ARIREX provides comprehensive validation and qualification services to ensure your facilities, equipment, utilities, and processes are fit for their intended use. We apply a risk-based approach to validation (ASTM E2500, ICH Q9), balancing regulatory compliance with operational efficiency.
From the initial Design Qualification (DQ) to the final Performance Qualification (PQ) and Process Validation (PV), our team generates robust documentation that serves as scientific proof of control. We support both new installations and legacy system remediation.
Validation Lifecycle Services
We handle validation projects of all sizes, ensuring that your critical assets are qualified on time and within budget.
- Commissioning & Qualification (IQ, OQ, PQ).
- Process Validation (PPQ, CPV).
- Cleaning Validation & Development.
- Analytical Method Validation.
- Utility & HVAC Validation.
Why Validation Matters
Proper validation is not just a regulatory requirement; it is the foundation of product consistency and patient safety.
- Scientific Integrity: Documented evidence that processes consistently reproduce the desired results.
- Reliable Operations: Minimize equipment downtime and process deviations through rigorous testing.
- Regulatory Trust: Demonstrate full control over your manufacturing and laboratory environment.