Product category:
R&D, Test and Evaluation Services
News Release from: Zwick Roell | Subject: testXpert ll
Edited by the Processingtalk Editorial
Team on 09 May 2007
Zwick testXpert integrates FDA 21 CFR
traceability
The Zwick testing software testXpert II has been developed with a fully integrated option to meet the requirements of FDA 21 CFR Part 11
These Part 11 guidelines, set by the US Food and Drug Administration, are intended to make sure that each record can be traced back to its source 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
This article was originally published on Processingtalk on 8 Mar 2007 at 8.00am (UK)
Related stories
Latest Zwick testing device tests rivets
The effect of different production parameters on blind rivet strength can now be easily tested with the new device from Zwick, which determines the mechanical properties in accordance with EN ISO14589
Getting a grip on foodstuff viscosity measurement
Zwick Roell introduces an enhanced backward extrusion apparatus with optimised testing software for measuring dynamic viscosity, for example with chunky fruit preparations or yogurt with fruit pieces
All Zwick testing systems which are used to evaluate the properties of materials and components in the pharmaceutical and medical engineering industry are controlled by the industry leading 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.
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 thereby 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 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.
In summary, 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 Roell ...
• Zwick Roell: contact details and other news
• Email this article to a colleague
• Register for the free Processingtalk email newsletter
• Processingtalk Home Page
Search the Pro-Talk network of sites
