Commissioning, Qualification & Validation (CQV)
Ensure your systems meet all requirements with our thorough commissioning, qualification, and validation services.
KAPS Automation provides comprehensive CQV services to verify that your automation systems function as designed, meet all requirements, and comply with applicable regulations. Our methodical approach ensures quality, reliability, and documented evidence of system performance.
Whether you're implementing new systems or modifying existing ones, our CQV expertise helps minimize risks, accelerate time-to-production, and establish a solid foundation for ongoing regulatory compliance.
Key Benefits
Regulatory Compliance
Documentation and evidence that meets FDA, EMA, and other regulatory requirements.
Quality Assurance
Verification that systems perform as designed and meet all user requirements.
Comprehensive Documentation
Thorough documentation package to support audits and regulatory inspections.
Risk Reduction
Systematic approach to identifying and addressing potential issues before they impact operations.
Our Approach
Commissioning
We verify that all system components are installed correctly, calibrated appropriately, and function according to specifications. This includes hardware installation verification, I/O checks, and initial system testing.
Qualification
Our qualification services include Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to verify that systems are installed and operate according to specifications and user requirements.
Validation
We develop and execute validation protocols that provide documented evidence that systems consistently perform as intended and meet all predefined requirements throughout their lifecycle.
Documentation & Reporting
We create comprehensive documentation packages including validation plans, protocols, test scripts, traceability matrices, and summary reports to support regulatory compliance.
Why Choose KAPS for CQV Services
- Experienced validation specialists with expertise in regulated industries
- Deep understanding of regulatory requirements (FDA, EMA, etc.) and industry standards
- Proven validation methodologies and documentation templates
- Risk-based approach that focuses resources on critical aspects
Ready to ensure your systems meet all requirements?
Contact us today to discuss your CQV needs.