Testing automation

Isolates from WFI shall be identified to species level (if possible) using API tests/automated identification system. This pertains to the detection of any isolate obtained from a sample that breaches the alert or action level. 

The information in this chapter applies specifically to the first element sample preparation. The sample preparation steps are usually the most tedious and labor-intensive part of an analysis. By automating the sample preparation, a significant improvement in efficiency can be achieved. It is important to make sure that (1) suitable instrument qualification has been concluded successfully before initiation of automated sample preparation validation [2], (2) the operational reliability of the automated workstation is acceptable, (3) the analyte measurement procedure has been optimized (e.g., LC run conditions), and (4) appropriate training in use of the instrument has been provided to the operator(s). The equipment used to perform automated sample preparation can be purchased as off-the-shelf units that are precustomized, or it can be built by the laboratory in conjunction with a vendor (custom-designed system). Off-the-shelf workstations for fully automated dissolution testing, automated assay, and content uniformity testing are available from a variety of suppliers, such as Zymark (www.zymark.com) and Sotax (www.sotax.com). These workstations are very well represented in the pharmaceutical industry and are all based on the same functional requirements and basic principles. 

Test Automated Testing of Materials for Evaluation of Performances 253... 

Fewster, M. and Graham, D. (1999), Software Test Automation Effective Use of Test Execution Tools, Addison-Wesley, London. 

Before any evaluation, the essential characteristics required of the instrument must be defined. These will include accuracy, precision, specificity, and speed, and methods for measuring these may need to be devised. To these objective criteria must be added a range of subjective factors, including ease of use, reliability, safety, and ease of maintenance. Finally, all these factors must be related to the price of the instrument. In Britain a schedule for testing automated equipment has been prepared (B17) which with minor modifications can be applied to many different types of instrument. 

Preferably such test and documentation of test results should be done automatically using always the same set of test files. In this way users are encouraged to perform the tests more frequently and user specific errors are eliminated. In some cases vendors provide test files and automated test routines for verification of a computer system s performance in the user s laboratory. For example, Agilent provides for the data systems such files and test automated test routines. 

Fewster M, Graham D (1999) Software test automation. ACM Press/Addison-Wesley... 

Blackburn, M., Busser, R., Nauman, A., Chandramouli, R. Model-based approach to security test automation. In Proc. of the 14th International Software and Internet Quality Week Conference, San Francisco, USA (June 2001)... 

Chandramouli, R., Blackburn, M. Security functional testing using an interface-driven model-based test automation approach. In Proc. of the 18th Computer Security Applications Conference, Las Vegas, USA (December 2002)... 

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