USDM’s cloud and digital transformation experts have more than 120 years of combined experience in the life sciences industry, including biotech, pharma, and medical devices.
Over the years, they have written blogs and white papers, participated in webinars and podcasts, and contributed to the completion of thousands of GxP projects globally. They’ve got a lot to say, so we thought it would be helpful to curate some of that knowledge to give you a starting point in finding answers to your cloud questions, including regulatory compliance, audit and assessment, and validation.
What you will find here
- Maximize the public cloud for GxP: maintain continuous compliance across IaaS, PaaS, and SaaS as your cloud maturity grows.
- Reframe the safety question: understand why modern cloud systems can reduce the burden of risk compared with on-premises infrastructure.
- Connect cloud to business continuity: see why digital transformation is now an execution question, not a should-we question.
- Match use cases to your journey: pick the migration and modernization path that fits where you are today.
- Start at the beginning: use the Cloud 101 series to learn service models, vendor management, and automation fundamentals.
How to Maximize Your GxP Use of the Public Cloud
Learn how to maintain continuous compliance of GxP workloads in the public cloud with your global infrastructure, cloud service platforms, and business application software (IaaS, PaaS, and SaaS). Get tips on how to scale your GxP use of the public cloud based on your cloud maturity and unique business needs. A managed approach such as USDM Cloud Assurance can help keep validated systems in a continuous state of compliance as platforms evolve.
Regulated GxP Workloads in the Public Cloud: Why Cloud Systems are Safer Than On-Premises Systems
As medical device, pharmaceutical, and biotech companies leverage the power of the cloud, there has never been a better time to dive into the calming waters the cloud offers. This white paper dispels the ingrained beliefs that on-premise systems are safer, and helps regulated companies understand the inherent benefit and decreased burden of risk with today’s cloud systems. As more of your stack moves to shared platforms, disciplined third-party risk management and life sciences cybersecurity become central to a defensible cloud posture.
The question is no longer “Should we move to the cloud?” It is “How quickly can we move, and how do we stay compliant once we get there?”
Digital Transformation is Critical to Business Continuity
Digital transformation is essential to enabling access to team resources and ensuring continuous security and compliance. While the life sciences industry has lagged in cloud adoption, the question is no longer, “Should we move to the cloud?” The question is, “How quickly can we move to the cloud?” For those who have made the move, you might be asking, “What now? How do we make the most of this technology throughout the company?” Read this blog for answers.
Use Cases in the GxP Public Cloud Journey
To reap the benefits of the cloud, you need to think holistically about your tech stack. Getting your infrastructure and platform services to the cloud provides you with faster delivery, lower costs, and greater efficiency. Where you begin depends on where you are in your cloud journey.
- Rapid Application Migration
- Data Migration
- Phased Migration of Critical Applications and Databases
- Content Orchestration
- DevOps Framework
- Advanced Analytics (AI/ML/RPA)
How to read these use cases by cloud maturity
- Just getting started: begin with rapid application migration and data migration to move foundational workloads with minimal disruption.
- Building momentum: use phased migration of critical applications and databases to move higher-risk systems with controlled validation.
- Operating in the cloud: add content orchestration and a DevOps framework to standardize delivery and reduce manual handoffs.
- Optimizing for value: apply advanced analytics and AI/ML capabilities once your data and platform foundation is governed and reliable.
Cloud 101 Blog Series
In Part 1 of the Cloud 101 blog series, we introduce the three cloud service models with examples, and provide links to digital transformation resources. In Part 2, we talk about vendor management and scaling to the cloud. In Part 3, we address several constraints from which your company will have to break free before it can embrace the cloud. In Part 4, we get into automation in the cloud.
FAQ: Cloud in Life Sciences
Can GxP workloads really run compliantly in the public cloud?
Yes. Regulated companies can maintain continuous compliance of GxP workloads across IaaS, PaaS, and SaaS by aligning their cloud strategy to their cloud maturity and unique business needs. The resources here explain how to scale public cloud use while keeping validation evidence and controls intact.
Are cloud systems actually safer than on-premises systems?
The white paper on regulated GxP workloads dispels the ingrained belief that on-premises systems are inherently safer. It helps regulated companies understand the inherent benefits and the decreased burden of risk that today’s cloud systems can offer when managed correctly.
Where should we begin our cloud journey?
Where you begin depends on where you are. Teams new to the cloud often start with rapid application migration and data migration, then progress to phased migration of critical applications, content orchestration, DevOps, and advanced analytics as maturity grows.
How do we keep cloud systems compliant after migration?
Continuous compliance is an ongoing operating discipline, not a one-time event. A risk-based Computer Software Assurance approach, managed cloud assurance, and strong third-party risk and cybersecurity practices help keep validated systems compliant as platforms evolve.
What is Cloud 101 and who is it for?
Cloud 101 is a four-part blog series for teams that want the fundamentals: cloud service models, vendor management and scaling, breaking free of common constraints, and automation in the cloud. It is a practical starting point before deeper migration and validation work.