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ƒRƒ“ƒsƒ…[ƒ^‰ŧ@“KģŠĮ—@‘Ð
No.1713

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ž@‘æ2ß@FMEA iFailure Mode Effects AnalysisjEFTA iFault Tree Analysisj

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ž@‘æ4ß@HAZOP iHazard Operability Analysisj

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@@‘æ1€@Watson LIMSiƒoƒCƒIƒAƒiƒŠƒVƒXŽŽŒąƒVƒXƒeƒ€j

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@@@@1.4 ƒ^ƒCƒ€ƒ‰ƒCƒ“‚ðl‚Ķ‚é
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@@@@2.5 Ý’č
@@@@2.6 PQ
@@@@2.7 Ždã‚°
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ž@‘æ1ß@‚Č‚šCSV‚âER/ES‚Š•K—v‚Č‚Ė‚ЁH

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@@@@2.1 ƒ\ƒtƒgƒEƒFƒA‚Ė“Á’Ĩ
@@@@2.2 CSV‚ĖŠî–{ŠT”O
@@@3D‚Č‚šER/ES‚ĖŠĮ—‚Š•K—v‚Č‚Ė‚Đ
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@@@@3.4 ER/ESŠĮ——vŒ

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@@‘æ1€@—Տ°ŠJ”­‚É‚Ļ‚Ŋ‚éCSVŽĀŽ{‘Ė§

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@@@1DŽÐ“ā‘Ė§‚ĖŠm—§
@@@2DŽÐ“āSOP‚Č‚Į‚ĖėŽ
@@@3DCSV‚ðl—ķ‚ĩ‚―CDMS‚Ė\’z‚ĖŽč‡B
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@@@5DƒeƒXƒgŠm”F•û–@
@@@6D•iŽŋŠĮ—

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@@@1D“KģŠĮ—ƒKƒCƒhƒ‰ƒCƒ“‚ĖŠT—Š
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@@@@3.6 ƒVƒXƒeƒ€ƒeƒXƒg
@@@@3.7 Žó“üŽŽŒą
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@@@@4.1 ƒoƒŠƒf[ƒVƒ‡ƒ“Œv‰æ‘‚ĖėŽ
@@@@4.2 “KŠiŦ•]‰ŋ
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@@@5D‰^—pŠĮ—‹Æ–ą
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@@@8D•ķ‘‚Ė•ÛŠĮ

@@‘æ2€@—Տ°ŽŽŒąŠÖ˜A‚ĖƒVƒXƒeƒ€ŠJ”­‚É‚Ļ‚Ŋ‚éCSVėŽ•ķ‘

@@m1n ƒTƒvƒ‰ƒCƒ„‚ð\•ŠŠˆ—p‚ĩ‚―CSVi•ķ‘ėŽ‚ðŠÜ‚ށj‘Ήž–@

@@@1DƒTƒvƒ‰ƒCƒA‚Ė—‰ð“x‚Ėl—ķ
@@@2DƒTƒvƒ‰ƒCƒAŠˆ—p‚Ėƒ|ƒCƒ“ƒg
@@@@2.1 ƒ\ƒtƒgƒEƒFƒAŠJ”­H’ö‚ÆCSV•W€‚Ė‘Ήž•t‚Ŋ
@@@@2.2 ‘Šú‚ĖCSVŽĀŽ{•ûj‚Ė‹Ī—L
@@@@2.3 ƒgƒŒ[ƒTƒrƒŠƒeƒB
@@@@2.4 ƒeƒXƒg‹L˜^
@@@@2.5 PQ

@@‘æ3€@CSV Vendor Audit‚ĖŽĀŽ{‚ÆCheck ListėŽ

@@m1n Vendor Audit‚ĖŽĀŽ{‚ÆCheck ListėŽ

@@@1DƒpƒbƒP[ƒWŧ•i‚ĖƒJƒeƒSƒŠ
@@@@1.1 ƒpƒbƒP[ƒWŧ•i‹@”\‚ðƒ†[ƒU‚Š”CˆÓ‚É—˜—p‚·‚é‚æ‚Ī‚Ȑŧ•i (GAMP Certegy Level 3)
@@@@1.2 ƒ†[ƒU‹Æ–ą‚ɉž‚ķ‚Ä‹@”\‚ĖŽĐ“ŪÝ’č“™‚ð‰Â”\‚Æ‚·‚éŧ•i (GAMP Certegy Level 4)
@@@@1.3 ƒRƒ“ƒtƒBƒOƒŒ[ƒVƒ‡ƒ“‰Â”\ŧ•i‚ðŠų‚É‹Æ–ą‚ɍ‡‚í‚đ‚ĐݒčÏ‚Ý‚Ėŧ•i (GAMP Certegy Level 4)
@@@2D•W€“I‚ČAudit Questioners
@@@@2.1 Company Details
@@@@2.2 Details of Specific Products
@@@@2.3 Quality Management System ? General for Product development and Support
@@@@2.4 Quality Management System ? Infrastructure and Support Processes
@@@3Dŧ•iƒJƒeƒSƒŠ‚É‘Ķ‚ĩ‚―Vender Audit‚Ėƒ|ƒCƒ“ƒg
@@@@3.1 ƒRƒ“ƒtƒBƒOƒŒ[ƒVƒ‡ƒ“Ï‚Ý‚ĖÝ’č‚ð•ÏX‚ĩ‚Č‚Ē
@@@@3.2 ƒRƒ“ƒtƒBƒOƒŒ[ƒVƒ‡ƒ“Ï‚Ý‚Ėŧ•i‚ð‚Ŧ‚ŋ‚ņ‚ƃxƒ“ƒ_[‚ŃeƒXƒg‚ĩo‰Ũ‚·‚é

@@m2n ASPiApplication Service Providerj‚Ö‚ĖAudit‚ĖŽĀŽ{‚Ėƒ|ƒCƒ“ƒg

@@@1DASP‚ð—˜—p‚·‚éÛ‚Ė—vŒ
@@@@1.1 ƒVƒXƒeƒ€ƒeƒBƒA[ƒh\‘Ē‚Ɛę—LŠÂ‹Ŧ
@@@@1.2 M—ŠŦ‚ƍ‚ƒVƒXƒeƒ€ƒpƒtƒH[ƒ}ƒ“ƒX
@@@@1.3 ƒZƒLƒ…ƒŠƒeƒB‚ƃRƒ“ƒvƒ‰ƒCƒAƒ“ƒX
@@@@1.4 ƒT[ƒrƒX‚ƃTƒ|[ƒg
@@@@1.5 ƒoƒbƒNƒAƒbƒv‚ƍЊQ•œ‹Œ
@@@2DASP‚ĖAudit•û–@
@@@@2.1 —vŒ‚ɑ΂·‚é‘Ήžó‹ĩ‚Æ‚ŧ‚ę‚ð•Ûá‚·‚éƒGƒrƒfƒ“ƒX‚ĖŽæ“ū
@@@@2.2 SLA(Service Level Agreement)‚ĖŽ–‘OŠm”F

@@m3n ƒf[ƒ^ƒZƒ“ƒ^[‚Ö‚ĖAudit‚ĖŽĀŽ{‚Ėƒ|ƒCƒ“ƒg

@@@1Dƒf[ƒ^ƒZƒ“ƒ^[Ž{Ý‚ĖŒŸØƒ|ƒCƒ“ƒg
@@@@1.1 Ž{Ý—§’nŠÂ‹Ŧ
@@@@1.2 Ž{Ý‚Ė‘ϐkŦE–h‰ÎŦE“dŒđ‹Ÿ‹‹Ŧ
@@@@1.3 Ž{Ý“üoŠĮ—
@@@@1.4 Ž{Ý“ā—vˆõ‚Ė‹ģˆį
@@@2Dƒf[ƒ^ƒZƒ“ƒ^[Ž{Ý‚Ė—˜—pŠé‹Æ‘Ī‚Å‚Ėd—v‚ȏ€”õ

@@‘æ4€@ŠÄļØÕ‚ĖŽæ‚č•û

@@@1D—Տ°ŽŽŒąƒf[ƒ^‚É‚Ļ‚Ŋ‚éŠÄļØÕ
@@@@1.1 EDCƒVƒXƒeƒ€‚Å‚Ė“dŽqĮ—á•ņ‘ėŽ‚É‚Ļ‚Ŋ‚éŠÄļØÕ
@@@@1.2 EDCƒVƒXƒeƒ€‚Đ‚į‚Ėƒf[ƒ^ˆÚŠĮ
@@@2D—Տ°ŽŽŒą‚Ė•ķ‘‚É‚Ļ‚Ŋ‚éŠÄļØÕ
@@@@2.1 —Տ°ŽŽŒą•ķ‘‚ð•ķ‘ŠĮ—ƒVƒXƒeƒ€‚ÅŠĮ—‚·‚éę‡iŽĄŒąˆË—ŠŽŌ‚Š•ķ‘ŠĮ—ƒT[ƒo‚ð‰^—p‚·‚éę‡j
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@@@@2.3 •ķ‘ŠĮ—ƒVƒXƒeƒ€‚ð—p‚Ē‚Č‚Ēę‡‚ĖƒAƒvƒ[ƒ`

@@‘æ5€@•Û‘ķƒf[ƒ^‚ĖƒoƒŠƒf[ƒVƒ‡ƒ“‚ĖŽæ‚č•û‚ƃf[ƒ^‚ðŠO•”•ÛŠĮiƒA[ƒJƒCƒuj‚ĩ‚Ä‚Ļ‚­Û‚Ė—ŊˆÓ“_

@@@1DCSV‚É‚Ļ‚Ŋ‚é•Û‘ķƒf[ƒ^‚ĖˆĘ’u‚ÂŊ
@@@2DCSV‚É‚Ļ‚Ŋ‚é•Û‘ķƒf[ƒ^ŒŸØŠÂ‹Ŧ
@@@3D•Û‘ķƒf[ƒ^‚ĖƒoƒŠƒf[ƒVƒ‡ƒ“•û–@
@@@@3.1 ‚ŧ‚Ė‚P
@@@@3.2 ‚ŧ‚Ė‚Q
@@@4Dƒf[ƒ^‚ðŠO•”•ÛŠĮ‚ĩ‚Ä‚Ļ‚­Û‚Ė—ŊˆÓ“_

ž@‘æ3ß@ˆã–ō•i—Տ°ŽŽŒą‚Å—p‚Ē‚į‚ę‚éITƒVƒXƒeƒ€‚ĖƒoƒŠƒf[ƒVƒ‡ƒ“

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@@@@1.1 CDISC•W€‚Æ‚Í
@@@@@1.1.1 ’č‹`
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@@@@@1.1.3 ’ʐMŽd—l
@@@@@1.1.4 ‚ŧ‚Ė‘ž
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@@@@1.3 ˆã—Ïî•ņ‚ÆCDISC‚ĖŠÖ‚í‚č
@@@@1.4 CDISC•W€‚ĖŦ—ˆ
@@@2DCDISC•W€‚ÆCSV
@@@@2.1 ‹ģˆį
@@@@2.2 ‹KŠi‚ē‚Æ‚ĖValidation‚ɂ‚Ē‚Ä
@@@@@2.2.1 ODM
@@@@@2.2.2 SDTM
@@@@@2.2.3 ADaM

@@m2n EDCƒVƒXƒeƒ€

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@@@2D—Տ°ŽŽŒą‚ĖˆË—ŠŽŌ‚É‚æ‚éEDCƒxƒ“ƒ_[ŠÄļ
@@@@2.1 EDC ƒVƒXƒeƒ€‘I’č‚Ė‚―‚ß‚ĖEDC ƒxƒ“ƒ_[ ŠÄļ
@@@@2.2 EDC ƒVƒXƒeƒ€‚Ė“Kģ‚ȉ^—p‚Ė‚―‚ß‚ĖEDC ƒxƒ“ƒ_[ ŠÄļ
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@@@@4.1 Œ_–ņ‘
@@@@4.2 EDCƒxƒ“ƒ_[‚Æ‚ĖCommunication Plan
@@@@4.3 ƒwƒ‹ƒvƒfƒXƒN‚Ė‰^—pE—˜—p‚ÉŠÖ‚·‚鍇ˆÓ
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@@@@5.1 EDC ƒVƒXƒeƒ€’PˆĘ‚ĖCSV‚ĖŽč‡
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@@@@5.3 ƒA[ƒJƒCƒrƒ“ƒO
@@@@5.4 EDCƒVƒXƒeƒ€ƒo[ƒWƒ‡ƒ“ƒAƒbƒv
@@@@5.5 •ÏXŠĮ—
@@@6DŽŽŒą’PˆĘ‚Å‚ĖEDCÝŒvŽž‚Ė—Տ°ŽŽŒą‚ĖˆË—ŠŽŌ‚É‚æ‚éCSVŠˆ“Ū
@@@@6.1 ŽŽŒąƒZƒbƒgƒAƒbƒv‚ĖCSVŠˆ“Ū
@@@@@6.1.1 ƒoƒŠƒf[ƒVƒ‡ƒ“Œv‰æ‘
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@@@@@6.1.3 ƒeƒXƒgEŽĀ‘•
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@@@@6.2 ŽŽŒąƒNƒ[ƒWƒ“ƒOEƒA[ƒJƒCƒrƒ“ƒO

@@‘æ2€@ƒf[ƒ^ƒ}ƒlƒWƒƒ“ƒgƒVƒXƒeƒ€

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