Qualification and validation
Aria Technology Solutions Qualification and validation
Aria Technology Solutions specializes in delivering top-notch quality assurance and validation services to ensure that your products and processes meet regulatory standards and industry expectations. Our comprehensive validation processes cover all aspects of product development and manufacturing, ensuring consistent quality, safety, and compliance. Qualification started during the project life cycle from the beginning of the design phase to delivery. Whether it’s software validation, equipment qualification, or utilities qualification, our expert team is committed to doing it the best way with the highest standards of excellence.
Qualification of clean rooms and HVAC systems:
In this regard, considering the years of experience inside and outside the country and familiarity with different production plants, qualification involves a series of mandatory tests designed to assess and maintain air quality, pressure, temperature, and other key parameters:
Airborne Particle Concentration
DOP Test or HEPA Filter Leakage Test
Air Pressure Difference Test
Air Change Rate (ACR)
Temperature & Humidity
Recovery Test
air flow measurement
air flow pattern
Equipment, Facilities, and Utilities Validation
Our Approach to Equipment, Facilities, and Utilities Validation
At Aria Technology Solutions, we strive to minimize qualification costs by concentrating on the most critical aspects of your business. Employing a risk-based approach aligned with industry standards such as the FDA and ISPE Baseline and Canadian Health Standards, we prioritize validation efforts on elements that significantly impact your product and processes. This strategy enhances efficiency and leads to substantial savings in time and resources.
Our Expertise
Our professional team brings over a decade of experience in the field. From documenting User Requirement Specifications (URS) to Design Qualification (DQ), we ensure comprehensive traceability to meet standards.
Comprehensive Documentation
Each project involves meticulous documentation. Some of the key documents we typically produce include:
Design Qualification (DQ)
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
Process Validation (PV)
Change Management Plans
Our dedicated team is committed to delivering high-quality validation services, ensuring compliance and operational excellence in every project.