Complaints Management

Ensure customer delight through end-to-end management of complaints from in-take to assessing risks, regulatory impact and submissions, quality investigation, resolution, and continuous improvement.

Make it easy for your workforce to handle complaints from intake to regulatory submissions to customer resolution.

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With CQ Complaints Management Solution, we ensure companies have comprehensive control over how customer complaints are collected, tracked and addressed in compliance with industry guidelines and regulations.

Besides regulatory compliance, an organization’s ability to deal with complaints effectively and proactively is critical for growth. With an automated platform for complaint handling, customer success leaders can work collaboratively with field sales and services, quality, engineering, and operations leaders to address a customer complaint timely and efficiently. CQ’s Complaints Management solution also drives continuous improvement (CI) of processes and workflows and comes with embedded intelligence that drives automation and efficiency. With our automated decision tree and regulatory reporting, the process of submitting a complaint to the FDA or other regulatory authorities saves valuable time for both the quality and regulatory affairs team.

- ComplianceQuest’s Complaints Management System provides organizations with the capability to track each complaint through its lifecycle from recording and initiation to investigation, regulatory assessment reporting, and closure, ensuring that nothing slips through the cracks. But that is not all. The solution comes with embedded intelligence that makes it easy for leaders to spot patterns and trends to prevent similar complaints in the future. The solution also enables the following: continuous improvement (CI) of workflows and processes, ease of collaboration among teams, and accelerates innovation throughout the product lifecycle.
- 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 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 speed of reporting by automatically generating the appropriate XML file(s), and then transmitting it 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 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 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 also can link to CQ Supplier Management to initiate and manage the SCAR process for any issues caused due to 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 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.

Support Your Entire Organization

Management

Protect brand reputation and increase customer satisfaction by ensuring that complaints are investigated and responded to on-time.
Customer/Field Service

Improve overall service levels by ensuring complaints are adequately dealt with in a timely fashion.
Complaint Manager/Coordinator

Seamless end-to-end complaint management and reduce compliance risk by accelerating consistent triage, handoffs, approvals, identifying systemic problems to prevent potential repeat complaints.
Quality

Gain complete and accurate information on all current and historical complaint data for audit and inspection readiness.
Regulatory

Quickly identify adverse events, electronically submit regulatory reports on time.
Manufacturing /Engineering

Improve investigations for identifying product or service shortfalls, resolve complaints efficiently, and leverage data to drive CI and product innovation.

What They Say About Us

We implemented ComplianceQuest (CQ) to replace our previous Complaints Management System. From the very first day, CQ went above and beyond to help provide expertise on how to automate our business processes in CQ, providing insight into how to properly migrate data to CQ, all while ensuring that our new processes were FDA compliant. They worked day and night to ensure our requirements were met. Beyond the incredible amount of support that CQ provided, their Complaints Management solution is extremely user friendly with a wonderful UI. Since moving to CQ we have received nothing but great feedback from our complaint handling users especially around productivity gains.

Jamal Austin

Livongo
Our company has been using this CQ product for our QMS beginning with January 2018. I couldn’t be more pleased with the support we have received developing and rolling out the Complaints Management tool with both internal and external customers.Thanks Lee and Prashanth!

Brian Banerdt

Global Director of QHSE
The Complaints Management System has made a huge impact on our day-to-day operations. We can track complaints from receipt to closure ensuring customer satisfaction and compliance with industry regulations. Our timeframe for investigating and resolving complaints has decreased by an average of 60%.

Manager of Quality Assurance

SPR Therapeutics

Key Features of CQ Complaints Management System

In-Take

Captures complaints from multiple media and mobile and automatically routes it for further triaging.
Triaging and Initiation

Automatic queuing up and notification of complaints for further triaging by the relevant complaint coordinator/manager.
Regulatory Assessments/Decision Trees

Embedded decision tree functionality supports the identification of reportable adverse events as well as the type of report.
Regulatory Reporting and FDA Electronic Gateway

Manage regulatory assessments and timelines for regulatory submissions.
Product History Review

Gain a better understanding of performance and stability of components and access valuable inputs for root cause analysis.
Investigation and 5 Why Root Cause Analysis

Complaint handlers from multiple sites and subject matter experts from the supply chain can collaborate to perform root cause analysis.
CAPA Evaluation

Systematically evaluate complaints against CAPA requirements and access CAPA results such as investigations, CAPA actions, effectiveness plans and verifications.
Communication/Collaboration

Collaborate using online portal, a central repository for information, chatter for in-house social networking, and a transaction-based communication approach.
CRM Integration

Seamlessly integrates with corporate CRM to provide end-to-end visibility and timely response to customer complaints.
Mobile Access

Access customer complaints on the go and initiate appropriate response without delays.
Reporting and Analytics

Utilize pre-developed best-practice-based reports or customize reports and dashboards for faster decision making.
Social Like & Follow

Like and follow relevant records in the system and be notified via email, dashboard, and mobile to stay abreast of developments.