Most biopharmaceuticals use cloud-based infrastructure at some level. But just how “cloudy” is your business? Many companies are in a hybrid state, on a path from traditional on-premise infrastructure to operating fully in the cloud. That journey can feel arduous, and it may seem easier to pause along the way. But a truly cloud-only approach to biopharmaceutical lifecycle management has the potential to radically accelerate the biopharma lifecycle. This objective is non-negotiable, as many software vendors provide new features only to the cloud and offer only critical updates for their on-premise offering.

Figure 1. Diagram illustrating traditional on-premise infrastructure to operating fully in the cloud. [Courtesy of IDBS.]
Of course, the migration journey itself can be full of challenges. All migrations come with complex requirements from a wide range of stakeholders. Precise project governance and program management are required to ensure compliance and to sustain data integrity going forward. But the transition is worth it. Moving to the cloud has many benefits that are industry neutral. But for regulated biopharmaceuticals, a truly cloud-only solution can transform the validation process.
Across industries, software running on a public cloud infrastructure can save time and create efficiencies not easily achieved via an on-premise installation. First, cloud solutions offer peace of mind. Automated disaster recovery, backups, and upgrades and patches are included as part of the subscription. Fewer components operate within the corporate firewall, reducing the technical surface area for the in-house teams to monitor.
Second, cloud solutions also provide ease of use. Most providers offer simple provisioning of test/sandbox environments as needed, as well as more streamlined deployments. Third, and perhaps most importantly, cloud solutions offer flexibility. Systems are designed for high availability and resilience, as well as the ability to scale up as business needs change. All of these benefits shift complexity from internal teams to external providers, freeing up internal IT resources, to focus on forward-looking, company-specific challenges.
Companies that are early in the process of transitioning from on-premise solutions may be wary of giving up control over their processes, worrying that external partners could introduce added risk. Often, though, the opposite happens. Software validation is precision work. Implementation partners have a stake in the ongoing success of foundational tools, so companies can benefit from well-maintained, validated infrastructure that already exists for all but the most tailored parts of their processes.
For validated businesses, the migration to the cloud brings a further key advantage: the ability to automate the entire biopharma lifecycle in a regulated environment. To really save time and free up resources means not just moving foundational infrastructure to the cloud, but outsourcing key parts of the biopharma lifecycle to cloud-based service providers.
This is where it becomes important to not pause along the path to a cloud-only destination. To ensure product safety, biopharma software solutions require validation at multiple stages, from initial installation and operational functionality to consistent performance over time. With a traditional approach, installation qualification and operational qualification can take more than a month. With an automated approach, total validation time can drop from weeks to days.
Validation reports that used to require painstaking manual work can be automatically generated by cloud providers. With the right partner, it is easy to generate risk assessments, requirements documentation, the validation plan itself, automated tests, and a readable qualification report that demonstrates the ALCOA standards are met by the system. And this can be done in a useful form: traditionally formatted documentation, written in natural language, that can’t be edited, along with screenshots for key evidence of failure and digital sign offs.
Faster validation means substantially less downtime during initial deployment and subsequent upgrades, all while meeting or exceeding GxP compliance requirements. Later, cloud providers can also automate performance qualification. While this is a fantastic benefit to initially onboarded regulated customers, the real power in automation is truly recognised during subsequent updates and upgrades. Organizations can quickly get the benefit and value from continuous updates.
One of the biggest pain points in the validation process comes when a bug or error in one process has cascading impacts on other processes. These challenges can lead to long delays that can even set back drug development timelines. Companies moving to cloud-based solutions should take advantage of the opportunity to isolate possible failures so they can be addressed individually without any “blast radius.” That’s why cloud microservices are a smart approach.

Figure 2. Topology of the IDBS GxP Cloud. [Courtesy of IDBS.]
In the ‘classic big-bang’ approach from legacy systems, any small change means changing—and re-qualifying—the entire software system. This is time-consuming, introduces additional points of failure, and requires cross-functional input from many different teams. biopharma software providers that use a cloud microservices approach can avoid these pitfalls. In this approach, various services are cleanly partitioned from each other in the smallest possible “chunks,” otherwise known as containers.
When one service needs updating, changes can be made cleanly without affecting the rest of the system. This is because containers enable services to be isolated and deployed with consistency by using predefined and streamlined build images. Updates can also be implemented automatically in rolling upgrades depending on company needs. Product changes and their impacts are documented by default, enabling businesses to efficiently focus their in-house qualification efforts on the areas with the highest impact.

Chris Ovett
Companies that complete the journey to a fully cloud-based infrastructure can streamline both the validation process and baseline IT functions, freeing up time and resources to focus on what really matters. A cloud-based approach can accelerate progress towards the final destination: developing and delivering life-changing therapies for patients.
Chris Ovett is the director of cloud solutions strategy at IDBS. He has more than twenty years of experience in product, solution architecture, sales engineering and services leading innovation and transformation in digital technology led verticals. As the director of cloud solutions strategy for the IDBS Platform, he takes accountability for defining IDBS strategy and executing the roadmap for the underpinning technology that enables teams across IDBS to deliver novel products and solutions to customers.
Filed Under: Data science, Drug Discovery and Development, machine learning and AI