April 18, 2023 | Lounges in Karlsruhe

Oliver Herrmann (CEO and founder of QFINITY) and Frank Henrichmann (Senior Executive Consultant at QFINITY) will give two presentations at the Lounges in Karlsruhe.

Oliver Herrmann will give a presentation titled GAMP®5 – 2nd Edition – Applying the Key Principles to enable Innovation

The presentation will provide an introduction to the key principles of GAMP 5 Second Edition and how they apply in an ever-changing world. It will also briefly introduce the new GAMP Guides. Key challenges arise in the areas of Critical Thinking/CSA/RBA, AI, Agile and IS (Cloud) Management. The presentation will also give an overview and share first practical experiences of applying these special topics and implementing them in projects in an integrated way.

Frank Henrichmann will give a presentation titled GAMP 5 Second Edition – Specifying Requirements

The presentation will provide an introduction to GAMP 5 Second Edition in general and then explore Requirements Management. After all, GAMP is embracing agile methodologies and the traditional separation into User Requirements, Functional requirements and other requirements is no longer present in the guide. However, some things did not change. Bad Requirements are still bad, whether expressed as user stories in a system or in a specification document. And bad requirements inevitably lead to systems that are not fit for purpose and do not meet regulatory expectations.