FDA eSubmitter tool User Manual 标准收集整理.pdfVIP

FDAeSubmitter

UserManual

DocumentVersion5.1

February5,2012

-1-

DOCUMENTHISTORY

VersionNumberDateDescription

Version1.0May26,2004OIVDPre-PilotRelease(Softwarev1.00.00)

Version1.1August27,2004Updatedtoreflecttheenhancementsincorporatedinthe

OfficialOIVDPilotRelease(Softwarev1.00.01)

Version2.0March15,2005Updatedtoreflectenhancementsincorporatedintothe

CeSubPilotRelease(softwareversion1.10).Updatedfor

applicabilitytoOIVDandRadiologicalHealth.

Version3.0June24,2005Updatedforcorrectionsandadditionaldescriptions.

AlsoupdatedtoreflecttheenhancementsinSoftware

versions1.02.00and1.03.00.

Version4.0October31,2005Updatedtoreflecttheenhancementsinsoftwareversions

1.04.00through1.07.00

Version4.1March2,2006Revisedtheproxyserversettings.

Version4.2August7,2007UpdatedtheinstructionsinthePackagingSubmissionFiles

sectiontoincorporatethenewpackagingfeature.

Version4.3January7,2008Updatedtheinstructionsforrelease1.28.01toincludelink

tospecialinstructionsforWindowsVistaUsers.

Version4.4May2,2008Updatedtheuninstallinstructions.

Version4.5March16,2009Update