Streamlining the product-release process
Figure 2: A revised product–release process.
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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.
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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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