Capture, Track, Investigate, and Resolve Complaints with Confidence
Transform your complaint handling process into a compliant, efficient, and insight-driven system that ensures patient safety and product quality.
Complaint Management
Zentixs Care enables pharmaceutical companies to systematically capture, investigate, and resolve complaints while ensuring compliance with USFDA, EU GMP, and ICH guidelines.
USFDAEU GMPICHPharmacovigilance
Capture
Structured intake across all complaint types.
Investigate
Root cause analysis with full audit trail.
Resolve
CAPA tracking, closure, and compliance reporting.
Key Features
Everything you need for end-to-end complaint management, built for the pharmaceutical industry.
Centralized Complaint Capture
Multi-channel intake (Email, Call, Portal, Field). Structured data capture with configurable forms & Unique ID generation.
Classification & Categorization
Product, batch, and market segmentation. Criticality classification (Critical/Major/Minor) and trend-based categorization.
End-to-End Workflow
Complaint logging to closure tracking. Configurable workflow with role-based assignments, notifications & escalations.
Investigation Management
Root Cause Analysis (RCA) tools, investigation templates, checklists, and cross-functional collaboration (QA, Production, QC).
Quality Event Integration
Link complaints with Deviations, CAPA, Change Control. Impact assessment on product quality with closed-loop management.
Batch & Product Traceability
Batch history and distribution tracking. Integration with manufacturing and supply chain data, plus recall decision support.
Regulatory Compliance
21 CFR Part 11 compliant. Comprehensive audit trails, electronic signatures, and data integrity aligned with ALCOA+ standards.
Trend Analysis & Signals
Complaint trending by product, batch, and region. Identify recurring issues and detect early signals for risk mitigation.
Complaint Handling Workflow
A systematic and streamlined approach to ensure every complaint is addressed properly from intake through closure.
Intake
Capture complaint from multiple channels
Assessment
Categorization and risk classification
Investigation
Assign to QA / relevant department
RCA
Identify source of issue
CAPA
Prevent recurrence & improve process
Closure
Final decision & customer communication
Powerful Modules & Reports
Everything you need to manage complaints, investigations, CAPA, compliance and reporting from a single platform.
Key Modules
Reports & Outputs
Integrate Across Your Enterprise
Zentixs Care does not exist in a silo. It seamlessly integrates with your existing quality and manufacturing ecosystems.
LIMS
Lab Information Management
QMS
Quality Management Systems
ERP
Enterprise Resource Planning
MES
Manufacturing Execution
Built for Global Regulatory Standards
Designed to meet the compliance, data integrity and audit readiness requirements of life sciences organizations.