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debugging and validation

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Product Details
Product Details

Yansin's experts are committed to providing our clients with timely, cost-effective commissioning and validation solutions. Our streamlined engineering practices employ a risk-based approach. Our strength lies in the fact that we understand your process flow and develop plans that focus on the key links while ensuring compliance. Our team of experienced experts has strong technical capabilities to ensure the success of your project. Our experience spans the pharmaceutical, biotechnology and medical apparatus industries, covering facilities, utility systems, support equipment, analytical instruments, cleaning processes and disinfection/sterilization processes. Through our services, clients can ensure that processes and systems comply with international regulatory requirements. Our services include but are not limited to the following areas.

• User request specification

• Functional requirements specification

• Critical aspects threat and risk assessment

• SAT/FAT

• DQ/IQ/OQ/PQ

• Clean validation

• SOP generation

• Change control assessment

• Deviation/survey management