LSPERF07-BP02 Design a compliant-by-design infrastructure

Design a computing architecture that addresses both performance and regulatory requirements through technical controls built directly into the infrastructure. Implement segregated computing environments with appropriate data controls between GxP and non-GxP workloads, deploy immutable infrastructure techniques that enhance both security and compliance, and use containerization with validated base images to accelerate deployment while maintaining regulatory integrity. Establish infrastructure templates with pre-validated components, automated audit trail generation, and built-in data integrity mechanisms that minimize the performance overhead typically associated with compliance retrofitting, while verifying that computational workloads execute in appropriately validated environments based on their regulatory classification.

Desired outcome: Create a computing infrastructure that balances performance and adherence through built-in controls, proper isolation, and automated validation, enabling efficient scientific work without regulatory burden.

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

Implementation guidance

Design distinct computing environments with appropriate boundaries for different regulatory contexts. Isolation allows tailored controls while avoiding regulatory requirements from limiting innovation in research-focused areas.

Use infrastructure as code and immutable deployment patterns that enhance both security and regulatory adherence. Immutable approaches block configuration drift while creating inherently more auditable and consistent environments.

Create a library of pre-validated infrastructure components and patterns. Pre-validated components accelerate deployment while maintaining compliance-aligned assurance through already-verified building blocks.

Integrate mechanisms directly into the infrastructure rather than as external processes. Embedded controls reduce overhead while blocking continuous compliance-aligned assurance without manual intervention.

Design infrastructure that maintains computational efficiency while meeting regulatory requirements. Performance-preserving approaches stop regulatory controls from becoming computational bottlenecks.

Implementation steps