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ISBT - EBA Symposium Tuesday 27 April 2004 The Netherlands Royal Academy of Sciences Kloveniersburgwal 29, Amsterdam, The Netherlands |
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Welcome The organisers are delighted to welcome you to Amsterdam to attend the ISBT - EBA Symposium on Validation. It is well known that the society expects a "zero risk" in blood transfusion. Although this does not exist blood services have to prove that risks are identified and addressed correctly. In this validation of automated systems and the continuous maintenance of their validation state is a necessity. Under the European regulations GMP is mandatory for blood services. This applies also to their Information Systems as is elaborated by PIC/S (Pharmaceutical Inspection Convention Scheme) in August 2003. (www.picscheme.org) The ISBT Working Party on Automation and Data Processing has developed guidelines for their validation; not only for initial validation but also for maintaining the validation state. (Vox Sanquinis, Vol. 85 Suppl. 1, August 2003 or www.isbt-web.org/guidelines.pdf) These ISBT guidelines are highly important to all blood services. Their content and application will be the main thread through the entire symposium. They help you to show - to yourself and others - that your system is doing what you have said it would do. |