Quick summary: Cloud has matured from an emerging technology into a ubiquitous delivery option for IT. To embrace it, life sciences companies must work through constraints such as legacy platforms, governance, budget, contracts, process, cloud skills, and legal and compliance limitations. This article walks through the public cloud challenges and possibilities across the value chain and the risks you must actively manage to become a cloud-first organization without compromising GxP compliance.
Cloud is no longer an emerging technology
As adoption accelerates, cloud is becoming a ubiquitous delivery option for all kinds of IT.
Constraints to Break Free From Before Embracing the Cloud
There are several constraints from which your company will have to break free before it can embrace the cloud. For example:
- Legacy platforms. Transitioning away from outdated technology such as mainframe computers and standalone servers and storage can be complicated, even when the financial incentives are compelling.
- Governance. Ownership of the hundreds of applications in an organization’s IT estate rests not only with the IT organization, but with stakeholders in all areas of the business.
- Budget and time. Even if the cloud promises savings through pay-as-you-go pricing without major upfront capital investments, budget and time are required to manage the transition securely.
- Contractual limitations. Licenses for the software or hardware currently in use, or outsourcing agreements may limit a company’s options by presenting additional costs for a move to cloud, or there may be prohibitive switching fees.
- Process limitations. Modernization of technologies demands modernization of business process. Cloud tends to demand changes to procurement (to be less CapEx-centric), ways of working between the business and IT, finance, legal, security, vendor management, and integration.
- Cloud skills limitations. IT professionals in a cloud-first enterprise need to know how to broker the right services and innovate for competitive advantage in a market that is changing constantly, while integrating cloud services into all other systems, cloud and non-cloud.
- Legal and compliance limitations. Laws and regulations can dictate how companies must treat particular types of data and where data can be stored, especially in sectors like financial services, healthcare and life sciences. Some enterprises play it safe by “over-engineering” to compliance laws, forcing them to avoid cloud technologies that are traditionally compliant.
Many of these constraints are not technical at all. Contracts, governance ownership, and rigid business processes derail more cloud transitions than infrastructure ever does. Treating cloud adoption as an operating-model change rather than a lift-and-shift is what separates programs that stall from programs that scale. A strong computer software assurance (CSA) mindset keeps validation effort proportional to risk so modernization does not get buried under documentation.
Public Cloud Challenges and Possibilities
Life sciences companies have operated in a highly regulated environment for decades. These regulatory challenges affect all areas of the value chain and their respective GxP workload.
| PUBLIC CLOUD | ||
| Challenges | Possibilities | |
| Research and development | Siloed and legacy infrastructure | De-risk and advance R&D with AI/ML tools that work across diverse data sets to accelerate and improve drug development. |
| Clinical trials | Slow, costly, low success rate, and stringent regulatory requirements | Improve and augment clinical trials with real-time data and biometrics to enhance intelligence, insight, and accuracy. |
| Manufacturing and distribution | Track-and-trace compliance through supply chain and quality events | Optimize manufacturing with ML and business insights, and highly secure IoT technology to modernize your manufacturing. |
| Post market surveillance | Product safety and product recalls | Proactively and securely monitor large volumes of real-world data that is distributed across disparate sources with compliance and security-built in. |
| Customer, patient | Data security risks | Improve patient value, adherence, and engagement by drawing integrated data and actionable insights from drugs, devices, and software. |
Cloud is no longer an emerging technology; as adoption accelerates, it’s becoming a ubiquitous delivery option for all kinds of IT.
Managing Risks, Becoming Cloud-First
It is important to recognize and manage risks in order to become a cloud-first company.
Seven risk areas to manage on the path to cloud-first
- Data confidentiality and privacy. Cloud service providers (CSPs) and their customers share responsibility for security in the cloud. While there have been no successful violations of CSP-operated cloud infrastructure to date, for many businesses the grave consequences of a possible data breach or loss of sovereignty preclude public cloud options. Strengthening your life sciences cybersecurity posture is foundational to a defensible cloud strategy.
- Data availability. Businesses demanding 99.999% availability for their most critical systems may prefer on-premises alternatives to a cloud architecture spread across multiple availability zones to improve resiliency.
- Business continuity. Downtime caused by technology change, data migration and service issues must be minimized for revenue-generating activities and customer experience.
- Disaster recovery. How to ensure nothing is lost and resume normal business operations as quickly as possible.
- Service provider failure. How would a failure of CSP architecture impact the business? Evaluating providers through structured third-party risk management helps you understand and govern that exposure.
- Service quality management. Enterprises depend on a high quality of service from providers and carriers and need the tools to measure it accurately.
- Organization transformation. What if we can’t get people to work in the new way that is needed to realize the full potential of a cloud operating model?
USDM’s Cloud Assurance supports a cloud-first strategy for life sciences companies through continuous compliance. Flexible cloud technologies enable the digital transformation that enterprises must achieve to keep pace with expectations for speed to market, compliance, cost effectiveness, scalability, and security. Making cloud-first a reality is the only way to ensure that IT operations can support the demands of the business. Enterprises that fail to make the transformation to the cloud risk being left behind. For GxP systems, that journey must keep pace with electronic records expectations such as 21 CFR Part 11 compliance.
Cloud 101 Blog Series
In Part 1 of this Cloud 101 blog series, we introduced the three cloud service models with examples, and provided links to digital transformation resources.
In Part 2, we talk about vendor management and scaling to the cloud.
In Part 4, we get into automation in the cloud.
Additional Resources
Becoming a Cloud-First Company
Continuous GxP Cloud Compliance
IS Health Check
Organizational Change Management
Project and Program Management
Your IT Roadmap – Guidance for Early Stage Life Sciences Startups
Whitepaper: Automate Validation Across Your Tech Stack
FAQ: Embracing the Cloud in Life Sciences
What constraints make it hard for life sciences companies to embrace the cloud?
Common constraints include legacy platforms, distributed governance and application ownership, budget and time required to transition securely, contractual and licensing limitations, process limitations that demand business-process modernization, cloud skills gaps, and legal and compliance requirements that dictate how and where data can be stored.
What are the public cloud possibilities across the life sciences value chain?
Across research and development, clinical trials, manufacturing and distribution, post-market surveillance, and customer and patient engagement, the cloud enables AI/ML on diverse data sets, real-time data and biometrics, secure IoT-enabled manufacturing, monitoring of distributed real-world data, and integrated insights that improve patient value and engagement.
What risks must be managed to become a cloud-first company?
Key risks include data confidentiality and privacy, data availability, business continuity, disaster recovery, service provider failure, service quality management, and organizational transformation. Recognizing and actively managing these risks is essential to a successful cloud-first strategy.
How does USDM support a cloud-first strategy?
USDM’s Cloud Assurance supports a cloud-first strategy for life sciences companies through continuous compliance, helping enterprises adopt flexible cloud technologies while keeping pace with expectations for speed to market, compliance, cost effectiveness, scalability, and security.
Ready to embrace the cloud without compromising compliance? Connect with USDM to map your cloud-first strategy across constraints, possibilities, and risks. Contact us to get started.