🔬 Pharmaceutical Lab RCA Tool
Comprehensive Root Cause Analysis for Laboratory Issues
Welcome to Advanced RCA Analysis Platform
Streamline your pharmaceutical laboratory investigations with our comprehensive Root Cause Analysis tool. Designed specifically for analytical labs to ensure regulatory compliance and quality excellence.
🎯 Why Choose Our RCA Tool?
- ✅ FDA/ICH compliant documentation structure
- ✅ Step-by-step guided analysis process
- ✅ Pharmaceutical industry-specific templates
- ✅ Professional report generation
- ✅ CAPA tracking and management
Issue Definition
Clearly define and categorize laboratory issues with pharmaceutical-specific severity levels and impact assessment.
Data Collection
Systematic evidence gathering with pre-defined categories for equipment, environmental, and procedural factors.
5-Why Analysis
Interactive root cause identification using the proven 5-Why methodology with guided prompts and validation.
CAPA Management
Comprehensive Corrective and Preventive Action planning with responsibility assignment and timeline tracking.
Professional Reports
Generate audit-ready documentation with proper formatting, severity coding, and complete investigation trail.
Compliance Ready
Built following industry best practices and regulatory guidelines for pharmaceutical quality systems.
📊 Data Collection & Initial Investigation
🔍 5 Why Analysis
Ask “Why?” repeatedly to drill down to the root cause. Each answer becomes the basis for the next question.
🔧 Corrective & Preventive Actions (CAPA)
📄 Root Cause Analysis Report
Generated on: