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White Paper

Using MongoDB Atlas in GxP Systems

This white paper outlines how MongoDB Atlas can be used in GxP-regulated environments, particularly for healthcare and life sciences organizations that must comply with strict regulatory standards for data management and security best practices.

Key aspects covered:

* Compliance with Good Practice (GxP) regulations and Title 21 CFR Part 11

* Data integrity and security features of MongoDB Atlas

* Clear division of responsibilities between MongoDB and customers

* Specific use cases including clinical trials, electronic health records (EHRs), and pharmacovigilance

* Implementation guidelines for maintaining regulatory compliance

* Security features including encryption, access controls, and audit trails

The white paper serves as a practical guide for organizations looking to leverage MongoDB Atlas while ensuring they meet all necessary regulatory requirements in regulated industries.


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