Complaints Management for the Medical Device Industry -
Rapid Containment and Traceability, with Strategic Field Performance Knowledge to Advance Product Quality

Camstar Complaint Management™ is an enterprise-class Complaint Management system for the Life Sciences Industry that provides the ability to document and categorize complaints, address the necessary regulatory requirements and facilitate timely closure.

   Camstar Quality – Module Functional Capabilities




Click on our functional capabilities matrix to see what solution areas may be implemented through the different modules offered within Camstar Quality.

View our functional capabilities matrix

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The following capabilities are an integral part of the Camstar Nonconformance Management ™ module:

  • Systematic capturing of field events
  • Triage, risk assessment and complaint escalation of events
  • Adaptable workflows to address Complaint Management business processes
  • CAPA escalation based on business rules
  • Closed-loop interoperability with Camstar Manufacturing for product traceability and sample tracking
  • Regulatory reporting and Electronic Medical Device Reporting support
  • Global reporting capabilities
  • Enterprise-class architecture and design
  • Web 2.0 technology for exceptional usability
  • Interoperability with 3rd party enterprise applications (ERP, MES, PLM…) to achieve closed-loop Quality
  • Easy mapping to any organizational hierarchy
  • Easy extendibility to your supply chain
  • Role-based access control
  • 21 CFR Part 11 compliance
Featured White Paper

Camstar White Paper
A Fundamental Shift Needed in the Approach to QMSDownload
Learn why a closed-loop platform advances product quality and trumps traditional forms-based, siloed systems

 
 


 

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Available Demos:

  • Next Generation CAPA
  • Nonconformance Management
  • Complaints Management
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