\n\u30fb\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u958b\u767a\u306e\u9032\u3081\u65b9\/\u3084\u308a\u65b9\/\u6d41\u308c\u3084\u65b9\u6cd5\/\u624b\u6cd5\/\u5de5\u7a0b\/\u624b\u9806<\/a>
\n\u30fb\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u958b\u767a\u3067\u304a\u3059\u3059\u3081\u306e\u958b\u767a\u4f1a\u793e\/\u30d9\u30f3\u30c0\u30fc6\u9078\u3068\u9078\u3073\u65b9<\/a>
\n\u30fb\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u958b\u767a\u306e\u898b\u7a4d\u76f8\u5834\u3084\u8cbb\u7528\/\u30b3\u30b9\u30c8\/\u5024\u6bb5\u306b\u3064\u3044\u3066<\/a>
\n\u30fb\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u958b\u767a\u306e\u767a\u6ce8\/\u5916\u6ce8\/\u4f9d\u983c\/\u59d4\u8a17\u65b9\u6cd5\u306b\u3064\u3044\u3066<\/a><\/p>\n\n\n\n
\u30fb\u696d\u52d9\u30b7\u30b9\u30c6\u30e0\u958b\u767a\u3092\u4f9d\u983c\u3059\u308b\u4f1a\u793e\u306e\u9078\u3073\u65b9\u3084RFP\u306e\u4f5c\u308a\u65b9\u306b\u3064\u3044\u3066\u306f\u3001\u7121\u6599\u30db\u30ef\u30a4\u30c8\u30da\u30fc\u30d1\u30fc\u300c\u696d\u52d9\u30b7\u30b9\u30c6\u30e0\u958b\u767a\u306e\u5b8c\u5168\u30ac\u30a4\u30c9\u30d6\u30c3\u30af\u300d<\/a>\u3067\u8a73\u3057\u304f\u89e3\u8aac\u3057\u3066\u3044\u307e\u3059\u3002 \u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u306f\u3001\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\uff08CSV\uff09\u3092\u7ba1\u7406\u3059\u308b\u305f\u3081\u306e\u4ed5\u7d44\u307f\u3067\u3059\u3002\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u306eCSA\uff08Computer Software Assurance\uff09\u306e\u6d3b\u52d5\u3082\u5bfe\u8c61\u306b\u542b\u307f\u307e\u3059\u3002<\/p>\n\n\n\n \u8a66\u9a13\u306e\u6570\u3092\u5897\u3084\u3059\u3053\u3068\u3088\u308a\u3082\u3001\u91cd\u8981\u306a\u8981\u6c42\u3068\u30ea\u30b9\u30af\u306b\u9069\u5207\u306a\u8a3c\u62e0\u3092\u6b8b\u3057\u3001\u5f8c\u304b\u3089\u518d\u73fe\u3067\u304d\u308b\u72b6\u614b\u3092\u4fdd\u3064\u3053\u3068\u306b\u76ee\u7684\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n \u300c\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u300d\u306b\u306f\u3001\u5165\u529b\u6587\u5b57\u5217\u304c\u30e1\u30fc\u30eb\u30a2\u30c9\u30ec\u30b9\u5f62\u5f0f\u304b\u3001\u6570\u5024\u304c\u7bc4\u56f2\u5185\u304b\u3092\u78ba\u8a8d\u3059\u308b\u3001\u30a2\u30d7\u30ea\u30b1\u30fc\u30b7\u30e7\u30f3\u4e0a\u306e\u5165\u529b\u5024\u691c\u8a3c\u3082\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n \u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u304c\u4e3b\u306b\u6271\u3046\u306e\u306f\u3001\u88fd\u9020\u3001\u54c1\u8cea\u8a66\u9a13\u3001\u81e8\u5e8a\u3001\u7269\u6d41\u3001\u7814\u7a76\u306a\u3069\u306e\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u3067\u3059\u3002<\/p>\n\n\n\n CSV\u3067\u306f\u3001\u3053\u3046\u3057\u305f\u30b7\u30b9\u30c6\u30e0\u304c\u610f\u56f3\u3057\u305f\u7528\u9014\u3069\u304a\u308a\u306b\u52d5\u304d\u3001\u54c1\u8cea\u3084\u30c7\u30fc\u30bf\u5b8c\u5168\u6027\u306e\u8981\u6c42\u3092\u6e80\u305f\u3059\u3053\u3068\u3092\u8a3c\u660e\u3057\u3001\u7dad\u6301\u3057\u307e\u3059\u3002\u5165\u529b\u5024\u691c\u8a3c\u306f\u6a5f\u80fd\u306e\u4e00\u90e8\u3067\u3059\u304c\u3001CSV\u306f\u54c1\u8cea\u4fdd\u8a3c\u3092\u542b\u3080\u696d\u52d9\u30d7\u30ed\u30bb\u30b9\u5168\u4f53\u3067\u3059\u3002<\/p>\n\n\n\n \u7ba1\u7406\u5bfe\u8c61\u306fURS\uff08\u30e6\u30fc\u30b6\u30fc\u8981\u6c42\u4ed5\u69d8\uff09\u306b\u3068\u3069\u307e\u308a\u307e\u305b\u3093\u3002\u30b7\u30b9\u30c6\u30e0\u53f0\u5e33\u3001\u6a5f\u80fd\u4ed5\u69d8\u30fb\u8a2d\u8a08\u4ed5\u69d8\u3001\u30ea\u30b9\u30af\u8a55\u4fa1\u3082\u5bfe\u8c61\u306b\u542b\u307f\u307e\u3059\u3002<\/p>\n\n\n\n \u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u8a08\u753b\u3001\u30c6\u30b9\u30c8\u30b1\u30fc\u30b9\u3001\u5b9f\u884c\u8a18\u9332\u3082\u542b\u307f\u307e\u3059\u3002\u30b9\u30af\u30ea\u30fc\u30f3\u30b7\u30e7\u30c3\u30c8\u3084\u30ed\u30b0\u3001\u9038\u8131\u30fb\u8ab2\u984c\u3001\u627f\u8a8d\u3082\u8a18\u9332\u306e\u5bfe\u8c61\u3067\u3059\u3002\u3055\u3089\u306b\u3001\u30ea\u30ea\u30fc\u30b9\u3084\u5909\u66f4\u8981\u6c42\u3001\u5b9a\u671f\u30ec\u30d3\u30e5\u30fc\u3001\u5ec3\u68c4\u8a18\u9332\u3082\u542b\u307f\u307e\u3059\u3002<\/p>\n\n\n\n \u3053\u308c\u3089\u3092\u540c\u3058\u30b7\u30b9\u30c6\u30e0\u3084\u30d0\u30fc\u30b8\u30e7\u30f3\u306b\u3072\u3082\u4ed8\u3051\u3066\u8ffd\u8de1\u3057\u307e\u3059\u3002\u305d\u306e\u305f\u3081\u3001\u8981\u6c42\u3092\u5909\u3048\u305f\u3068\u304d\u306b\u3001\u30c6\u30b9\u30c8\u3001\u6587\u66f8\u3001\u627f\u8a8d\u3001\u6559\u80b2\u3078\u53ca\u3076\u5f71\u97ff\u3092\u305f\u3069\u308c\u307e\u3059\u3002\u5358\u306a\u308b\u30d5\u30a1\u30a4\u30eb\u4fdd\u7ba1\u3068\u306e\u9055\u3044\u306f\u3001\u3053\u306e\u70b9\u306b\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n \u5229\u7528\u8005\u306fQA\u3084CSV\u62c5\u5f53\u306b\u9650\u3089\u305a\u3001\u85ac\u4e8b\u3084IT\u306e\u62c5\u5f53\u3001\u5de5\u5834\u30fb\u7814\u7a76\u6240\u306e\u8cac\u4efb\u8005\u306b\u3082\u53ca\u3073\u307e\u3059\u3002\u3055\u3089\u306b\u3001\u696d\u52d9\u30aa\u30fc\u30ca\u30fc\u3084\u7ba1\u7406\u8005\u3082\u5229\u7528\u8005\u306b\u542b\u307e\u308c\u307e\u3059\u3002\u30c6\u30b9\u30c8\u5b9f\u884c\u8005\u3068\u627f\u8a8d\u8005\u3082\u5bfe\u8c61\u3067\u3059\u3002<\/p>\n\n\n\n \u5225\u3005\u306e\u53f0\u5e33\u3067\u306f\u3001\u540c\u3058\u30b7\u30b9\u30c6\u30e0\u3067\u3082\u7bc4\u56f2\u3084\u8cac\u4efb\u8005\u304c\u98df\u3044\u9055\u3044\u307e\u3059\u3002\u305d\u3053\u3067\u5171\u901a\u53f0\u5e33\u3092\u4f7f\u3044\u3001GxP\u5f71\u97ff\u3001\u91cd\u8981\u5ea6\u3001\u5229\u7528\u30b5\u30a4\u30c8\u3092\u7ba1\u7406\u3057\u307e\u3059\u3002\u52a0\u3048\u3066\u3001\u6240\u6709\u8005\u3001\u30c7\u30fc\u30bf\u306e\u6d41\u308c\u3001\u59d4\u8a17\u5148\u3068\u306e\u8cac\u4efb\u5206\u754c\u3082\u540c\u3058\u53f0\u5e33\u3067\u6271\u3044\u307e\u3059\u3002<\/p>\n\n\n\n\n\n \u30dd\u30a4\u30f3\u30c8<\/strong><\/p>\n\n\n \u5bfe\u8c61\u7bc4\u56f2\u306f\u3001\u5165\u529b\u5024\u30c1\u30a7\u30c3\u30af\u3067\u306f\u306a\u304f\u3001\u8981\u6c42\u304b\u3089\u5ec3\u68c4\u307e\u3067\u306e\u8a3c\u8de1\u3092\u542b\u3081\u3066\u8003\u3048\u307e\u3059\u3002GxP\u5f71\u97ff\u3068\u30c7\u30fc\u30bf\u5b8c\u5168\u6027\u306e\u89b3\u70b9\u3067\u7bc4\u56f2\u3092\u6c7a\u3081\u308b\u3068\u3001\u5f8c\u5de5\u7a0b\u306e\u898b\u901a\u3057\u304c\u7acb\u3066\u3084\u3059\u304f\u306a\u308a\u307e\u3059\u3002<\/p>\n\n<\/div>\n\n\n\n \u88fd\u54c1\u3084\u69cb\u6210\u306f\u3001\u6a5f\u80fd\u540d\u306e\u591a\u3055\u3088\u308a\u3001\u8981\u6c42\u304b\u3089\u904b\u7528\u307e\u3067\u306e\u6d41\u308c\u304c\u9014\u5207\u308c\u306a\u3044\u304b\u3067\u6bd4\u3079\u307e\u3059\u3002\u5c02\u7528\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u7ba1\u7406\u578b\u3001QMS\u3084\u6587\u66f8\u7ba1\u7406\u306e\u62e1\u5f35\u578b\u3001\u30c6\u30b9\u30c8\u30fb\u30c1\u30b1\u30c3\u30c8\u7ba1\u7406\u3068\u306e\u9023\u643a\u578b\u306a\u3069\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n \u3069\u306e\u578b\u3067\u3082\u3001\u96fb\u5b50\u8a18\u9332\u3001\u76e3\u67fb\u8a3c\u8de1\u3001\u6a29\u9650\u304c\u5b9f\u969b\u306eSOP\u3068\u5408\u3046\u304b\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002\u627f\u8a8d\u3068\u5909\u66f4\u7ba1\u7406\u3082\u3001\u540c\u3058SOP\u306b\u6cbf\u3063\u3066\u898b\u307e\u3059\u3002<\/p>\n\n\n\n \u53f0\u5e33\u3067\u306f\u3001\u30b7\u30b9\u30c6\u30e0\u306e\u5229\u7528\u30b5\u30a4\u30c8\u3001\u696d\u52d9\u3001\u30c7\u30fc\u30bf\u306e\u4f5c\u6210\u30fb\u5909\u66f4\u30fb\u627f\u8a8d\u30fb\u4fdd\u5b58\u3092\u628a\u63e1\u3057\u307e\u3059\u3002\u53f0\u5e33\u306b\u6b21\u306e\u60c5\u5831\u3092\u305d\u308d\u3048\u3066\u304a\u304f\u3068\u3001\u5bfe\u8c61\u306e\u629c\u3051\u6f0f\u308c\u3092\u6e1b\u3089\u305b\u307e\u3059\u3002<\/p>\n\n\n\n \u53f0\u5e33\u3068\u5408\u308f\u305b\u3066\u3001\u8981\u6c42\u304b\u3089\u8a66\u9a13\u307e\u3067\u3092\u95a2\u4fc2\u4ed8\u3051\u307e\u3059\u3002URS\u3084\u6a5f\u80fd\u8981\u4ef6\u3001\u30ea\u30b9\u30af\u3092\u8d77\u70b9\u306b\u3001\u30c6\u30b9\u30c8\u30b1\u30fc\u30b9\u306e\u7d50\u679c\u3084\u9038\u8131\u3001\u627f\u8a8d\u307e\u3067\u3092\u8ffd\u3048\u308b\u3088\u3046\u306b\u3057\u307e\u3059\u3002<\/p>\n\n\n\n IQ\u30fbOQ\u30fbPQ\u3001UAT\u3001\u56de\u5e30\u30c6\u30b9\u30c8\u306e\u30b9\u30af\u30ea\u30d7\u30c8\u3092\u767b\u9332\u3057\u307e\u3059\u3002\u8a66\u9a13\u306e\u8a18\u9332\u306b\u306f\u3001\u524d\u63d0\u6761\u4ef6\u3001\u5b9f\u65bd\u8005\u3001\u5b9f\u65bd\u65e5\u6642\u3092\u6b8b\u3057\u3001\u671f\u5f85\u7d50\u679c\u3068\u5b9f\u6e2c\u7d50\u679c\u3001\u5224\u5b9a\u3082\u66f8\u304d\u8fbc\u307f\u307e\u3059\u3002\u518d\u5b9f\u884c\u306e\u7406\u7531\u3084\u8a3c\u8de1\u30d5\u30a1\u30a4\u30eb\u3001\u30ec\u30d3\u30e5\u30fc\u306e\u8a18\u9332\u3082\u6b8b\u3057\u307e\u3059\u3002<\/p>\n\n\n\n \u5931\u6557\u3057\u305f\u30c6\u30b9\u30c8\u3082\u524a\u9664\u305b\u305a\u3001\u5c65\u6b74\u3068\u3057\u3066\u6b8b\u3057\u307e\u3059\u3002\u521d\u56de\u7d50\u679c\u3084\u9038\u8131\u3001\u539f\u56e0\u306e\u8a18\u9332\u306b\u52a0\u3048\u3066\u3001\u662f\u6b63\u3068\u518d\u8a66\u9a13\u306e\u5185\u5bb9\u3082\u4fdd\u6301\u3057\u307e\u3059\u3002<\/p>\n\n\n\n \u96fb\u5b50\u7f72\u540d\u3092\u4f7f\u3046\u5834\u5408\u306f\u3001\u672c\u4eba\u6027\u3068\u7f72\u540d\u306e\u610f\u5473\u3092\u3001\u904b\u7528\u624b\u9806\u3068\u3068\u3082\u306b\u78ba\u304b\u3081\u307e\u3059\u3002\u518d\u5229\u7528\u306e\u9632\u6b62\u3084\u6a29\u9650\u3001\u6642\u523b\u3082\u5bfe\u8c61\u3067\u3059\u3002\u8a18\u9332\u3068\u306e\u7d50\u3073\u4ed8\u304d\u3082\u78ba\u8a8d\u3057\u307e\u3059\u3002<\/p>\n\n\n\n \u76e3\u67fb\u8a3c\u8de1\u306b\u306f\u3001\u30ed\u30b0\u30a4\u30f3\u8a18\u9332\u306b\u52a0\u3048\u3066\u3001GxP\u8a18\u9332\u306e\u4f5c\u6210\u3001\u5909\u66f4\u3001\u524a\u9664\u3001\u627f\u8a8d\u306e\u5c65\u6b74\u304c\u5fc5\u8981\u3067\u3059\u3002\u8ab0\u304c\u4f55\u3092\u3044\u3064\u306a\u305c\u884c\u3063\u305f\u304b\u3092\u3001\u5f8c\u304b\u3089\u518d\u69cb\u6210\u3067\u304d\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002<\/p>\n\n\n\n \u6a29\u9650\u306f\u3001\u6700\u5c0f\u6a29\u9650\u3068\u8077\u52d9\u5206\u96e2\u306e\u8003\u3048\u65b9\u3067\u8a2d\u8a08\u3057\u3001\u30a2\u30af\u30bb\u30b9\u6a29\u306e\u30ec\u30d3\u30e5\u30fc\u3082\u6c7a\u3081\u3066\u304a\u304d\u307e\u3059\u3002\u52a0\u3048\u3066\u3001\u30d0\u30c3\u30af\u30a2\u30c3\u30d7\u3068\u30c7\u30fc\u30bf\u4fdd\u6301\u3001\u30a8\u30af\u30b9\u30dd\u30fc\u30c8\u3068\u691c\u7d22\u3001\u6642\u523b\u306e\u57fa\u6e96\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002<\/p>\n\n\n\n QMS\u3001\u6587\u66f8\u7ba1\u7406\u3001LIMS\u3001MES\u3001ERP\u3001\u30c1\u30b1\u30c3\u30c8\u7ba1\u7406\u306a\u3069\u306e\u5916\u90e8\u30b7\u30b9\u30c6\u30e0\u3068\u9023\u643a\u3059\u308b\u5834\u5408\u306f\u3001\u9023\u643a\u306e\u8a2d\u8a08\u3082\u6b20\u304b\u305b\u307e\u305b\u3093\u3002API\u306e\u5931\u6557\u3084\u518d\u9001\u3001\u30de\u30b9\u30bf\u5909\u66f4\u6642\u306e\u539f\u672c\u6027\u3068\u5c65\u6b74\u3082\u3001\u3042\u308f\u305b\u3066\u8a2d\u8a08\u3057\u307e\u3059\u3002<\/p>\n\n\n\n\n\n \u30dd\u30a4\u30f3\u30c8<\/strong><\/p>\n\n\n \u578b\u3092\u9078\u3076\u3068\u304d\u306f\u3001\u6a5f\u80fd\u306e\u591a\u3055\u3088\u308a\u3001\u81ea\u793e\u306eSOP\u3068\u8981\u6c42\u304b\u3089\u904b\u7528\u307e\u3067\u306e\u6d41\u308c\u306b\u5408\u3046\u304b\u3067\u6c7a\u3081\u308b\u3068\u3001\u5c0e\u5165\u5f8c\u306e\u624b\u623b\u308a\u3092\u6e1b\u3089\u305b\u307e\u3059\u3002<\/p>\n\n<\/div>\n\n\n\n \u5c0e\u5165\u3067\u306f\u3001\u30c4\u30fc\u30eb\u306e\u9078\u5b9a\u3068\u8a2d\u5b9a\u306b\u52a0\u3048\u3066\u3001\u5bfe\u8c61\u696d\u52d9\u3001\u898f\u5236\u3001\u30ea\u30b9\u30af\u3001\u8cac\u4efb\u5206\u754c\u3092\u5b9a\u3081\u307e\u3059\u3002SOP\u3084\u904b\u7528\u3082\u542b\u3081\u3066\u78ba\u8a8d\u3057\u307e\u3059\u3002<\/p>\n\n\n\n PoC\u3092\u5c0f\u3055\u304f\u59cb\u3081\u308b\u5834\u5408\u3067\u3082\u3001\u8907\u6570\u30b5\u30a4\u30c8\u3084\u4ed6\u30b7\u30b9\u30c6\u30e0\u3078\u5e83\u3052\u308b\u4e88\u5b9a\u304c\u3042\u308b\u306a\u3089\u3001\u30c7\u30fc\u30bf\u30e2\u30c7\u30eb\u3001\u6a29\u9650\u3001\u7248\u7ba1\u7406\u3001\u8a3c\u8de1\u306b\u62e1\u5f35\u6027\u3092\u6301\u305f\u305b\u3066\u304a\u304f\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n \u25b6 \u8a73\u7d30\u306f\u3053\u3061\u3089\uff1a\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u958b\u767a\u306e\u9032\u3081\u65b9\/\u3084\u308a\u65b9\/\u6d41\u308c\u3084\u65b9\u6cd5\/\u624b\u6cd5\/\u5de5\u7a0b\/\u624b\u9806<\/a><\/p>\n\n\n\n \u307e\u305a\u3001\u5bfe\u8c61\u30b5\u30a4\u30c8\u3001\u696d\u52d9\u3001\u30b7\u30b9\u30c6\u30e0\u3001\u30c7\u30fc\u30bf\u3001\u5229\u7528\u8005\u3001\u5916\u90e8\u59d4\u8a17\u5148\u3092\u4e00\u89a7\u306b\u3057\u307e\u3059\u3002\u305d\u306e\u3046\u3048\u3067\u3001\u5f71\u97ff\u306b\u5fdc\u3058\u3066\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306e\u6df1\u3055\u3092\u6c7a\u3081\u307e\u3059\u3002\u8a55\u4fa1\u3067\u306f\u3001GxP\u3001\u60a3\u8005\u3084\u88fd\u54c1\u54c1\u8cea\u3001\u30c7\u30fc\u30bf\u5b8c\u5168\u6027\u3001\u696d\u52d9\u505c\u6b62\u6642\u306e\u5f71\u97ff\u3092\u898b\u307e\u3059\u3002<\/p>\n\n\n\n QA\u3001IT\u3001\u696d\u52d9\u30aa\u30fc\u30ca\u30fc\u3001\u30b7\u30b9\u30c6\u30e0\u30aa\u30fc\u30ca\u30fc\u3001\u627f\u8a8d\u8005\u3001\u59d4\u8a17\u5148\u306e\u5f79\u5272\u3092\u3001RACI\u306a\u3069\u3067\u660e\u78ba\u306b\u3057\u307e\u3059\u3002\u7279\u306b\u3001URS\u306e\u627f\u8a8d\u8005\u3084\u30c6\u30b9\u30c8\u5b9f\u884c\u8005\u3001\u9038\u8131\u306e\u5224\u5b9a\u8005\u3092\u5148\u306b\u6c7a\u3081\u3066\u304a\u304f\u3068\u3001\u5f8c\u5de5\u7a0b\u306e\u624b\u623b\u308a\u3092\u6291\u3048\u3089\u308c\u307e\u3059\u3002<\/p>\n\n\n\n \u8981\u6c42\u306b\u306f\u3001\u3069\u306e\u8a18\u9332\u3092\u8ab0\u304c\u3069\u306e\u6761\u4ef6\u3067\u4fdd\u5b58\u3057\u3001\u3069\u306e\u8a3c\u8de1\u3067\u8aac\u660e\u3059\u308b\u304b\u3092\u8a18\u3057\u307e\u3059\u3002<\/p>\n\n\n\n \u8981\u6c42\u306f\u8981\u6c42\u5358\u4f4d\u306b\u5206\u89e3\u3057\u307e\u3059\u3002\u524d\u534a\u3067\u306f\u6587\u66f8\u3001\u30c6\u30b9\u30c8\u3001\u5909\u66f4\u3001\u5b9a\u671f\u30ec\u30d3\u30e5\u30fc\u3001\u6a29\u9650\u3092\u6271\u3044\u3001\u5f8c\u534a\u3067\u306f\u96fb\u5b50\u7f72\u540d\u3001\u76e3\u67fb\u8a3c\u8de1\u3001\u9023\u643a\u3001\u30ec\u30dd\u30fc\u30c8\u3001\u79fb\u884c\u3001\u969c\u5bb3\u5fa9\u65e7\u3092\u6271\u3044\u307e\u3059\u3002<\/p>\n\n\n\n \u6a19\u6e96\u6a5f\u80fd\u3067\u6e80\u305f\u305b\u308bFit\u3068\u3001\u8a2d\u5b9a\u3084\u8ffd\u52a0\u958b\u767a\u304c\u5fc5\u8981\u306aGap\u3001\u904b\u7528\u3067\u88dc\u3046Gap\u3092\u5206\u3051\u3066\u6574\u7406\u3057\u307e\u3059\u3002\u6a19\u6e96\u6a5f\u80fd\u306b\u5bc4\u305b\u308bFit to Standard\u3092\u57fa\u672c\u306b\u3059\u308b\u3068\u3001\u66f4\u65b0\u6642\u306e\u518d\u8a55\u4fa1\u306e\u8ca0\u62c5\u3092\u6291\u3048\u3084\u3059\u304f\u306a\u308a\u307e\u3059\u3002<\/p>\n\n\n\n \u8a66\u9a13\u306e\u7bc4\u56f2\u306f\u3001\u610f\u56f3\u3057\u305f\u7528\u9014\u3068\u30c7\u30fc\u30bf\u306e\u91cd\u8981\u5ea6\u304b\u3089\u6c7a\u3081\u307e\u3059\u3002\u5931\u6557\u6642\u306e\u5f71\u97ff\u3084\u691c\u51fa\u53ef\u80fd\u6027\u3001\u65e2\u5b58\u306e\u7ba1\u7406\u7b56\u3082\u5224\u65ad\u6750\u6599\u306b\u306a\u308a\u307e\u3059\u3002<\/p>\n\n\n\n ICH Q9(R1)\u306f\u54c1\u8cea\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u3092\u3001\u30ea\u30b9\u30af\u8a55\u4fa1\u3001\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u3001\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u3001\u30ec\u30d3\u30e5\u30fc\u306e\u7d99\u7d9a\u7684\u306a\u30d7\u30ed\u30bb\u30b9\u3068\u3057\u3066\u6574\u7406\u3057\u3066\u3044\u307e\u3059\uff08\u51fa\u5178: ICH Q9(R1) Quality Risk Management\u30012021\u5e74\uff09\u3002<\/p>\n\n\n\n \u3053\u306e\u8003\u3048\u65b9\u306f\u3001\u8981\u4ef6\u3068\u30c6\u30b9\u30c8\u306b\u53cd\u6620\u3055\u305b\u307e\u3059\u3002\u91cd\u8981\u306a\u6a5f\u80fd\u3067\u306f\u3001\u8ca0\u8377\u3084\u7570\u5e38\u7cfb\u306e\u8a66\u9a13\u306b\u52a0\u3048\u3066\u3001\u6a29\u9650\u3001\u76e3\u67fb\u8a3c\u8de1\u3001\u30d0\u30c3\u30af\u30a2\u30c3\u30d7\u5fa9\u65e7\u3082\u8a66\u9a13\u3057\u307e\u3059\u3002<\/p>\n\n\n\n \u958b\u767a\u3001\u691c\u8a3c\u3001\u672c\u756a\u306e\u74b0\u5883\u3092\u5206\u3051\u3001\u8a2d\u5b9a\u5024\u3068\u30de\u30b9\u30bf\u3092\u7ba1\u7406\u3057\u307e\u3059\u3002\u6a29\u9650\u3084\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u3001\u901a\u77e5\u3001\u4fdd\u6301\u671f\u9593\u3001\u9023\u643a\u8a2d\u5b9a\u3082\u3001\u540c\u3058\u7ba1\u7406\u306e\u5bfe\u8c61\u3067\u3059\u3002<\/p>\n\n\n\n \u672c\u756a\u753b\u9762\u3067\u8a2d\u5b9a\u3092\u76f4\u63a5\u5909\u3048\u308b\u3068\u3001\u5909\u66f4\u5185\u5bb9\u3092\u8aac\u660e\u3067\u304d\u306a\u304f\u306a\u308a\u307e\u3059\u3002\u305d\u306e\u305f\u3081\u3001\u958b\u767a\u30fb\u691c\u8a3c\u30fb\u672c\u756a\u306e\u79fb\u9001\u624b\u9806\u3068\u627f\u8a8d\u3092\u7528\u610f\u3057\u307e\u3059\u3002<\/p>\n\n\n\n \u30d1\u30c3\u30b1\u30fc\u30b8\u3084SaaS\u3067\u3082\u3001\u81ea\u793e\u306e\u8a2d\u5b9a\u3001\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\u3001\u30de\u30b9\u30bf\u3001\u904b\u7528\u624b\u9806\u306f\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u5bfe\u8c61\u306b\u306a\u308a\u5f97\u307e\u3059\u3002\u30d9\u30f3\u30c0\u30fc\u306e\u6a19\u6e96\u6587\u66f8\u3092\u4f7f\u3046\u5834\u5408\u3082\u3001\u5bfe\u8c61\u30d0\u30fc\u30b8\u30e7\u30f3\u3068\u81ea\u793e\u306e\u610f\u56f3\u3057\u305f\u7528\u9014\u306b\u7167\u3089\u3057\u3066\u9069\u7528\u7bc4\u56f2\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002<\/p>\n\n\n\n \u627f\u8a8d\u6e08\u307f\u306e\u30b9\u30af\u30ea\u30d7\u30c8\u3068\u30c7\u30fc\u30bf\u3067\u30c6\u30b9\u30c8\u3057\u3001\u7d50\u679c\u3068\u8a3c\u8de1\u3092\u305d\u306e\u5834\u3067\u8a18\u9332\u3057\u307e\u3059\u3002<\/p>\n\n\n\n \u671f\u5f85\u7d50\u679c\u3068\u5b9f\u6e2c\u7d50\u679c\u304c\u7570\u306a\u308b\u5834\u5408\u306f\u3001\u9038\u8131\u3084\u8ab2\u984c\u3068\u3057\u3066\u8d77\u7968\u3057\u307e\u3059\u3002\u5f71\u97ff\u3084\u539f\u56e0\u3001\u662f\u6b63\u3001\u518d\u8a66\u9a13\u3001\u6700\u7d42\u5224\u5b9a\u3092\u6b8b\u3057\u3066\u304a\u304d\u307e\u3059\u3002<\/p>\n\n\n\n KPI\u3092\u5408\u683c\u7387\u3060\u3051\u306b\u7d5e\u308b\u3068\u3001\u8a18\u9332\u306e\u4e0d\u5099\u3084\u518d\u8a66\u9a13\u306e\u8ca0\u62c5\u306f\u898b\u3048\u306a\u304f\u306a\u308a\u307e\u3059\u3002\u305d\u3053\u3067\u3001\u30ea\u30ea\u30fc\u30b9\u5224\u5b9a\u3067\u306f\u3001\u672a\u89e3\u6c7a\u306e\u9038\u8131\u3084\u6559\u80b2\u3001\u624b\u9806\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002\u3055\u3089\u306b\u3001\u30d0\u30c3\u30af\u30a2\u30c3\u30d7\u3001\u6a29\u9650\u3001\u30b5\u30dd\u30fc\u30c8\u7a93\u53e3\u3001\u5207\u308a\u623b\u3057\u6761\u4ef6\u3082\u898b\u307e\u3059\u3002<\/p>\n\n\n\n \u79fb\u884c\u5f8c\u3082\u8a3c\u8de1\u3092\u4fdd\u3064\u305f\u3081\u3001\u30c7\u30fc\u30bf\u6574\u7406\u304b\u3089\u5b9a\u671f\u30ec\u30d3\u30e5\u30fc\u307e\u3067\u3092\u9806\u306b\u9032\u3081\u307e\u3059\u3002<\/p>\n\n\n \u5c0e\u5165\u306e\u5b8c\u4e86\u306f\u3001\u8aac\u660e\u53ef\u80fd\u306a\u72b6\u614b\u3092\u7dad\u6301\u3067\u304d\u308b\u3068\u3053\u308d\u307e\u3067\u542b\u3081\u3066\u5b9a\u7fa9\u3057\u307e\u3059\u3002\u7a3c\u50cd\u3092\u59cb\u3081\u305f\u65e5\u306f\u3001\u305d\u306e\u901a\u904e\u70b9\u306e\u4e00\u3064\u3067\u3059\u3002<\/p>\n\n\n\n\n\n \u30dd\u30a4\u30f3\u30c8<\/strong><\/p>\n\n\n \u5bfe\u8c61\u7bc4\u56f2\u3068\u8cac\u4efb\u5206\u754c\u3092\u5148\u306b\u6c7a\u3081\u3066\u304a\u304f\u3068\u3001\u5f8c\u5de5\u7a0b\u306e\u624b\u623b\u308a\u3092\u6291\u3048\u3089\u308c\u307e\u3059\u3002PoC\u304b\u3089\u5e83\u3052\u308b\u4e88\u5b9a\u304c\u3042\u308c\u3070\u3001\u30c7\u30fc\u30bf\u30e2\u30c7\u30eb\u3084\u6a29\u9650\u3001\u7248\u7ba1\u7406\u3001\u8a3c\u8de1\u3092\u3069\u3053\u307e\u3067\u62e1\u5f35\u3067\u304d\u308b\u5f62\u306b\u3059\u308b\u304b\u3092\u521d\u671f\u306b\u6c7a\u3081\u3066\u304a\u304d\u307e\u3059\u3002<\/p>\n\n<\/div>\n\n\n\n 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RFP\u306b\u306f\u3001\u5fa9\u65e7\u76ee\u6a19\u3084\u30c7\u30fc\u30bf\u306e\u6240\u5728\u3092\u8a18\u8f09\u3057\u307e\u3059\u3002\u52a0\u3048\u3066\u3001\u30b5\u30d6\u30d7\u30ed\u30bb\u30c3\u30b5\u30fc\u3084\u30ed\u30b0\u306e\u53d6\u5f97\u671f\u9593\u3001\u76e3\u67fb\u6642\u306e\u8cc7\u6599\u63d0\u4f9b\u3001\u5951\u7d04\u7d42\u4e86\u6642\u306e\u8fd4\u5374\u5f62\u5f0f\u3082\u542b\u3081\u307e\u3059\u3002<\/p>\n\n\n\n \u9078\u5b9a\u3067\u306f\u753b\u9762\u3084\u521d\u671f\u8cbb\u7528\u3060\u3051\u3067\u306a\u304f\u3001GxP\u696d\u52d9\u306e\u7406\u89e3\u3001CSV\u30fbCSA\u306e\u65b9\u6cd5\u8ad6\u3001\u6587\u66f8\u3068\u30c6\u30b9\u30c8\u306e\u9023\u643a\u3001\u30af\u30e9\u30a6\u30c9\u306e\u8cac\u4efb\u5206\u754c\u3092\u8a55\u4fa1\u3057\u307e\u3059\u3002<\/p>\n\n\n\n \u5c0e\u5165\u5f8c\u306e\u5909\u66f4\u7ba1\u7406\u3084\u3001\u56fd\u5185\u306e\u554f\u3044\u5408\u308f\u305b\u4f53\u5236\u3082\u78ba\u8a8d\u3057\u307e\u3059\u3002RFP\u306b\u306f\u3001\u5bfe\u8c61\u7bc4\u56f2\u3084\u30e6\u30fc\u30b6\u30fc\u30fb\u30b5\u30a4\u30c8\u6570\u3001\u9023\u643a\u5148\u3001\u79fb\u884c\u91cf\u3092\u8a18\u3057\u307e\u3059\u3002\u3042\u308f\u305b\u3066\u3001\u898f\u5236\u5e02\u5834\u3001\u6210\u679c\u7269\u3001\u9867\u5ba2\u4f5c\u696d\u3001\u7d0d\u671f\u3001\u4e88\u7b97\u3001\u4fdd\u5b88\u6761\u4ef6\u3082\u66f8\u304d\u8fbc\u307f\u307e\u3059\u3002<\/p>\n\n\n\n \u904e\u53bb\u306e\u958b\u767a\u4ef6\u6570\u3088\u308a\u3082\u3001\u5bfe\u8c61\u696d\u52d9\u3068\u8cac\u4efb\u7bc4\u56f2\u304c\u81ea\u793e\u306b\u8fd1\u3044\u304b\u3092\u898b\u307e\u3059\u3002\u88fd\u9020\u3084\u54c1\u8cea\u8a66\u9a13\u3001\u81e8\u5e8a\u3001\u7814\u7a76\u3001\u7269\u6d41\u306a\u3069\u3001\u5bfe\u8c61\u9818\u57df\u306e\u7d4c\u9a13\u3092\u8cea\u554f\u3057\u307e\u3059\u3002\u898f\u5236\u5e02\u5834\u3068\u6210\u679c\u7269\u306e\u4f5c\u6210\u62c5\u5f53\u3082\u3001\u3042\u308f\u305b\u3066\u805e\u3044\u3066\u304a\u304d\u307e\u3059\u3002<\/p>\n\n\n\n GAMP 5\u3084CSA\u306e\u53d6\u308a\u5165\u308c\u65b9\u306b\u3064\u3044\u3066\u3001\u5b9f\u4f8b\u3092\u6319\u3052\u3066\u8aac\u660e\u3067\u304d\u308b\u304b\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002\u30ea\u30b9\u30af\u8a55\u4fa1\u3084\u8981\u6c42\u3068\u8a66\u9a13\u306e\u8ffd\u8de1\u3082\u3001\u540c\u3058\u89b3\u70b9\u3067\u898b\u307e\u3059\u3002\u3055\u3089\u306b\u3001\u9038\u8131\u30fbCAPA\u3068\u5b9a\u671f\u30ec\u30d3\u30e5\u30fc\u306b\u3064\u3044\u3066\u3082\u3001\u5b9f\u4f8b\u3067\u8a9e\u308c\u308b\u304b\u3092\u78ba\u304b\u3081\u307e\u3059\u3002<\/p>\n\n\n\n \u8aac\u660e\u3067\u304d\u308b\u4e8b\u696d\u8005\u306f\u3001\u5c0e\u5165\u5f8c\u306e\u5224\u65ad\u3082\u652f\u63f4\u3057\u3084\u3059\u3044\u50be\u5411\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n \u88fd\u54c1\u306e\u7d39\u4ecb\u3088\u308a\u3082\u3001\u81ea\u793e\u306e\u4ee3\u8868\u7684\u306a\u8981\u6c42\u3092\u4f7f\u3063\u305f\u4e00\u9023\u306e\u64cd\u4f5c\u3092\u30c7\u30e2\u3057\u3066\u3082\u3089\u3044\u307e\u3059\u3002<\/p>\n\n\n\n \u76e3\u67fb\u8a3c\u8de1\u306e\u5b9f\u884c\u8005\u3001\u5185\u5bb9\u3001\u6642\u523b\u3001\u7406\u7531\u3082\u3001\u753b\u9762\u3067\u78ba\u304b\u3081\u307e\u3059\u3002\u7f72\u540d\u306e\u610f\u5473\u3084\u65e7\u7248\u306e\u53c2\u7167\u3001\u6a29\u9650\u306b\u3088\u308b\u5236\u9650\u3001CSV\u8cc7\u6599\u306e\u30a8\u30af\u30b9\u30dd\u30fc\u30c8\u3082\u3001\u3042\u308f\u305b\u3066\u898b\u3066\u304a\u304d\u307e\u3059\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u904b\u7528\u306e\u8ca0\u8377\u3092\u628a\u63e1\u3057\u3084\u3059\u304f\u306a\u308a\u307e\u3059\u3002<\/p>\n\n\n\n \u898b\u7a4d\u7bc4\u56f2\u3068\u5951\u7d04\u5f8c\u306e\u5f79\u5272\u3092\u63c3\u3048\u308b\u305f\u3081\u3001\u6b21\u306e\u9805\u76ee\u3092\u5206\u3051\u3066\u78ba\u8a8d\u3057\u307e\u3059\u3002<\/p>\n\n\n\n \u25b6 \u8a73\u7d30\u306f\u3053\u3061\u3089\uff1a\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u958b\u767a\u3067\u304a\u3059\u3059\u3081\u306e\u958b\u767a\u4f1a\u793e\/\u30d9\u30f3\u30c0\u30fc6\u9078\u3068\u9078\u3073\u65b9<\/a><\/p>\n\n\n\n \u25b6 \u8a73\u7d30\u306f\u3053\u3061\u3089\uff1a\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u958b\u767a\u306e\u767a\u6ce8\/\u5916\u6ce8\/\u4f9d\u983c\/\u59d4\u8a17\u65b9\u6cd5\u306b\u3064\u3044\u3066<\/a><\/p>\n\n\n\n\n\n \u30dd\u30a4\u30f3\u30c8<\/strong><\/p>\n\n\n \u958b\u767a\u4f1a\u793e\u3092\u9078\u3076\u3068\u304d\u306f\u3001\u753b\u9762\u306e\u826f\u3055\u3084\u521d\u671f\u8cbb\u7528\u3088\u308a\u3001GxP\u696d\u52d9\u306e\u7406\u89e3\u3068CSV\u30fbCSA\u306e\u65b9\u6cd5\u8ad6\u3001\u5909\u66f4\u7ba1\u7406\u306e\u4f53\u5236\u3092\u78ba\u304b\u3081\u308b\u3053\u3068\u304c\u5224\u65ad\u306e\u4e2d\u5fc3\u306b\u306a\u308a\u307e\u3059\u3002RFP\u306b\u306f\u5bfe\u8c61\u7bc4\u56f2\u3068\u9867\u5ba2\u4f5c\u696d\u3092\u5206\u3051\u3066\u66f8\u304d\u307e\u3059\u3002<\/p>\n\n<\/div>\n\n\n\n \u5c0e\u5165\u76f4\u5f8c\u306b\u52d5\u3044\u3066\u3044\u3066\u3082\u3001\u5909\u66f4\u3084\u4eba\u306e\u5165\u308c\u66ff\u308f\u308a\u3067\u8a3c\u8de1\u304c\u5d29\u308c\u308b\u3053\u3068\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n \u539f\u56e0\u306f\u3001\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306e\u5916\u306b\u7f6e\u304b\u308c\u305f\u9805\u76ee\u306b\u3042\u308b\u3053\u3068\u3082\u3042\u308a\u307e\u3059\u3002\u5bfe\u8c61\u7bc4\u56f2\u3001\u8cac\u4efb\u5206\u754c\u3001SOP\u3001\u30c7\u30fc\u30bf\u79fb\u884c\u3001\u627f\u8a8d\u3001\u5b9a\u671f\u30ec\u30d3\u30e5\u30fc\u304c\u305d\u306e\u4f8b\u3067\u3059\u3002\u305d\u3053\u3067\u3001\u5178\u578b\u7684\u306a\u5931\u6557\u3092\u60f3\u5b9a\u3057\u3001\u904b\u7528KPI\u3068\u30ec\u30d3\u30e5\u30fc\u5468\u671f\u3092\u6c7a\u3081\u3066\u304a\u304d\u307e\u3059\u3002<\/p>\n\n\n\n Excel\u3092\u53d6\u308a\u8fbc\u3080\u3060\u3051\u3067\u306f\u3001\u65e7\u7248\u3001\u91cd\u8907\u3001\u7a7a\u6b04\u3001\u81ea\u7531\u8a18\u8ff0\u3001\u500b\u4eba\u30d5\u30a9\u30eb\u30c0\u306e\u30d5\u30a1\u30a4\u30eb\u304c\u6b8b\u308a\u307e\u3059\u3002<\/p>\n\n\n\n \u305d\u3053\u3067\u3001\u6b63\u672c\u3084\u4fdd\u5b58\u671f\u9593\u3001\u627f\u8a8d\u72b6\u614b\u3092\u5b9a\u3081\u3066\u304a\u304d\u307e\u3059\u3002\u5bfe\u8c61\u30b7\u30b9\u30c6\u30e0\u3084\u7248\u3001\u6240\u6709\u8005\u3082\u6c7a\u3081\u3066\u3001\u79fb\u884c\u524d\u5f8c\u306e\u4ef6\u6570\u3068\u5185\u5bb9\u3092\u7167\u5408\u3057\u307e\u3059\u3002<\/p>\n\n\n\n \u79fb\u884c\u30c7\u30fc\u30bf\u3092\u65b0\u30b7\u30b9\u30c6\u30e0\u306e\u8a18\u9332\u3068\u3057\u3066\u6271\u3046\u5834\u5408\u306f\u3001\u79fb\u884c\u624b\u9806\u3068\u691c\u8a3c\u7d50\u679c\u3001\u4f8b\u5916\u51e6\u7406\u3001\u627f\u8a8d\u3092\u3001\u5225\u306e\u8a3c\u8de1\u3068\u3057\u3066\u6b8b\u3057\u307e\u3059\u3002<\/p>\n\n\n\n SaaS\u3084\u30d1\u30c3\u30b1\u30fc\u30b8\u306e\u66f4\u65b0\u306f\u5fc5\u8981\u3067\u3059\u304c\u3001\u5f71\u97ff\u304c\u53ca\u3076\u53ef\u80fd\u6027\u3082\u3042\u308a\u307e\u3059\u3002\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u3084\u6a29\u9650\u3001\u5e33\u7968\u3001API\u3001\u76e3\u67fb\u8a3c\u8de1\u3001\u30c6\u30b9\u30c8\u30b9\u30af\u30ea\u30d7\u30c8\u304c\u5bfe\u8c61\u306b\u306a\u308a\u5f97\u307e\u3059\u3002<\/p>\n\n\n\n \u30ea\u30ea\u30fc\u30b9\u30ce\u30fc\u30c8\u3092\u53d7\u3051\u53d6\u3063\u305f\u3089\u3001\u5909\u66f4\u306e\u91cd\u8981\u5ea6\u3092\u8a55\u4fa1\u3057\u3001\u5f71\u97ff\u3092\u53d7\u3051\u308b\u8981\u6c42\u3001\u30c6\u30b9\u30c8\u3001\u624b\u9806\u3001\u6559\u80b2\u3092\u7279\u5b9a\u3057\u307e\u3059\u3002<\/p>\n\n\n\n \u91cd\u8981\u306a\u5909\u66f4\u306b\u9650\u3063\u3066\u56de\u5e30\u30c6\u30b9\u30c8\u3092\u884c\u3046\u306a\u3069\u3001\u30ea\u30b9\u30af\u306b\u5fdc\u3058\u3066\u518d\u8a55\u4fa1\u3092\u6c7a\u3081\u307e\u3059\u3002\u305d\u3046\u3059\u308b\u3068\u3001\u6bce\u56de\u3059\u3079\u3066\u3092\u3084\u308a\u76f4\u3059\u8ca0\u62c5\u3092\u6291\u3048\u3089\u308c\u307e\u3059\u3002<\/p>\n\n\n\n AI\u3067\u30c6\u30b9\u30c8\u30b1\u30fc\u30b9\u3001\u30ea\u30b9\u30af\u5019\u88dc\u3001\u6587\u66f8\u306e\u4e0b\u66f8\u304d\u3092\u4f5c\u308b\u3068\u3001\u4f5c\u696d\u6642\u9593\u3092\u77ed\u7e2e\u3067\u304d\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002\u5229\u7528\u6642\u306f\u3001\u6b21\u306e\u30ea\u30b9\u30af\u3068\u7ba1\u7406\u4e8b\u9805\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002<\/p>\n\n\n\n EMA\u3068FDA\u304c2026\u5e741\u6708\u306b\u516c\u8868\u3057\u305f\u533b\u85ac\u54c1\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u5411\u3051AI\u306e\u539f\u5247\u3082\u3001\u4eba\u306e\u76e3\u7763\u3068\u54c1\u8cea\u7ba1\u7406\u3092\u91cd\u8996\u3059\u308b\u65b9\u5411\u6027\u3067\u3059\uff08\u51fa\u5178: EMA\u30fbFDA\u30012026\u5e74\uff09\u3002<\/p>\n\n\n\n \u898f\u5236\u5bfe\u5fdc\u3067\u306f\u3001\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u3092\u57cb\u3081\u308b\u3053\u3068\u81ea\u4f53\u3092\u76ee\u6a19\u306b\u3059\u308b\u3088\u308a\u3001\u9069\u7528\u898f\u5247\u3001\u30ac\u30a4\u30c0\u30f3\u30b9\u3001\u793e\u5185SOP\u3001\u610f\u56f3\u3057\u305f\u7528\u9014\u3092\u7d50\u3073\u4ed8\u3051\u308b\u3053\u3068\u304c\u5927\u5207\u3067\u3059\u3002<\/p>\n\n\n\n \u898f\u5236\u3084\u30ac\u30a4\u30c0\u30f3\u30b9\u306e\u6539\u8a02\u306b\u5099\u3048\u3066\u3001\u60c5\u5831\u6e90\u3001\u5f71\u97ff\u8a55\u4fa1\u3001\u5bfe\u5fdc\u65b9\u91dd\u3001\u627f\u8a8d\u3001\u5b9f\u65bd\u72b6\u6cc1\u3092\u5909\u66f4\u7ba1\u7406\u306b\u767b\u9332\u3067\u304d\u308b\u4ed5\u7d44\u307f\u3092\u4f5c\u308a\u307e\u3059\u3002<\/p>\n\n\n\n FDA\u306ePart 11\u30ac\u30a4\u30c0\u30f3\u30b9\u306f\u3001\u6cd5\u4ee4\u4e0a\u4fdd\u5b58\u30fb\u63d0\u51fa\u304c\u5fc5\u8981\u306a\u8a18\u9332\u3092\u96fb\u5b50\u5f62\u5f0f\u3067\u7dad\u6301\u3057\u3001\u898f\u5236\u696d\u52d9\u3067\u4fe1\u983c\u3059\u308b\u5834\u5408\u306a\u3069\u306b\u9069\u7528\u7bc4\u56f2\u3092\u5224\u65ad\u3059\u308b\u8003\u3048\u65b9\u3092\u793a\u3057\u3066\u3044\u307e\u3059\uff08\u51fa\u5178: FDA, Part 11 Electronic Records; Electronic Signatures – Scope and Application\u30012003\u5e74\uff09\u3002<\/p>\n\n\n\n \u30a2\u30af\u30bb\u30b9\u5236\u5fa1\u3084\u6a29\u9650\u78ba\u8a8d\u3001\u6559\u80b2\u8a13\u7df4\u3001\u96fb\u5b50\u7f72\u540d\u3001\u6587\u66f8\u7ba1\u7406\u3082\u3001\u6b20\u304b\u305b\u306a\u3044\u8981\u7d20\u3067\u3059\u3002\u5bfe\u8c61\u8a18\u9332\u3068\u6b63\u672c\u3001\u96fb\u5b50\u8a18\u9332\u3092\u4fe1\u983c\u3059\u308b\u696d\u52d9\u3092\u6587\u66f8\u306b\u307e\u3068\u3081\u3001\u3059\u3079\u3066\u306e\u30c7\u30fc\u30bf\u306b\u4e00\u5f8b\u306e\u7ba1\u7406\u3092\u304b\u3051\u306a\u3044\u3088\u3046\u306b\u3057\u307e\u3059\u3002<\/p>\n\n\n\n \u6b27\u5dde\u59d4\u54e1\u4f1a\u306f2025\u5e747\u6708\u3001GMP Chapter 4\u3068Annex 11\u306e\u6539\u8a02\u306b\u3064\u3044\u3066\u610f\u898b\u52df\u96c6\u3092\u958b\u59cb\u3057\u307e\u3057\u305f\u3002AI\u3092\u6271\u3046\u65b0\u3057\u3044Annex 22\u3082\u5bfe\u8c61\u3067\u3001\u52df\u96c6\u306f\u540c\u5e7410\u6708\u306b\u7de0\u3081\u5207\u3089\u308c\u307e\u3057\u305f\u3002<\/p>\n\n\n\n \u3053\u306e\u5354\u8b70\u306f\u6539\u8a02\u306e\u65b9\u5411\u6027\u3092\u793a\u3059\u3082\u306e\u3067\u3001\u8a18\u4e8b\u57f7\u7b46\u6642\u70b9\u3067\u78ba\u5b9a\u3057\u305f\u6700\u7d42\u8981\u4ef6\u3068\u306f\u7570\u306a\u308a\u307e\u3059\uff08\u51fa\u5178: European Commission, Stakeholders\u2019 Consultation on EudraLex Volume 4\u30012025\u5e74\uff09\u3002<\/p>\n\n\n\n \u305d\u306e\u305f\u3081\u3001\u30b7\u30b9\u30c6\u30e0\u8a2d\u8a08\u3067\u306f\u3001\u73fe\u884c\u306e\u9069\u7528\u898f\u5236\u3092\u6e80\u305f\u3057\u3064\u3064\u3001AI\u306e\u7528\u9014\u3001\u30c7\u30fc\u30bf\u306e\u51fa\u6240\u3001\u30e2\u30c7\u30eb\u5909\u66f4\u3001\u51fa\u529b\u30ec\u30d3\u30e5\u30fc\u3001\u76e3\u67fb\u53ef\u80fd\u6027\u3092\u7ba1\u7406\u3067\u304d\u308b\u4f59\u5730\u3092\u6b8b\u3057\u307e\u3059\u3002<\/p>\n\n\n\n MHRA\u306eGxP\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u30ac\u30a4\u30c0\u30f3\u30b9\u306f\u3001\u76e3\u67fb\u8a3c\u8de1\u3092\u8a18\u9332\u306e\u4f5c\u6210\u30fb\u5909\u66f4\u30fb\u524a\u9664\u306a\u3069\u306e\u5c65\u6b74\u3068\u3057\u3066\u6271\u3044\u307e\u3059\u3002<\/p>\n\n\n \u540c\u30ac\u30a4\u30c0\u30f3\u30b9\u306f\u3001\u8ab0\u304c\u4f55\u3092\u3044\u3064\u306a\u305c\u884c\u3063\u305f\u304b\u3092\u518d\u69cb\u6210\u3067\u304d\u308b\u3053\u3068\u3082\u8aac\u660e\u3057\u3066\u3044\u307e\u3059\uff08\u51fa\u5178: MHRA, Guidance on GxP Data Integrity\u30012018\u5e74\u30fb\u6700\u7d42\u66f4\u65b02021\u5e74\uff09\u3002<\/p>\n\n\n\n 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AI\u3084\u898f\u5236\u6539\u8a02\u3092\u60f3\u5b9a\u3057\u3066\u3001\u904b\u7528\u30eb\u30fc\u30eb\u3092\u8a2d\u8a08\u3057\u307e\u3059\u3002\u5229\u7528\u76ee\u7684\u3084\u30c7\u30fc\u30bf\u306e\u51fa\u6240\u3001\u30e2\u30c7\u30eb\u3084\u8a2d\u5b9a\u306e\u7248\u3001\u51fa\u529b\u30ec\u30d3\u30e5\u30fc\u3092\u8a18\u9332\u306e\u5bfe\u8c61\u306b\u3057\u307e\u3059\u3002\u76e3\u67fb\u8a3c\u8de1\u3068\u518d\u8a55\u4fa1\u306e\u624b\u9806\u3082\u3001\u3042\u308f\u305b\u3066\u6574\u3048\u307e\u3059\u3002<\/p>\n\n\n\n \u5c0e\u5165\u306e\u5b8c\u4e86\u306f\u3001\u5909\u66f4\u5f8c\u3082\u54c1\u8cea\u3068\u30c7\u30fc\u30bf\u5b8c\u5168\u6027\u3092\u8aac\u660e\u3067\u304d\u308b\u904b\u7528\u304c\u7d9a\u304f\u72b6\u614b\u3068\u3057\u3066\u5b9a\u3081\u307e\u3059\u3002\u7a3c\u50cd\u958b\u59cb\u306e\u65e5\u306f\u3001\u305d\u306e\u901a\u904e\u70b9\u306b\u3059\u304e\u307e\u305b\u3093\u3002<\/p>\n\n\n\n \u25bc\u95a2\u9023\u8a18\u4e8b\u4e00\u89a7<\/strong> 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<\/figure>\n<\/div>\n<\/div>\n\n\n\n![\"\"](\"https:\/\/www.ripla.co.jp\/blog\/wp-content\/uploads\/2025\/05\/\u30b9\u30af\u30ea\u30fc\u30f3\u30b7\u30e7\u30c3\u30c8-2026-07-07-144340-1024x369.png\")
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<\/a><\/figure>\n\n\n\n![\"\u5f35\u7530\u8c37\u51cc\u592e\"](\"https:\/\/www.ripla.co.jp\/blog\/wp-content\/uploads\/2026\/03\/\u30d7\u30ed\u30d5\u753b\u50cf.png\")
\n <\/div>\n