{"id":5192,"date":"2026-04-22T15:24:17","date_gmt":"2026-04-22T07:24:17","guid":{"rendered":"https:\/\/www.jianpaitech.com\/?post_type=blog&#038;p=5192"},"modified":"2026-04-22T15:24:17","modified_gmt":"2026-04-22T07:24:17","slug":"choosing-a-tablet-coating-machine-the-ultimate-fda-21-cfr-part-11-compliance-guide","status":"publish","type":"blog","link":"https:\/\/www.jianpaitech.com\/ja\/blog\/choosing-a-tablet-coating-machine-the-ultimate-fda-21-cfr-part-11-compliance-guide\/","title":{"rendered":"\u9320\u5264\u30b3\u30fc\u30c6\u30a3\u30f3\u30b0\u6a5f\u306e\u9078\u629e: \u7a76\u6975\u306e FDA 21 CFR Part 11 \u6e96\u62e0\u30ac\u30a4\u30c9"},"content":{"rendered":"<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u73fe\u4ee3\u306e\u533b\u85ac\u54c1\u88fd\u9020\u3067\u306f\u3001\u00a0<\/span><a href=\"https:\/\/www.jianpaitech.com\/ja\/product_category\/tablet-coating\/\" target=\"_blank\" rel=\"noopener\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u9320\u5264\u30b3\u30fc\u30c6\u30a3\u30f3\u30b0\u6a5f<\/span><\/strong><\/a><span class=\"ng-star-inserted\">\u00a0\u91cd\u8981\u306a\u306e\u306f\u3001\u3082\u306f\u3084\u6a5f\u68b0\u7684\u6027\u80fd\u3001\u30b9\u30c6\u30f3\u30ec\u30b9\u92fc\u306e\u30b0\u30ec\u30fc\u30c9\u3001\u30b9\u30d7\u30ec\u30fc\u30ac\u30f3\u306e\u7cbe\u5ea6\u3060\u3051\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u30e8\u30fc\u30ed\u30c3\u30d1\u304a\u3088\u3073\u5317\u7c73\u5e02\u5834\u3092\u30bf\u30fc\u30b2\u30c3\u30c8\u3068\u3059\u308b\u7d4c\u53e3\u56fa\u5f62\u88fd\u5264 (OSD) \u30e1\u30fc\u30ab\u30fc\u306b\u3068\u3063\u3066\u3001\u6a5f\u68b0\u3092\u5b9f\u884c\u3059\u308b\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306f\u3001\u305d\u308c\u4ee5\u4e0a\u3067\u306f\u306a\u3044\u306b\u3057\u3066\u3082\u3001\u540c\u69d8\u306b\u91cd\u8981\u3067\u3059\u3002<\/span><\/p>\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u30b3\u30fc\u30c6\u30a3\u30f3\u30b0\u30b7\u30b9\u30c6\u30e0\u304c\u7d76\u5bfe\u7684\u306a\u30c7\u30fc\u30bf\u5b8c\u5168\u6027\u3092\u4fdd\u8a3c\u3067\u304d\u306a\u3044\u5834\u5408\u3001FDA \u307e\u305f\u306f EU-GMP \u691c\u67fb\u306b\u5408\u683c\u3057\u307e\u305b\u3093\u3002\u3053\u3053\u304c\u00a0<\/span><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">FDA 21 CFR \u30d1\u30fc\u30c8 11<\/span><\/strong><span class=\"ng-star-inserted\">\u00a0\u304c\u767b\u5834\u3057\u307e\u3059\u3002<\/span><\/p>\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u3053\u306e\u5305\u62ec\u7684\u306a\u30ac\u30a4\u30c9\u3067\u306f\u300121 CFR Part 11 \u3068\u306f\u4f55\u304b\u3001\u305d\u308c\u304c\u30b3\u30fc\u30c6\u30a3\u30f3\u30b0 \u30d7\u30ed\u30bb\u30b9\u306b\u3068\u3063\u3066\u91cd\u8981\u3067\u3042\u308b\u7406\u7531\u3001\u304a\u3088\u3073\u65bd\u8a2d\u304c 100% \u76e3\u67fb\u306b\u5bfe\u5fdc\u3067\u304d\u308b\u3088\u3046\u306b\u3059\u308b\u9320\u5264\u30b3\u30fc\u30c6\u30a3\u30f3\u30b0\u6a5f\u306e\u9078\u3073\u65b9\u306b\u3064\u3044\u3066\u8aac\u660e\u3057\u307e\u3059\u3002<\/span><\/p>\n<p><img fetchpriority=\"high\" decoding=\"async\" class=\"alignleft size-full wp-image-3239\" src=\"https:\/\/i1.wp.com\/www.jianpaitech.com\/wp-content\/uploads\/2025\/05\/Model-JGB-Series-High-efficient-Sugar-Flim-Coating-Machine.png?quality=85&strip=all\" alt=\"\" width=\"968\" height=\"968\" srcset=\"https:\/\/i1.wp.com\/www.jianpaitech.com\/wp-content\/uploads\/2025\/05\/Model-JGB-Series-High-efficient-Sugar-Flim-Coating-Machine.png?quality=85&strip=all 968w, https:\/\/i1.wp.com\/www.jianpaitech.com\/wp-content\/uploads\/2025\/05\/Model-JGB-Series-High-efficient-Sugar-Flim-Coating-Machine-300x300.png?quality=85&strip=all 300w, https:\/\/i1.wp.com\/www.jianpaitech.com\/wp-content\/uploads\/2025\/05\/Model-JGB-Series-High-efficient-Sugar-Flim-Coating-Machine-150x150.png?quality=85&strip=all 150w, https:\/\/i1.wp.com\/www.jianpaitech.com\/wp-content\/uploads\/2025\/05\/Model-JGB-Series-High-efficient-Sugar-Flim-Coating-Machine-768x768.png?quality=85&strip=all 768w\" sizes=\"(max-width: 968px) 100vw, 968px\" \/><\/p>\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_76 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">\u76ee\u6b21<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"\u30b3\u30f3\u30c6\u30f3\u30c4\u306e\u30c6\u30fc\u30d6\u30eb\u3092\u5207\u308a\u66ff\u3048\u307e\u3059\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">\u30c8\u30b0\u30eb<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewbox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewbox=\"0 0 24 24\" version=\"1.2\" baseprofile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.jianpaitech.com\/ja\/blog\/choosing-a-tablet-coating-machine-the-ultimate-fda-21-cfr-part-11-compliance-guide\/#What_Is_FDA_21_CFR_Part_11\" >FDA 21 CFR \u30d1\u30fc\u30c8 11 \u3068\u306f\u4f55\u3067\u3059\u304b?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.jianpaitech.com\/ja\/blog\/choosing-a-tablet-coating-machine-the-ultimate-fda-21-cfr-part-11-compliance-guide\/#Why_Part_11_is_Critical_for_the_Tablet_Coating_Process\" >\u30d1\u30fc\u30c8 11 \u304c\u9320\u5264\u306e\u30b3\u30fc\u30c6\u30a3\u30f3\u30b0\u30d7\u30ed\u30bb\u30b9\u306b\u3068\u3063\u3066\u91cd\u8981\u3067\u3042\u308b\u7406\u7531<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.jianpaitech.com\/ja\/blog\/choosing-a-tablet-coating-machine-the-ultimate-fda-21-cfr-part-11-compliance-guide\/#4_Core_Part_11_Features_to_Look_for_in_a_Tablet_Coater\" >4 \u30b3\u30a2\u30d1\u30fc\u30c8 11 \u30bf\u30d6\u30ec\u30c3\u30c8\u30b3\u30fc\u30bf\u30fc\u306b\u6c42\u3081\u3089\u308c\u308b\u6a5f\u80fd<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.jianpaitech.com\/ja\/blog\/choosing-a-tablet-coating-machine-the-ultimate-fda-21-cfr-part-11-compliance-guide\/#Strict_Audit_Trails\" >\u53b3\u683c\u306a\u76e3\u67fb\u8a3c\u8de1<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.jianpaitech.com\/ja\/blog\/choosing-a-tablet-coating-machine-the-ultimate-fda-21-cfr-part-11-compliance-guide\/#Role-Based_Access_Control_RBAC\" >\u5f79\u5272\u30d9\u30fc\u30b9\u306e\u30a2\u30af\u30bb\u30b9\u5236\u5fa1 (RBAC)<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.jianpaitech.com\/ja\/blog\/choosing-a-tablet-coating-machine-the-ultimate-fda-21-cfr-part-11-compliance-guide\/#Secure_Electronic_Signatures\" >\u5b89\u5168\u306a\u96fb\u5b50\u7f72\u540d<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.jianpaitech.com\/ja\/blog\/choosing-a-tablet-coating-machine-the-ultimate-fda-21-cfr-part-11-compliance-guide\/#Data_Integrity_Retrieval\" >\u30c7\u30fc\u30bf\u306e\u6574\u5408\u6027\u3068\u53d6\u5f97<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/www.jianpaitech.com\/ja\/blog\/choosing-a-tablet-coating-machine-the-ultimate-fda-21-cfr-part-11-compliance-guide\/#The_JianPai_Advantage_Compliant_Automated_Coating_Systems\" >JianPai \u306e\u5229\u70b9: \u6e96\u62e0\u3057\u305f\u81ea\u52d5\u5316\u3055\u308c\u305f\u30b3\u30fc\u30c6\u30a3\u30f3\u30b0 \u30b7\u30b9\u30c6\u30e0<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/www.jianpaitech.com\/ja\/blog\/choosing-a-tablet-coating-machine-the-ultimate-fda-21-cfr-part-11-compliance-guide\/#Conclusion\" >\u7d50\u8ad6<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/www.jianpaitech.com\/ja\/blog\/choosing-a-tablet-coating-machine-the-ultimate-fda-21-cfr-part-11-compliance-guide\/#Frequently_Asked_Questions_FAQ\" >\u3088\u304f\u3042\u308b\u8cea\u554f (FAQ)<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"ng-star-inserted\"><span class=\"ez-toc-section\" id=\"What_Is_FDA_21_CFR_Part_11\"><\/span><span class=\"ng-star-inserted\">FDA 21 CFR \u30d1\u30fc\u30c8 11 \u3068\u306f\u4f55\u3067\u3059\u304b?<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u8981\u3059\u308b\u306b\u3001\u00a0<\/span><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">21 CFR \u30d1\u30fc\u30c8 11<\/span><\/strong><span class=\"ng-star-inserted\">\u00a0\u96fb\u5b50\u8a18\u9332\u3068\u96fb\u5b50\u7f72\u540d\u304c\u4fe1\u983c\u3067\u304d\u308b\u3082\u306e\u3067\u3042\u308a\u3001\u4e00\u822c\u306b\u7d19\u306e\u8a18\u9332\u3068\u540c\u7b49\u3067\u3042\u308b\u3068\u307f\u306a\u3055\u308c\u308b\u57fa\u6e96\u3092\u78ba\u7acb\u3059\u308b\u7c73\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5c40 (FDA) \u306e\u898f\u5236\u3067\u3059\u3002<\/span><\/p>\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u30d1\u30fc\u30c8 11 \u3067\u306f\u3001\u7f6e\u304d\u5fd8\u308c\u305f\u308a\u6539\u3056\u3093\u3055\u308c\u3084\u3059\u3044\u7d19\u306e\u65e5\u8a8c\u306b\u983c\u308b\u306e\u3067\u306f\u306a\u304f\u3001\u88fd\u85ac\u6a5f\u68b0\u3092\u5236\u5fa1\u3059\u308b\u30c7\u30b8\u30bf\u30eb \u30b7\u30b9\u30c6\u30e0\u304c\u9ad8\u5ea6\u306b\u5b89\u5168\u3067\u3042\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3057\u307e\u3059\u3002\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u3001\u30a2\u30af\u30bb\u30b9\u5236\u5fa1\u3001\u30c7\u30fc\u30bf\u691c\u8a3c\u306b\u95a2\u3059\u308b\u53b3\u683c\u306a\u30eb\u30fc\u30eb\u3092\u7fa9\u52d9\u4ed8\u3051\u3001\u88fd\u85ac\u696d\u52d9\u306b\u304a\u3051\u308b\u5b89\u5168\u306a\u30c7\u30b8\u30bf\u30eb\u5909\u9769\u3092\u53ef\u80fd\u306b\u3057\u307e\u3059\u3002<\/span><\/p>\n<h2 class=\"ng-star-inserted\"><span class=\"ez-toc-section\" id=\"Why_Part_11_is_Critical_for_the_Tablet_Coating_Process\"><\/span><span class=\"ng-star-inserted\">\u30d1\u30fc\u30c8 11 \u304c\u9320\u5264\u306e\u30b3\u30fc\u30c6\u30a3\u30f3\u30b0\u30d7\u30ed\u30bb\u30b9\u306b\u3068\u3063\u3066\u91cd\u8981\u3067\u3042\u308b\u7406\u7531<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u5358\u7d14\u306a\u88fd\u9020\u5de5\u7a0b\u3068\u306f\u7570\u306a\u308a\u3001\u00a0<\/span><a href=\"https:\/\/www.jianpaitech.com\/ja\/product_category\/tablet-coating\/\" target=\"_blank\" rel=\"noopener\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u30bf\u30d6\u30ec\u30c3\u30c8\u30b3\u30fc\u30c6\u30a3\u30f3\u30b0<\/span><\/strong><\/a><span class=\"ng-star-inserted\">\u00a0\u306f\u975e\u5e38\u306b\u8907\u96d1\u306a\u71b1\u529b\u5b66\u7684\u30d7\u30ed\u30bb\u30b9\u3067\u3059\u3002\u30d5\u30a3\u30eb\u30e0\u30b3\u30fc\u30c6\u30a3\u30f3\u30b0\u9320\u307e\u305f\u306f\u8178\u6eb6\u30b3\u30fc\u30c6\u30a3\u30f3\u30b0\u9320\u306e\u54c1\u8cea\u306f\u3001\u6b21\u306e\u3088\u3046\u306a\u6b63\u78ba\u306a\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0\u30d1\u30e9\u30e1\u30fc\u30bf\u306b\u5b8c\u5168\u306b\u4f9d\u5b58\u3057\u307e\u3059\u3002<\/span><\/p>\n<ul class=\"ng-star-inserted\">\n<li class=\"ng-star-inserted\">\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u5438\u6c17\u6e29\u5ea6\u3068\u6392\u6c17\u6e29\u5ea6<\/span><\/p>\n<\/li>\n<li class=\"ng-star-inserted\">\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u9727\u5316\u5727\u529b\u3068\u5674\u9727\u91cf<\/span><\/p>\n<\/li>\n<li class=\"ng-star-inserted\">\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u30b3\u30fc\u30c6\u30a3\u30f3\u30b0\u30d1\u30f3\uff08\u30c9\u30e9\u30e0\uff09\u901f\u5ea6<\/span><\/p>\n<\/li>\n<li class=\"ng-star-inserted\">\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u61f8\u6fc1\u6db2\u306e\u9001\u6db2<\/span><\/p>\n<\/li>\n<\/ul>\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u6a29\u9650\u306e\u306a\u3044\u30aa\u30da\u30ec\u30fc\u30bf\u30fc\u304c\u30d0\u30c3\u30c1\u306e\u9014\u4e2d\u3067\u30b9\u30d7\u30ec\u30fc\u901f\u5ea6\u3092\u8aa4\u3063\u3066\u5909\u66f4\u3057\u305f\u308a\u3001\u30b7\u30b9\u30c6\u30e0\u304b\u3089\u6e29\u5ea6\u30a2\u30e9\u30fc\u30e0\u304c\u524a\u9664\u3055\u308c\u305f\u308a\u3057\u305f\u5834\u5408\u3001\u6df1\u523b\u306a\u30d0\u30c3\u30c1\u969c\u5bb3\u3084\u898f\u5236\u4e0a\u306e\u7f70\u5247\u306b\u3064\u306a\u304c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002\u3042\u00a0<\/span><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">21 CFR Part 11 \u6e96\u62e0\u306e\u30bf\u30d6\u30ec\u30c3\u30c8\u30b3\u30fc\u30bf\u30fc<\/span><\/strong><span class=\"ng-star-inserted\">\u00a0\u30d1\u30e9\u30e1\u30fc\u30bf\u306e\u5909\u66f4\u3001\u30a2\u30e9\u30fc\u30e0\u3001\u30ec\u30b7\u30d4\u306e\u8abf\u6574\u304c\u3059\u3079\u3066\u6c38\u7d9a\u7684\u306b\u8a18\u9332\u3055\u308c\u3001\u88fd\u54c1\u306e\u54c1\u8cea\u3068\u4f1a\u793e\u306e\u8a55\u5224\u304c\u78ba\u4fdd\u3055\u308c\u307e\u3059\u3002<\/span><\/p>\n<h2 class=\"ng-star-inserted\"><span class=\"ez-toc-section\" id=\"4_Core_Part_11_Features_to_Look_for_in_a_Tablet_Coater\"><\/span><span class=\"ng-star-inserted\">4 \u30b3\u30a2\u30d1\u30fc\u30c8 11 \u30bf\u30d6\u30ec\u30c3\u30c8\u30b3\u30fc\u30bf\u30fc\u306b\u6c42\u3081\u3089\u308c\u308b\u6a5f\u80fd<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u533b\u85ac\u54c1\u30b3\u30fc\u30c6\u30a3\u30f3\u30b0 \u30b7\u30b9\u30c6\u30e0\u3092\u8a55\u4fa1\u3059\u308b\u3068\u304d\u306f\u3001\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u304c\u300c\u6e96\u62e0\u300d\u3057\u3066\u3044\u308b\u304b\u3069\u3046\u304b\u3092\u30d9\u30f3\u30c0\u30fc\u306b\u5c0b\u306d\u308b\u3060\u3051\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002 PLC\/HMI \u30b7\u30b9\u30c6\u30e0\u304c\u6b21\u306e 4 \u3064\u306e\u30b3\u30a2\u6a5f\u80fd\u3092\u5099\u3048\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/span><\/p>\n<h3 class=\"ng-star-inserted\"><span class=\"ez-toc-section\" id=\"Strict_Audit_Trails\"><\/span><span class=\"ng-star-inserted\">\u53b3\u683c\u306a\u76e3\u67fb\u8a3c\u8de1<\/span><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u76e3\u67fb\u8a3c\u8de1\u306f\u30c7\u30fc\u30bf\u306e\u6574\u5408\u6027\u306e\u6839\u5e79\u3067\u3059\u3002\u30b3\u30fc\u30c6\u30a3\u30f3\u30b0\u6a5f\u306f\u3001\u3059\u3079\u3066\u306e\u30aa\u30da\u30ec\u30fc\u30bf\u306e\u30a2\u30af\u30b7\u30e7\u30f3\u306b\u3064\u3044\u3066\u3001\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u3067\u751f\u6210\u3055\u308c\u305f\u5b89\u5168\u306a\u30bf\u30a4\u30e0\u30b9\u30bf\u30f3\u30d7\u4ed8\u304d\u8a18\u9332\u3092\u81ea\u52d5\u7684\u306b\u751f\u6210\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u8ab0\u304b\u304c\u5165\u53e3\u6e29\u5ea6\u3092 60\u00b0C \u304b\u3089 65\u00b0C \u306b\u5909\u66f4\u3057\u305f\u5834\u5408\u3001\u30b7\u30b9\u30c6\u30e0\u306f\u8a18\u9332\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u00a0<\/span><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u8ab0\u304c<\/span><\/strong><span class=\"ng-star-inserted\">\u00a0\u3084\u3063\u305f\u3001\u00a0<\/span><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u3044\u3064<\/span><\/strong><span class=\"ng-star-inserted\">\u00a0\u305d\u308c\u306f\u8d77\u3053\u3063\u305f\u3001\u00a0<\/span><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u53e4\u3044\u5024<\/span><\/strong><span class=\"ng-star-inserted\">\u3001\u00a0<\/span><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u65b0\u3057\u3044\u4fa1\u5024<\/span><\/strong><span class=\"ng-star-inserted\">\u3001\u305d\u3057\u3066\u00a0<\/span><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u7406\u7531<\/span><\/strong><span class=\"ng-star-inserted\">\u00a0\u5909\u5316\u306e\u305f\u3081\u306b\u3002\u3053\u308c\u3089\u306e\u30ed\u30b0\u306f\u7de8\u96c6\u3067\u304d\u306a\u3044\u3088\u3046\u306b\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/span><\/p>\n<h3 class=\"ng-star-inserted\"><span class=\"ez-toc-section\" id=\"Role-Based_Access_Control_RBAC\"><\/span><span class=\"ng-star-inserted\">\u5f79\u5272\u30d9\u30fc\u30b9\u306e\u30a2\u30af\u30bb\u30b9\u5236\u5fa1 (RBAC)<\/span><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u6e96\u62e0\u3057\u305f\u5857\u88c5\u6a5f\u306f\u3001\u4e0d\u6b63\u30a2\u30af\u30bb\u30b9\u3092\u9632\u6b62\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u3067\u306f\u3001\u3055\u307e\u3056\u307e\u306a\u6a29\u9650\u30ec\u30d9\u30eb\u3092\u5272\u308a\u5f53\u3066\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u306f\u305a\u3067\u3059\u3002\u4f8b\u3048\u3070\uff1a<\/span><\/p>\n<ul class=\"ng-star-inserted\">\n<li class=\"ng-star-inserted\">\n<p class=\"ng-star-inserted\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u30aa\u30da\u30ec\u30fc\u30bf\u30fc:<\/span><\/strong><span class=\"ng-star-inserted\">\u00a0\u30d0\u30c3\u30c1\u306e\u958b\u59cb\/\u505c\u6b62\u3068\u30a2\u30e9\u30fc\u30e0\u306e\u78ba\u8a8d\u306e\u307f\u53ef\u80fd\u3067\u3059\u3002<\/span><\/p>\n<\/li>\n<li class=\"ng-star-inserted\">\n<p class=\"ng-star-inserted\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u76e3\u7763\u8005:<\/span><\/strong><span class=\"ng-star-inserted\">\u00a0\u30b3\u30fc\u30c6\u30a3\u30f3\u30b0\u30ec\u30b7\u30d4\u3092\u7de8\u96c6\u304a\u3088\u3073\u627f\u8a8d\u3067\u304d\u307e\u3059\u3002<\/span><\/p>\n<\/li>\n<li class=\"ng-star-inserted\">\n<p class=\"ng-star-inserted\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u7ba1\u7406\u8005\/IT:<\/span><\/strong><span class=\"ng-star-inserted\">\u00a0\u30e6\u30fc\u30b6\u30fc\u30a2\u30ab\u30a6\u30f3\u30c8\u3068\u30b7\u30b9\u30c6\u30e0\u69cb\u6210\u3092\u7ba1\u7406\u3067\u304d\u307e\u3059\u3002<\/span><br class=\"ng-star-inserted\" \/><span class=\"ng-star-inserted\">\u30d1\u30b9\u30ef\u30fc\u30c9\u306e\u5171\u6709\u306f\u3001\u30b7\u30b9\u30c6\u30e0 \u30a2\u30fc\u30ad\u30c6\u30af\u30c1\u30e3\u306b\u3088\u3063\u3066\u7269\u7406\u7684\u306b\u5236\u9650\u3055\u308c\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/span><\/p>\n<\/li>\n<\/ul>\n<h3 class=\"ng-star-inserted\"><span class=\"ez-toc-section\" id=\"Secure_Electronic_Signatures\"><\/span><span class=\"ng-star-inserted\">\u5b89\u5168\u306a\u96fb\u5b50\u7f72\u540d<\/span><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u65b0\u3057\u3044\u30b3\u30fc\u30c6\u30a3\u30f3\u30b0\u30ec\u30b7\u30d4\u306e\u627f\u8a8d\u3084\u30d0\u30c3\u30c1\u30ec\u30dd\u30fc\u30c8\u306e\u30ea\u30ea\u30fc\u30b9\u306a\u3069\u3001\u91cd\u8981\u306a\u30a2\u30af\u30b7\u30e7\u30f3\u304c\u767a\u751f\u3059\u308b\u5834\u5408\u3001\u30b7\u30b9\u30c6\u30e0\u306f\u96fb\u5b50\u7f72\u540d\u3092\u5fc5\u8981\u3068\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u30d1\u30fc\u30c8 11 \u3067\u306f\u3001\u3053\u306e\u7f72\u540d\u306f\u5c11\u306a\u304f\u3068\u3082 2 \u3064\u306e\u7570\u306a\u308b\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8 (\u4e00\u610f\u306e ID \u3068\u30d7\u30e9\u30a4\u30d9\u30fc\u30c8 \u30d1\u30b9\u30ef\u30fc\u30c9\u306a\u3069) \u3067\u69cb\u6210\u3055\u308c\u3001\u305d\u308c\u305e\u308c\u306e\u96fb\u5b50\u8a18\u9332\u306b\u6c38\u7d9a\u7684\u306b\u30ea\u30f3\u30af\u3055\u308c\u3066\u3044\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002<\/span><\/p>\n<h3 class=\"ng-star-inserted\"><span class=\"ez-toc-section\" id=\"Data_Integrity_Retrieval\"><\/span><span class=\"ng-star-inserted\">\u30c7\u30fc\u30bf\u306e\u6574\u5408\u6027\u3068\u53d6\u5f97<\/span><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u30b3\u30fc\u30c6\u30a3\u30f3\u30b0\u30d7\u30ed\u30bb\u30b9\u4e2d\u306b\u751f\u6210\u3055\u308c\u308b\u3059\u3079\u3066\u306e\u30d0\u30c3\u30c1\u30ec\u30dd\u30fc\u30c8\u3001\u30a2\u30e9\u30fc\u30e0\u30ed\u30b0\u3001\u76e3\u67fb\u8a3c\u8de1\u306f\u5b89\u5168\u306b\u4fdd\u7ba1\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u306e\u30de\u30b7\u30f3\u306f\u3001\u81ea\u52d5\u5316\u3055\u308c\u305f\u30c7\u30fc\u30bf \u30d0\u30c3\u30af\u30a2\u30c3\u30d7 \u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3 (\u6697\u53f7\u5316\u3055\u308c\u305f PDF \u3092\u5b89\u5168\u306a\u5de5\u5834\u30b5\u30fc\u30d0\u30fc\u306b\u30a8\u30af\u30b9\u30dd\u30fc\u30c8\u3059\u308b\u306a\u3069) \u3092\u63d0\u4f9b\u3057\u3001\u4fdd\u5b58\u671f\u9593\u5168\u4f53\u3092\u901a\u3058\u3066\u8a18\u9332\u304c\u8aad\u307f\u53d6\u308a\u53ef\u80fd\u304b\u3064\u53d6\u5f97\u53ef\u80fd\u3067\u3042\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/span><\/p>\n<h2 class=\"ng-star-inserted\"><span class=\"ez-toc-section\" id=\"The_JianPai_Advantage_Compliant_Automated_Coating_Systems\"><\/span><span class=\"ng-star-inserted\">JianPai \u306e\u5229\u70b9: \u6e96\u62e0\u3057\u305f\u81ea\u52d5\u5316\u3055\u308c\u305f\u30b3\u30fc\u30c6\u30a3\u30f3\u30b0 \u30b7\u30b9\u30c6\u30e0<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u6a5f\u68b0\u306e\u5353\u8d8a\u6027\u3068\u9ad8\u5ea6\u306a\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2 \u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u30b7\u30fc\u30e0\u30ec\u30b9\u306b\u6a4b\u6e21\u3057\u3059\u308b\u6a5f\u5668\u3092\u9078\u629e\u3059\u308b\u3053\u3068\u304c\u91cd\u8981\u3067\u3059\u3002 1997\u5e74\u306b\u8a2d\u7acb\u3055\u308c\u3001\u00a0<\/span><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">Zhijiang Jianpai Technology Co.\u3001Ltd<\/span><\/strong><span class=\"ng-star-inserted\">\u00a0\u306f\u3001\u30df\u30c3\u30c9\u30a8\u30f3\u30c9\u304b\u3089\u30cf\u30a4\u30a8\u30f3\u30c9\u306e OSD \u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\u3092\u5c02\u9580\u3068\u3059\u308b\u300c\u4e2d\u56fd\u306e\u30c8\u30c3\u30d7 10 \u88fd\u85ac\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u300d\u3068\u3057\u3066\u4e16\u754c\u7684\u306b\u8a8d\u3081\u3089\u308c\u3066\u3044\u307e\u3059\u3002<\/span><\/p>\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u5f53\u793e\u306e\u4e3b\u529b\u88fd\u54c1\u00a0<\/span><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u30d7\u30ec\u30df\u30a2\u30e0\u9320\u5264\u30b3\u30fc\u30c6\u30a3\u30f3\u30b0\u6a5f<\/span><\/strong><span class=\"ng-star-inserted\">\u00a0\u9ad8\u5ea6\u306b\u898f\u5236\u3055\u308c\u305f\u5e02\u5834 (FDA\/EU-GMP) \u5411\u3051\u306b\u7279\u5225\u306b\u8a2d\u8a08\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/span><\/p>\n<ul class=\"ng-star-inserted\">\n<li class=\"ng-star-inserted\">\n<p class=\"ng-star-inserted\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u691c\u8a3c\u6e08\u307f\u306e\u5236\u5fa1\u30b7\u30b9\u30c6\u30e0:<\/span><\/strong><span class=\"ng-star-inserted\">\u00a0\u5f53\u793e\u306e\u9ad8\u5ea6\u306a PLC\/HMI \u30a2\u30fc\u30ad\u30c6\u30af\u30c1\u30e3\u306f 21 CFR Part 11 \u306b\u5b8c\u5168\u306b\u6e96\u62e0\u3057\u3066\u304a\u308a\u3001\u5805\u7262\u306a\u76e3\u67fb\u8a3c\u8de1\u3001\u30de\u30eb\u30c1\u30ec\u30d9\u30eb\u306e\u30d1\u30b9\u30ef\u30fc\u30c9\u4fdd\u8b77\u3001\u81ea\u52d5\u30d0\u30c3\u30c1 \u30ec\u30dd\u30fc\u30c8\u3092\u5099\u3048\u3066\u3044\u307e\u3059\u3002<\/span><\/p>\n<\/li>\n<li class=\"ng-star-inserted\">\n<p class=\"ng-star-inserted\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u6838\u3068\u306a\u308b\u30c7\u30fc\u30bf\u306e\u6574\u5408\u6027:<\/span><\/strong><span class=\"ng-star-inserted\">\u00a0\u5b89\u5168\u306a\u30a8\u30af\u30b9\u30dd\u30fc\u30c8\u6a5f\u80fd\u306b\u3088\u308a\u30c7\u30fc\u30bf\u640d\u5931\u30bc\u30ed\u3092\u4fdd\u8a3c\u3057\u3001\u6b21\u56de\u306e\u898f\u5236\u76e3\u67fb\u3092\u30b9\u30e0\u30fc\u30ba\u304b\u3064\u30b9\u30c8\u30ec\u30b9\u30d5\u30ea\u30fc\u306b\u3057\u307e\u3059\u3002<\/span><\/p>\n<\/li>\n<\/ul>\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u3055\u3089\u306b\u3001JianPai \u306f\u56fa\u5f62\u88fd\u5264\u88fd\u9020\u306e\u305f\u3081\u306e\u5b8c\u5168\u306a\u30a8\u30b3\u30b7\u30b9\u30c6\u30e0\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002\u5f53\u793e\u306e\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u7d71\u5408\u3059\u308b\u3053\u3068\u306b\u3088\u308a\u3001\u00a0<\/span><a href=\"https:\/\/www.jianpaitech.com\/ja\/product_category\/high-shear-mixer\/\" target=\"_blank\" rel=\"noopener\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u30cf\u30a4\u305b\u3093\u65ad\u30df\u30ad\u30b5\u30fc<\/span><\/strong><\/a><span class=\"ng-star-inserted\">\u00a0\u305d\u3057\u3066\u00a0<\/span><a href=\"https:\/\/www.jianpaitech.com\/ja\/product_category\/fluid-bed-dryer\/\" target=\"_blank\" rel=\"noopener\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u6d41\u52d5\u5c64\u4e7e\u71e5\u6a5f<\/span><\/strong><\/a><span class=\"ng-star-inserted\">\u00a0\u5f53\u793e\u306e\u30b3\u30fc\u30c6\u30a3\u30f3\u30b0\u6a5f\u3092\u4f7f\u7528\u3059\u308b\u3068\u3001\u9020\u7c92\u304a\u3088\u3073\u30b3\u30fc\u30c6\u30a3\u30f3\u30b0\u30e9\u30a4\u30f3\u5168\u4f53\u306b\u308f\u305f\u3063\u3066\u30a8\u30f3\u30c9\u30c4\u30fc\u30a8\u30f3\u30c9\u306e\u30c7\u30fc\u30bf\u306e\u6574\u5408\u6027\u3092\u78ba\u4fdd\u3067\u304d\u307e\u3059\u3002<\/span><\/p>\n<h2 class=\"ng-star-inserted\"><span class=\"ez-toc-section\" id=\"Conclusion\"><\/span><span class=\"ng-star-inserted\">\u7d50\u8ad6<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">FDA 21 CFR Part 11 \u3092\u7406\u89e3\u3057\u3066\u5b9f\u88c5\u3059\u308b\u3053\u3068\u306f\u3001\u898f\u5236\u4e0a\u306e\u7f70\u91d1\u3092\u56de\u907f\u3059\u308b\u3053\u3068\u3060\u3051\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u305d\u308c\u306f\u3001\u3088\u308a\u30b9\u30de\u30fc\u30c8\u3067\u3001\u3088\u308a\u5b89\u5168\u3067\u3001\u3088\u308a\u52b9\u7387\u7684\u306a\u88fd\u9020\u30d7\u30ed\u30bb\u30b9\u3092\u69cb\u7bc9\u3059\u308b\u3053\u3068\u3067\u3059\u3002\u5b8c\u5168\u306b\u6e96\u62e0\u3057\u305f\u9320\u5264\u30b3\u30fc\u30c6\u30a3\u30f3\u30b0\u6a5f\u306b\u6295\u8cc7\u3059\u308b\u3053\u3068\u3067\u3001\u30c7\u30fc\u30bf\u3001\u88fd\u54c1\u306e\u54c1\u8cea\u3001\u60a3\u8005\u3092\u4fdd\u8b77\u3067\u304d\u307e\u3059\u3002<\/span><\/p>\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u533b\u85ac\u54c1\u30b3\u30fc\u30c6\u30a3\u30f3\u30b0\u696d\u52d9\u3092\u30a2\u30c3\u30d7\u30b0\u30ec\u30fc\u30c9\u3059\u308b\u6e96\u5099\u306f\u3067\u304d\u3066\u3044\u307e\u3059\u304b?\u00a0<\/span><a class=\"ng-star-inserted\" href=\"https:\/\/www.jianpaitech.com\/ja\/product_category\/tablet-coating\/\" target=\"_blank\" rel=\"noopener\"><span class=\"ng-star-inserted\">JianPai Technology \u306e\u9ad8\u5ea6\u306a\u9320\u5264\u30b3\u30fc\u30c6\u30a3\u30f3\u30b0 \u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\u3092\u63a2\u7d22\u3059\u308b<\/span><\/a><span class=\"ng-star-inserted\">\u00a0\u4e16\u754c\u7684\u306aGMP\u306e\u671f\u5f85\u3092\u8d85\u3048\u308b\u751f\u7523\u30e9\u30a4\u30f3\u3092\u69cb\u7bc9\u3057\u307e\u3059\u3002<\/span><\/p>\n<h2 class=\"ng-star-inserted\"><span class=\"ez-toc-section\" id=\"Frequently_Asked_Questions_FAQ\"><\/span><span class=\"ng-star-inserted\">\u3088\u304f\u3042\u308b\u8cea\u554f (FAQ)<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p class=\"ng-star-inserted\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">1. 21 CFR Part 11 \u306f\u3059\u3079\u3066\u306e\u9320\u5264\u30b3\u30fc\u30c6\u30a3\u30f3\u30b0\u6a5f\u306b\u5fc5\u9808\u3067\u3059\u304b?<\/span><\/strong><br class=\"ng-star-inserted\" \/><span class=\"ng-star-inserted\">\u306f\u3044\u3001\u88fd\u85ac\u65bd\u8a2d\u304c\u96fb\u5b50\u30b7\u30b9\u30c6\u30e0\u3092\u4f7f\u7528\u3057\u3066 FDA \u304c\u8981\u6c42\u3059\u308b\u8a18\u9332\u3092\u4f5c\u6210\u3001\u5909\u66f4\u3001\u7dad\u6301\u3001\u9001\u4fe1\u3059\u308b\u5834\u5408\u3001\u6a5f\u68b0\u306e\u5236\u5fa1\u30b7\u30b9\u30c6\u30e0\u306f\u30d1\u30fc\u30c8 11 \u898f\u5236\u306b\u6e96\u62e0\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/span><\/p>\n<p class=\"ng-star-inserted\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">2. \u53e4\u3044\u3001\u975e\u6e96\u62e0\u306e\u5857\u88c5\u6a5f\u3092\u30a2\u30c3\u30d7\u30b0\u30ec\u30fc\u30c9\u3067\u304d\u307e\u3059\u304b?<\/span><\/strong><br class=\"ng-star-inserted\" \/><span class=\"ng-star-inserted\">\u591a\u304f\u306e\u5834\u5408\u3001\u305d\u3046\u3067\u3059\u3002\u6a5f\u68b0\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8\u306e\u30a2\u30c3\u30d7\u30b0\u30ec\u30fc\u30c9\u306f\u5fc5\u8981\u306a\u3044\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u304c\u3001\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb \u30d1\u30cd\u30eb (PLC\/HMI \u30bd\u30d5\u30c8\u30a6\u30a7\u30a2) \u306f\u3001\u591a\u304f\u306e\u5834\u5408\u3001JianPai Tech \u306e\u3088\u3046\u306a\u5c02\u9580\u30e1\u30fc\u30ab\u30fc\u306b\u3088\u3063\u3066\u6539\u9020\u3055\u308c\u300121 CFR Part 11 \u8981\u4ef6\u3092\u6e80\u305f\u3059\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/span><\/p>\n<p class=\"ng-star-inserted\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">3. Part 11 \u3078\u306e\u6e96\u62e0\u306f\u3001FDA \u306e\u691c\u67fb\u6642\u306b\u3069\u306e\u3088\u3046\u306b\u5f79\u7acb\u3061\u307e\u3059\u304b?<\/span><\/strong><br class=\"ng-star-inserted\" \/><span class=\"ng-star-inserted\">\u6e96\u62e0\u30b7\u30b9\u30c6\u30e0\u306b\u306f\u3001\u7de8\u96c6\u4e0d\u53ef\u80fd\u306a\u76e3\u67fb\u8a3c\u8de1\u3068\u5b89\u5168\u306a\u96fb\u5b50\u7f72\u540d\u304c\u5099\u308f\u3063\u3066\u3044\u307e\u3059\u3002\u691c\u67fb\u5b98\u304c\u7279\u5b9a\u306e\u9320\u5264\u30b3\u30fc\u30c6\u30a3\u30f3\u30b0\u5b9f\u884c\u306e\u30d0\u30c3\u30c1\u5c65\u6b74\u306e\u78ba\u8a8d\u3092\u8981\u6c42\u3057\u305f\u5834\u5408\u3001\u6b63\u78ba\u3067\u6539\u3056\u3093\u9632\u6b62\u306e\u30c7\u30b8\u30bf\u30eb \u30ec\u30dd\u30fc\u30c8\u3092\u5373\u5ea7\u306b\u53d6\u5f97\u3067\u304d\u3001\u88fd\u9020\u30d7\u30ed\u30bb\u30b9\u306e\u5b8c\u5168\u306a\u5236\u5fa1\u3092\u5b9f\u8a3c\u3067\u304d\u307e\u3059\u3002<\/span><\/p>","protected":false},"excerpt":{"rendered":"<p>\u73fe\u4ee3\u306e\u533b\u85ac\u54c1\u88fd\u9020\u306b\u304a\u3044\u3066\u3001\u9320\u5264\u30b3\u30fc\u30c6\u30a3\u30f3\u30b0\u6a5f\u306e\u8cfc\u5165\u306f\u3001\u3082\u306f\u3084\u6a5f\u68b0\u7684\u6027\u80fd\u3001\u30b9\u30c6\u30f3\u30ec\u30b9\u92fc\u306e\u30b0\u30ec\u30fc\u30c9\u3001\u30b9\u30d7\u30ec\u30fc\u30ac\u30f3\u306e\u7cbe\u5ea6\u3060\u3051\u3092\u91cd\u8996\u3059\u308b\u3082\u306e\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u30e8\u30fc\u30ed\u30c3\u30d1\u304a\u3088\u3073\u5317\u7c73\u5e02\u5834\u3092\u30bf\u30fc\u30b2\u30c3\u30c8\u3068\u3059\u308b\u7d4c\u53e3\u56fa\u5f62\u88fd\u5264 (OSD) \u30e1\u30fc\u30ab\u30fc\u306b\u3068\u3063\u3066\u3001\u6a5f\u68b0\u3092\u5b9f\u884c\u3059\u308b\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306f\u3001\u305d\u308c\u4ee5\u4e0a\u3067\u306f\u306a\u3044\u306b\u3057\u3066\u3082\u3001\u540c\u69d8\u306b\u91cd\u8981\u3067\u3059\u3002\u30b3\u30fc\u30c6\u30a3\u30f3\u30b0\u30b7\u30b9\u30c6\u30e0\u304c\u7d76\u5bfe\u7684\u306a\u30c7\u30fc\u30bf\u5b8c\u5168\u6027\u3092\u4fdd\u8a3c\u3067\u304d\u306a\u3044\u5834\u5408\u3001FDA \u307e\u305f\u306f EU-GMP \u691c\u67fb\u306b\u5408\u683c\u3057\u307e\u305b\u3093\u3002\u3053\u3053\u3067 FDA 21 CFR Part 11 \u304c\u767b\u5834\u3057\u307e\u3059\u3002\u3053\u306e\u4e2d\u3067\u3053\u306e\u5305\u62ec\u7684\u306a\u30ac\u30a4\u30c9\u3067\u306f\u300121 CFR Part 11 \u3068\u306f\u4f55\u304b\u3001\u30b3\u30fc\u30c6\u30a3\u30f3\u30b0 \u30d7\u30ed\u30bb\u30b9\u306b\u3068\u3063\u3066\u305d\u308c\u304c\u91cd\u8981\u3067\u3042\u308b\u7406\u7531\u3001\u304a\u3088\u3073\u65bd\u8a2d\u304c 100% \u76e3\u67fb\u306b\u5bfe\u5fdc\u3067\u304d\u308b\u3088\u3046\u306b\u3059\u308b\u9320\u5264\u30b3\u30fc\u30c6\u30a3\u30f3\u30b0\u6a5f\u306e\u9078\u3073\u65b9\u306b\u3064\u3044\u3066\u8aac\u660e\u3057\u307e\u3059\u3002 FDA\u3068\u306f [\u2026]<\/p>","protected":false},"featured_media":5193,"template":"","meta":{"_acf_changed":false,"footnotes":""},"blog_category":[16],"class_list":["post-5192","blog","type-blog","status-publish","has-post-thumbnail","hentry","blog_category-industry-news"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.jianpaitech.com\/ja\/wp-json\/wp\/v2\/blog\/5192","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.jianpaitech.com\/ja\/wp-json\/wp\/v2\/blog"}],"about":[{"href":"https:\/\/www.jianpaitech.com\/ja\/wp-json\/wp\/v2\/types\/blog"}],"version-history":[{"count":1,"href":"https:\/\/www.jianpaitech.com\/ja\/wp-json\/wp\/v2\/blog\/5192\/revisions"}],"predecessor-version":[{"id":5194,"href":"https:\/\/www.jianpaitech.com\/ja\/wp-json\/wp\/v2\/blog\/5192\/revisions\/5194"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.jianpaitech.com\/ja\/wp-json\/wp\/v2\/media\/5193"}],"wp:attachment":[{"href":"https:\/\/www.jianpaitech.com\/ja\/wp-json\/wp\/v2\/media?parent=5192"}],"wp:term":[{"taxonomy":"blog_category","embeddable":true,"href":"https:\/\/www.jianpaitech.com\/ja\/wp-json\/wp\/v2\/blog_category?post=5192"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}