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. It identifies the shared responsibilities between Microsoft and its life sciences customers for meeting regulatory requirements, such as US-FDA 21 CFR Part 11 Electronic Records, Electronic Signatures (21 CFR Part 11), and EudraLex Volume 4 – Annex 11 Computerised Systems (EMA Annex 11).