The Quality-Safety Connection eliminates the manual communication and data transfer associated with relaying Product Quality Complaint (PQC) information between Safety and Quality Vaults and Adverse Event information between Quality and Safety Vaults and minimizes the potential for missed Quality complaint data and investigations, which can lead to a more compliant operation.
Transferring PQCs from Safety to Quality
With the Quality-Safety Connection, Vault supports the automatic transfer of PQCs from your Safety Vault to your Quality Vault for the Complaint Intake process. After an Case Adverse Event in your Safety Vault has been identified as a potential PQC via the Potential PQC field on the Case, Safety Vault users can run the Transfer PQCs to Quality action on the Case to transfer the identified PQC, along with all relevant patient and product information, via this connection and initiate the Complaint Intake process in their Quality Vault.
Vault will create a Complaint Intake record in your Quality Vault via the PQC identified and transferred from the Case in your Safety Vault. When Safety Vault users run the Transfer PQCs to Quality action on the 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.
Creating Safety Inbox Items from Quality
With the Quality-Safety Connection, Vault also supports creating Complaints in your Quality Vault and sending the data to your Safety Vault for investigation. If your Quality organization receives a PQC containing a potential Adverse Event, Quality users can send information about the Complaint record using the Transfer to Safety action. Vault then creates an Inbox Item record in the Safety Vault for each Complaint record received from a Quality Vault. The Inbox Item includes an event for each reported adverse event in the Complaint.
If the Complaint record in the Quality Vault does not include a Case Number, Vault creates a new Inbox Item record and updates the Complaint record in the Quality Vault with the Safety Inbox Item ID for traceability. If the Complaint record includes a Case Number, the newly-created Inbox Item in the Safety Vault links to the original Case record as a follow-up Case.