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Successful first QP-meets-IT dialogue initiated by comes compliance services and Systec & Services
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Erfolgreicher erster QP-meets-IT Dialog initiiert durch comes compliance services und Systec & Serv…
www.systec-services.comAnnex 6.1
Page of Pages 1 of 1 qmh_ptb_anl_6.1_v03b_en.doc 6.1 List of quality procedures (QP) of the PTB
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www.ptb.deDr. Renger was able to show that action is imperative, as the revised regulations ( Annex 16 but also the existing Annex 11 ) necessarily call for the inclusion of software solutions.
Here he sees the QP (Qualified Person) with the responsibility.
Markus Roemer presented how these changing regulations affecting the validation approaches and validation methods.
www.systec-services.comDr. Renger konnte aufzeigen, dass zwingend Handlungsbedarf besteht, da die neu gefassten Regularien ( Annex 16 aber auch der bestehende Annex 11 ) zwingend die Einbeziehung von Software-Lösungen fordert.
Hier sieht er die Sachkundige Person (Qualified Person) mit in der Verantwortung.
Markus Roemer stellt dar, wie sich diese sich verändernden Regularien auf die Validierungsansätze und die Validierungsmethoden auswirkt.
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Erfolgreicher erster QP-meets-IT Dialog initiiert durch comes compliance services und Systec & Serv…
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Successful first QP-meets-IT dialogue initiated by comes compliance services and Systec & Services
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