Process Optimization Expert
InnovationExperts Team
Yin Zilin

Expert in Computerized System Validation, Senior Engineer, Master of Power Electronics and Power Drives from Shijiazhuang Tiedao University, Technical Manager of the Validation Center at TIANS Group.

Over the years, I have been committed to the validation of computerized systems and data integrity compliance work in pharmaceutical enterprises. I am well-versed in regulations and guidelines related to computerized system validation and data reliability, such as NMPA, EU, FDA, ISPE, and PIC/S. I have rich experience in validating computerized systems including Cleanroom Air-Conditioning Automation BMS, Environmental Monitoring System (EMS), Particle Monitoring System (PMS), Process Automation System (PCS), Distributed Control System (DCS), and LIMS.

Clients served include North China Pharmaceutical, Gan & Lee Pharmaceuticals, Shanghai Institute of Biological Products, Wuhan Institute of Biological Products, Hepalink, Corning Jerry, Tianke Pharmaceutical, Shenzhen Mindray, and other top 100 domestic enterprises. I have participated in the establishment and improvement of computerized system management systems in pharmaceutical enterprises and third-party data integrity compliance audits, and have been involved in the compilation of the book "Pharmaceutical Equipment and Process Validation".