CQ’s complaint handling solution can help you in submitting Complaint data to FDA in just one click with the help of a fully integrated MDR e-Gateway. Therefore, you can reduce complexity and streamline the workflow while sending out reports and receiving acknowledgments through the FDA Electronic Submission Gateway (ESG)​.
This solution also enables you to automatically generate an XML file and then transmit it to the FDA ESG FAER database including attachments and any follow-up reports in case of high volume complaints. You can minimize manual effort and improve efficiency and productivity by eliminating the need to submit files through the FDA’s e-Submitter.
An integrated, cloud-based complaint management solution like the one from ComplianceQuest supports the latest HL7 R3, ICSR R2, XML, and AS2 protocol with client digital certificate.