VDI/VDE 3516 Part 2:2013 Edition

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Validation in the GxP area – Small manufacturing and testing devices

Published By	Publication Date	Number of Pages
DIN	2013-11	72

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Categories: 25.040.40 - Industrial process measurement and control, DIN

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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.

Additional information

Published Code	DIN
Published By	Deutsches Institut für Normung
Publication Date	2013-11
Pages Count	72
Language	Germany
Descriptors	Blank forms, Classes, Classes of apparatus, Control engineering, Coordination, Data processing, Digital connections, Digital data, Digital engineering, Digital signals, Electronic engineering, Equipment, Firmware, Forms (paper), Glossaries, Hardware, Information supplied by the manufacturer, Life cycles, Marking, Metrology, PC, Personal computers, Sensors, Signal processing, Small appliances, Software, Test equipment, Validation, Computer hardware, Computer software
File Size	972.8 KB
ICS Codes	25.040.40 - Industrial process measurement and control

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VDI/VDE 3516 Part 2:2013 Edition

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