The testing software testXpert II has been developed with a fully integrated option to meet the requirements of FDA 21 CFR Part 11. All Zwick’s testing systems which are used to evaluate the properties of materials and components in the pharmaceutical and medical engineering industry are controlled by the testXpert software which has many levels of administration and security protection allowing only authorized people to create test results, or amend previously stored data.
As an example, assume an operator has logged into testXpert with their user name and password and has the right, through the user administration system, to change the testing speed. After changing the value testXpert will ask why the speed needs to be changed. The operator must answer this question then all data such as the old and new speed setting, operator identity, date and time are all stored into a special data file.
In summary, users of Zwick systems can be totally confident that the data they produce is traceable and secure. Any amendments are clearly controlled and labeled accordingly. The data files cannot be edited by standard text editors.
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