Software data handling

Figure 20-30 Effect of signal averaging on a simulated noisy spectrum. Labels refer to number of scans averaged. [From R. Q. Thompson, Experiments in Software Data Handling," J. Chem. 

Wastewater treatment assistance. Software includes Data Handling System, Lab Dench File, Lab Stock Inventory, Scheduled Work System, Unscheduled Work System, Facility Stock Inventory, Tool Record System, Personnel Record System, Budget Control System, Equipment Record System, and Industrial Pretreaiment File. 

Data handling and process control software program for wastewater treatment plants. Requires Apple II. 

Note As is often the case, the HPLC system will be under computer control, which is likely to be part of a data-handling system. Since the data generated from the OQ hardware tests typically require chromatographic data handling, the data-handling software should be validated beforehand. The data-handlingfLC control software installation and IQ/OQ implementation, which are not addressed in this chapter, may take a considerable amount of time. This is often the case since this process typically involves an initial client/server implementation. 

The LC control software, either stand-alone or as part of an overall data-handling system, should be tested by means of a separate OQ protocol. This protocol only needs to address the communica-tions/control integrity of the hardware (e.g., setting up a run/sequence with the proper instrument parameters, the ability to start and stop the pump, etc.). It should cover all the required instrument control functions listed as part of the protocol s functional specifications. It does not need to include specific hardware performance testing, such as linearity or flow rate. The latter tests are performed separately, as part of the individual hardware validation described below. 

A system is typically comprised of multiple instrument components. Therefore, there is usually an individual IQ for each of these instruments and for any corresponding instrument control/data-handling software. The typical instrument components making up an HPLC system include a binary or quaternary HPLC pump, an autosampler supporting multiple vials or microtiter plates (autosamplers often include cooled Peltier trays for sample stability), a column oven, and a UV-Vis or photodiode array (PDA) detector. 

This chapter will address the validation of the hardware and will not specifically address the validation of the data-handling software as this is beyond the intended scope. 

Many of these issnes are bom of the fact that, nnlike development software, deployment software must be an integral part of a much larger data handling and process control system. 

The GALP standards require that a written description of the system s hardware be maintained. Overall descriptions of the purpose and use of the system and specific listing of hardware and software involved in data handling are required. 

The data handling or integration software can also cause peak distortion if the settings are altered throughout the lifetime of the method and it is often necessary to test these for ruggedness. 

In addition to testing the system components, a test of software functionality would be performed to test the system software operation and electronic records and electronic signatures (ERES) compliance (security, data integrity, data backup, and archive). In order to test the software functionality, a predetermined set of instructions can be entered step by step into the system. The system responses are then compared to the expected outcomes of the instruction and any problems with the execution are determined. Some vendors will provide a standard set of data which can be processed by the system to verify the data-handling capability of the system. 

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