In the pharmaceutical and medical engineering industries, in particular, increasing demands are being placed on software which aims at documenting the traceability of the actions executed. In line with these key requirements, Zwick now offers a special option for its proprietary testing software testXpert® that meets these demands.

When evaluating materials and components, a wide variety of testing machines may be used depending on the application at hand. The documentation of the properties determined from these experiments is typically done using test reports, which are then signed by the test staff responsible. Yet, for reasons of convenience, the alternative of electronic archival is growing in importance. In order that electronic documents may be afforded the same validity as their paper-based counterparts, certain measures need to be taken to ensure that the relevant rules and precautions are followed, e.g. protection from intentional or unintentional damage, completeness, unambiguous assignment to the tests performed.

The software option provided for by Zwick enables complete and consistent documentation of all the actions executed during the testXpert® run, with no possibility of manipulation. Together with the user administration feature integrated in testXpert®, this option offers the ideal tool for compliance with the requirements of FDA 21 CFR Part 11 (guidelines set by the US Food and Drug Administration).