EtQ, Inc. | Enterprise Quality and Compliance Management Software

Enterprise Quality and Compliance Management Software

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Complaint Handling Software

Complaint Handling Software Overview

 
Complaint Handling Software manages the investigation and resolution of customer complaints in compliance with FDA guidelines. It records all complaints reported by customers and/or consumers to investigate the problems, keeps records of these complaints including information about the customers and the products. Complaint Handling Software also provides an electronic MedWatch form, with electronic submission to the FDA (eMDR).

Complaint Handling Software is just one of the dozens of processes EtQ's Quality Management Software System streamlines and simplifies. EtQ's Quality Management Software System lets you take full advantage of the familiarity that most of your users already have with a web browser by providing an interface with which they are already comfortable and productive. Other Modules include: Document Control Software, Audit Management Software, Employee Training Software, Nonconformance Software, Change Management Software, Corrective Action (CAPA) Software, Calibration Software, Risk Assessment Software and EtQ's Centralized Reporting Tool, and more!

EtQ's applications offer power and simplicity built on our "Flexible Workflow" and "Escalation Management" Engines. EtQ also features unmatched utility technology built to support the monitoring, data gathering, and reporting mandated by compliance management. With EtQ's Escalation, Delegation, Data Rollup and Centralized Reporting features, gathering and presenting status and historical data from across your organization is fast and easy. EtQ is a pioneer in achieving the next level of quality through exception reporting. EtQ Quality Alerts automatically notifies specific individuals of recurring events that you define.
EtQ Complaint Handling System Module
 
Event Initiation for Complaint Handling

Automatic creation of complaints from 3rd party CRM systems (e.g. SAP, Oracle)
Automatic assignment based on CRM data
Automatically lookup and display related complaints
Automatically notify affected Departments and personnel
Automatically load product, patient and customer information
Drag & Drop configuration using EtQ Designer

Event Handling for Complaint Handling

Issue and track RMA and samples
Integrate with Microsoft Office to create form letter templates for various types of correspondence
Create and assign multiple action items to accelerate resolution
Easily configurable workflow to automate review and approval process
Intuitive workflow display to show document status
Assign documents to individuals, groups or roles
Multiple routing options: Parallel, Sequential, Voting
Conditional routing options to accommodate complex business processes
Automatically send reminder notifications to assigned users and escalate to their managers

Adverse Event Reporting for Complaint Handling

Decision trees are configured out of the box (e.g. MDR, ADI)
Additional product specific decision trees can easily be configured
Many regulatory reporting forms (e.g. MedWatch, MHRA, MedSafe)
Force creation of regulatory reports based on user definable conditions
Automatic PDF conversion
21 CFR Part 11 compliant

Initial Assessment for Complaint Handling

Record initial assessment results
Option to close appropriate events at this stage
Use Risk Assessment to help guide decision making
Use Centralized Reporting to identify trends

Investigation & CAPA
Automatically inherit complaint data into the investigation
Dual link between Event and investigation
Link complaint to existing open investigation
Link multiple complaints to a single investigation
 



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