The Quality-Safety Connection eliminates the manual email communication associated with relaying PQC information from Safety to Quality personnel and minimizes the potential for missed Quality complaint data and investigations, which can lead to a more compliant operation.
Transfer PQCs from Safety to Quality
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 via the Product Quality Complaint field and promoted to a Case, Safety Vault users can select the Transfer PQCs to Quality action on a Case 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 can create a Complaint Intake record in a Quality Vault via a Product Quality Complaint (PQC) identified and transferred from a Case in a Safety Vault. When Safety Vault users run the Transfer PQCs to Quality action on a Case record in their Safety Vault, Quality Vault creates a Complaint Intake record for each Case Assessment record that has been flagged via the Potential PQC field as containing a PQC. This process also creates a Reported Product record in Quality Vault for each Product associated with the respective Case Assessment records.
Once Vault creates the Complaint Intake record in the Quality Vault, Vault sends the Complaint Intake ID back to the Safety Vault, and Quality Vault users can begin the investigation and triage process to determine whether a Complaint record is needed. If follow-up Cases are created for a PQC, Vault also creates subsequent Related Complaint Intake records in the Quality Vault and associates them with the original Complaint Intake.