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  • Complaint Handling

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    EtQ's Complaint Handling module 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. This database also provides an electronic MedWatch form.

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    ComplaintHandling

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    EtQ's Complaint Handling module 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. This database also provides an electronic MedWatch form.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PDF, TXT or read online from Scribd
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    72 views2 pages

    Complaint Handling

    Uploaded by

    ziggie_lenz
    EtQ's Complaint Handling module 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. This database also provides an electronic MedWatch form.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    of 2

    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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