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W 11: Integral Authoring: A New Paradigm for Data-Driven Structured Authoring of Documents in the Life Sciences Industry





Poster Presenter

      Romuald Braun

      • Vice President Strategy Life Sciences
      • AMPLEXOR Life Sciences
        Switzerland

Objectives

Regulatory Information Management (RIM) in broader context has been challenged by permanent Health Authorities (HA’s) driven changes like IDMP or eCTD module 1. RIM can also become part of MDM itself.

Method

The poster will utilize the example of Labeling documents to discuss the potential options for automation of business processes, and business intelligence driven decision making, using the Integral reflection of MDM- and RIM-driven business processes.

Results

The traditional approach to managing data and content separately has been driving the modularity of respective focused applications in the Life Sciences industry. Those applications, developed to support specific parts of a process, were built proprietary, with a simplified data model and needed to be interfaced with each other to attempt to support the end to end process. Both aspects led to increasing complexity and exponential maintenance efforts of such systems and interfaces. Regulatory Information Management (RIM) including submission, document, process and data management has been challenged by permanent changes in regulatory standards resulting in higher standards for the delivery of consistent data and content to Health Authorities (HA’s). One timely example of this is the recent ISO IDMP/XEVMPD or eCTD Module 1 requirements. On one hand, proper Regulatory Information (RI) relies on proper Master Data (MD). On the other hand, RI can also become part of MD itself. The question arises, what boundaries and synergies can be identified and utilized? What setups would allow mutual leveraging in order to positively impact business process designs to increase and sustain a company’s competitiveness and efficiency?

Conclusion

The use of an Integral design model within solutions for managing content, processes and data, enables an entity (object) oriented approach; processes and data can therefore be managed within the same entity model. In this context, structured authoring becomes a natural element of the overall capability as data entities can drive automation of content entities and in this way ensure their consistency.