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Technical rule [CURRENT]

VDI/VDE 3516 Blatt 5:2019-03

Validation in the GxP area - Types of raw data

German title
Validierung im GxP-Umfeld - Arten von Rohdaten
Publication date
2019-03
Original language
German, English
Pages
23

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Publication date
2019-03
Original language
German, English
Pages
23

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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. 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.
Content
ICS
25.040.40
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