February 1, 1999
1)
PeakSimple for Windows software andChromatography Data System
( PeakSimple ) iswritten, manufactured andmaintained by SRI Instruments, Inc. a
Nevada Corporation.
2)
PeakSimple forWindows software hasbeen under continuousdevelopment
since 1994. Periodic testing of the software is performed by SRI employees.
3)
PeakSimple software is designed to beself-validating to enable quick verifi-
cation by customers that PeakSimple is functioning consistently, reliably and ac–
cording to specificationsunder actual operating conditions.
4)
Self-validation is performed by configuringPeakSimple into the "Loopback
mode" ( see loopback instructions inmanual ). In thismode, anactual user gener–
ated chromatogramwhich is loaded into channel 4 is re-played ( like a tape re–
corder) through the TP2 output channel, and then re-acquired and processed
through any one of the remaining input channels. This is done 7 ormore times to
insure that data isbeingprocessedconsistentlyandreliably.
The results frommultiple loopback analyses are used to calculate the percent rela–
tive standard deviation ( precision) of each peak in the chromatogram. Chroma–
tographic data is highly variable, and the precisionobtained isdependent onmany
factors including the peak shape, signal to noise ratio, interferences, co-eluting
peaks, data acquistion rate and customer selected integration parameters. For this
reason, self-validation ismore valid thanfactoryvalidation, since self-validation
takes intoaccount the exact chromatographicconditionsanduser specifiedpa–
rameters ineffect for the particular applicationwhereas factoryvalidationcannot.
