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".