The Quality-Safety Connection eliminates manual data transfer when sharing Product Quality Complaint (PQC) and adverse event information between Quality and Safety Vaults. By automating this transfer, the connection minimizes missed PQC data, supports compliant operations, and allows you to link Quality Complaint Intakes to Safety Inbox Items to track associated Complaints and Cases in both Vaults.
Transferring PQCs from Safety to Quality
After identifying a potential PQC for an Inbox Item in your Safety Vault, you can promote it to a Case, then run the Transfer PQCs to Quality action to transfer the relevant PQC, patient, event, contact, and product details to your Quality Vault to initiate the complaint intake process. When the action completes, Vault generates corresponding records in your Quality Vault, including:
- One Complaint Intake for each Case Assessment with a Potential PQC value of Yes.
- The Safety Case Assessment section includes the corresponding Case Assessments.
- One related Reported Product for each specified Case Product.
- Complaint Contacts for all Case Contacts:
- One Initial Reporter type for the specified primary reporter (Rank of 1).
- One Alternate type for each non-primary contact.
In your Safety Vault, you can review the corresponding records in the Quality Complaint Information section of the Case. When you transfer PQC details for a follow-up Case after generating a Complaint Intake for a previous Case version, the connection creates subsequent Related Complaint Intakes in your Quality Vault, relates them to the original Complaint Intake, and updates the Type of Complaint Intake field value with Follow-up on the Complaint Intake and any applicable Complaints.
Creating Safety Inbox Items from Quality
If you identify a potential adverse event for a Complaint or Quality Event in your Quality Vault, you can run the Transfer to Safety action to transfer the event details to your Safety Vault to generate an Inbox Item for further investigation and intake triage. When the action completes, Vault generates an Inbox Item for each Complaint, with an event for each reported adverse event in the Complaint. Vault also transfers any Complaint classified documents attached to the Complaint or Quality Event in the record’s Related Documents section to the generated Inbox Item.
Note: After running the Transfer to Safety action, update transferred related documents only in your Safety Vault. The connection does not track or sync document updates from your Quality Vault after transfer.
In your Quality Vault, the following Complaint fields allow you to track the promotion status and lifecycle state of Inbox Items generated by the connection, as well as their associated Cases:
- Safety Inbox Item Status
- Safety Case State
- Safety Case ID
If the Quality Complaint does not include a Case Number, Vault creates a new Inbox Item and updates the Complaint with the Safety Inbox Item ID for traceability. If the Complaint includes a Case Number, the newly created Safety Inbox Item links to the original Case as a follow-up Case. When you run the Mark as Follow-Up action on an Inbox Item generated by the connection, Vault updates the Intake Method value to Manual Follow-up.