Lenze Controller-based Automation - Manual (Page 57)

Lenze · Controller-based Automation - Visualisation · System Manual · DMS 1.5 EN · 04/2014 · TD17
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7 Appendix
7.1 Information regarding the FDA conformance
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7 Appendix
7.1 Information regarding the FDA conformance
»VisiWinNET®« can provide a visualisation that complies with FDA regulations 21 CFR part 11 of the
Food and Drug Administration. These regulations are applicable to machines exported into the U.S..
Industry therefore demands that the operating system and, in some cases, also the production
machines must contain data backup functions and functions protecting against the manipulation
of data.
A basic demand of the FDA is that electronic data shall be equivalent to paper data and that
electronic signatures shall have the same significance and unambiguousness as handwritten
signatures. The system should provide an easy but yet effective protection against manipulation,
although it is commonly known that electronic data and even paper data can almost always be
subsequently changed or deleted in the event of a criminal intent.
Using »VisiWinNET®«, completely FDA-compliant visualisation applications can be created by
means of the following functions:
• User management
• Recording of all parameter changes
• Start / stop recording
• Managing/changing passwords
• Saving encoded data in a database.