VDI/VDE 3516 Blatt 5:2017-08

This standard is concerned primarily with raw data covering GxP rules. The archiving of data is only considered marginally in this context. Firstly the essential terms are defined to establish a basis for common understanding. Subsequently, basic 'models and methods' are presented, so that processes can be described, and the corresponding raw data be identified and specified within them. Subsequently, a practical section follows, which transfers the specified terms, models and methods to the concrete world of GxP-relevant processes.