LSPERF09-BP01 Evaluate data stores based on regulatory requirements and data governance capabilities

Select data stores that provide features for healthcare regulations (HIPAA, FDA 21 CFR Part 11, GxP) including audit trails, data integrity controls, and encryption at rest and in transit. Assess the data store's ability to implement role-based access controls, data lineage tracking, and automated retention policies. For clinical data, prioritize solutions offering validated environments and regulatory documentation, while verifying that research data stores can accommodate less restrictive access patterns for collaboration and discovery workflows.

Desired outcome: Implement balanced security and governance framework that enforces robust controls while maintaining research flexibility, automates processes with minimal manual intervention, and provides comprehensive audit documentation across critical systems.

Level of risk exposed if this best practice is not established: High

Implementation guidance

Establish a comprehensive evaluation system for assessing data store audit capabilities. This foundation aligns with healthcare regulations while maintaining required security and governance features.

Implement robust role-based access management across different data stores. This framework should support varied access patterns while maintaining strict regulatory requirements for clinical data.

Deploy comprehensive security measures including encryption and audit mechanisms. This system should preserve data integrity while supporting both clinical and research workflows.

Design integrated governance framework that spans different data stores. This assists with consistent policy enforcement while accommodating different workflow requirements.

Establish systematic validation processes for clinical data environments. This framework should maintain regulatory adherence while enabling efficient research collaboration.

Implementation steps

Resources