The New Biopharmaceutical Blueprint: Service-Oriented Architecture in Manufacturing - Pharmaceutical Technology

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PharmTech Europe

The New Biopharmaceutical Blueprint: Service-Oriented Architecture in Manufacturing
More than ever, drug makers need to be fleet and flexible—and they need their software to be the same.


Pharmaceutical Technology


The SOA-enabled ECMS provides a standards-based approach allowing other systems to deposit reports and documents and maintain those documents over time. This approach involves defining SOA services for distinct document-management functions such as depositing a document or report, or retrieving one. In our example, not only can the initial batch documents be stored, but downstream documents that must be retained, such as the certificate of analysis and electronic batch records can be stored collectively by any system participating in the process. This can help simplify the generation of regulated documents. It enables staff to resolve issues that are tracked in the CAPA system and not have to chase after supporting documents.

The value of SOA. SOA delivers tighter internal integration among players. The SOA-enabled ECMS solution is one example of how SOA can impact the manufacturing environment. SOA brings value to the overall organization as follows.

  • Reusable data/repeatable processes: SOA establishes an environment that supports the evolution to quality by design and continuous "real-time" quality assurance to help build in efficiency within the organization and with global partners. The use of a service-driven approach, such as SOA, enables processes that help departments, manufacturing sites, and organizations adapt to changes in the environment.
  • Reuse of SOA services: In this example, services can be reused by any application producing documentation for the manufacturing process, which represents a common, high-impact process. Consider how valuable SOA services would be for other central or key applications such as ERP.
  • Facilitated business process change: SOA services make it easier to adapt to changes in the business processes required for manufacturing. SOA makes system functionality more granular, so the process activities that use them can be easily accessed and applied to other systems. IT systems become more flexible and reduce development times as SOA services are reused.
  • Improved risk management: An SOA framework can also help monitor execution of a process. The same SOA services that connect two business applications can also support any of the monitoring applications.
  • Support for automated processes across applications: SOA allows process management or workflow systems to "talk" to required applications needed to support the process. This helps reduce administrative burden and increase compliance. It also allows processes to extend into new areas of the organizations or to external partners.
  • Efficient partnerships: Business partners can be integrated with the BioPharma company in a nonintrusive manner using industry-standard interfaces. Business partners do not need to change their current software, nor does the BioPharma company. SOA offers a way to integrate without wholesale change to existing applications.
  • New business strategies: SOA offers connectivity options for new partners and allows companies to explore new product capabilities. Support systems can be built more easily using portal technology and SOA services.

Conclusion

Although the BioPharma industry is actively addressing its challenges, many current environments are not scalable or responsive enough to meet future demands or to efficiently compete on a global scale. Service Oriented Architecture enables companies to simplify the complex nature of today's BioPharma business to facilitate "smart" system interactions and "built-in" compliance.

SOA can be a little daunting to an organization. Like anything else of this scale, it must be applied with a sense of vision, purpose, and strategy that involves:

  • Focusing on a business problem and using SOA to solve it
  • Focusing on revenue-generating capabilities or on areas where inefficiencies affect overall costs
  • Thinking long-term. Once a company makes its initial investment in an SOA architecture, additions or changes can become much less expensive (and faster) to integrate. The return and benefits on this initial investment can be dramatic.
  • Addressing governance, which is an enterprise approach to managing services inside and outside the organization.

SOA allows a step-wise approach to preserving internal investments and aligning the business with the technology that supports it. Once companies begin using SOA services to manage a small portion of their environment, they can scale this efficiency through reusable information and repeatable processes across other departments and with partners. They can then proactively respond to today's changing regulatory environment and competitive landscapes


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FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
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