ワンズワークスの資料翻訳シリーズ

要 約
FDA Guidance Document (旧:Guides #75)
FDA Guidance #75
Part 11 電子記録;電子署名 - 範囲、および適用
Guidance for Industry - Part 11, Electronic Records ; Electronic Signatures - Scope and Application (August 2003, Pharmaceutical CGMPs)

Guidance for Industry
Part 11, Electronic Records ;
Electronic Signatures ―
Scope and Application
Part 11電子記録;電子署名 -
範囲、および適用
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
Center for Devices and Radiological Health (CDRH)
Center for Food Safety and Applied Nutrition (CFSAN)
Center for Veterinary Medicine (CVM)
Office of Regulatory Affairs (ORA)
August 2003
Pharmaceutical CGMPs

目 次
Ⅰ. 緒論 [Introduction]
Ⅱ.背景 [Background]
Ⅲ.論議[Discussion]
 A.Part 11要求事項への全体的アプローチ[Overall Approach to Part 11 Requirements]
 B.アプローチの詳細 - Part 11の範囲[Details of Approach – Scope of Part 11]
  1.狭義の範囲の解釈[Narrow Interpretation of Scope]
  2.Part 11の記録の定義[Definition of Part 11 Records]
 C.特定のPart 11要求事項に対するアプローチ[Approach to Specific Part 11 Requirements]
  1.バリデーション[Validation]
  2.監査証跡[Audit Trail]
  3.伝来のシステム[Legacy Systems]
  4.記録のコピー[Copies of Records]
  5.記録の保管[Record Retention]
Ⅳ.参考資料[References]



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