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