Product category:
Materials testing equipment
News Release from: Zwick Testing Machines | Subject: testXpert II
Edited by the Engineeringtalk Editorial
Team on 26 April 2007
Testing software meets FDA standards
Users of Zwick systems can be totally confident that the data they produce is traceable and secure.
Zwick's testing software testXpert II has been developed with a fully integrated option to meet the requirements of FDA 21 CFR Part 11 These guidelines, set by the US Food and Drug Administration, are intended to make sure that each record can be traced back to its source
This article was originally published on Engineeringtalk on 28 Oct 2005 at 8.00am (UK)
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Test software capitalises on 80 year development
More than 10,000 successful test software installations and more than 80 years of experience in materials testing have gone into the development of the new generation testXpert II software.
Solution monitors tests
Zwick's testXpert II overcome small timing delays in the Windows operating system, using a combination of hardware and software.
The time and date of any data produced and/or changed must also be recorded and data can only be amended by authorised personnel, who must be clearly indicated within the amendment process.
All Zwick's testing systems which are used to evaluate the properties of materials and components in the pharmaceutical and medical engineering industry are controlled by the testXpert software which has many levels of administration and security protection allowing only authorised people to create test results, or amend previously stored data.
The testing sequence itself is often defined by international or individual company standards and, with testXpert, even the most sophisticated testing methods can be easily configured and password protected to prevent unauthorised changes.
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The benefit of testXpert compared to many other existing materials testing packages is that the FDA 21 CFR Part 11 traceability is integrated into the operating core of the software, avoiding the need for third-party solutions, audits and associated high costs.
As an example, assume an operator has logged into testXpert with their user name and password and has the right, through the user administration system, to change the testing speed.
After changing the value testXpert will ask why the speed needs to be changed.
The operator must answer this question, and then all data such as the old and new speed setting, operator identity, date and time are all stored into a special data file.
testXpert also offers another significant advantage compared to existing testing systems which can only store their test results in ASCII or other easily edited formats.
testXpert data is securely stored in a data file which cannot be edited by standard text editors and thus ensures that data cannot be tampered with.
Users of Zwick systems can be totally confident that the data they produce is traceable and secure.
Any amendments are clearly controlled and labeled accordingly.
The data files cannot be edited by standard text editors.
In addition this product can be applied to other industries such as aerospace, and for safety equipment manufacturers where traceability of data is of paramount importance. Request a free brochure from Zwick Testing Machines ...
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