Guides
Grouped by subject and numbered in reading order. New to GxP? Start at the top.
- Start here
- 01What GxP means for ITThe GxP family, predicate rules, the regulations and guidance that matter for computer systems, ALCOA+, and who is responsible for what in the cloud.
- Regulations and validation
- 02Part 11 and Annex 11, requirement by requirementWhat 21 CFR Part 11 and EU GMP Annex 11 actually require, what the 2025 Annex 11 draft adds, and which technical control answers each requirement.
- 03Validation: GAMP 5 and computer software assuranceThe validation life cycle, GAMP software categories, how FDA's CSA guidance changes testing, and a lean set of deliverables for a cloud-hosted GxP system.
- Platforms
- 04Qualifying Azure and AWSAssessing the cloud provider as a supplier, designing a GxP landing zone, qualifying it with infrastructure as code, and keeping it qualified as the platform changes under you.
- Controls
- 05Data integrity and audit trailsApplication audit trails versus platform logs, making cloud logs tamper-evident and long-lived, time synchronization, and how to run audit trail review.
- 06Access control for GxP systemsBuilding an access control program inspectors accept: unique accounts, role design, segregation of duties, joiners and leavers, privileged access, periodic access reviews and electronic signatures.
- 07Change control and configuration managementChange classes, impact on the validated state, pipelines as change records, drift detection, patching validated systems, and emergency changes.
- 08Backup, disaster recovery and business continuityBuilding a GxP disaster recovery program: criticality and recovery targets, immutable backups, restore testing as evidence, DR drills, business continuity and archiving for long retention.
- Documents and operations
- 09SharePoint and Microsoft 365 for GxP documentsWhat SharePoint Online can and can't do for controlled documents and records, library settings that matter, retention labels, audit, and where a validated add-on is needed.
- 10Periodic review and inspection readinessWhat a periodic review of a GxP system covers, building an evidence pack with the scripts, incidents and deviations, and what inspectors ask IT.