QCSFusion Complaint Management Module

An efficient Product Complaint Management system is a vital component in the pharmaceutical industry, addressing compliance, regulatory, and business imperatives. Swift action in response to customer complaints is paramount, making the management of product complaints, from initiation to resolution, a necessity.

A robust complaint management software system is crucial in achieving key objectives, including customer retention, ensuring customer safety, compliance with industry regulations, and mitigating the risk of potential product liability lawsuits.

The QCSFusion Complaint Management module offers capabilities to record, investigate, and respond to complaints while monitoring trends. This automated process significantly enhances your company's quality performance, ensuring a streamlined and effective approach to managing customer feedback.


  • Document Repository for all documents types - internal and external
  • GMP and 21 CFR part 11 compliant
  • E-signatures
  • Communication via e-mail (alerts / reminders)
  • Multi-level file structure so that documents can be organized effectively
  • Secure documents so that only authorized personnel can move, edit, archive
  • Detailed audit trail include:

    • System-stamped date and time

    • User who performs the activity

    • Information of action performed

    • Reason for changes

  • Flexible roles / responsibilities that can be assigned based on customer needs
  • Review and Approval workflow
  • Cross-references to link related documents
  • Task list so users can see what tasks are assigned to them
  • Assign time requirements for certain workflows and issue alerts / reminders to assure timely completion
  • Searchable
  • Revision history
  • Option to stamp document for printing
  • Capability to control variety of Deviations types:

    • SOPs, policies, work instructions

    • Forms

    • Batch records

    • Certificates of Analysis (C of As)

    • Regulatory submissions

    • Regulatory correspondence

    • Deviations / Investigations - CAPA

    • Documentation related to change control

    • Validation documentation

    • Manuals, instructions

    • Employee training and qualification records

    • Project documentation

    • Investigation documents, photographs, etc.

    • Audit reports and follow-ups

  • Editable templates (default and / or user created)
  • Ability to email a copy of Deviations to any party (auditors, customers, suppliers, etc.)