Notes / GxP
GxP
Running regulated systems on Azure, AWS and SharePoint: what Part 11 and Annex 11 ask of IT, validation without the paper mountain, qualified cloud platforms, and the controls inspectors test most (audit trails, access, change, backup and disaster recovery). 10 guides and 7 evidence scripts.
How GxP works in the cloud
Each layer depends on the one before it. Practical notes from real GxP and HIPAA work, not legal or regulatory advice.
- Predicate rulesWhich records you must keep
- Intended use and riskHow much control each system needs
- Qualified platformAzure or AWS landing zone under control
- Validated systemYour configuration, tested for its use
- EvidenceReviews, restores and audit trails, on record
Explore GxP notes
Open only the section you need.
- Guides10 guides covering regulations, validation, cloud qualification, controls and periodic review.Open
- Scripts7 read-only PowerShell scripts that collect access, audit trail, backup and document control evidence.Open
- Example environmentExample names used consistently throughout the GxP examples.Reference