COMPLAINT MANAGEMENT SYSTEM WITH REGULATORY REPORTING
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Why a Complaint Management System Is Required?
The CQ Complaint Management System enables customer service representatives to record a product or service complaint coming in from multiple sources such as phone, fax, mail, email, or the web. All critical and pertinent details about the product as well as the incident are captured using a user friendly input form. Depending on the complaint data captured, the complaint record is automatically routed for further triaging based on the company’s policies. The solution also provides capability for the customer facing personnel to record a complaint using mobile friendly App (iOS, Android, Windows) along with evidence.
The CQ Complaint Management system automatically queues all complaints that need further triaging to be reviewed by the relevant complaints coordinator/manager. Coordinator of the complaint will get to analyze the risk using pre-defined risk standards of the reported complaint. Following the triage, a complaint can then be routed for further investigation, and evaluated for the need to report to regulatory authority. Notifications are also automatically sent to the relevant departments and personnel, and escalation mechanisms are triggered based on the severity and priority of the complaint.
Failure in a finished product may be attributed to one or more of its components. The CQ Complaint Management system provides the capability to list the anatomy of the finished product and cross check for any Non-conformance, CAPAs, Inspections, etc. created against it and it’s outcome. This historical data helps complaint handlers better understand the performance and stability of the components and provide valuable inputs while investigating the root cause of the problem.
ComplianceQuest provides a strong platform for collaboration that stretches beyond personnel within a single department as is usually the case. In fact, it allows complaint handlers from a single or multiple sites and subject matter experts from the supply chain to perform root cause analysis together. Complaint Management Solution by CQ allows documentation of multiple 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 reuse the analysis. The system also provides capability to identify if the failed component was from a Supplier, and trigger the initiation of a SCAR.
Collaborating through this solution is a delight. It offers collaboration capabilities such as online portal, a central repository for information including documents, Chatter for in-house social networking, and a transaction based communication approach on certain aspects of investigations and samples. The CQ Complaint Management system also provides capability to generate responses which can be emailed to the appropriate personnel within or outside the organization using pre-defined templates and using the reminder capability to remind complaint coordinators / investigators to reach out when specific milestones are reached.
The Complaint Management system comes with embedded best practices for Life Sciences combined with decision tree functionality to support the identification of reportable adverse events as well as the type of report (e.g. 5-day, 30-day). The process of regulatory reporting for regions such as US FDA, Health Canada, EMEA, Japan and Australia alike are greatly simplified as the system helps manage the regulatory assessments required and corresponding timelines for the submissions to be made to ensure compliance.
The CQ Complaint Management system provides for every complaint to be systematically evaluated against the CAPA requirements of your organization, and for a CAPA to be generated if required. The CAPA results, including the investigations, corrective and preventive actions, effectiveness plans and verifications are all accessible from this solution.
Reach out to others across the enterprise and in the supply chain to solicit feedback without having to give up on the ownership of the tasks.
Access your EQMS solution on the go- anywhere, anytime and on any device. Complete access to the solution including reports, approvals, record views, reviews, alerts etc. ensures business continuity and improves efficiency, visibility and flexibility.
Turning complaints into customer loyalty and success
Complaint Management Overview
Complaint Management Screenshots