testXpert II offers special functions for the medical industry

testXpert®II testing software offers special functions for the medical engineering and pharmaceutical industries

testXpert®II is the common software platform for all Zwick machines and equipment, ranging from small testing instruments to automated multi-axial testing systems used to check the operation of medication delivery pens.

Whatever the equipment,  testXpert®II delivers the same ergonomic operator interface and renowned operating convenience, providing a  solution for every test situation.

User management
testXpert®II provides sophisticated user management with freely configurable user profiles and detailed rights management. This enables authorization levels to be shown in the software and allows menu items, standard actions (e.g. printing reports) or test programs to be authorized or blocked individually, reducing the probability of critical input errors. Blocking user accounts in the event of unauthorized log-in attempts allows manipulation to be prevented, while attempted access of this kind can be reported via a notification system.

The ‘Expanded Traceability’ function provides all the tools needed, in conjunction with organizational procedures, to fulfil the essential conditions of the requirements set out in  FDA 21 CFR Part 11 

Electronic records
The ‘electronic records’ function allows complete, non-manipulable documentation of all actions and changes performed in testXpert®II. The level at which actions are to be logged and, if necessary, explained is specified by the user in accordance with his regulatory guidelines (e.g. changes to a test-relevant parameter such as test speed). This data is stored in the audit trail.

Electronic signature
The ‘electronic signature’ function allows documentation of assumption of responsibility plus a change to ‘paper-free documentation’, as the signature on the test report can be replaced by a digital signature for the test program or series by entering user identification and password in testXpert®II. It is possible to specify precisely how many people must sign and who is authorized to do so. The test program and test series are safeguarded against unauthorized changes when in signed status..

Video Capturing
The Video Capturing Plus option enables display and documentation of test sequences. A video is recorded parallel to the test on webcam or camcorder. Integrated hardware synchronization enables frame-accurate synchronization of the testXpert®II test data and the video. When the video is played back the corresponding test data are displayed in the curve graphic via crosshairs; alternatively the user selects any desired measured value line via the crosshairs and automatically obtains the corresponding video image. In this way the test sequence can be visually evaluated, even retrospectively, or a special material behavior can be documented.

In addition to numerous standard test programs, individual test programs can also be implemented with testXpert II. Online language-swapping in up to nine languages also provides an ideal working environment for international project teams. 

More information about testXpert II

Contact

Zwick Testing Machines Ltd.
Tel.  +44 1568-61 5201
E-Mail  sales.info@zwick.co.uk