(Treffer aus pharmind, Nr. 05, Seite 742 (2017))
Schönberger G | Schumacher W | Zimmer T
Organization and Governance of GxP Related Computerized Systems / An Industrial Benchmark Survey · Schönberger G, Schumacher W, Zimmer T · 1
ZS.CTIS GmbH, Harxheim und 2
PCS Möhlin, Switzerland
Computerized systems consist of hardware, software and a business environment, i.e., business processes, SOPs and the related documentation of the work done [ 1 ]. In the pharmaceutical industry almost all business processes are computer systems supported and support processes connecting a number of functions along the pharmaceutical value chain. There is almost no information in the relevant regulation, how a system’s governance needs to be organized in companies or along the supply chain. This is due to the complexity of the subject: there is an impact of the product portfolio, the number of stops in the supply chain upstream and ...