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Technical rule [CURRENT]

VDI/VDE 3516 Blatt 2:2013-11

Validation in the GxP area - Small manufacturing and testing devices

German title
Validierung im GxP-Umfeld - Kleine Produktions- und Prüfgeräte
Publication date
2013-11
Original language
German, English
Pages
72

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Publication date
2013-11
Original language
German, English
Pages
72

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Short description
The scope of this standard is to provide guidance for an adapted and efficient use of FDA 21 CFR Part 11 and to provide guidance on a pragmatic validation approach for small manufacturing and testing devices. Examples of small devices in discussion are, to name only few: pH meters, balances, digital controlled equipment, PLC controlled equipment, electronic recorders, optical sensor instruments and measuring transducers. All of the above examples are inclusive parameters. Medical devices are not within the scope of this standard.
Content
ICS
25.040.40
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