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 in Ulm 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. Users define the level of the actions to be logged and substantiated, harmonizing them with the requirements set out in the QM handbook used or in any external specifications which may be applicable. In individual cases this may, for example, mean that any and all changes to test-relevant parameters such as the testing speed are to be fully recorded.
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). And the extended traceability option in testXpert® boosts performance, making testXpert® the optimal tool when used with the appropriately defined processes for testing according to 21 CFR Part 11 and to achieve the necessary certification for release of such products to the American market.
Figure 1. Dialog in testXpert® for the definition of the actions to be logged and substantiated. The audit trail, which shows the logged actions in readable form, is displayed in the foreground.
With these outstanding features that Zwick has built into testXpert®, the materials testing machine vendor has put forward a unique selling proposition for its proprietary testing software. The ability to ensure availability of the desired quality characteristics while at the same time providing protection against data manipulation now enables manufacturers of safety-relevant products to optimize their processes and effectively boost product quality. More than 50 satisfied customers are proof of the usefulness of this product.