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Lenze · Controller-based Automation - Visualisation · System Manual · DMS 1.5 EN · 04/2014 · TD17 57

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.

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Lenze Controller-based Automation Manual do Utilizador Página 57