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Planning and Implementation of an Electronic Document Management System within a Pharmaceu-tical Company

Jürgen Höfer a, Thomas Geyer a, Katharina Arnold-Gross a und Dr. Klaus von Jan b

ESCS Software-Entwicklungs GmbH a, Gorxheimertal, und Chiron Behring GmbH & Co. b, Marburg

In pharmaceutical companies, the amount of information, like data and documents is increasing dramatically. To have control over these documents and to distribute them in a global organisation to all relevant business units, the implementation of an electronic document management system (EDMS) is required. Different languages and different user requirements have to be taken into account. Finally, the requirements from authorities, especially those from the FDA concerning validation and 21 CFR Part 11, have to be met. The following article describes the planning, evaluation and implementation of an EDMS at different european sites within a global pharmaceutical company. The large number of users as well as the extend of documents to be handled underlines the complexicity of this electronic system.