Forum Discussion
New Azure GxP guidelines help pharmaceutical and biotech customers build GxP solutions
We recently released a detailed set of GxP 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.
Read about it in the Azure blog.
1 Reply
Thanks for relase. How do companies deal with frequent changes (MS Updates) in Azure and Microsoft 365 to ensure compliance with GMP requirements? How are updates and feature rollouts handled ? Are validation and documentation provided for regulated environments? What proactive measures exist for notifying and supporting GMP-regulated customers?
Thank you,
Alma
