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.