VDI/VDE 3516 Blatt 5
Validation in the GxP area - Types of raw data
At a glance
- Publication date
- 2019-03
- German title
-
Validierung im GxP-Umfeld - Arten von Rohdaten
- Number of pages
- 23
- Available in
- German, English
- Related manuals
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.