testXpert II - Zwick - #9

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9 Expanded Traceability according to FDA testXpert® II generally records all testing activities to make your results traceable. The ‘Expanded Traceability’ is available in particular for critical applications: This function offers all the tools needed – together with organizational procedures – to comply with the requirements demanded by FDA 21 CFR part 11, the highest security level currently existing. Your administrator determines what needs to be protocolled and for which procedures and events the user needs to input explanations. Following this, all relevant action, events and changes in essential data are recorded and archived. In combination with the User Management, this function offers your administrator the tools necessary to clearly control access of the test machine and the measurement data. Nobody can offer you more security! When does who do what, and why?