GxP is a shortened term for the stringent good practice quality guidelines and regulations which govern the production of medical and food products including pharmaceuticals, biologics, medical devices and mobile medical applications. Life sciences organizations that develop and manufacture these products must comply with GxP regulations to ensure consumer and product safety, and ensure data integrity in decision-making processes. GxP requirements include specific guidelines around the usage of business applications and systems within critical functions such as research and development, clinical trials, quality and manufacturing.
Traditional IT infrastructures found in life sciences organizations pose numerous challenges to GxP compliance, limiting the security, performance and compatibility needed to satisfy these requirements. To be considered GxP compliant, life sciences organizations must be ready to prove that the aggregation of their technologies, personnel, policies and procedures are developed, operated and maintained within GxP guidelines as a whole, as they are subject to inspection by national health authorities (e.g.; US FDA) and customer audit.