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W-185
Keywords:Softwareandcomputersystemvalidation,back-up,limited
access,audittrail,dataencryption,accuratecopies
Primarydeviations:Inadequatestorageandback-up,missingabilityto
discerninvalidoralteredelectronicrecords,accesstocomputerrecords
withoutuniqueuserIDandpassword,noorinadequatevalidation,
inaccuratecopiesofelectronicrecords.
Examples:
-Failuretostorerecordssoastominimizedeterioration,preventloss
andbackupofautomateddataprocessingsystems
-Theelectronicdatadidnotcorrelatewiththepaperrecords;youhad
notestablishedanelectronicdataback-upprocedure;andfinally,data
wascopiedontotheserverfromonesystemtothenextviafloppy:
therefore,nolimitedaccessordataprotectionhadbeenestablished
-Youfailedtoencryptand/orphysicallysecureyourdataback-up
systemtocomplywiththerequirementstopreventdeteriorationor
deletionoftheanalyzerdata
-FailuretoadequatelyvalidatetheintendeduseofthisPCandits
software
-ThededicatedPC[redacted]attachedtothe[redacted]wasnot
secureinthataccesstothedataon[redacted]wasnotgrantedbya
uniqueusernameandpasswordorequivalentmethod
-thereasnodocumentationassociatedwiththeelectronicdatafor
whomwasresponsibleforcollectionoftheanalyticalresultsasseveral
qualitycontrolpersonnelhaveaccesstothe[redacted]nosoftware
changesinthestudydatacouldbedetectedastherewasnoaudittrail
capability;andfinally,theelectronicdatadidnotcorrelatewiththe
paperrecords.
-yourresponseandhaveconcludedthatitisinadequatebecauseno
systemvalidationwasconductedtoensureaccuracy,reliability,
consistentintendedperformance,andtheabilitytodi
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