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Complaint Management

Complaint Management


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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

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With CQ Complaint 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 Complaint 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.

Benefit #2: Automate Regulatory Submissions and Compliance

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 Reporting 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 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.

Benefit #1: Improve Customer Experience
Benefit #2: Automate Regulatory Submissions and Compliance

Process High Volume Complaints (eMDRs) to the FDA with CQ’s MDR eGateway for Medical Devices

CQ’s Complaint Management solution offers a fully integrated regulatory reporting, MDR eGateway, to automate the process of submitting eMDRs to the FDA. 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.

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.

Benefit #3: Leverage Predictive Analytics and AI enabled Triage
Benefit #4: Automated Investigation and Root Cause Analysis

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 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.

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.

Benefit #5: Seamless integration with your CRM

Support Your Entire Organization

Management

Management

Protect brand reputation and increase customer satisfaction by ensuring that complaints are investigated and responded to on-time

Customer / Field Service

Customer/
Field Service

Improve overall service levels by ensuring complaints are adequately dealt with in a timely fashion

Complaint Manager/ Coordinator

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

Quality

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

Regulatory

Regulatory

Quickly identify adverse events, electronically submit regulatory reports on time

Manufacturing /Engineering

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

Key CQ Complaint Management Features

Complaint Management

In-Take

 

In-Take

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

Triaging and Initiation

 

Triaging and Initiation

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

Regulatory Assessments/Decision Trees

 

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

 

Regulatory Reporting and FDA Electronic Gateway

Manage regulatory assessments and timelines for regulatory submissions.

Product History Review

 

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

 

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

 

CAPA Evaluation

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

Communication/Collaboration

 

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

 

CRM Integration

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

Mobile Access

 

Mobile Access

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

Reporting and Analytics

 

Reporting and Analytics

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

Social Like & Follow

 

Social Like & Follow

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

Complaint Management Datasheet

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