The Quality-Safety Connection supports the automatic transfer of Product Quality Complaints (PQCs) from your Safety Vault to your Quality Vault to initiate the Complaint Intake process. After identifying an Inbox Item in your Safety Vault as a potential PQC and promoting it to a Case, Safety Vault users can run the Transfer PQCs to Quality action on a Case to transfer the PQC details, along with all relevant patient and product information, and initiate the complaint intake process in your Quality Vault. Vault also supports creating Complaints in your Quality Vault and transferring the data to your Safety Vault to generate Inbox Items for investigation. If your Quality Vault receives a PQC containing a potential adverse event, Quality users can use the Transfer to Safety action to send information about the Complaint to your Safety Vault, which generates an Inbox Item 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.
Your Quality Vault includes the following Integrations and Integration Points:
| Integration | Integration Point | 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 |
Your Safety Vault includes the following Integrations with Integration Points:
| Integration | Integration Point | 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. You can use Integration Rules to incorporate configurable rules for mapping object and document fields between two Vaults. You can also create custom Field Rules as needed.
Quality Integration Rules
The Quality-Safety: PQC Integration includes:
| 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 |
| Complaint Intake 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 |
Note: The Complaint Intake Case Contact Integration Rule and Reported Product Integration Rule do not support custom Field Rules.
The Quality-Safety: Inbox Item Integration includes:
| 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 Quality-Safety: PQC Integration includes:
| Integration Rule | Integration Point | Primary Query Object |
|---|---|---|
| Case Assessment Integration Rule | Quality-Safety: PQC Inbound Integration Point | Complaint Intake |
The Quality-Safety: Inbox Item Integration includes:
| 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 |
| Inbound Quality Source Document | Quality-Safety: Inbox Inbound Integration Point | Complaint (Queries Complaint classified document attachments) |
| Inbound Quality Source Document (QE) | Quality-Safety: Inbox Inbound Integration Point | Quality Event (Queries Complaint classified document attachments) |
Queues
The Quality-Safety: PQC Integration includes the following standard queues. 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 Inbound 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. 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.
Configuring the Quality-Safety Connection
In both Vaults, ensure the applicable components are active and complete the steps below to configure your Quality and Safety Vaults for this connection.
Configuring Your Quality Vault
Complete the following steps in your Quality Vault:
- Update any required 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 and Reported Product objects mapping to appropriate object fields in your Safety Vault.
- Activate the following fields and add them to the applicable object layouts:
- For the Quality-Safety: PQC Integration:
- Complaint Intake object: Safety Case Number, Safety Case Assessment ID, Complaint Intake Source, Contains Combination Product?, and Type of Complaint Intake fields.
- Reported Product object: Product Reported, Product Component Details, Combination Product, and Combination Product Reported fields.
- Complaint object: Safety Case Number, Contains Combination Product?, Product Component Details, Combination Product, and Combination Product Reported fields.
- Quality Event object: Contains Combination Product?, Product Component Details, Combination Product, and Combination Product Reported fields.
- For the Quality-Safety: Inbox Item Integration:
- Complaint and Quality Event objects: Safety Inbox Item ID, Reported Adverse Event Name, Product Reported, and Last Sent to Safety Date.
- Complaint Intake object: Potential Adverse Event? and Reported Adverse Event Name.
- For the Quality-Safety: PQC Integration:
- 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 it as a related object section to the Complaint Intake object layout.
- Activate the appropriate Integration Rules to map values for all applicable data.
- 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 the 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 in your Safety Vault:
- Update any required fields that are not defined in the connection to either have a default value or to make values not required.
- Activate the following fields and add them to the applicable object layouts:
- Case Assessment object: Potential PQC and Complaint Intake ID fields.
- Case Adverse Event object: Type field.
- Case Product object (Case and Imported Case object types): Potential PQC field.
- Inbox Item and Case objects: Quality Summary & Conclusion and Complaint ID fields.
- Configure the Transfer PQCs to Quality action as an entry or user action on the applicable states of the Case lifecycle.
- 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.
- Activate the appropriate Integration Rules to map values for all applicable data.
- To transfer related Complaint documents from your Quality Vault, activate the Inbound Quality Source Document and Inbound Quality Source Document (QE) rules in the Quality-Safety: Inbox Item Integration.
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 |