Zwick's Testing Software Meets FDA 21 CFR Part 11 Requirements for Traceability

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. The time and date of any data produced and/or changed must also be recorded and data can only be amended by authorized 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 industry leading testXpert® software which has many levels of administration and security protection allowing only authorized 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 unauthorized 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.

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