Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

White Spots in Document Management in the Life Sciences Industry

Romuald Braun (Abschlußjahr: 2010)

Language: English

Traditionally the Life Sciences industry manages documents in a spectrum of scenarios between monolithic, specialized document management systems and simply file systems (desktop or network). In the Regulatory Submission area, these systems usually feed Submission Publishing systems. In the compliance area, they are often part of a Quality Management Systems. Bigger companies implemented highly sophisticated solutions supported by the "time to market" or "compliance" business case. For smaller companies the return on investment (ROI) for an EDMS usually was not very attractive and they became very creative in using existing applications or even submission publishing systems for managing documents. Unfortunately, aspects like interfacing with data driven systems and collaboration in a business process could only be reflected by building expensive custom and expensive integrations or just by manual activities.

These circumstances lead to an "organic" growth of specialized applications with many "White Spots"1in and between those applications. Some examples for "White Spots" on the Document Management "territory" are listed below:

  • Disconnected, fragmented application - complex, requiring manual synchronization of content and process;
  • Redundant - the same content, or content with the same meaning, is created and stored in multiple applications. This is also applicable for metadata;
  • Bespoke - data model and user interface specific for each application;
  • Specialized - complex way to make them part of an automated process;
  • Inflexible - because based on specialized platforms;
  • Not user friendly - every application has a different user interface;
  • Different data models - from data driven (highly structured) vs. document (monolithic, not structured);
  • Somehow artificial - for historical reasons;
  • Different standards exist in different sectors of Life Sciences (Pharma, Biotech, Medical Devices, Animal Health, etc.).
Microsoft SharePoint (6) allows a new generation of content management applications. The addition of compliance relevant elements does not limit SharePoint capabilities like user friendliness, collaboration, integration and scalability. In this way, Content Management enables support of, and integration with other business processes, which the "old generation" of systems cannot support by design and/or because of costs. The "new generation" of systems makes applications listed below feasible:
  • Integrated Quality Management (processes, process data (parameters and collected data) and documents (specifications and batch records) in one system);
  • Integrated Clinical Study Management - secure collaboration with external partners (eTMF) and integration with other study relevant systems;
  • Integrated PharmacoVigilance - processing of PV data to reports, intelligent distribution of reports and collection of process steps related metrics.

The objective of this document is to present ideas for a new integrated concept for managing content in Life Sciences processes to fill the "White Spots" IN DOCUMENT MANAGEMENT in the Life Sciences industry.

Pages: 88, Annexes: 40 pages

1 There is no clear definition of "White Spots" in English. It is a direct translation of the German term "Weisse Flecken". In English it should be associated with:
1. Gaps
2. Unmapped areas
3. Blank spots
4. Uncharted territory

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