Commissioning & Qualification
Yanxin’s experts are committed to helping clients with cost-effective solutions of commissioning and qualification in a timely manner. Our streamlined engineering practices use a risk-based approach. Our advantage is that we understand your process and we build a plan focused on the critical aspects while maintaining regulatory compliance. The experienced SMEs are backed by real technical skills to make your project a success. Our experience covers pharma, biotechnology and medical device industries and includes facilities, utility system, support equipments, analytical instruments, cleaning processes and sanitization/sterilization processes. Through our service, the clients can make sure that the process and systems are in accordance with international regulatory requirement. Our service includes but not limited to the following fields.
• User Requirement Specifications
• Function Requirement Specifications
• Critical Aspect Risk Assessments
• SAT/FAT
• DQ/IQ/OQ/PQ
• Cleaning Validation
• SOP generation
• Change Control Assessments
• Deviation/Investigation Management