Global | Healthcare and life sciences

GxP

In the life sciences industry, GxP is an abbreviation referencing the various “good practice” regulations and guidelines that apply to medical products. The “x” variable in GxP covers a wide range of processes utilized in the development, manufacturing, and distribution of regulated products. Particular GxP criteria can be found in government agency regulations and guidance (e.g., Federal Food, Drug, and Cosmetic Act) as well as industry best-practice frameworks. Though GxP may cover any number of specified topics, for regulatory oversight purposes, government agencies have almost uniformly adopted requirements related to product manufacturing processes, documentation procedures, staff qualifications and training, and distribution/storage. For life sciences organizations doing business in the U.S., GxP requirements can generally be found in the U.S. Food and Drug Administration’s (FDA) Code of Federal Regulations (“CFR”).

Our life sciences customers, many of whom are subject to GxP requirements, utilize Google Cloud in ways that not only help to achieve compliance, but also result in differentiated capabilities, technological advancements, and organizational efficiencies.

Google Cloud’s administrative, physical, and technical controls help our life sciences customers meet their quality, documentation, and security objectives. In addition to the underlying infrastructure and operations managed by Google, Google Cloud products also provide capabilities which can make it easier for our customers to meet applicable GxP requirements. For more information on using Google Cloud in GxP systems, please view our GxP whitepaper.


ISO/IEC 27001

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ISO/IEC 27017

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ISO/IEC 27018

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