Qualification & Validation
Ensuring systems are qualified, validated, and inspection-ready
Qualification
• Commissioning & Qualification (C&Q) support
• Equipment (lab & production), facilities and utilities qualification
• Test strategy and execution
Validation
• Process validation (PPQ)
• Process & Cleaning validation
• Data analysis and documentation
Computerized System Validation (CSV)
• GxP computerized systems validation (GAMP 5)
• URS definition and supplier assessment
• IQ/OQ/PQ documentation and execution
• Data integrity and audit trail review
Validation Lifecycle & Compliance
• Validation Master Plan (VMP)
• Risk assessments and traceability matrices
• Maintaining systems in a validated state through calibration and maintenance strategies