Guiding our customer to prepare for equipment URS, assist in reviewing FAT, SAT, FS, DS and other documents provided by suppliers, and propose revision suggestions for different equipment use needs.

Reviewing DQ, IQ, OQ, PQ protocol, resting records and reports provided by our customer or their suppliers with reference to URS to ensure each document will comply with the requirements of regulations or guidelines against NMPA, FDA, EMA, PIC/s, TGA and WHO.

Assisting our customer to prepare or review validation protocols and reports for cleaning, sterilization, process and analytical methods to ensure their compliance.