Enterprise Quality and Compliance Management Software

ISO 9001:2000 certified

	Home
	Contact

	Solutions	Industries	Services	Company	News & Events	Resources	Customers

SOLUTIONS

EtQ Medical Device	>>

EtQ Pharma/Bio	>>

EtQ Manufacturing	>>

EtQ Environmental Health & Safety	>>

EtQ OnDemand	>>

INDUSTRIES

Life Sciences
Pharmaceuticals	>>

Medical Device	>>

Biotechnology	>>

Blood Services	>>

Process Manufacturing
Chemicals/Metals	>>

Energy	>>

Food & Beverage	>>

Discrete Manufacturing
Aerospace	>>

Automotive	>>

Technology	>>

Government/Services
Government	>>

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