Oliver Herrmann will give a presentation on the topic 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 In addition, the new GAMP Guides will be briefly introduced. Key challenges arise in the areas of Critical Thinking/CSA/RBA, AI, Agile and IS (Cloud) Management. In addition, the presentation will give an overview and first practical experiences in the application of these special topics as well as their integrated implementation in projects.
Frank Henrichmann will give a presentation about the topic 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 are inevitably lead to systems that are not fit for purpoase and not meeting regulatory expectations.