Complaints Management

In highly regulated sectors like medical devices, mandatory regulatory submissions are often time-consuming and inefficient. Failure to capture and manage customer feedback and complaints appropriately — or receiving too many of the same complaints — can lead to audits, fines, and reputational risk. With CQ Complaints Management, quality assurance leaders can automate the process of running decision trees for reportability and generate regulatory reports such as MDR to the FDA in the U.S. or MIR forms in the EU. For agencies besides the FDA and EU, such as Health Canada, Australia, Japan, Brazil, and other Health Authorities, CQ provides the capability to generate the approved document format for email or via print/mail for submitting the required report information on a timely basis.

CQ’s Complaints Management solution offers a fully integrated regulatory reporting, MDR eGateway, which means the process of submitting an eMDR to the FDA takes just one click. It eliminates the complexity of managing multiple servers and IT infrastructure in transmitting reports and attachments and receiving acknowledgements through the FDA Electronic Submission Gateway (ESG). For high-volume complaints, it helps increase the speed of reporting by automatically generating the appropriate XML file(s) and then transmitting them to the FDA ESG FAER database, including attachments and any follow-up reports. All acknowledgements and errors are captured in the Complaints record, and automatic alerts are sent to appropriate personnel about any failures or messaging errors. By eliminating the need to submit files through the FDA’s eSubmitter, it reduces manual effort and improves efficiency and productivity. ComplianceQuest is a registered FDA Transaction Partner for eMDRs and supports the latest XML, HL7 R3, ICSR R2, and AS2 protocol with a client digital certificate.

The CQ Complaints Management system automatically queues all complaints requiring further triaging to be reviewed by the relevant complaint coordinator. By taking advantage of data and the Artificial Intelligence framework of Einstein Predictive Analytics, complaint handling teams can automatically triage complaints based on risk level and urgency. Following the triage, a complaint is routed for further investigation and evaluated for the need to report to a regulatory authority. Notifications are also automatically sent to the relevant departments and personnel, and escalation mechanisms are triggered based on the complaint’s severity and priority.

ComplianceQuest provides a robust platform for collaboration, which allows complaint handlers from single or multiple sites and subject matter experts from the supply chain to perform root cause analysis together. CQ Complaints Management Solution provides 5-Why root cause analysis functionality to document numerous root causes, attach evidence, and capture decisions needed as part of the investigation. Investigators can utilize the cloning capability to perform additional investigations and re-use previously performed investigations. The system can also link to CQ Supplier Management to initiate and manage the SCAR process for any issues caused by a failed supplier-provided component.

Our EQMS is built on the cloud-based Salesforce platform with REST API based integration at its core. To avoid disconnected systems that drive inefficiencies, leverage the power of the CQ integration framework to connect the CQ Complaints Management system with your on-premise or cloud-based CRM. With integration to your CRM, your sales, field services, and customer service personnel have complete visibility into the status of each complaint.