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Complaint Management System Overview

EtQ's Complaint Handling module manages customer complaints to ensure compliance with FDA guidelines. It records all complaints, tracks related information about customers and products. The module also provides an electronic MedWatch form and allows users to investigate problems, identify trends in complaints, and take corrective actions.

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49 views2 pages

Complaint Management System Overview

EtQ's Complaint Handling module manages customer complaints to ensure compliance with FDA guidelines. It records all complaints, tracks related information about customers and products. The module also provides an electronic MedWatch form and allows users to investigate problems, identify trends in complaints, and take corrective actions.

Uploaded by

ziggie_lenz
Copyright
© Attribution Non-Commercial (BY-NC)
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

EtQ’s Complaint Handling module manages the investigation and resolution of customer complaints in compliance with FDA guide-

lines. It records all complaints reported by customers and/or consumers to investigate the problems, keeps records of these com-
plaints including information about the customers and the products. This database also provides an electronic MedWatch form.

Complaint Handling

• Automatic creation of • Issue and track RMA and • Configurable Decision trees • Record initial assessment • Initiate a full investigation for
Complaints from 3rd party sample requests (e.g., MDR, ADI) results and immediate cor- confirmed adverse and sys-
systems (e.g., SAP, Oracle) rective action taken temic events
• Form letter templates for var- • Force creation of regulatory
• Assignment based on com- ious correspondences reports based on user-defin- • Option to close appropriate • Complaint data will be auto-
plaint data able conditions complaints at this stage matically inherited into the
(e.g., type, severity) • Create / assign multiple investigation
action items to accelerate • Many regulatory reporting • Identify trends using built-in
• Automatically load product, resolution forms (e.g., MedWatch, Charts and Reports • Dual link between event and
patient and customer infor- MHRA, MedSafe) investigation
mation • Configurable workflow auto- • Perform Risk Assessment
mates review and approval • Automatic PDF conversion using two, three or four • Automatically lookup and dis-
• Display related complaints process dimensions play related investigations
and CAPAs
• Quality Alerts automatically • Graphical workflow presenta- • Automatic risk calculation
monitors repeated complaints tion and results based on your
policies
• Automatic notification of • Intuitive workflow displays
complaints complaint status • Display decision guidelines
based on calculated risk
• Conditional routing options level

• Automatically send reminder • Risk mitigation history


notifications to assigned
users

• Escalation management

• Update complaint status in


3rd party systems (e.g., SAP,
Oracle)
Implementing different applications for Quality and Compliance Management is costly, time-consuming and confusing to users.
With all its functionality built around a common platform, EtQ has developed a Management System that unifies both quality
and compliance processes for all industries:

Total Quality Solution

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