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 Tracking Software

Customer Complaint & Tracking Software

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).

The eMDR Requirement: Best Practices for Enhancing Collaboration with the FDA. View White Paper

Through our comprehensive complaint tracking software module, organizations are able to investigate any incoming customer or regulatory complaints, keep records and track these complaints including information about the customers, suppliers and the products in order to identify, mitigate and prevent recurrence of common complaint types. The complaint handling module is able to incorporate risk management tools to quantify the risk of the complaint being tracked, and immediately generate a Corrective Action (CAPA) from the complaint record, inheriting all relevant complaint data.

EtQ Reliance complaint handling software module is integrated with the electronic submission gateway for medical device reporting, and can generate eMDRs directly from the Complaint record, and automatically submit this data to the FDA.

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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