「バックアップリカバリー計画書」「サービスレベルアグリーメント」の書き方...
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5,000 円ぽっきりの CSV セミナー 【 第 8 講 】. 「バックアップリカバリー計画書」「サービスレベルアグリーメント」の書き方. 2013 年 2 月 28 日. イーコンプライアンス http://eCompliance.co.jp. サービスレベルアグリーメントと災害対策. 災害対策計画書. Disaster. Recovery. Backup & Recovery Plan. サービスレベルアグリーメント. Incident. Backup. Business Continuity Plan. Disaster. ▲. - PowerPoint PPT PresentationTRANSCRIPT
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http://eCompliance.co.jp20132285,000CSV8
Copyright eCompliance 2013 Copyright eCompliance 2013#1eCTDFDAFDA==============================================================DisasterIncidentBackup & RecoveryPlanBackupRecoveryBackupDisasterBusiness ContinuityPlanRecoveryRestoreVerification
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Table of contents
Copyright eCompliance 2013#3SOPSOPPracticalSOP
CSVDuplicateMTMTMT ER/ES
Copyright eCompliance 2013#
Copyright eCompliance 2013#3.1.3.1.1. ER/ES
Copyright eCompliance 2013#61. CSVCSVCSVCSVCSV1.1 FDAPrinciple: Data quality and quality assurance should not decrease when a computerized system replaces a paper operation.FDASo what ?FDAFDACSV3.1.1.
Copyright eCompliance 2013#71. CSVCSVCSVCSVCSV1.1 FDAPrinciple: Data quality and quality assurance should not decrease when a computerized system replaces a paper operation.FDASo what ?FDAFDACSVGCP261
Copyright eCompliance 2013#ER/ES
Copyright eCompliance 2013#ER/ESER/ES(1)(2)(3)
Copyright eCompliance 2013#
Copyright eCompliance 2013#11FDAFDA
3ICHQC()QA()QCQA199731340327GCP28
CSVQASDLCQACVQAComputer Validation Quality AssuranceSDLCSDLC15.115.2 415.3QMS ISMSEU GMP Annex 11Back Up; Migration; Archiving; Retrieval
Copyright eCompliance 2013#121. CSVCSVCSVCSVCSV1.1 FDAPrinciple: Data quality and quality assurance should not decrease when a computerized system replaces a paper operation.FDASo what ?FDAFDACSVFDA /
Copyright eCompliance 2013#CSVQAQAFDA
Copyright eCompliance 2013#14QAQAFDA
Copyright eCompliance 2013#15FDA Warning Letter2007731822008114Tomita Pharmaceutical Co., Ltd
XXX30FDA-483XXXFDA
Copyright eCompliance 2013#FDA Warning LetterHPLC21 CFR Part 11, Electronic Records
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Table of contents
Copyright eCompliance 2013#18SOPSOPPracticalSOP
CSVIS
Copyright eCompliance 2013#191. CSVCSVCSVCSVCSV1.1 FDAPrinciple: Data quality and quality assurance should not decrease when a computerized system replaces a paper operation.S/WS/WFDASo what ?FDAFDACSVSLASLASLA
Copyright eCompliance 2013#201. CSVCSVCSVCSVCSV1.1 FDAPrinciple: Data quality and quality assurance should not decrease when a computerized system replaces a paper operation.S/WS/WFDASo what ?FDAFDACSV1) 2) 3)
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Copyright eCompliance 2013#211. CSVCSVCSVCSVCSV1.1 FDAPrinciple: Data quality and quality assurance should not decrease when a computerized system replaces a paper operation.S/WS/WFDASo what ?FDAFDACSVOperational Level AgreementUnderpinning Contract21) 2) 3)
Copyright eCompliance 2013#221. CSVCSVCSVCSVCSV1.1 FDAPrinciple: Data quality and quality assurance should not decrease when a computerized system replaces a paper operation.S/WS/WFDASo what ?FDAFDACSVSLA1)SLA2)3)4)
Copyright eCompliance 2013#231. CSVCSVCSVCSVCSV1.1 FDAPrinciple: Data quality and quality assurance should not decrease when a computerized system replaces a paper operation.S/WS/WFDASo what ?FDAFDACSV1)2)3)4)5)6)
Copyright eCompliance 2013#241. CSVCSVCSVCSVCSV1.1 FDAPrinciple: Data quality and quality assurance should not decrease when a computerized system replaces a paper operation.S/WS/WFDASo what ?FDAFDACSV1)2)3)1)2)3)
Copyright eCompliance 2013#251. CSVCSVCSVCSVCSV1.1 FDAPrinciple: Data quality and quality assurance should not decrease when a computerized system replaces a paper operation.S/WS/WFDASo what ?FDAFDACSV1)2)3)1)2)3)
Copyright eCompliance 2013#261. CSVCSVCSVCSVCSV1.1 FDAPrinciple: Data quality and quality assurance should not decrease when a computerized system replaces a paper operation.S/WS/WFDASo what ?FDAFDACSVSLASLASLASLASLM1)2)2(1)(2)3)4)5)
Copyright eCompliance 2013#271. CSVCSVCSVCSVCSV1.1 FDAPrinciple: Data quality and quality assurance should not decrease when a computerized system replaces a paper operation.S/WS/WFDASo what ?FDAFDACSV(SLA)6. SLASLASLA
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12. (SLA)
Copyright eCompliance 2013#(SLA)12.1 12.2 12.3 SLAOLA
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Copyright eCompliance 2013#
Copyright eCompliance 2011#