Equipment Validation

CTI, in accordance with the GMP regulations and guidelines of various countries, JJF, GB and other requirements, combined with the user's actual use of the scope, to provide storage temperature and humidity, refrigerator/incubator/sterilization cabinets and other chamber parameters (temperature, carbon dioxide, pressure, etc.) performance confirmation services to ensure that the warehouse, the chamber in the normal operating methods and process conditions can be sustained.Under normal operating methods and process conditions, we can continuously meet the established acceptance standards.
 

Analytical Instruments and Computerized Systems Validation

CTI provides full validation cycle services (including URS, VP, RA, FS, CS, DQ, IQ, OQ, PQ, VSR, etc.) from validation plan to final system release according to the requirements of GMP regulations and guidelines such as GAMP5 Risk Benchmarking, and in combination with the user's actual needs, in order to prove that the computerized system meets the user's needs and works stably in the long term, and meets the requirements of data integrity. data integrity requirements