FDA的警告信翻译.pdf

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