VDI/VDE 3516 Blatt 5:2017-08 - Draft

Validation in the GxP area - Types of raw data

German title: Validierung im GxP-Umfeld - Arten von Rohdaten
Publication date: 2017-08
Original language: German, English
Pages: 24

Publication date: 2017-08
Original language: German, English
Pages: 24

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Short description

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.

Content

ICS

25.040.40, 35.080

Replacement amendments

This document has been replaced by: VDI/VDE 3516 Blatt 5:2019-03 .

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