VDI
The Association of German Engineers
 
The Association of German Engineers (VDI)
Folgen:  FacebookTwitter

VDI-Standard: VDI/VDE 3516 Blatt 5

Commentary
Generic information
Abstract
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.

Table of contents: of the standard
Keywords:

Automation, Data processing, Data records, Definitions, Information technology, Metadata, Open systems, Pharmacy, Process measuring and control technology, Properties, Software, Testing, Tools, Validation

Date:

2019-03

German Title:
English Title:

Validation in the GxP area - Types of raw data

Technical rules: Richtlinie
Issuing body:

VDI/VDE-Gesellschaft Mess- und Automatisierungstechnik

Author:

Fachbereich Engineering und Betrieb automatisierter Anlagen

Associated VDI Manuals: VDI-Handbuch Informationstechnik Band 1
VDI/VDE-Handbuch Automatisierungstechnik
Price:

81,00 EUR

Pages:

23

Classification:

25.040.40

available in:

Deutsch, Englisch

Keywords:

Automation, Data processing, Data records, Definitions, Information technology, Metadata, Open systems, Pharmacy, Process measuring and control technology, Properties, Software, Testing, Tools, Validation

Fields marked with an asterisk (*) are required.
Please fill all fields marked with an asterisk (*).

VDI/VDE 3516 Blatt 5

Given name*:
Surname*:
Company:
Street*:
Postal code, City*:
Email*:
Telephone number:
Upload:

(pdf, doc, docx)
VDI Membership ID:
Commentaries from VDI Members are handled with priority
Your Commentary
ReCaptcha*:
Back to VDI Standard Search