Enabling GxP-Regulated Research Computing for Pharma on AWS

Our client, a global biopharmaceutical organization, needed to move beyond rigid, capacity-constrained on-premises environments to accelerate PK/PD, PBPK, and Monte Carlo modelling, simulation, and analytics workloads, without compromising the compliance, traceability, and audit readiness required under GxP regulations. To address this, Relevance Lab extended AWS Research & Engineering Studio (RES) into a self-service research platform that could be configured, validated, and operated within a GxP framework.

Friction Points

• Capacity-Constrained Infrastructure: Rigid, on-premises environments limited the scalability of compute-intensive modelling and simulation workloads.
• Strict GxP Requirements: Cloud adoption had to support compliance, traceability, and audit readiness, not just scalability and performance.
• Validation Gaps: Even a capable platform like RES could not be used confidently in regulated research without proper configuration, validation, and governance.
• Perceived Complexity: The perceived complexity of cloud adoption was one of the biggest barriers for regulated Pharma organizations.

Solution

• Self-Service Research Portal: Deployed AWS Research & Engineering Studio (RES) to give scientists a self-service portal for launching interactive and batch research workspaces.
• GxP-Aligned Architecture: Implemented private, secure deployment with enterprise identity integration, encrypted data storage, and centralized, immutable logging.
• Validated Environment Design: Standardized version-controlled workspace templates and validated AMI/image pipelines, with separated DEV, VALIDATION, and PROD environments.
• IQ/OQ/PQ Validation Framework: Mapped RES capabilities to Installation, Operational, and Performance Qualification, with ready-to-use validation artifacts and traceability.
• Operational Governance &Jump-Start Delivery: Defined SOPs for access and change management, audit-ready logging and reporting, and rapid deployment through the RES Enterprise Jump-Start Program.

Impact

• Self-Service Access for Scientists: Empowered researchers to launch approved environments and run analyses without depending on IT.
• Efficient Workload Scaling: Enabled interactive and batch workloads, including PK/PD, PBPK, and Monte Carlo modelling, to scale on demand.
• Audit-Ready Compliance: Strengthened traceability and audit readiness aligned with GxP requirements.
• Reduced Platform Lock-In: Decreased dependence on rigid, proprietary on-premises platforms.
• Rapid Deployment: Enabled a path from zero to a fully deployed, custom-domain, secure RES environment ina few weeks.