Validation Services (Clinical Domain)
Regulatory Compliance & System Validation
Comprehensive validation services ensuring compliance with FDA, EMA, and other regulatory standards.
Core Features
CSV (Computer System Validation)
IQ/OQ/PQ Documentation
Risk Assessment & Management
Regulatory Compliance Support
Technologies & Standards
GAMP 5FDA 21 CFR Part 11EU Annex 11ISO 13485ISPE Guidelines
Our Process
A structured approach to ensure successful delivery
1
System Assessment
Evaluate system requirements and regulatory scope
2
Validation Planning
Develop comprehensive validation strategy and protocols
3
Execution
Execute IQ/OQ/PQ protocols with detailed documentation
4
Compliance Review
Final review and regulatory compliance certification
Key Benefits
Why choose our services for your business transformation
✅
Regulatory Compliance
Full compliance with FDA, EMA, and global regulatory standards
🛡️
Risk Mitigation
Comprehensive risk assessment and mitigation strategies
📋
Expert Documentation
Complete IQ/OQ/PQ documentation packages
🔍
Audit Ready
Documentation and processes ready for regulatory audits