Karlsruhe, August 27th 2014 – On 4 February 2014 , numerous experts met for the first QPmeetsIT dialogue in at the Schlosshotel in Karlsruhe, Germany. As a media partner the publisher Editio Cantor (ecv) could be obtained for the event.
Modern quality philosophies promote a paradigm shift towards continuous improvement through lean quality systems and in-depth quality risk management. But how can vision turned into reality?
This is the question that the four speakers Dr. Bernd Renger, Markus Roemer, Lukas Eberle and Titus Krauss went after together with the participants.
Dr. 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. Both he substantiated with practical examples.
In the afternoon Titus Krauss showed how the requirements can already be met with a methods based data modeling and software solutions already today. Using a live demo, the participants could get an impression of the solution. Following Lukas Eberle could show live that F. Hoffmann-La Roche already have those methods and software solutions practically in use.
The response from the participants was very positive. All participants suggested to continue this dialogue series. comes compliance services and Systec & Services will be happy to meet this desire.
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