Companies, engaged in the life sciences industry, e.g., pharmaceutical, medical devices, should establish a quality management system in accordance with relevant GMP regulations. The system should cover all factors affecting product quality which include all activities that assure product quality meets its intended use.
However, in order to accommodate the richness and diversity of products, national regulations are often generalized principal requirements. It is challenging for an enterprise to ensure that in the process ofestablishing a quality system, the relevant requirements can be fully covered, and the generalized principal requirements can be transformed into executable, operable and implementable documents for an enterprise.
gempex has many years of experience in the quality systems establishment in the field of life science fields. With the professional knowledge and accumulated industry experience, gempex can not only design management system structure for diversified enterprises, but also provide one-stop system establishment service for enterprises, as well provide check and review services for the quality system.
