What Is GxP?

GxP is an umbrella term for regulated good-practice requirements; the “x” stands for the relevant area, such as manufacturing (GMP), laboratory work (GLP) or clinical practice (GCP). In a regulated operation, people, procedures, records and computerized systems must support the applicable requirements. The exact controls depend on the product, activity and jurisdiction. Calling a system “GxP compliant” is not enough on its own: intended use, validation, data integrity and operating procedures need to be assessed.

Related: GAMP software categories · EBR.