Connections | Ability to set up the Quality to Safety Connection |
| Security Profile | Object: User Exception Item, User Exception Message: Read | Ability to see User Exception Items and User Exception Messages when connection failures occur |