FOR MANUFACTURING AND LIFE SCIENCES INDUSTRIES

Complaint ManagementCREATE LOYALTY BY ADDRESSING CUSTOMER COMPLAINTS SMARTLY

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COMPLAINT MANAGEMENTIn any business, customer satisfaction is of paramount importance. This is especially true in highly regulated industries such as Life Sciences, where compliance with industry regulations and avoidance of potential product liability lawsuits is necessary for business viability. That is why, it is essential for such businesses to have an effective complaint management system, enabling them to listen to customers. It then insures and ensure that the regulatory submissions of information collected through complaints is done in a timely fashion.

COMPLAINT TRIAGINGCOMPLAINT INITIATION PRODUCT HISTORY REVIEWThe 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.

INVESTIGATION AND ROOT CAUSE ANALYSIS

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.

CUSTOMER COMMUNICATION/COLLABORATION

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.

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SOCIAL LIKE & FOLLOW

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

REPORTING AND ANALYTICS

Utilize pre-developed best practices-based reports. Create any number of additional reports and dashboards to suit your requirement. Information is easily retrievable, helping you make quick decisions.

MOBILE ACCESS

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.

REGULATORY REPORTING AND SUBMISSIONSThe 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.

CAPA EVALUATION

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.

COLLABORATION

Reach out to others across the enterprise and in the supply chain to solicit feedback without having to give up ownership of the tasks.

Turning Complaints into Customer Loyalty and SuccessComplianceQuest’s Complaint Management System fulfills this requirement perfectly. It provides organizations the capability to track each complaint through its lifecycle from recording and initiation, to investigation, reporting, and closure, ensuring that nothing slips through the cracks.

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Copyright © 2020 ComplianceQuest Inc. All rights reserved.The information contained in this document is intended for general information purposes only and is subject to change without notice. Any third-partybrand names and/or trademarks referenced are trademarks of their respective owners.

About ComplianceQuest

ComplianceQuest is a highly flexible, 100% cloud-based EQMS built using the Salesforce platform. We streamline quality, compliance, content and collaboration management workflows across your company and globally-based supply chain networks, using the world's most proven enterprise cloud platform from Salesforce.

Fastest Growing 100% Native Salesforce Based EQMS Solution – Mobile, Secure, Reliable, Scalable, Configurable

COMPLIANCEQUEST : ONE PLATFORM - SEAMLESS CONNECTION

Pre-Integrated

Authentication/Security/SSO Compliance/Trust Chatter (Social Collaboration)

Multi-Tenant Architecture/Cloud/App Exchange Community Framework

Integration – APIs/Web Services Validation (IQ and OQ) Audit Trail, e-Signature - 21 CFR Part 11

Dashboards, Reports Collaboration Communication MobileCommunityAnalyticsAutomatedValidation

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CCRRMM

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LLIIMMSS

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Artificial Intelligence

Platform Powered by

Analytics/Portal Object Flow Builder User Interface Process Builder Language Mobile

ComplaintsManagement

IncidentManagement

RiskManagement

AuditManagement

DocumentManagement

InspectionManagement

SupplierManagement

CAPAManagement

Non-ConformanceManagement

TrainingManagement

EquipmentManagement

ChangeManagement

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