Testing automation tools

Extraction scientist who is responsible for sample preparation should be certified prior to extracting real study samples. The validated extraction method has to be followed exactly. The raw data entries have to be documented promptly such as lot numbers of STD and QC, IS, extraction reagents, matrix, the IDs of automation tool and pipette, the time for study sample removal and return to storage and the completion of extraction. Instrument operator who is responsible for analysis has to perform SST test and assess sensitivity and carryover prior to initialing batch. Instrument operator has to... 

Automated tools are best used for regression testing (to see if operation of the software remains the same after change). 

Some suppliers offer automated tools for the IQ and OQ. These are likely to be useful as a quick means of establishing that a CDS has been installed correctly and the software frmctions as the supplier intended it to. The case for automated testing tools for PQ is less clear. In either case, the tool should be assessed to determine whether its use brings tangible benefits and meets GxP compliance requirements. 

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

This chapter provides an overview of expert-system verification and validation (V V) techniques. Several methods are presented. First, many of the conventional software V V techniques such as requirements analysis and unit testing can be applied to expert-system development. Second, an expert-system developer can use automated tools to test rule consistency and structure. A more viable alternative, however, is for the developer to create his own set of consistency and completeness tests. Finally, a developer should rely on qualitative judgment to determine the validity of a knowledge base. This judgment could include expert opinion as well as specialized tests designed to determine knowledge-base certification. The chapter suggests that methods should be combined into an optimal mix in order to best undertake V V. 

While automated tools and software are available for system qualification, method validation, and system suitability testing, achieving regulatory compliance for an HPLC laboratory remains a complex, costly, and time-consuming process. Many companies are adopting a risk-based approach to balance productivity and compliance. For instance, many pharmaceutical research... 

If the language used at level 3 is formal (rigorously defined), then it can play an important role in system validation. For example, the models can be executed in system simulation environments to identify system requirements and design errors early in development. They can also be used to automate the generation of system and component test data, various types of mathematical analyses, and so forth. It is important, however, that the black-box (that is, transfer function) models be easily reviewed by domain experts—most of the safety-related errors in specifications will be found by expert review, not by automated tools or formal proofs. 

It provides the ability to update predictions based on test data and addresses factors such as development process robustness. Available as an automated tool (as opposed to a handbook compendium of models like the others), PRISM interfaces directly with RAC s electronic and nonelectronic automated databases and provides an elaborate methodology to assess the quality of the system development process. 

It is not a complete answer for the validation and verification of safety-critical software even with the use of automated tools. Other forms of testing (for example dynamic) are required to verify certain aspects, like executing critical features. 

Examples of test data sets available (e.g., test scripts or automated test tools that would be suitable for version purchased) Boundary/stress/unexpected input tests Structural/functional testing (documentation of walkthroughs, etc.)... 

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