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' Section 12 <br /> ONSITE Environmental Laboratories Inc Revision 0 <br /> ' Quality Assurance Plan February 15, 1996 <br /> Page 5 of 6 <br /> ' processed to demonstrate that the program is fully operational Industry <br /> standard programs are defined as those commercial software programs which <br /> are widely used throughout the environmental laboratory industry and used to <br /> the laboratory without modification <br /> 1242 Laboratory Developed Software <br /> ' Complete checking of performance is required for programs that are developed <br /> within the laboratory and for externally prepared programs that are modified <br /> by ONSITE Validation is dependent upon the function of the software and <br /> may include <br /> 1 > For software that only performs numerical manipulation, sample sets of <br /> numbers for which the results are known (by hand calculations or <br /> equivalent pre-validated software) are processed and compared <br /> ' Sample sets must test both the theory or basis for computation, and the <br /> ability of the software to store and manage files <br /> > Software that performs as part of instrument operation should be <br /> verified by processing reference materials through the instrument <br /> system The processed instrument response should be compared <br /> against the standards used <br /> 1243 Software Modification <br /> ' Whenever a program is modified, reverification is required If the software <br /> has had features added, previous test problems should be rerun to demonstrate <br /> its function has not been affected New test problems should be processed as <br /> discussed above to verify added performance If software revision changes the <br /> basic operation of the program, complete reverification of the program is <br /> ' required <br /> 1244 Spreadsheets and Unprotected Software <br /> ' Unprotected software are reverified on an annual basis The test problems <br /> used to provide initial verification may be reprocessed and the results <br /> ' compared to demonstrate that performance of the software is unchanged If <br /> software performance has changed, corrective actions must be assessed and the <br /> effect of the change upon intended function and usage since the last verification <br /> ' assessed If necessary, the data sha11 be reprocessed and recipients of affected <br /> data reports notified <br /> Word 6 0 loelseci2 doe <br />