Life sciences organizations need to streamline processes, increase efficiency, and reduce costs all while ensuring patient safety, product quality, and data integrity. This document provides a comprehensive toolset for using Azure while adhering to GxP guidelines, best practices and regulations.
"The most comprehensive Cloud GxP Guidelines available in the Industry" - Michael Zwetkow, VP - Professional Services & Alliances
The goal of this GxP guidelines document is to provide life sciences organizations with a comprehensive toolset for using Microsoft Azure while adhering to industry best practices and applicable regulations.
The document identifies the shared responsibilities between Microsoft and its life sciences customers for meeting regulatory requirements, such as FDA 21 CFR Part 11 Electronic Records, Electronic Signatures, and EudraLex Volume 4 – Annex 11 Computerised Systems.