Software testing tools and load testing information

Testing software testXpert® II has been developed by Zwick to be 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 software testing services 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.

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