The life sciences industry is adopting manufacturing execution systems (MES) at a faster rate than any other vertical market. Pharmaceutical manufacturers are recognizing the benefits of managing and monitoring operations in real-time, while there is also a growing appreciation of how these systems can help simplify compliance processes. Coordinating all aspects of production from tracking inventory to managing quality control, MES solutions have evolved into highly sophisticated technologies that can manage processes across multiple worldwide facilities.

The next step in the evolution of MES is a move towards cloud-based deployments. While security has been an area of concern for many organizations, the technology now exists to protect mission critical data. This article addresses the migration of MES technology to the cloud, looking at how this approach makes MES accessible and affordable to small and mid-sized manufacturers. It also discusses the implementation challenges and explains how they can be overcome.

MES in the cloud
The cloud’s role in life sciences is growing rapidly. The potential to drive fast deployment and improve an organization’s flexibility while reducing costs, means that the use of virtualization and remote hosting makes good business sense. Many organizations are now approaching new processes and architecture with a cloud first mentality. In time, it is likely that the industry will see all functions of R&D, commercial and supply chain extended to the cloud.

Cloud MES refers to a web-based application, not an application that is installed centrally and deployed with a Citrix infrastructure, but a ‘native’ application that is hosted remotely by a third-party provider. Currently, single tenancy models are the norm in which the MES application manages data associated with one client in an isolated IT environment. It’s very clear that many in the industry are not at a point where they are ready to let their data co-exist with competitors’ data. Each company has its own instance of the software application and supporting infrastructure.

While the industry may be accustomed to having an application where functionality is configured on a per client basis, as more organizations look to migrate to the cloud, a change in perspective is needed. Accepting the fact that multiple companies will be running the same software will allow real economies of scale to be achieved, making the adoption of MES in the cloud accessible to manufacturers of all sizes.

The cloud brings a standardization of processes where all users rely on the same version of the software; this is reasonable given the maturity of the technology achieved with standards like ISA/S95. This means that the need for customization has decreased. With this type of system, scalability can occur naturally, in the background, as more resources are used. Because web applications are inherently scalable, management tools are available to scale the application on demand or based on some performance measure, for example, memory or database usage. With the standard availability of advanced tools to manage application security, testing and performance, the benefits of deploying to the cloud are becoming increasingly obvious. 

Deployment options
When talking about the potential of the cloud, many organizations immediately think about losing control of their application, with security being the overarching concern. One way that organizations can migrate their application to the cloud is by first purchasing a web-based application in-house, and then migrating it to the cloud environment—either private or outsourced—to achieve more benefits.

A web-based solution can be deployed in many ways. In-house deployment provides users with total control at the highest cost, given that a complete IT infrastructure needs to be deployed without the benefits of any cost sharing. On the other hand, moving to a private cloud in a corporate data center maintains control, but reduces IT support costs as a single support center manages multiple production sites. This is currently the preferred approach that safeguards intellectual property rights. Nevertheless, this places the burden of developing business continuity—disaster recovery—security and backup processes solely on the organization’s resources, which is an expensive proposition.

Given the high level of skills and knowledge required to build robust computing centers, it is not surprising to find that many companies are willing to outsource most of their computing needs to third party organizations. With the advent of significant bandwidth availability, this has meant placing applications in the cloud. Of course this raises new issues in the areas of maintaining business responsibility while delegating operational control, providing secure environments, maintaining data integrity, auditing suppliers, validating applications or integrating plant systems into coherent solutions. We cover some of these issues below after reviewing some of the benefits of cloud solutions over their counterparts.

Benefits of deploying in the cloud
Most companies are now forced to outsource some of their services due to the need to quickly respond to changes in market conditions, the lack of internal expertise and the high cost of developing non-strategic internal capabilities. The key benefit of deploying MES in the cloud is that there is no requirement for upfront capital investments in IT. Moving to the cloud means migrating to a model where projects can be funded out of operating budgets—the subscription model offers a recurring monthly/annual expense. There is no major requirement for deploying hardware, purchasing software or hiring support personnel. By initiating a subscription, you are instantaneously provided access to a complete solution environment.

Deployment of the solution is fast for two fundamental reasons. One, you are starting a project with training, quickly followed by configuration of business processes—no more architecture development, selection and purchase of components and their qualification. Second, it also means that the focus is no longer on customizing software, but on building business solutions, where it’s acceptable to adjust internal processes to industry best practices, consistent with industry maturity.

On-demand scalability is also key. Elastic computing means that organizations pay for what they need and there is no requirement to invest large sums of money. This agility and flexibility means that it is easy to adapt to changing needs and companies have the freedom to try something out and change it later if need be.

The cloud brings better business continuity and delivers standard replication of client data that can only be achieved at a high cost by individual organizations given that each organization has to carry the full cost of such resources for occasional usage.

With permission, any individual, in any location can have access to the solution at no extra cost. This is not the case with typical client-server applications where similar capabilities are achieved by deploying citrix-type solutions that are complex to maintain, integrate and require their own server farms. As a side effect, there is no longer a need to migrate batch records to separate document management systems for broader access; batch records can be accessed directly from the MES.

Finally, with HTML5 support, relevant functionality can be deployed to mobile devices and tablets as an off-the-shelf feature. It is now clear that for many organizations, the next level of improvement requires a high degree of mobility, for which web solutions are best suited. All that is needed is to redesign the web page to account for potentially very small visualization footprints.

The reliability of cloud solutions is now a well-proven model. This is a reflection of the robustness of infrastructures that are deployed to support the Internet, the high bandwidth that is available and the increased competitive landscape due to globalization that forces organizations to focus on their core strengths.

When you combine all of the above benefits, MES becomes much more affordable for small to medium-sized companies because they no longer have to absorb all the upfront costs across a small number of users.

Slow adoption: Industry challenges
In spite of all the benefits, the industry has been slow to adopt cloud-based architectures. One reason can be attributed to a lack of guidance for deploying solutions and addressing challenges in the cloud. Currently, there is no ‘GxP certification’ model for this approach, which may make manufacturers wary about ensuring compliance when it’s unclear how the FDA will evaluate these solutions. Although adherence is paramount, the FDA does understand and value the need to innovate to improve compliance. The newly created “Cloud SIG” within the ISPE/GAMP group is a good indication that the industry is ready to tackle this challenge.

We have identified five areas that create significant concerns in the industry: security, data integrity, validation, availability, and integration. In the second part of this article (JanFeb 2017), we will explore these five areas in detail as well as what companies can do to begin taking steps towards the deployment of a cloud-based MES.