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Biotech, CMO, CRO, Medical Device, Pharma

How to Maximize Your GxP Use of the Public Cloud – Video

Stepheni Norton
February 3, 2022

Now that the urgency to onboard cloud systems and activities like e-signature and content collaboration has calmed, you can start to think about your bigger priorities and the overall IT footprint.

This video is an edited version of the webinar presented by Stepheni Norton and Jim Lyle. Click here to watch the full-length, on-demand webinar. You can find the Q&A from the webinar here.

Contact USDM and connect with your GxP experts.

Transcript

There are some recurring themes that we hear over and over in terms of your business challenges. You’re under constant pressure to reduce costs, outsource IT, focus on core competencies, and innovate faster. As we all know, COVID-19 kickstarted this. It moved us into high gear and a prime example of this was how quickly we had to shift. Now that the urgency to onboard cloud systems and activities like e-signature and content collaboration has calmed, you can start to think about your bigger priorities and the overall IT footprint.

Given we all work in a highly regulated environment, changing agency requirements impact the way we implement, validate, and maintain our systems. While these challenges are ever-present, we also see them as opportunities; opportunities to increase the speed of your operations, to ensure greater security and scalability, and to take advantage of new regulations like FDA’s computer software assurance (CSA) to minimize validation burdens.

In order to start reaping the tangible benefits of the cloud—faster delivery of functionality, decreased IT costs, overall efficiency gains—you need to start thinking about your tech stack holistically. Getting your infrastructure and platform services to the cloud reaps faster delivery, less infrastructure costs, and greater efficiency gains to achieve those outcomes expected from your cloud initiatives. And if you enable your cloud infrastructure to also include your GxP data content workflows, you optimize your technology and amplify your ROI. Remember, fewer technologies means less licensing costs.

One holistic approach is the USDM Unify Public Cloud (UPC). Our UPC framework keeps your entire public cloud stack in compliance. Our solution facilitates rapid implementation, validation, and maintenance to enable a continuously compliant tech stack from infrastructure and platform to your SaaS applications.

So where do we begin? USDM has been working with many of our customers assessing their current IT landscape and planning a roadmap to get greater value out of their systems and data. Although each company has their own starting point via a project or specific priorities, we’re going to look at a few key initiatives that leverage public cloud to drive value over time. We’ll spend some time going through each of these use cases and detailing the business challenges, how a validated public cloud tech stack can help you solve those challenges, and what business outcomes we can improve.

Rapid Application Migration. We’ll start with Rapid Application Lift and Shift. This is the moving of applications from on-prem to a cloud. It’s a really good starting place, especially if you don’t know where to start or haven’t started moving over to the cloud at all. It may seem daunting but one thing to keep in mind is that this scenario isn’t changing technical or business functionality. There’s no development, no new code. Of course, assuming that the application is cloud ready. You’re simply re-hosting it from on-prem to a cloud. Using USDM’s Unified Public Cloud blueprint for governance and operations, we can create a GxP compliant cloud, allowing you to re-host the application quickly.

Data Migration. The next step once you get on the cloud is your data migration. Life sciences companies have enormous amounts of data. We know that. Data migration to the cloud enables data backup archival, and retrieval of on-prem systems in the cloud, provides governance and operational know-how for a GxP compliant and continuously validated state of the infrastructure and platform. It solves the basic need for backup, archival, and retrieval with greater security compliance and a reduction in the total cost of ownership.

Phased Migration. So after we’ve done the Lift and Shift and we’ve brought your data over, and again they don’t have to happen in this order but this is typically what I see with some of our clients, then we would move into the Phased Migration of Critical Applications and Databases. This is more for highly complex, data-sensitive, externally facing GxP applications. It’s best suited for those high volume, transactional data, complex architectures. These are your high-impact business systems. They have a need for reliable cross-region, disaster recovery solutions. They are your mission critical applications. The scalability and flexibility for the enterprise-grade security features and controlled access to sensitive data gives you a more economical solution for that data and that data storage, those applications.

Content Orchestration. Content Orchestration is best suited for scenarios where you have a business need for centrally located services. This is bigger than a quality management system or document management system. It’s not simply about file or document management, it’s the bigger picture of data assets and actions across your enterprise. This is the stuff that makes organizations run smoothly, and creates greater accessibility, collaboration, efficiency, and ultimately, compliance. These are the things that lead to a better customer experience, employee experience, and even a supplier experience. Content orchestrations include things like regulated and non-regulated content on one platform.

Better internal and external collaboration, GxP workflow optimization, and minimizing manual configuration, time-consuming communications, and siloed systems and stakeholders. By deploying a qualified infrastructure and validated applications, USDM can show you how you can configure and optimize automated tasks and then build end-to-end process automation.

DevOps Framework. Our compliance framework for DevOps is ideal for use cases where you need continuous integration and continuous development of your development process. A DevOps framework increases frequency and quality and enables the software delivery pipeline. Our UPC solution delivers the DevOps framework to ensure continued validation and compliance. It provides DevOps tools to fully manage your private code repository and automate workflows with verification and validation aspects embedded right into your process. The result is a GxP-compliant software delivery pipeline with automated compliance and security. It allows you to increase the quality and frequency of your deployments to meet the customer and business needs.

Advanced Analytics – RPA. Now we can start doing some really cool things which is this advanced analytics, artificial intelligence, and machine learning. We’ll basically bring your pools of information and data together–both regulated and non-regulated–to create or enhance signaling algorithms, make validations and assessments more efficient, and ultimately, get the answers for quality, safety, and regulatory questions faster.

AI can be used to identify new drug targets, as well as a whole myriad of other things. The UPC provides a blueprint for the use of cloud-based advanced analytics and makes validation adjustments more efficient. By centralizing the GxP and non-GxP data, it enables the AI platform. It results in business answers to complex safety and quality questions, it helps drive better decision-making because we’re looking at enormous, centralized datasets now. It harmonizes the business process and optimizes the user experience.

And then finally, under the really cool factor is robotics process automation (RPA). So here, we’re reinventing the drug discovery process. We’re optimizing manufacturing processes. It’s really best for repetitive, mundane, back-office tasks that takes people hours to complete. Because if you think about it, if we take those off their plate, RPA can allow for life sciences companies to do with 50 people what a typical drug company would do with 5,000. It frees up human resources for higher value work.

For a deeper dive into these use cases,
watch the full-length, on-demand webinar: How to Maximize Your GxP Use of the Public Cloud

Why Robotic Process Automation (RPA)?

Why is Robotic Process Automation such a hot topic these days? Well, RPA software acts like a robot to emulate how humans interact with digital systems to execute routine or repetitive business tasks. RPA robots use standard user interfaces to capture data and manipulate applications like humans do and they can interpret results, trigger responses, and communicate with other systems to perform a variety of repetitive tasks.

By automating some of the most cumbersome tasks associated with a job, companies are better able to focus on the high-value responsibilities within their resources’ roles. Additionally, companies are achieving great cost savings and process improvements and then helping employees work more efficiently. Process improvements through RPA is the automation foundation and prepares the way for future automation tech like artificial intelligence and machine learning.

Here are a few highlights of our learnings so far. Custom GxP apps may need a redesigned governance structure (SDLC), which we talked about a little bit before. A cloud-based tool set for central management is key. We improve processes and save time and resource costs by using validated RPA apps for GxP uses such as repeatable configuration and intended use verifications and cloud systems. We focus on validating the business flows and business exceptions. For reusability, we identify the usable components in each bot workflow, fully validating new workflow steps and components that can leverage and map to reuse component validations to limit retesting.

For a glimpse of USDM’s test automation in action,
watch the full-length, on-demand webinar: How to Maximize Your GxP Use of the Public Cloud

Harness the Technology

So one of the things we hope you gleaned from today is that your success depends on how quickly and how well you harness this technology. Getting your infrastructure and platform services to the cloud reaps faster delivery, less infrastructure costs, and greater efficiency gains to your cloud initiatives. If enable your cloud infrastructure to include GxP data, content, and workflows, you’re going to optimize your technology, differentiate your company, and innovate faster than ever before. Just know that we’re here to help.

Contact USDM and connect with your GxP experts.