Complaint Management

Seamless Management of Complaints – From Intake to Resolution

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.

With CQ Complaint Management Software, we ensure companies have comprehensive control over how customer complaints are collected, recorded, reported, and tracked in compliance with industry guidelines and regulations.

In addition to 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 quality, engineering, and operations leaders to address a customer complaint timely and efficiently. CQ’s Complaint Management solution also drives Continuous Improvement (CI) of processes and workflows and comes with embedded intelligence that drives automation and efficiency.

Improve Customer Experience

ComplianceQuest’s Complaint 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.

Automate Regulatory Submissions and Compliance

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 Complaint Management, quality assurance leaders can automate the process of regulatory submissions – MDR to the FDA in the U.S. or MIR forms in the EU. We also automate the process of generating and submitting the MedWatch Form FDA 3500 and ESG reports through our approved and validated AS2 Gateway.

Leverage Predictive Analytics and AI enabled Triage

The CQ Complaint 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.

Automated Investigation and Root Cause Analysis

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 Complaint Management Solution allows documentation of numerous root causes, including supporting tools, documentation, and evidence that is used to conclude on the root cause analysis. 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.

Seamless integration with your CRM

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 Complaint 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

“We implemented ComplianceQuest (CQ) to replace our previous Complaint Management System. From the very first day, CQ went above and beyond to help provide expertise on how to automate our business processes, 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”

-VP of Quality at a leading medical device company

Complaint Management System Features

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Key CQ Complaint Management Features

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 Submissions

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 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.