White Paper
Using MongoDB Atlas in GxP Systems
This white paper provides guidance for using MongoDB Atlas in GxP-regulated environments across pharmaceuticals, biotechnology, medical devices, food, cosmetics, and other life sciences sectors. It covers GMP, GCP, GLP, data integrity principles, computerized-system requirements, regulatory bodies, the shared responsibility model, security and compliance features, electronic records, electronic signatures, and Title 21 CFR Part 11. MongoDB Atlas supports regulated workloads through security controls, auditability, high availability, encryption, compliance certifications, and support for healthcare standards such as HL7 FHIR. However, the paper stresses that Atlas provides enabling technology rather than automatic compliance: customers must validate, configure, operate, document, and govern
