{"id":3027,"date":"2018-02-21T00:00:00","date_gmt":"2018-02-21T00:00:00","guid":{"rendered":"https:\/\/azure.microsoft.com\/blog\/new-azure-gxp-guidelines-help-pharmaceutical-and-biotech-customers-build-gxp-solutions"},"modified":"2025-06-27T08:35:20","modified_gmt":"2025-06-27T15:35:20","slug":"new-azure-gxp-guidelines-help-pharmaceutical-and-biotech-customers-build-gxp-solutions","status":"publish","type":"post","link":"https:\/\/azure.microsoft.com\/en-us\/blog\/new-azure-gxp-guidelines-help-pharmaceutical-and-biotech-customers-build-gxp-solutions\/","title":{"rendered":"New Azure GxP guidelines help pharmaceutical and biotech customers build GxP solutions"},"content":{"rendered":"\n

We recently released a detailed set of GxP qualification guidelines for our Azure customers<\/a>. These guidelines give life sciences organizations, such as pharmaceutical and biotechnology companies, a comprehensive toolset for building solutions that meet GxP compliance regulations. <\/p>\n\n\n\n

GxP is a general abbreviation for “good practice” quality guidelines and regulations. Technology systems that use GxP processes such as Good Laboratory Practices (GLP), Good Clinical Practices (GCP), and Good Manufacturing Practices (GMP) require validation of adherence to GxP. Solutions are considered qualified when they can demonstrate the ability to fulfill GxP requirements. GxP regulations include pharmaceutical requirements, such as those outlined in the U.S. Food and Drug Administration CFR Title 21 Part 11, and EU GMP Annex 11.  <\/p>\n\n\n\n

Life sciences organizations are increasingly moving to the cloud to increase efficiency and reduce costs, but in order to do so they must be able to select a cloud service provider with processes and controls that help to assure the confidentiality, integrity, and availability of data stored in the cloud. Of equal importance are those processes and controls that must be implemented by life sciences customers to ensure that GxP systems are maintained in a secured and validated state.<\/p>\n\n\n\n

Life sciences organizations building GxP solutions on Azure can take advantage of the cloud\u2019s efficiencies while at the same time helping protect patient safety, product quality, and data integrity. Customers also benefit from Azure\u2019s multiple layers of security and governance technologies, operational practices, and compliance policies to enforce data privacy and integrity at very specific levels.<\/p>\n\n\n\n

The Azure GxP qualification guidelines give customers the tools they need to build on Azure\u2019s security foundation by providing:<\/p>\n\n\n\n