Methodisches Management von IT-Validierungsprojekten Dr. Jörg Schwamberger, Frank Schalldach Merck KGaA, Darmstadt Korrespondenz: Dr. Jörg Schwamberger, Merck KGaA, CI-OS, Frankfurter Str. 250, 64293 Darmstadt (Germany), e-mail: joerg.schwamberger@merck.de Efficient management of projects is an art, as it requires balancing budget constraints, committed delivery dates, and compliance requirements. This is often challenging, particularly in the area of validation of IT systems. Based on best practices, the following article describes a structured approach to manage IT projects, ensuring compliance with the validation requirements for IT systems used in GxP-regulated environment. |
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pharmind 2010, Nr. 9, Seite 1628
