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. The connection allows you to link Complaint Intakes in your Quality Vault to Inbox Items in your Safety Vault, as well as track the status of their associated Complaints and Cases.
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.
Each time the action executes, Vault creates a Complaint Intake 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 in their Safety Vault, Quality Vault creates a Complaint Intake for each Case Assessment that has been flagged via the Potential PQC field as containing a PQC. Quality Vault can also create a single Complaint Intake for multiple Case Assessments for a single Product or a Combination Product and store the associated data on a Safety Case Assessment in Quality Vault.
Creating a Complaint Intake through this connection also creates a Reported Product in the Quality Vault for each Product associated with the respective Case Assessments. When available, the Reported Product associated with the generated Complaint Intake indicates the Product Family and Product Variant and the Combination Product and Product Constituent information.
Once Vault creates the Complaint Intake in the Quality Vault, Vault generates a corresponding Quality Complaint Information in the Safey Vault, and Quality Vault users can begin the investigation and triage process to determine whether a Complaint is needed. In your Safety Vault, you can track Complaint Intakes transferred to your Quality Vault in the Quality Complaint Information section of the corresponding Case. If follow-up Cases are created for a PQC, Vault also creates subsequent Related Complaint Intakes in the Quality Vault and associates them with the original Complaint Intake. The Quality Vault also automatically populates the Type of Complaint Intake field on the Complaint Intake and any applicable Complaints with a value of Follow-up to connect existing records and eliminate the need to manually identify and mark records as follow-ups.
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 using the Transfer to Safety action. Each time the action executes, Vault creates an Inbox Item in the Safety Vault for each Complaint received from a Quality Vault. The Inbox Item includes an event for each reported adverse event in the Complaint. In your Quality Vault, you can track the promotion status and lifecycle state of Inbox Items generated by the connection, as well as their associated Cases, using the following fields on the corresponding Complaint:
- Safety Inbox Item Status
- Safety Case State
- Safety Case ID
If the Complaint in the Quality Vault does not include a Case Number, Vault creates a new Inbox Item and updates the Complaint in the Quality Vault with the Safety Inbox Item ID for traceability. If the Complaint includes a Case Number, the newly-created Inbox Item in the Safety Vault 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.