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| Nutzung eines IT-Systems zur Dokumentation von Audits Dr. Jörg Fetsch und Denise Mocha Schering AG, Berlin Use of an IT System for Audit Documentation EU directive 2003/94/EG (directive laying down the principles and guidelines of Good Manufacturing Practice in respect of medicinal products for human use and investigational medicinal products for human use) as well as the German regulations for pharmaceutical manufacturers (Betriebsverordnung für pharmazeutische Unternehmer, PharmBetrV) require that self inspections are performed and documented by the pharmaceutical manufacturer. The documentation has to be archived. The performance and documentation of self inspections is also required by the EU GMP guideline. This documentation is required in order „(...) to monitor the implementation and respect of Good Manufacturing Practice (...)“ (article 14 EU directive 2003/94/ EG) and thus offers a support for the continuous improvement of the processes and products of the manufacturer. It also serves as a proof for the performance of self inspections during inspections performed by authorities or customers. Besides self inspections (or: internal audits) also supplier audits as well as inspections by authorities and customers have to be documented. In order to create, control, and retrieve this huge amount of documents, the support by an IT system has proved to be very useful. The advantages of such an IT system are the collection of different kinds of information, the standardization of the reports, the efficient follow-up of corrective actions, and the possibility to retrieve information. This article describes the requirements for such a system to create and control audit reports and its realization and implementation. Key words Audit, Dokumentation • Datenbank • Elektronische Dokumentenmanagementsysteme (EDMS) • Informationstechnologie • Inspektionen, Dokumentation |
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pharmind 2004, Nr. 10, Seite 1269
