Part 11, Electronic Records; Electronic Signatures - Scope and Application: Guidance for Industry

FDA 官方历史目录记录；Final guidance；发布日期：2003-09-05。官方主题：Postmarket, Compliance, Electronic Submissions, Investigation & Enforcement, Administrative / Procedural, Current Good Manufacturing Practice (CGMP), Good Clinical Practice (GCP), Food & Color Additives。请通过官方原文与附件查阅文件。