Market Complaint

Need for Market Complaint

Pharmaceutical companies are required to have a robust process for handling market complaints. Complaints, whether related to product quality, efficacy, labelling, or adverse events, must be systematically captured, investigated, and resolved to ensure patient safety, maintain regulatory compliance, and protect brand reputation. A standardized complaint handling system allows organizations to efficiently manage customer feedback, perform root cause analysis, implement corrective actions, and prevent recurrence, ensuring compliance with regulatory requirements and enhancing customer trust. 

How it Benefits  

Ensures regulatory compliance with global standards (USFDA, EMA, MHRA, WHO) for complaint handling.

Skill Matrix & Gap Analysis

Enables timely investigation, root cause identification, and implementation of CAPA to prevent recurrence of quality issues.

Strengthens communication and documentation with complainants, distributors, and regulatory authorities.

Training Extension Forms

Facilitates complaint acknowledgment, tracking, escalation, and closure through pre-defined workflows, minimizing delays.

Training Evaluation & Compliance

Auto-linkage with CAPAs, deviations, and change controls makes complaint handling part of a closed-loop quality management system.

Process Diagram

Complaint Receipt and Logging

Capture complaints from patients, healthcare professionals, or distributors with all relevant details in a centralized system

Preliminary Assessment / Risk Evaluation

Classify and assess the complaint’s severity and regulatory impact 

Investigation & Root Cause Analysis

Initiate investigation and identify root cause using structured quality tools 

Corrective & Preventive Action Planning

Define corrective measures to resolve the complaint and preventive actions to avoid recurrence 

Complaint Review & Approval

Cross-functional review including QA to ensure adequacy, feasibility, and compliance before approval 

Implementation of Actions

Execute corrective and preventive actions addressing the root cause of the complaint 

Verification of Effectiveness & Closure

Confirm that actions resolved the complaint, perform effectiveness checks, ensure complainant acknowledgement and close out documentation 

Handling of Market Complaint with QEdge

  • Centralized complaint lifecycle management from receipt to closure
  • Risk-based prioritization and automated escalation of overdue complaints
  • Integration with CAPA, deviations, and change management
  • Complainant acknowledgement and communication tracking
  • Controlled re-open workflow to address incomplete investigations

Results of Implementation

Investigation Accuracy & Root Cause Identification improved by

0 %

Customer / Market Feedback Response Time reduced by

0 %

Audit readiness improved up to

0 %

Manual Documentation Effort reduced by

0 %

Operational efficiency & Productivity increased up to

0 %