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

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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

Streamlining the product-release process

Figure 2: A revised product–release process.
To support good manufacturing practices (GMPs) of global regulators such as the US Food and Drug Administration in the United States and the European Medicines Agency in Europe, staff and equipment must be in compliance at all times. Compliance is often supported through business processes like those presented in Figure 1. In many cases to improve this process, companies need to eliminate the paper and have systems that can store and share required reports and documents systematically from system to system. This level of integration ideally would not impose custom programming requirements on the systems actually generating the reports. Figure 2 shows how the process improves with an SOA-enabled enterprise content management system (ECMS) that manages data stored in a database (structured data) and documents stored in a document store or repository (unstructured data).

Integrated systems as shown in Figure 2 provide a number of advantages:

  • The departments supporting the batch-release process continue to use their existing systems with a new efficiency that allows staff to focus on value-add activity. These systems communicate to an SOA-enabled content management system to store any required reports.
  • Paper generation and movement can be eliminated, removing the uncertainty that can potentially reduce overall cycle time
  • The system can help manage the process, for example, only allowing the process to continue when all of the proper documents have been generated, collected, and stored appropriately
  • The qualified person who is responsible for releasing the batch, can now more easily see if there are open deviations in the documentation collected
  • The development of a more efficient and effective process platform is possible by integrating the supporting systems using SOA.

Figure 3: A closer look at an enterprise content management system providing Service Oriented Architecture services.
In the past, this platform development often required custom, point-to-point programming dependent upon proprietary platforms and programming interfaces provided by the software vendor. This has been notoriously difficult, complicated by the nature of storing documents and reports from various sources, in a variety of formats. The complexity is only increased when the process requires the integration of multiple business partners around the globe. There are many software solutions for enterprise content management. If the enterprise content management solution provides SOA services, a company such as IBM can provide the level of integration shown above with a compelling integration approach for both the sponsor's and the business partner's IT departments. Figure 3 shows how this level of systems integration can be achieved using SOA.

Using Figure 3 and continuing with the example,

  • If the quality assurance person had closed the release blocking incidents and wanted to publish an incident status report, he or she would use the Corrective and Preventive Actions (CAPA) system as normally done. The CAPA system would generate the report and would use the SOA service from the content management system and "store document" to store the report associated with the batch.
  • The qualified person who reviews all the documents in the content management system and wants to set the release decision would do so in the ERP system, as is done today. However, when the production order needs to be published, the ERP system would do so and would use the SOA service from the content management system and "store document" to store the report associated with the batch.
  • If the quality control department were releasing the batch and wanted to generate the certificate of analysis, it would do so in the laboratory information management system (LIMS), as is normally done. The LIMS would use the SOA service from the content management system and "store document" to store the report associated with the batch.


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