testXpert^® II fulfils the requirements of the medical technology and pharmaceutical industries.

The increasing demands placed on software used in these industries to document the traceability of completed actions are comfortably met by Zwick’s ‘Expanded Traceability’ option for testXpert^® II testing software.

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 explained is specified by the user in accordance with his guidelines (these can be taken from his QM handbook or based on external requirements). In individual cases this may, for example, mean that each change made to a test-relevant parameter such as test speed is recorded complete in an audit trail.

The ‘electronic signature’ allows documentation of assumption of responsibility plus the change to a ‘paper-free laboratory’, as the signature on the document can be replaced by a digital signature for the test series by entering user identification and password in testXpert^® II. It is possible to specify precisely how many signatures are necessary for each digital signature and which user groups are authorized for this. The test series is safeguarded against unauthorized changes when in signed status.

Together with the user management option also integrated into testXpert^® II, the ‘Expanded Traceability’ option offers the ideal tool to fulfil the requirements set out by the FDA in 21 CFR Part 11 in conjunction with organizational procedures  in the company involved.