Buyer’s Guide 2012 Update: Testing and Quality Control Software platform for test machines includes special medtech functions
As the common software platform for all Zwick test machines and equipment, from small instruments to automated multiaxis systems used to check the operation of drug-delivery pens, testXpertII provides a convenient and ergonomic solution for every test situation.
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The software offers sophisticated user management, including freely configurable user profiles and detailed rights management. This enables authorisation levels to be shown and allows menu items, standard actions and test programmes to be authorised or blocked individually. Thus, the probability of critical input errors is reduced. Attempts at unauthorised access can be reported via a notification system. In addition, an “expanded traceability” function, in conjunction with organisational procedures, provides tools needed to fulfil the essential requirements set out in the US FDA regulation in 21 CFR Part 11.
Electronic records and signature
An electronic records function makes possible complete, secure documentation of all actions and changes performed in testXpertII. The level at which actions are to be logged and explained is specified by the user in accordance with applicable regulatory guidelines and such actions are stored in the audit trail.
The electronic signature function allows assumption of responsibility to be documented and supports the transition to paper-free documentation. How many people must sign and who is authorised to do so can be specified. The test programme and test series are safeguarded against unauthorised changes when in “signed” status.
The Video Capturing Plus option in testXpertII enables test sequences to be displayed and documented. Via webcam or camcorder, a video is recorded parallel to the test, and an integrated function enables frame-accurate synchronisation of the testXpertII test data and the video. When the video is played back, the corresponding test data are displayed, and vice versa.
In addition to numerous standard test programmes, individual test programmes can be implemented with testXpert II. Online language swapping in up to nine languages provides a comfortable working environment for international project teams.
For further information:
Zwick GmbH & Co. KG
89079 Ulm, Germany