In highly regulated industries like pharma and life sciences, data-driven insights drive progress, and the tools and environments we depend on play a crucial role. 

Learn simple steps to navigate GxP compliance and keep your pharmaceutical projects on track.

As traditional deployments face delays, inconsistencies, and challenges with validation and compliance across environments, modern cloud-native approaches and Infrastructure as Code (IaC) offer tools and solutions that address these issues, enabling teams to collaborate effectively and stay aligned.

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A statistical computing environment (SCE) is a platform that supports analytical workflows and ensures accuracy. In most cases, these platforms also adhere to strict regulation requirements, like GxP compliance.  

An SCE sits between raw infrastructure (like cloud or on-prem servers) and end-user tools (R, Python, or statistical software such as the Posit stack, Domino Data Lab, and Databricks). It can be considered a platform because it centralizes key functionalities, such as compute resources, data storage, collaboration tools, and compliance controls.

Find out how Domino Data Lab can help managers boost data science results and keep their teams working smoothly together

As platform engineers at Appsilon, we work on SCEs that are tailored for data scientists and data engineers, and we tackle challenges such as environment validation, compliance, and cost or performance optimization. We help ensure that SCEs enable high-quality analysis and ensure strict regulatory compliance. Other key features include supporting secure and reproducible development. 

In line with best practices, we take an Infrastructure as Code (IaC) and Cloud Native first approach. IaC (managing infrastructure through code) ensures consistent, repeatable environments, while Cloud Native (leveraging cloud-based tools and platforms) focuses on scalability and resilience. Together, they support effective change management and enhance quality assurance by ensuring key elements are reproducible across multiple environments.

With IaC, SCEs now strike a balance by providing secure, centralized environments that enable collaboration, high-quality analysis, and reproducibility, following best practices and easing regulatory compliance. We can have, with much less effort, multiple equal environments, as opposed to traditional SCE deployments.

Challenges in Traditional SCE Deployments

Traditional SCEs were once sufficient for regulated industries like pharma, but these approaches now often fall short in supporting scalability, reproducibility, collaboration, and operational efficiency. 

One major challenge is that in traditional SCE deployments, GxP environments and non-GxP environments are frequently separated. Over time, this separation can result in a configuration drift, where inconsistencies emerge between different environments. This not only undermines reproducibility but also complicates validation processes while also making it difficult to trace changes and ensure compliance.

Scaling on-premise environments also poses a significant challenge. On-premise infrastructure is inherently limited by the physical resources available. The provisioning of additional compute power also generally requires lengthy processes like procurement, installation, and additional compliance checks. 

Compliance in traditional deployments is also often treated as a driver for technical decisions rather than an integrated part of the development process. As a result, any updates to environments require significant time and effort to validate, stalling progress and efficiency.

The reliance on manual deployments can also slow down the ability to introduce changes or improvements in traditional setups.

How Cloud-Native and IaC Solve the Challenges

Cloud-native and IaC approaches effectively address the challenges faced by traditional SCEs by leveraging modern infrastructure, automation, and quality assurance tools (such as Git).

One advantage of cloud-native solutions is the potential for standardization across environments. Cloud providers like AWS offer consistent, standardized services such as the EC2 service, that can be used similarly across different SCEs. This uniformity in the provided services can eliminate configuration drift, facilitating  reproducibility, and simplifying  the deployment of environments for collaboration and testing across teams or companies.

A shared, standardized codebase also improves collaboration across teams, streamlining reviews and ensuring better alignment. Embracing another key element from software development practices, IaC’s utilization of modularity makes complex environments more manageable. IaC’s modular design breaks infrastructure into reusable components that simplify complex environments, reduce friction, and allow teams to implement changes quickly without impacting the entire system. This approach improves communication between teams, accelerates workflows, and ensures efficient, scalable, and more easily maintainable deployments.

If you tie together IaC with Cloud Native platforms, the scalability potential is much higher . Unlike traditional on-premise environments, cloud solutions can provide virtually unlimited dynamic scaling. Compute resources can be turned on and off on demand, scaling environments up or down as needed in a manner of minutes.

Regulatory alignment is another strength of IaC and Cloud Native solutions. Built-in security tools such as encryption, identity and access management (IAM), and audit logging are now commonly included by cloud providers. Not to mention the number of security certifications that major Cloud Providers provide and their hard-to-beat Service Level Agreements (SLAs) for up-time, resolution, and security, these features simplify adherence to regulatory standards like GxP by ensuring data is secure, access is controlled, and every action is traceable. Combined with automated workflows, compliance becomes an integrated byproduct of the SCE.

Instead of manual deployment, IaC leverages tools like Terraform, Ansible, and Kubernetes to automate deployments and configurations. These tools reduce manual effort while ensuring consistency, traceability, and version control. Changes to the infrastructure and configuration can be tested in isolated environments before production, enabling safer, more efficient change management. 

From an operational perspective, cloud-native environments empower teams to focus on their own workflows and product development rather than infrastructure challenges and management. Automated scaling, monitoring, and security reduce the burden on operations teams, while data scientists and engineers benefit from reliable, reproducible, and user-centric environments. This combination of standardization, scalability, automation, and compliance makes cloud-native SCEs far more efficient and adaptable than their traditional counterparts.

IaC also future-proofs infrastructure by enabling teams to adapt to evolving requirements and technologies. Changes can be implemented relatively quickly and tested safely in isolated environments, making it easier to adopt new tools or workflows. This agility ensures that systems remain scalable, compliant, and adaptable in the face of growing demands and technological advances.

Benefits of Cloud-Native IaC and Automation

1. Cost Efficiency
2. Consistency Across Environments
3. Version Control and Traceability
4. Automation of Deployments and Configurations
5. Effective Change Management
6. Improved Collaboration Across Teams
7. Modular Design for Complex Environments
8. Scalability and Flexibility
9. Built-In Compliance Support
10. Future-Proofing Infrastructure

By implementing cloud-native technologies and IaC, your SCE ensures reproducibility, validation, and compliance while fostering collaboration between teams. 

At Appsilon, we specialize in collaborating with infrastructure teams to build user-centric SCEs that are GxP-compliant, robust, scalable, and designed to meet the needs of data-driven teams. Contact us to help you design your ideal SCE.