With the introduction and development of automation, informatization and intelligent technologies in pharmaceutical industry, and the requirements and guidelines of the domestic and international drug regulatory on computerized systems are also continuously updating and become more and more stricter.It becomes a key issue for all pharmaceutical enterprises that how to apply and manage computerized system under the complex GMP environment.
gempex GMP consultants, who are expertise in CS compliance field, have over 20 years of experience in multinational pharmaceutical companies, CDMO, CRO and information technology companies. What’s more, gempex can provide the computerized compliance services with GMP requirements of China, EU, FDA, PIC/S, TGA, NMPA, etc.