{"id":11833,"date":"2026-04-09T02:31:48","date_gmt":"2026-04-09T02:31:48","guid":{"rendered":"https:\/\/pharmamachinecn.com\/?p=11833"},"modified":"2026-03-09T02:34:11","modified_gmt":"2026-03-09T02:34:11","slug":"your-guide-to-21-cfr-part-11-guidelines-for-pharmaceuticals","status":"publish","type":"post","link":"https:\/\/pharmamachinecn.com\/ja\/your-guide-to-21-cfr-part-11-guidelines-for-pharmaceuticals\/","title":{"rendered":"\u533b\u85ac\u54c1\u306b\u95a2\u3059\u308b21 CFR Part 11\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306e\u624b\u5f15\u304d"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"11833\" class=\"elementor elementor-11833\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-656075b4 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"656075b4\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-78348194\" data-id=\"78348194\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-2b902b66 product-data-tab elementor-widget elementor-widget-text-editor\" data-id=\"2b902b66\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>\u533b\u85ac\u54c1\u306b\u95a2\u3059\u308b21 CFR Part 11\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u304c\u5b58\u5728\u3059\u308b\u306e\u306f\u3001\u898f\u5236\u5f53\u5c40\u304c\u30c7\u30fc\u30bf\u3092\u7ba1\u7406\u3001\u8ffd\u8de1\u3001\u4fdd\u8b77\u3057\u306a\u3044\u9650\u308a\u4fe1\u7528\u3057\u306a\u3044\u304b\u3089\u3067\u3042\u308b\u3002\u76e3\u67fb\u8a3c\u8de1\u306e\u6b20\u843d\u3001\u30ed\u30b0\u30a4\u30f3\u306e\u5171\u6709\u3001\u3042\u308b\u3044\u306f\u7ba1\u7406\u3055\u308c\u3066\u3044\u306a\u3044\u30b7\u30b9\u30c6\u30e0\u304c\u4e00\u3064\u3067\u3082\u3042\u308c\u3070\u3001\u6df1\u523b\u306a\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u554f\u984c\u306b\u767a\u5c55\u3059\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002.<\/p><figure id=\"attachment_11898\" aria-describedby=\"caption-attachment-11898\" style=\"width: 1000px\" class=\"wp-caption aligncenter\"><img fetchpriority=\"high\" decoding=\"async\" class=\"size-full wp-image-11898\" src=\"https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/04\/21-CFR-Part-11-Guidelines-for-Pharmaceuticals-Define.jpg\" alt=\"21 CFR Part 11 \u533b\u85ac\u54c1\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306e\u5b9a\u7fa9\" width=\"1000\" height=\"616\" srcset=\"https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/04\/21-CFR-Part-11-Guidelines-for-Pharmaceuticals-Define.jpg 1000w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/04\/21-CFR-Part-11-Guidelines-for-Pharmaceuticals-Define-300x185.jpg 300w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/04\/21-CFR-Part-11-Guidelines-for-Pharmaceuticals-Define-768x473.jpg 768w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/04\/21-CFR-Part-11-Guidelines-for-Pharmaceuticals-Define-18x12.jpg 18w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/04\/21-CFR-Part-11-Guidelines-for-Pharmaceuticals-Define-600x370.jpg 600w\" sizes=\"(max-width: 1000px) 100vw, 1000px\" \/><figcaption id=\"caption-attachment-11898\" class=\"wp-caption-text\"><em><strong>21 CFR Part 11 Guidelines for Pharmaceuticals \u5b9a\u7fa9\u3002.<\/strong><\/em><\/figcaption><\/figure><p>\u3057\u304b\u3057\u3001\u5927\u304d\u306a\u554f\u984c\u306f\u300121 CFR Part 11\u304c\u3057\u3070\u3057\u3070\u8aa4\u89e3\u3055\u308c\u3066\u3044\u308b\u305f\u3081\u3001\u591a\u304f\u306e\u88fd\u85ac\u4f1a\u793e\u304c\u82e6\u616e\u3057\u3066\u3044\u308b\u3053\u3068\u3067\u3042\u308b\u3002\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u30d9\u30f3\u30c0\u30fc\u306b\u9069\u7528\u3055\u308c\u308b\u3068\u8003\u3048\u308b\u4eba\u3082\u3044\u308c\u3070\u3001\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u3060\u3051\u3067\u5341\u5206\u3060\u3068\u8003\u3048\u308b\u4eba\u3082\u3044\u308b\u3002.<\/p><p>\u3042\u306a\u305f\u306e\u65bd\u8a2d\u3067\u3053\u306e\u3088\u3046\u306a\u3053\u3068\u304c\u8d77\u3053\u3089\u306a\u3044\u3088\u3046\u306b\u300121 CFR Part 11\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3068\u306f\u4f55\u304b\u3001\u3069\u3046\u3059\u308c\u3070\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u7dad\u6301\u3067\u304d\u308b\u304b\u3092\u8aac\u660e\u3057\u307e\u3059\u3002.<\/p><h2><strong><b>21 CFR Part 11\u3068\u306f\uff1f<\/b><\/strong><\/h2><figure id=\"attachment_10754\" aria-describedby=\"caption-attachment-10754\" style=\"width: 624px\" class=\"wp-caption aligncenter\"><img decoding=\"async\" class=\"size-full wp-image-10754\" src=\"https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/12\/The-FDA-headquarters.png\" alt=\"FDA\u672c\u90e8\" width=\"624\" height=\"351\" srcset=\"https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/12\/The-FDA-headquarters.png 624w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/12\/The-FDA-headquarters-300x169.png 300w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/12\/The-FDA-headquarters-18x10.png 18w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/12\/The-FDA-headquarters-600x338.png 600w\" sizes=\"(max-width: 624px) 100vw, 624px\" \/><figcaption id=\"caption-attachment-10754\" class=\"wp-caption-text\"><em><strong>FDA\u672c\u90e8\u3002.<\/strong><\/em><\/figcaption><\/figure><p><a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/part-11-electronic-records-electronic-signatures-scope-and-application\" target=\"_blank\" rel=\"noopener\"><u>21 CFR\u30d1\u30fc\u30c811<\/u><\/a>\u00a0\u306f\u3001\u96fb\u5b50\u8a18\u9332\u3068\u96fb\u5b50\u7f72\u540d\u3092\u3069\u306e\u3088\u3046\u306b\u6271\u308f\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u304b\u3092\u5b9a\u7fa9\u3057\u305f\u7c73\u56fdFDA\u306e\u898f\u5236\u3067\u3042\u308b\u3002\u305d\u306e\u76ee\u7684\u306f\u5358\u7d14\u3067\u3042\u308b\u3002\u7d19\u306e\u4ee3\u308f\u308a\u306b\u96fb\u5b50\u30b7\u30b9\u30c6\u30e0\u3092\u4f7f\u7528\u3059\u308b\u5834\u5408\u3001FDA\u306f\u305d\u306e\u30c7\u30fc\u30bf\u3092\u4fe1\u983c\u3067\u304d\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002.<\/p><p>\u3053\u306e\u898f\u5236\u306f\u3001\u88fd\u85ac\u4f1a\u793e\u304c\u7d19\u306e\u8a18\u9332\u304b\u3089\u306e\u8131\u5374\u3092\u59cb\u3081\u305f\u3068\u304d\u306b\u5c0e\u5165\u3055\u308c\u305f\u3002.<\/p><p>\u76e3\u67fb\u8a3c\u8de1\u3001\u30e6\u30fc\u30b6\u30fc\u30a2\u30af\u30bb\u30b9\u5236\u5fa1\u3001\u30b7\u30b9\u30c6\u30e0\u691c\u8a3c\u3001\u5b89\u5168\u306a\u96fb\u5b50\u7f72\u540d\u306a\u3069\u306e\u7ba1\u7406\u304c\u5fc5\u8981\u3067\u3042\u308b\u3002\u3053\u308c\u3089\u306e\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u306b\u3088\u308a\u3001\u898f\u5236\u5f53\u5c40\u306f\u3001\u8ab0\u304c\u4f55\u3092\u3044\u3064\u884c\u3063\u305f\u304b\u3001\u30c7\u30fc\u30bf\u304c\u5909\u66f4\u3055\u308c\u305f\u304b\u3069\u3046\u304b\u3092\u691c\u8a3c\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3002.<\/p><h2><strong><b>21 CFR Part 11 \u533b\u85ac\u54c1\u306b\u95a2\u3059\u308b\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3<\/b><\/strong><\/h2><p>\u305d\u306e <a href=\"https:\/\/www.fda.gov\/media\/75414\/download\" target=\"_blank\" rel=\"noopener\"><u>21 CFR Part 11\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3<\/u><\/a>\u00a0\u306f\u3001\u88fd\u85ac\u4f1a\u793e\u304c\u96fb\u5b50\u30b7\u30b9\u30c6\u30e0\u3092\u4f7f\u7528\u3059\u308b\u969b\u306bFDA\u304c\u671f\u5f85\u3059\u308b\u3053\u3068\u3092\u8aac\u660e\u3057\u3066\u3044\u308b\u3002\u3053\u308c\u3089\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u304c\u6e80\u305f\u3055\u308c\u3066\u3044\u306a\u3044\u5834\u5408\u3001\u96fb\u5b50\u8a18\u9332\u306f\u691c\u67fb\u4e2d\u306b\u7570\u8b70\u3092\u5531\u3048\u3089\u308c\u305f\u308a\u3001\u62d2\u5426\u3055\u308c\u305f\u308a\u3059\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u3002.<\/p><p>\u4ee5\u4e0b\u306f\u3001\u5404\u4e3b\u8981\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306e\u5b9f\u8df5\u7684\u306a\u8aac\u660e\u3067\u3042\u308b\u3002.<\/p><h3><strong><b>1.1 \u96fb\u5b50\u8a18\u9332\u306e\u8981\u4ef6<\/b><\/strong><\/h3><figure id=\"attachment_11836\" aria-describedby=\"caption-attachment-11836\" style=\"width: 627px\" class=\"wp-caption aligncenter\"><img decoding=\"async\" class=\"size-full wp-image-11836\" src=\"https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/01\/Electronic-records-requirements.png\" alt=\"\u96fb\u5b50\u8a18\u9332\u306e\u8981\u4ef6\" width=\"627\" height=\"156\" srcset=\"https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/01\/Electronic-records-requirements.png 627w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/01\/Electronic-records-requirements-300x75.png 300w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/01\/Electronic-records-requirements-18x4.png 18w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/01\/Electronic-records-requirements-600x149.png 600w\" sizes=\"(max-width: 627px) 100vw, 627px\" \/><figcaption id=\"caption-attachment-11836\" class=\"wp-caption-text\"><em><strong>\u96fb\u5b50\u8a18\u9332\u306e\u8981\u4ef6.<\/strong><\/em><\/figcaption><\/figure><p>\u96fb\u5b50\u8a18\u9332\u306f\u3001\u7d19\u306e\u8a18\u9332\u3068\u540c\u69d8\u306b\u4fe1\u983c\u3067\u304d\u308b\u5834\u5408\u306b\u9650\u308a\u3001Part 11\u306e\u3082\u3068\u3067\u53d7\u3051\u5165\u308c\u3089\u308c\u308b\u3002\u3064\u307e\u308a\u3001\u8a18\u9332\u306f\u6b63\u78ba\u3067\u3001\u5b8c\u5168\u3067\u3001\u4e0d\u9069\u5207\u306a\u5909\u66f4\u304b\u3089\u4fdd\u8b77\u3055\u308c\u3066\u3044\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002.<\/p><p>\u6b63\u78ba\u3055\u3068\u306f\u3001\u30c7\u30fc\u30bf\u304c\u88fd\u9020\u3001\u30c6\u30b9\u30c8\u3001\u307e\u305f\u306f\u30ec\u30d3\u30e5\u30fc\u4e2d\u306b\u5b9f\u969b\u306b\u8d77\u3053\u3063\u305f\u3053\u3068\u3092\u53cd\u6620\u3057\u3066\u3044\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3053\u3068\u3092\u610f\u5473\u3059\u308b\u3002\u5024\u304c\u5909\u66f4\u3055\u308c\u305f\u5834\u5408\u3001\u30b7\u30b9\u30c6\u30e0\u306f\u8ab0\u304c\u3001\u3044\u3064\u3001\u306a\u305c\u5909\u66f4\u3057\u305f\u304b\u3092\u8a18\u9332\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002.<\/p><p>\u307e\u305f\u3001\u8a18\u9332\u306f\u4fdd\u5b58\u671f\u9593\u4e2d\u3001\u8aad\u307f\u53d6\u308c\u308b\u72b6\u614b\u3067\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002\u3053\u308c\u306b\u306f\u3001\u660e\u78ba\u306a\u30d5\u30a9\u30fc\u30de\u30c3\u30c8\u3001\u9069\u5207\u306a\u30bf\u30a4\u30e0\u30b9\u30bf\u30f3\u30d7\u3001\u6570\u5e74\u5f8c\u306b\u8a18\u9332\u3092\u898b\u76f4\u3059\u6a5f\u80fd\u306a\u3069\u304c\u542b\u307e\u308c\u308b\u3002\u30b7\u30b9\u30c6\u30e0\u304c\u53e4\u3044\u8a18\u9332\u3092\u8868\u793a\u3067\u304d\u306a\u3044\u5834\u5408\u3001\u3053\u306e\u8981\u4ef6\u306f\u4e0d\u5408\u683c\u3068\u306a\u308b\u3002.<\/p><h3><strong><b>1.2 \u96fb\u5b50\u7f72\u540d\u306e\u8981\u4ef6<\/b><\/strong><\/h3><figure id=\"attachment_11837\" aria-describedby=\"caption-attachment-11837\" style=\"width: 627px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-11837\" src=\"https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/01\/Electronic-signatures-requirements.png\" alt=\"\u96fb\u5b50\u7f72\u540d\u306e\u8981\u4ef6\" width=\"627\" height=\"131\" srcset=\"https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/01\/Electronic-signatures-requirements.png 627w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/01\/Electronic-signatures-requirements-300x63.png 300w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/01\/Electronic-signatures-requirements-18x4.png 18w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/01\/Electronic-signatures-requirements-600x125.png 600w\" sizes=\"(max-width: 627px) 100vw, 627px\" \/><figcaption id=\"caption-attachment-11837\" class=\"wp-caption-text\"><em><strong>\u96fb\u5b50\u7f72\u540d\u306e\u8981\u4ef6.<\/strong><\/em><\/figcaption><\/figure><p>\u96fb\u5b50\u7f72\u540d\u306f\u624b\u66f8\u304d\u306e\u7f72\u540d\u306b\u53d6\u3063\u3066\u4ee3\u308f\u308b\u3053\u3068\u304c\u8a8d\u3081\u3089\u308c\u3066\u3044\u308b\u304c\u3001\u305d\u308c\u306f\u5b89\u5168\u3067\u4e00\u500b\u4eba\u306b\u4e00\u610f\u306b\u30ea\u30f3\u30af\u3055\u308c\u3066\u3044\u308b\u5834\u5408\u306b\u9650\u3089\u308c\u308b\u3002.<\/p><p>\u6709\u52b9\u306a\u96fb\u5b50\u7f72\u540d\u306b\u306f\u3001\u30e6\u30fc\u30b6\u30fcID\u3068\u30d1\u30b9\u30ef\u30fc\u30c9\u3001\u307e\u305f\u306f\u305d\u306e\u4ed6\u306e\u5b89\u5168\u306a\u8a8d\u8a3c\u65b9\u6cd5\u306a\u3069\u3001\u5c11\u306a\u304f\u3068\u30822\u3064\u306e\u69cb\u6210\u8981\u7d20\u304c\u542b\u307e\u308c\u3066\u3044\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002\u3053\u306e\u7f72\u540d\u306f\u3001\u8ab0\u304c\u3001\u3069\u306e\u8a18\u9332\u306b\u3001\u3044\u3064\u7f72\u540d\u3057\u305f\u304b\u3092\u660e\u78ba\u306b\u793a\u3059\u3082\u306e\u3067\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002.<\/p><p>\u6cd5\u7684\u306b\u306f\u3001\u96fb\u5b50\u7f72\u540d\u306b\u306f\u62d8\u675f\u529b\u304c\u3042\u308b\u3002\u3064\u307e\u308a\u3001\u4f01\u696d\u306f\u96fb\u5b50\u7f72\u540d\u306e\u767a\u884c\u65b9\u6cd5\u3001\u4f7f\u7528\u65b9\u6cd5\u3001\u5931\u52b9\u65b9\u6cd5\u3092\u7ba1\u7406\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002\u5171\u6709\u30a2\u30ab\u30a6\u30f3\u30c8\u3084\u4e00\u822c\u7684\u306a\u30ed\u30b0\u30a4\u30f3\u306f\u96fb\u5b50\u7f72\u540d\u3092\u7121\u52b9\u306b\u3057\u3001\u91cd\u5927\u306a\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u4e0a\u306e\u554f\u984c\u3068\u307f\u306a\u3055\u308c\u308b\u3002.<\/p><h3><strong><b>1.3 \u76e3\u67fb\u8a3c\u8de1\u306e\u8981\u4ef6<\/b><\/strong><\/h3><figure id=\"attachment_11838\" aria-describedby=\"caption-attachment-11838\" style=\"width: 627px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-11838\" src=\"https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/01\/Audit-trail-requirements.png\" alt=\"\u76e3\u67fb\u8a3c\u8de1\u306e\u8981\u4ef6\" width=\"627\" height=\"278\" srcset=\"https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/01\/Audit-trail-requirements.png 627w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/01\/Audit-trail-requirements-300x133.png 300w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/01\/Audit-trail-requirements-18x8.png 18w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/01\/Audit-trail-requirements-600x266.png 600w\" sizes=\"(max-width: 627px) 100vw, 627px\" \/><figcaption id=\"caption-attachment-11838\" class=\"wp-caption-text\"><em><strong>\u76e3\u67fb\u8a3c\u8de1\u306e\u8981\u4ef6.<\/strong><\/em><\/figcaption><\/figure><p><a href=\"https:\/\/www.pharmaguideline.com\/2014\/06\/audit-trial-requirements-in-pharmaceuticals.html\" target=\"_blank\" rel=\"noopener\"><u>\u76e3\u67fb\u8a3c\u8de1<\/u><\/a>\u00a0\u306f 21 CFR Part 11 \u306e\u6700\u3082\u91cd\u8981\u306a\u90e8\u5206\u306e\u4e00\u3064\u3067\u3042\u308b\u3002\u691c\u67fb\u5b98\u306f\u3001\u8a18\u9332\u306e\u5c65\u6b74\u3092\u7406\u89e3\u3059\u308b\u305f\u3081\u306b\u3053\u308c\u3092\u983c\u308a\u306b\u3059\u308b\u3002.<\/p><p>\u76e3\u67fb\u8a3c\u8de1\u306f\u3001\u30e6\u30fc\u30b6\u30fc\u304c\u305d\u308c\u3092\u7121\u52b9\u306b\u3057\u305f\u308a\u7de8\u96c6\u3057\u305f\u308a\u3059\u308b\u3053\u3068\u306a\u304f\u3001\u30c7\u30fc\u30bf\u3078\u306e\u5909\u66f4\u3092\u81ea\u52d5\u7684\u306b\u8a18\u9332\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002\u3053\u308c\u306b\u306f\u3001\u5024\u306e\u5909\u66f4\u3001\u524a\u9664\u3001\u4e0a\u66f8\u304d\u3001\u3055\u3089\u306b\u306f\u30ec\u30b3\u30fc\u30c9\u3092\u5909\u66f4\u3057\u3088\u3046\u3068\u3059\u308b\u8a66\u307f\u306e\u5931\u6557\u3082\u542b\u307e\u308c\u308b\u3002.<\/p><p>\u5404\u30a8\u30f3\u30c8\u30ea\u30fc\u306f\u3001\u8ab0\u304c\u3001\u4f55\u3092\u3001\u3044\u3064\u3001\u306a\u305c\u5909\u66f4\u3057\u305f\u304b\u3092\u8a18\u9332\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002\u76e3\u67fb\u8a3c\u8de1\u306f\u30c7\u30fc\u30bf\u306e\u5b8c\u5168\u6027\u306e\u554f\u984c\u3092\u660e\u3089\u304b\u306b\u3059\u308b\u305f\u3081\u3001\u691c\u67fb\u5b98\u306f\u76e3\u67fb\u8a3c\u8de1\u3092\u975e\u5e38\u306b\u6c17\u306b\u3059\u308b\u3002.<\/p><h3><strong><b>1.4 \u30e6\u30fc\u30b6\u30fc\u30a2\u30af\u30bb\u30b9\u3068\u30bb\u30ad\u30e5\u30ea\u30c6\u30a3\u30fb\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb<\/b><\/strong><\/h3><figure id=\"attachment_11839\" aria-describedby=\"caption-attachment-11839\" style=\"width: 627px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-11839\" src=\"https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/01\/Security-controls-requirements.png\" alt=\"\u30bb\u30ad\u30e5\u30ea\u30c6\u30a3\u7ba1\u7406\u8981\u4ef6\" width=\"627\" height=\"284\" srcset=\"https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/01\/Security-controls-requirements.png 627w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/01\/Security-controls-requirements-300x136.png 300w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/01\/Security-controls-requirements-18x8.png 18w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/01\/Security-controls-requirements-600x272.png 600w\" sizes=\"(max-width: 627px) 100vw, 627px\" \/><figcaption id=\"caption-attachment-11839\" class=\"wp-caption-text\"><em><strong>\u30bb\u30ad\u30e5\u30ea\u30c6\u30a3\u7ba1\u7406\u8981\u4ef6\u3002.<\/strong><\/em><\/figcaption><\/figure><p>\u30d1\u30fc\u30c811\u3067\u306f\u3001\u8ab0\u304c\u96fb\u5b50\u30b7\u30b9\u30c6\u30e0\u306b\u30a2\u30af\u30bb\u30b9\u3057\u3001\u3069\u306e\u3088\u3046\u306a\u64cd\u4f5c\u3092\u884c\u3048\u308b\u304b\u3092\u53b3\u3057\u304f\u7ba1\u7406\u3059\u308b\u3053\u3068\u304c\u7fa9\u52d9\u4ed8\u3051\u3089\u308c\u3066\u3044\u308b\u3002.<\/p><p>\u5404\u30e6\u30fc\u30b6\u30fc\u306f\u56fa\u6709\u306e\u30e6\u30fc\u30b6\u30fcID\u3092\u6301\u305f\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002\u30d1\u30b9\u30ef\u30fc\u30c9\u306f\u4fdd\u8b77\u3055\u308c\u3001\u5b9a\u671f\u7684\u306b\u7ba1\u7406\u3055\u308c\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002\u5f79\u5272\u30d9\u30fc\u30b9\u306e\u30a2\u30af\u30bb\u30b9\u304c\u60f3\u5b9a\u3055\u308c\u308b\u305f\u3081\u3001\u30e6\u30fc\u30b6\u30fc\u306f\u81ea\u5206\u306e\u8077\u52d9\u306b\u95a2\u9023\u3059\u308b\u30bf\u30b9\u30af\u3057\u304b\u5b9f\u884c\u3067\u304d\u306a\u3044\u3002\u4f8b\u3048\u3070\u3001\u30aa\u30da\u30ec\u30fc\u30bf\u30fc\u306f\u8a18\u9332\u3092\u627f\u8a8d\u3059\u3079\u304d\u3067\u306f\u306a\u3044\u3057\u3001\u30ec\u30d3\u30e5\u30a2\u30fc\u306f\u751f\u30c7\u30fc\u30bf\u3092\u4fee\u6b63\u3059\u3079\u304d\u3067\u306f\u306a\u3044\u3002.<\/p><p>\u5171\u6709\u30ed\u30b0\u30a4\u30f3\u306f\u3053\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u76f4\u63a5\u9055\u53cd\u3059\u308b\u3002\u8907\u6570\u306e\u4eba\u304c\u540c\u3058\u30a2\u30ab\u30a6\u30f3\u30c8\u3092\u4f7f\u7528\u3059\u308b\u3068\u3001\u8cac\u4efb\u3092\u8a3c\u660e\u3059\u308b\u3053\u3068\u304c\u4e0d\u53ef\u80fd\u306b\u306a\u308a\u307e\u3059\u3002.<\/p><h3><strong><b>1.5 \u30b7\u30b9\u30c6\u30e0\u30fb\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u3078\u306e\u671f\u5f85<\/b><\/strong><\/h3><p>\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306f\u3001\u30b7\u30b9\u30c6\u30e0\u304c\u7279\u5b9a\u306e\u7528\u9014\u3067\u610f\u56f3\u3057\u305f\u3068\u304a\u308a\u306b\u6a5f\u80fd\u3059\u308b\u3053\u3068\u3092\u8a3c\u660e\u3059\u308b\u305f\u3081\u306b\u5fc5\u8981\u3067\u3042\u308b\u3002\u30d9\u30f3\u30c0\u30fc\u304c\u3001\u30b7\u30b9\u30c6\u30e0\u304c\u6b21\u306e\u3088\u3046\u306a\u3082\u306e\u3067\u3042\u308b\u3068\u4e3b\u5f35\u3059\u308b\u3060\u3051\u3067\u306f\u4e0d\u5341\u5206\u3067\u3042\u308b\u3002 <strong>\u201c\u30d1\u30fc\u30c811\u5bfe\u5fdc\u201d<\/strong><\/p><p>\u4f01\u696d\u306f\u3001\u4f7f\u7528\u76ee\u7684\u306b\u57fa\u3065\u3044\u3066\u30b7\u30b9\u30c6\u30e0\u3092\u691c\u8a3c\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002\u3053\u308c\u306b\u306f\u3001\u8981\u4ef6\u306e\u6587\u66f8\u5316\u3001\u4e3b\u8981\u6a5f\u80fd\u306e\u30c6\u30b9\u30c8\u3001\u30bb\u30ad\u30e5\u30ea\u30c6\u30a3\u7ba1\u7406\u306e\u691c\u8a3c\u3001\u76e3\u67fb\u8a3c\u8de1\u306e\u52d5\u4f5c\u78ba\u8a8d\u306a\u3069\u304c\u542b\u307e\u308c\u308b\u3002.<\/p><p>\u3053\u306e\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306f\u3001\u30b7\u30b9\u30c6\u30e0\u304a\u3088\u3073\u95a2\u9023\u3059\u308b\u3059\u3079\u3066\u306e\u3082\u306e\u304c\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u3082\u306e\u3067\u3042\u308b\u3053\u3068\u3092\u793a\u3055\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002 <a href=\"https:\/\/pharmamachinecn.com\/ja\/gxp-in-pharmaceutical-industry-a-complete-compliance-guide\/\"><u>GxP\u30d7\u30ed\u30bb\u30b9<\/u><\/a>\u00a0\u306f\u5e38\u306b\u6b63\u3057\u304f\u5b9f\u884c\u3055\u308c\u308b\u3002\u691c\u67fb\u5b98\u306f\u3057\u3070\u3057\u3070\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u6587\u66f8\u3092\u78ba\u8a8d\u3057\u3001\u30b7\u30b9\u30c6\u30e0\u304c\u7ba1\u7406\u4e0b\u306b\u3042\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u3002.<\/p><h3><strong><b>1.6 \u8a18\u9332\u306e\u4fdd\u6301\u3068\u691c\u7d22<\/b><\/strong><\/h3><p>\u96fb\u5b50\u8a18\u9332\u306f\u3001GMP\u898f\u5247\u306b\u57fa\u3065\u304d\u3001\u7d19\u306e\u8a18\u9332\u3068\u540c\u3058\u671f\u9593\u4fdd\u6301\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002\u3053\u306e\u671f\u9593\u4e2d\u3001\u8a18\u9332\u306f\u5b89\u5168\u3067\u3001\u8aad\u307f\u53d6\u308a\u53ef\u80fd\u3067\u3001\u30a2\u30af\u30bb\u30b9\u53ef\u80fd\u3067\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002.<\/p><p>\u691c\u7d22\u306f\u4fdd\u7ba1\u3068\u540c\u69d8\u306b\u91cd\u8981\u3067\u3042\u308b\u3002\u67fb\u5bdf\u5b98\u306f\u3001\u76e3\u67fb\u4e2d\u306b\u8a18\u9332\u304c\u8fc5\u901f\u304b\u3064\u5b8c\u5168\u306b\u4f5c\u6210\u3055\u308c\u308b\u3053\u3068\u3092\u671f\u5f85\u3057\u3066\u3044\u308b\u3002\u9045\u308c\u304c\u3042\u3063\u305f\u308a\u3001\u30c7\u30fc\u30bf\u304c\u306a\u304b\u3063\u305f\u308a\u3001\u30d5\u30a1\u30a4\u30eb\u304c\u8aad\u3081\u306a\u304b\u3063\u305f\u308a\u3059\u308b\u3068\u3001\u3059\u3050\u306b\u8d64\u4fe1\u53f7\u304c\u706f\u308a\u307e\u3059\u3002.<\/p><h2><strong><b>21 CFR Part 11\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u5f93\u308f\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u30b7\u30b9\u30c6\u30e0\u3068\u306f\uff1f<\/b><\/strong><\/h2><p>21 CFR Part 11\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306f\u3001\u4ee5\u4e0b\u3092\u6e80\u305f\u3059\u305f\u3081\u306b\u4f7f\u7528\u3055\u308c\u308b\u96fb\u5b50\u8a18\u9332\u3092\u4f5c\u6210\u3001\u5909\u66f4\u3001\u7dad\u6301\u3001\u307e\u305f\u306f\u4fdd\u5b58\u3059\u308b\u3059\u3079\u3066\u306e\u30b7\u30b9\u30c6\u30e0\u306b\u9069\u7528\u3055\u308c\u308b\u3002 <a href=\"https:\/\/pharmamachinecn.com\/ja\/gmp-for-pharmaceutical-manufacturing\/\"><u>GMP\u8981\u4ef6<\/u><\/a>. .\u30b7\u30b9\u30c6\u30e0\u306e\u7a2e\u985e\u306f\u3001\u305d\u308c\u304c\u3069\u306e\u3088\u3046\u306b\u4f7f\u308f\u308c\u308b\u304b\u3088\u308a\u3082\u91cd\u8981\u3067\u306f\u306a\u3044\u3002.<\/p><p>\u30b7\u30b9\u30c6\u30e0\u304c\u88fd\u54c1\u306e\u54c1\u8cea\u3001\u5b89\u5168\u6027\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306b\u95a2\u9023\u3059\u308b\u610f\u601d\u6c7a\u5b9a\u3092\u30b5\u30dd\u30fc\u30c8\u3059\u308b\u5834\u5408\u3001\u30d1\u30fc\u30c811\u304c\u9069\u7528\u3055\u308c\u308b\u3002\u4e00\u822c\u7684\u306a\u30b7\u30b9\u30c6\u30e0\u306b\u306f\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u3082\u306e\u304c\u3042\u308a\u307e\u3059\uff1a<\/p><ul><li><b><\/b><strong><b>\u88fd\u9020\u5b9f\u884c\u30b7\u30b9\u30c6\u30e0<\/b><\/strong>:MES\u30b7\u30b9\u30c6\u30e0\u306f\u30d0\u30c3\u30c1\u5b9f\u884c\u3001\u30d7\u30ed\u30bb\u30b9\u30d1\u30e9\u30e1\u30fc\u30bf\u3001\u751f\u7523\u8a18\u9332\u3092\u7ba1\u7406\u3059\u308b\u3002\u3053\u306e\u8a18\u9332\u306f\u7d19\u306e\u30d0\u30c3\u30c1\u8a18\u9332\u306b\u53d6\u3063\u3066\u4ee3\u308f\u308b\u3082\u306e\u3067\u3042\u308b\u305f\u3081\u3001\u30d1\u30fc\u30c811\u306e\u7ba1\u7406\u306f\u5fc5\u9808\u3067\u3042\u308b\u3002.<\/li><li><b><\/b><strong><b>\u7814\u7a76\u5ba4\u60c5\u5831\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0<\/b><\/strong>:LIMS \u30b7\u30b9\u30c6\u30e0\u306f\u3001\u8a66\u9a13\u7d50\u679c\u3001\u8a08\u7b97\u3001\u304a\u3088\u3073\u627f\u8a8d\u3092\u4fdd\u5b58\u3059\u308b\u3002\u30ea\u30ea\u30fc\u30b9\u307e\u305f\u306f\u5b89\u5b9a\u6027\u306e\u305f\u3081\u306b\u4f7f\u7528\u3055\u308c\u308b\u96fb\u5b50\u30e9\u30dc\u30c7\u30fc\u30bf\u306f\u3001Part 11 \u306e\u8981\u4ef6\u3092\u6e80\u305f\u3059\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002.<\/li><li><b><\/b><strong><b>\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0<\/b><\/strong>:QMS\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u306f\u3001\u9038\u8131\u3001CAPA\u3001\u5909\u66f4\u7ba1\u7406\u3001\u627f\u8a8d\u3092\u53d6\u308a\u6271\u3046\u3002\u3053\u308c\u3089\u306e\u8a18\u9332\u306f\u898f\u5236\u4e0a\u306e\u8a3c\u62e0\u3068\u306a\u308b\u305f\u3081\u3001Part 11\u304c\u9069\u7528\u3055\u308c\u308b\u3002.<\/li><li><b><\/b><strong><b>\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u3068\u7d44\u8fbc\u307f\u30b7\u30b9\u30c6\u30e0<\/b><\/strong>:\u591a\u304f\u306e\u88fd\u9020\u6a5f\u5668\u3084\u691c\u67fb\u6a5f\u5668\u306f\u96fb\u5b50\u30c7\u30fc\u30bf\u3092\u751f\u6210\u3059\u308b\u3002\u305d\u306e\u30c7\u30fc\u30bf\u3092GMP\u306e\u6c7a\u5b9a\u306b\u4f7f\u7528\u3059\u308b\u5834\u5408\u3001\u30b7\u30b9\u30c6\u30e0\u306b\u306f\u30a2\u30af\u30bb\u30b9\u5236\u5fa1\u3001\u76e3\u67fb\u8a3c\u8de1\u3001\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u304c\u5fc5\u8981\u3067\u3042\u308b\u3002.<\/li><li><b><\/b><strong><b>\u30b9\u30d7\u30ec\u30c3\u30c9\u30b7\u30fc\u30c8\u3068\u30ab\u30b9\u30bf\u30e0\u30c4\u30fc\u30eb<\/b><\/strong>:\u30b9\u30d7\u30ec\u30c3\u30c9\u30b7\u30fc\u30c8\u306f\u898b\u843d\u3068\u3055\u308c\u304c\u3061\u3067\u3042\u308b\u3002\u7d50\u679c\u306e\u8a08\u7b97\u3001\u30c7\u30fc\u30bf\u306e\u8ffd\u8de1\u3001\u610f\u601d\u6c7a\u5b9a\u306e\u30b5\u30dd\u30fc\u30c8\u306b\u4f7f\u7528\u3055\u308c\u3066\u3044\u308b\u5834\u5408\u306f\u3001Part 11\u306e\u5bfe\u8c61\u3068\u306a\u308a\u307e\u3059\u3002.<\/li><\/ul><h2><strong><b>21 CFR Part 11\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u95a2\u3059\u308b\u3088\u304f\u3042\u308b\u8aa4\u89e3<\/b><\/strong><\/h2><p>21 CFR Part 11\u306b\u95a2\u9023\u3059\u308b\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u554f\u984c\u306e\u591a\u304f\u306f\u3001\u30b7\u30b9\u30c6\u30e0\u3084\u6280\u8853\u306e\u4e0d\u8db3\u304b\u3089\u751f\u3058\u308b\u3082\u306e\u3067\u306f\u306a\u3044\u3002\u305d\u308c\u306f\u3001\u8aa4\u3063\u305f\u601d\u3044\u8fbc\u307f\u306b\u8d77\u56e0\u3059\u308b\u3082\u306e\u3067\u3042\u308b\u3002\u3060\u304b\u3089\u3053\u305d\u3001\u5f8c\u3005\u6df1\u523b\u306a\u7d50\u679c\u3092\u62db\u304b\u306a\u3044\u3088\u3046\u3001\u65e9\u671f\u306b\u8aa4\u89e3\u3092\u89e3\u3044\u3066\u304a\u3044\u305f\u65b9\u304c\u826f\u3044\u306e\u3067\u3042\u308b\u3002.<\/p><h3><strong><b>1.\u5f53\u793e\u306e\u30d9\u30f3\u30c0\u30fc\u306fPart 11\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306b\u5bfe\u5fdc\u3057\u3066\u3044\u307e\u3059\u3002.<\/b><\/strong><\/h3><p>\u3053\u308c\u306f\u6700\u3082\u3088\u304f\u3042\u308b\u9593\u9055\u3044\u306e\u4e00\u3064\u3067\u3042\u308b\u3002\u30d9\u30f3\u30c0\u30fc\u306f\u3001\u76e3\u67fb\u8a3c\u8de1\u3084\u30a2\u30af\u30bb\u30b9\u5236\u5fa1\u306a\u3069\u3001\u30d1\u30fc\u30c811\u306b\u5bfe\u5fdc\u3057\u305f\u6a5f\u80fd\u3092\u5099\u3048\u305f\u30b7\u30b9\u30c6\u30e0\u3092\u63d0\u4f9b\u3059\u308b\u3053\u3068\u306f\u3067\u304d\u308b\u3002\u3057\u304b\u3057\u3001\u30d9\u30f3\u30c0\u30fc\u306f\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u6240\u6709\u3059\u308b\u308f\u3051\u3067\u306f\u306a\u3044\u3002.<\/p><p>\u30b7\u30b9\u30c6\u30e0\u3092\u4f7f\u7528\u3059\u308b\u88fd\u85ac\u4f1a\u793e\u306f\u3001\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u3001\u30e6\u30fc\u30b6\u30fc\u7ba1\u7406\u3001\u624b\u9806\u3001\u7d99\u7d9a\u7684\u7ba1\u7406\u306b\u8cac\u4efb\u3092\u6301\u3064\u3002.<\/p><h3><strong><b>2.\u201c\u30b7\u30b9\u30c6\u30e0\u304c\u691c\u8a3c\u3055\u308c\u308c\u3070\u3001\u6211\u3005\u306f\u6e96\u62e0\u3057\u3066\u3044\u308b\u3002.<\/b><\/strong><\/h3><p><a href=\"https:\/\/pharmamachinecn.com\/ja\/what-is-pharmaceutical-process-validation\/\"><u>\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3<\/u><\/a>\u00a0\u306f\u5fc5\u8981\u3067\u3042\u308b\u304c\u3001\u305d\u308c\u3060\u3051\u3067\u306f\u5341\u5206\u3067\u306f\u306a\u3044\u3002\u30d0\u30ea\u30c7\u30fc\u30c8\u3055\u308c\u305f\u30b7\u30b9\u30c6\u30e0\u3067\u3042\u3063\u3066\u3082\u3001\u30a2\u30af\u30bb\u30b9\u7ba1\u7406\u304c\u4e0d\u5341\u5206\u3067\u3042\u3063\u305f\u308a\u3001\u76e3\u67fb\u8a3c\u8de1\u304c\u30ec\u30d3\u30e5\u30fc\u3055\u308c\u3066\u3044\u306a\u304b\u3063\u305f\u308a\u3001\u624b\u9806\u304c\u6b20\u3051\u3066\u3044\u305f\u308a\u3059\u308c\u3070\u3001\u30d1\u30fc\u30c811\u306b\u4e0d\u5408\u683c\u3068\u306a\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u3002.<\/p><p>\u30d1\u30fc\u30c811\u3067\u306f\u30011\u56de\u9650\u308a\u306e\u691c\u8a3c\u6d3b\u52d5\u3067\u306f\u306a\u304f\u3001\u7d99\u7d9a\u7684\u306a\u7ba1\u7406\u3092\u6c42\u3081\u3066\u3044\u308b\u3002\u691c\u67fb\u5b98\u306f\u3001\u30b7\u30b9\u30c6\u30e0\u304c\u6bce\u65e5\u3069\u306e\u3088\u3046\u306b\u4f7f\u7528\u3055\u308c\u3066\u3044\u308b\u304b\u3092\u898b\u3066\u3044\u308b\u3002.<\/p><h3><strong><b>3.\u201c\u30d1\u30fc\u30c811\u306f\u5927\u898f\u6a21\u306a\u30b7\u30b9\u30c6\u30e0\u306b\u306e\u307f\u9069\u7528\u3055\u308c\u308b\u201d<\/b><\/strong><\/h3><p>Part11\u306f\u3001\u898f\u6a21\u306b\u95a2\u4fc2\u306a\u304f\u3001GMP\u3084\u898f\u5236\u306e\u6c7a\u5b9a\u306b\u4f7f\u7528\u3055\u308c\u308b\u3042\u3089\u3086\u308b\u30b7\u30b9\u30c6\u30e0\u306b\u9069\u7528\u3055\u308c\u308b\u3002\u5c0f\u898f\u6a21\u306a\u30c4\u30fc\u30eb\u3001\u30b9\u30d7\u30ec\u30c3\u30c9\u30b7\u30fc\u30c8\u3001\u307e\u305f\u306f\u7d44\u307f\u8fbc\u307f\u6a5f\u5668\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306f\u3001\u898b\u843d\u3068\u3055\u308c\u304c\u3061\u3067\u3042\u308b\u3002.<\/p><p>\u30b7\u30b9\u30c6\u30e0\u304c\u3001\u88fd\u54c1\u306e\u54c1\u8cea\u307e\u305f\u306f\u30ea\u30ea\u30fc\u30b9\u3092\u30b5\u30dd\u30fc\u30c8\u3059\u308b\u305f\u3081\u306b\u4f7f\u7528\u3055\u308c\u308b\u96fb\u5b50\u8a18\u9332\u3092\u4f5c\u6210\u307e\u305f\u306f\u4fee\u6b63\u3059\u308b\u5834\u5408\u3001Part 11\u306e\u8981\u6c42\u4e8b\u9805\u304c\u9069\u7528\u3055\u308c\u308b\u3002.<\/p><h3><strong><b>4.\u201c\u5171\u6709\u30e6\u30fc\u30b6\u30fc\u30a2\u30ab\u30a6\u30f3\u30c8\u306f\u8a31\u5bb9\u3055\u308c\u308b\u201d<\/b><\/strong><\/h3><p>\u5171\u6709\u30ed\u30b0\u30a4\u30f3\u306f\u91cd\u5927\u306a\u9055\u53cd\u3067\u3042\u308b\u3002\u30d1\u30fc\u30c811\u3067\u306f\u3001\u8aac\u660e\u8cac\u4efb\u3068\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u3092\u78ba\u4fdd\u3059\u308b\u305f\u3081\u306b\u3001\u4e00\u610f\u306e\u30e6\u30fc\u30b6\u30fc\u8b58\u5225\u304c\u8981\u6c42\u3055\u308c\u3066\u3044\u308b\u3002.<\/p><p>\u8907\u6570\u306e\u4eba\u9593\u304c\u30af\u30ec\u30c7\u30f3\u30b7\u30e3\u30eb\u3092\u5171\u6709\u3059\u308b\u3068\u3001\u8ab0\u304c\u884c\u52d5\u3057\u305f\u304b\u3092\u8a3c\u660e\u3059\u308b\u3053\u3068\u304c\u4e0d\u53ef\u80fd\u306b\u306a\u308b\u3002\u30c7\u30fc\u30bf\u306e\u5b8c\u5168\u6027\u304c\u640d\u306a\u308f\u308c\u308b\u305f\u3081\u3001\u691c\u67fb\u5b98\u306f\u65e5\u5e38\u7684\u306b\u3053\u306e\u554f\u984c\u3092\u6319\u3052\u3066\u3044\u308b\u3002.<\/p><h2><strong><b>\u3088\u304f\u3042\u308b\u8cea\u554f<\/b><\/strong><\/h2><h3><strong><b>1.FDA\u306b\u3088\u308b\u300c\u96fb\u5b50\u8a18\u9332\u300d\u306e\u5b9a\u7fa9\u306f\uff1f<\/b><\/strong><\/h3><p>\u96fb\u5b50\u8a18\u9332\u3068\u306f\u3001\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u30b7\u30b9\u30c6\u30e0\u3067\u51e6\u7406\u3055\u308c\u308b\u30c7\u30b8\u30bf\u30eb\u5f62\u5f0f\u3067\u8868\u73fe\u3055\u308c\u305f\u30c6\u30ad\u30b9\u30c8\u3001\u30b0\u30e9\u30d5\u30a3\u30c3\u30af\u3001\u30c7\u30fc\u30bf\u3001\u97f3\u58f0\u3001\u753b\u50cf\u60c5\u5831\u306e\u3042\u3089\u3086\u308b\u7d44\u307f\u5408\u308f\u305b\u306e\u3053\u3068\u3067\u3042\u308b\u3002\u88fd\u85ac\u4f1a\u793e\u306b\u3068\u3063\u3066\u306f\u3001\u691c\u67fb\u7d50\u679c\u3084\u30d0\u30c3\u30c1\u8a18\u9332\u304b\u3089\u54c1\u8cea\u76e3\u67fb\u3084\u81e8\u5e8a\u8a66\u9a13\u30c7\u30fc\u30bf\u307e\u3067\u3001\u3042\u3089\u3086\u308b\u3082\u306e\u304c\u542b\u307e\u308c\u308b\u3002.<\/p><h3><strong><b>2.\u30b5\u30a4\u30f3\u30fb\u30de\u30cb\u30d5\u30a7\u30b9\u30c8\u306b\u306f\u3069\u306e\u3088\u3046\u306a\u60c5\u5831\u3092\u8a18\u8f09\u3057\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u304b\uff1f<\/b><\/strong><\/h3><p>\u96fb\u5b50\u7f72\u540d\u304c\u9069\u7528\u3055\u308c\u308b\u5834\u5408\u306f\u5e38\u306b\u3001\u30b7\u30b9\u30c6\u30e0\u306f\u7f72\u540d\u8005\u306e\u5370\u5237\u540d\u3001\u5b9f\u884c\u65e5\u6642\u3001\u304a\u3088\u3073\u8457 \u4f5c\u8005\u3084\u627f\u8a8d\u306a\u3069\u306e\u7f72\u540d\u306e\u610f\u5473\u3092\u660e\u78ba\u306b\u8868\u793a\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002\u3053\u306e\u30e1\u30bf\u30c7\u30fc\u30bf\u306f\u3001\u6539\u3056\u3093\u3084\u524a\u9664\u304c\u3067\u304d\u306a\u3044\u3088\u3046\u3001\u96fb\u5b50\u8a18\u9332\u306b\u6052\u4e45\u7684\u306b\u30ea\u30f3\u30af\u3055\u308c\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002.<\/p><h3><strong><b>3.\u88fd\u85ac\u4f1a\u793e\u306f\u5171\u6709\u30ed\u30b0\u30a4\u30f3\u3092\u3069\u306e\u3088\u3046\u306b\u6271\u3046\u3079\u304d\u304b\uff1f<\/b><\/strong><\/h3><p>\u5171\u6709\u307e\u305f\u306f\u6c4e\u7528\u30ed\u30b0\u30a4\u30f3\u30fb\u30af\u30ec\u30c7\u30f3\u30b7\u30e3\u30eb\u306e\u4f7f\u7528\u306f\u3001\u500b\u4eba\u306e\u8aac\u660e\u8cac\u4efb\u3092\u6392\u9664\u3059\u308b\u305f\u3081\u300121 CFR Part 11 \u3067\u306f\u53b3\u3057\u304f\u7981\u3058\u3089\u308c\u3066\u3044\u308b\u3002\u30b7\u30b9\u30c6\u30e0\u5185\u306e\u3059\u3079\u3066\u306e\u30a2\u30af\u30b7\u30e7\u30f3\u304c\u7279\u5b9a\u306e\u4eba\u7269\u306b\u8ffd\u8de1\u53ef\u80fd\u3067\u3042\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3059\u308b\u305f\u3081\u306b\u3001\u5404\u30e6\u30fc\u30b6\u306f\u56fa\u6709\u306e\u8b58\u5225\u30b3\u30fc\u30c9\u3068\u30d1\u30b9\u30ef\u30fc\u30c9\u306e\u7d44\u307f\u5408\u308f\u305b\u3092\u6240\u6709\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002.<\/p><h2><strong><b>\u88fd\u9020\u73fe\u5834\u3067\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u6a5f\u80fd\u3055\u305b\u308b<\/b><\/strong><\/h2><p>\u533b\u85ac\u54c1\u306e21 CFR Part11\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306f\u3001\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u3060\u3051\u3067\u306f\u5b88\u308c\u306a\u3044\u3002\u6a5f\u5668\u304c\u3069\u306e\u3088\u3046\u306b\u8a2d\u7f6e\u3055\u308c\u3001\u30b7\u30b9\u30c6\u30e0\u304c\u3069\u306e\u3088\u3046\u306b\u4f7f\u7528\u3055\u308c\u3001\u4eba\u3005\u304c\u65e5\u3005\u3069\u306e\u3088\u3046\u306b\u8a13\u7df4\u3055\u308c\u308b\u304b\u306b\u304b\u304b\u3063\u3066\u3044\u308b\u3002.<\/p><p>\u30d5\u30a1\u30a4\u30f3\u30c6\u30c3\u30af\u3067\u306f\u3001\u6a5f\u68b0\u306e\u67a0\u3092\u8d85\u3048\u3066\u30e1\u30fc\u30ab\u30fc\u3092\u30b5\u30dd\u30fc\u30c8\u3057\u307e\u3059\u3002\u79c1\u305f\u3061\u306f <a href=\"https:\/\/pharmamachinecn.com\/ja\/machine-installation-and-commissioning-at-site\/\"><u>\u6a5f\u6750\u3092\u30bb\u30c3\u30c8\u30a2\u30c3\u30d7\u3059\u308b<\/u><\/a>\u00a0\u3092\u6b63\u3057\u304f\u7406\u89e3\u3057\u3066\u3044\u308b\u3001, <a href=\"https:\/\/pharmamachinecn.com\/ja\/machine-operation-training\/\"><u>\u9244\u9053\u4e8b\u696d\u8005<\/u><\/a>, \u307e\u305f\u3001\u52b9\u7387\u7684\u306a\u751f\u7523\u30e9\u30a4\u30f3\u3092\u8a2d\u8a08\u3057\u3001\u5b89\u5b9a\u3057\u305f\u64cd\u696d\u3068\u691c\u67fb\u4f53\u5236\u3092\u7dad\u6301\u3059\u308b\u305f\u3081\u306e\u7d99\u7d9a\u7684\u306a\u6280\u8853\u30b5\u30dd\u30fc\u30c8\u3092\u63d0\u4f9b\u3059\u308b\u3002.<\/p><p>\u65b0\u898f\u30e9\u30a4\u30f3\u306e\u8a08\u753b\u3001\u65e2\u5b58\u8a2d\u5099\u306e\u30a2\u30c3\u30d7\u30b0\u30ec\u30fc\u30c9\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u4e0a\u306e\u8ab2\u984c\u306b\u76f4\u9762\u3057\u3066\u3044\u308b\u5834\u5408\u300130\u5e74\u4ee5\u4e0a\u306e\u7d4c\u9a13\u3092\u6301\u3064\u5f53\u793e\u306e\u30c1\u30fc\u30e0\u304c\u304a\u624b\u4f1d\u3044\u3057\u307e\u3059\u3002.<\/p><p><a href=\"https:\/\/pharmamachinecn.com\/ja\/contact-us\/\"><em><u><i>\u4eca\u3059\u3050\u30d5\u30a1\u30a4\u30f3\u30c6\u30c3\u30af\u306b\u304a\u554f\u3044\u5408\u308f\u305b\u304f\u3060\u3055\u3044<\/i><\/u><\/em><\/a><em><i>\u00a0\u3092\u3054\u89a7\u304f\u3060\u3055\u3044\uff01<\/i><\/em><\/p><h2><strong>\u53c2\u8003\u6587\u732e:<\/strong><\/h2><p><a href=\"https:\/\/www.anritsu.com\/en-au\/product-inspection\/knowledge-center\/technical-note-2\/2019-03\" target=\"_blank\" rel=\"noopener\"><em><strong>21 CFR Part 11 \u30c7\u30fc\u30bf\u7ba1\u7406\u306f\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u306e\u57fa\u790e\u3067\u3042\u308b<\/strong><\/em><\/a>.<\/p><p><a href=\"https:\/\/www.malvernpanalytical.com\/en\/products\/industry-standards\/21-cfr-part-11\" target=\"_blank\" rel=\"noopener\"><span style=\"text-decoration: underline;\"><em><strong>21 CFR Part 11 \u5b8c\u5168\u306a\u4fe1\u983c\u3002\u7d76\u5bfe\u7684\u306a\u5b8c\u5168\u6027\u3002.<\/strong><\/em><\/span><\/a><\/p><p><a href=\"https:\/\/learn.microsoft.com\/en-us\/compliance\/regulatory\/offering-fda-cfr-title-21-part-11\" target=\"_blank\" rel=\"noopener\"><span style=\"text-decoration: underline;\"><em><strong>\u98df\u54c1\u533b\u85ac\u54c1\u5c40 CFR Title 21 Part 11<\/strong><\/em><\/span><\/a>.<\/p><h2><b>\u8457\u4f5c\u6a29\u306b\u3064\u3044\u3066\u00a0<\/b><\/h2><p>\u30d5\u30a1\u30a4\u30f3\u30c6\u30c3\u30af\u30fb\u30b0\u30eb\u30fc\u30d7\u306e\u66f8\u9762\u306b\u3088\u308b\u4e8b\u524d\u306e\u660e\u793a\u7684\u306a\u627f\u8a8d\u304c\u306a\u3044\u9650\u308a\u3001\u672c\u30a6\u30a7\u30d6\u30b5\u30a4\u30c8\u4e0a\u306e\u30b3\u30f3\u30c6\u30f3\u30c4\u3092\u8907\u88fd\u3001\u5909\u66f4\u3001\u516c\u958b\u3001\u8868\u793a\u3001\u9001\u4fe1\u3001\u305d\u306e\u4ed6\u306e\u65b9\u6cd5\u3067\u5229\u7528\u3057\u305f\u308a\u3001\u305d\u306e\u3088\u3046\u306a\u30b3\u30f3\u30c6\u30f3\u30c4\u3092\u4f7f\u7528\u3057\u3066\u4f55\u3089\u304b\u306e\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u3092\u69cb\u7bc9\u3057\u305f\u308a\u3059\u308b\u3053\u3068\u306f\u3067\u304d\u307e\u305b\u3093\u3002\u30b3\u30f3\u30c6\u30f3\u30c4\u306e\u4f7f\u7528\u8a31\u53ef\u306b\u3064\u3044\u3066\u306f\u3001\u3053\u3061\u3089\u307e\u3067\u304a\u554f\u3044\u5408\u308f\u305b\u304f\u3060\u3055\u3044\uff1a <a href=\"mailto:info@pharmamachinecn.com\"><span style=\"text-decoration: underline;\">info@pharmamachinecn.com<\/span><\/a><\/p><h2><b>\u514d\u8cac\u4e8b\u9805:<\/b><\/h2><p>\u672c\u8a18\u4e8b\u306b\u542b\u307e\u308c\u308b\u60c5\u5831\u306f\u3001\u4e00\u822c\u7684\u306a\u60c5\u5831\u63d0\u4f9b\u306e\u307f\u3092\u76ee\u7684\u3068\u3057\u3066\u3044\u307e\u3059\u3002\u5f53\u793e\u306f\u3001\u3044\u304b\u306a\u308b\u60c5\u5831\u306b\u3064\u3044\u3066\u3082\u3001\u305d\u306e\u6b63\u78ba\u6027\u3001\u59a5\u5f53\u6027\u3001\u9069\u6642\u6027\u3001\u5b8c\u5168\u6027\u3092\u4fdd\u8a3c\u3059\u308b\u3082\u306e\u3067\u306f\u306a\u304f\u3001\u307e\u305f\u3001\u672c\u8a18\u4e8b\u306e\u5185\u5bb9\u306e\u8aa4\u8b2c\u307e\u305f\u306f\u8131\u6f0f\u306b\u3064\u3044\u3066\u4e00\u5207\u306e\u8cac\u4efb\u3092\u8ca0\u3044\u307e\u305b\u3093\u3002.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>21 CFR Part 11 guidelines for pharmaceuticals exist because regulators do not trust data unless it is controlled, traceable, and [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":11898,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[65],"tags":[],"class_list":["post-11833","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-manufacturers"],"acf":[],"_links":{"self":[{"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/posts\/11833","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/comments?post=11833"}],"version-history":[{"count":10,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/posts\/11833\/revisions"}],"predecessor-version":[{"id":12846,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/posts\/11833\/revisions\/12846"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/media\/11898"}],"wp:attachment":[{"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/media?parent=11833"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/categories?post=11833"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/tags?post=11833"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}