Complaint Handling Software

Complaint Handling

EtQ’s Complaint Handling solution provides an efficient method for collecting post-market data and quickly turning this data around to improve quality.

Complaint Handling

Complaint Handling management software manages complaint handling 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 form, for Electronic Medical Device Reporting (eMDR).

Complaint Handling software is just one of many processes EtQ's Quality, Environmental, Health and Safety (EHS), and Compliance Management Software streamlines and simplifies. EtQ's Quality, EHS and Compliance 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: Audit Management, Employee Training Software, Corrective Action (CAPA) Software, Calibration Management Software, Risk Assessment Software, and more!

Click through the workflow to see how EtQ can help.

Event Initiation for Complaint Handling Software

  • 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 in EtQ Reliance

Event Handling for Complaint Handling Software

  • Issue and track RMA and samples
  • Microsoft Office Integrated 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 Software

  • 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. eMDR, MHRA, MedSafe)
  • Force creation of regulatory reports based on user definable conditions
  • Automatic PDF conversion
  • 21 CFR Part 11 compliance

Initial Assessment for Complaint Handling Software

  • 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

Complaint Handling Software 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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