VDI/VDE 3516 Blatt 5
Validation in the GxP area - Types of raw data
At a glance
- German title
-
Validierung im GxP-Umfeld - Arten von Rohdaten
- Publication date
- 2019-03
- Publisher
- Engl. VDI/VDE-Gesellschaft Mess- und Automatisierungstechnik
- Related manuals
- Number of pages
- 23
- Available in
- German, English
- Abstract
-
This standard is concerned primarily with raw data covering GxP rules. The archiving of data is only considered marginally in this context. The standard defines the essential terms 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 transferring the specified terms, models and methods to the concrete world of GxP-relevant processes.