{"id":15983,"date":"2021-09-14T12:54:54","date_gmt":"2021-09-14T03:54:54","guid":{"rendered":"https:\/\/www.fsz.co.jp\/?post_type=fszblog&#038;p=15983"},"modified":"2025-04-18T15:30:40","modified_gmt":"2025-04-18T06:30:40","slug":"dataintegrity","status":"publish","type":"news","link":"https:\/\/www.fsz.co.jp\/?news=dataintegrity","title":{"rendered":"\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3 Data Integrity \u30af\u30e9\u30a6\u30c9\u30b7\u30b9\u30c6\u30e0\u5c0e\u5165\u30c1\u30a7\u30c3\u30af\u30dd\u30a4\u30f3\u30c8"},"content":{"rendered":"\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p>\u306f\u3058\u3081\u306b<br>\u533b\u85ac\u3001\u88fd\u85ac\u3001\u533b\u7642\u6a5f\u5668\u696d\u754c\u306b\u304a\u3051\u308bGMP\u3001GQP\u3001GDP\u3001GCP\u3001GLP\u3001GPSP\u3001GVP\u306a\u3069\u306a\u3069GxP\u95a2\u9023\u696d\u52d9\u3001\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30a3\u30b0\u30ea\u30c6\u30a3\uff08Data Integrity\uff09\u306e\u30af\u30e9\u30a6\u30c9\u30b7\u30b9\u30c6\u30e0\u5c0e\u5165\u306e\u305f\u3081\u306e\u30c1\u30a7\u30c3\u30af\u30dd\u30a4\u30f3\u30c8\u3092\u5217\u6319\u3057\u3066\u304a\u308a\u307e\u3059\u3002\u304d\u308c\u3044\u306b\u6574\u7406\u306f\u3067\u304d\u3066\u304a\u308a\u307e\u305b\u3093\u304c\u3001\u5fa1\u53c2\u8003\u306b\u306a\u308c\u3070\u5e78\u3044\u3067\u3059\u3002<br><br>\u5f0a\u793e\u3067\u306f\u3001GMP\u5bfe\u5fdc\u30b7\u30b9\u30c6\u30e0\u958b\u767a\u3001RFP\u30fbURS\u4f5c\u6210\u3001\u5c0e\u5165\u30b3\u30f3\u30b5\u30eb\u30c6\u30a3\u30f3\u30b0\u306a\u3069\u304a\u5f15\u304d\u53d7\u3051\u3057\u3066\u3044\u307e\u3059\u306e\u3067\u3001\u304a\u6c17\u8efd\u306b\u3054\u76f8\u8ac7\u304f\u3060\u3055\u3044\u3002<\/p>\n<cite>\u30d5\u30a3\u30e9\u30fc\u30b7\u30b9\u30c6\u30e0\u30ba GxP\u30b7\u30b9\u30c6\u30e0\u30b5\u30fc\u30d3\u30b9\u30c1\u30fc\u30e0<\/cite><\/blockquote>\n\n\n\n<ul class=\"is-style-vk-triangle-mark wp-block-list\">\n<li>\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30a3\u30b0\u30ea\u30c6\u30a3\uff08Data Integrity\uff09\u89b3\u70b9\u3068\u3044\u3048\u3070\u3001ALCOA\u304c\u539f\u70b9\u3002<br>\u30e8\u30fc\u30ed\u30c3\u30d1\u304b\u3089\u59cb\u307e\u3063\u305f\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u3078\u306e\u95a2\u5fc3\u306e\u9ad8\u307e\u308a\u306f\u3001\u88fd\u85ac\u696d\u754c\u306b\u304a\u3051\u308b\u30b0\u30ed\u30fc\u30d0\u30eb\u3067\u306e\u8ab2\u984c\u3068\u306a\u3063\u3066\u304d\u3066\u3044\u307e\u3059\u30022018\u5e74\u306b\u5b9f\u65bd\u3055\u308c\u308b\u65e5\u672c\u306e\u6539\u6b63GMP\u7701\u4ee4\u3067\u3082\u3001\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u306f\u6539\u6b63\u306e\u5927\u304d\u306a\u67f1\u306e\u4e00\u3064\u306b\u306a\u3063\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u898f\u5236\u8981\u4ef6\u306e\u57fa\u672c\u7684\u306a\u8003\u3048\u65b9\u306f\u3001ALCOA\uff5cALCOA-CCEA\u306e\u539f\u5247\u3092\u8003\u3048\u308b\u3053\u3068\u3060\u3068\u601d\u3044\u307e\u3059\u3002\u4e0b\u8a18\u306fALCOA-CCEA\uff5c\u30a2\u30eb\u30b3\u30a2-\u30d7\u30e9\u30b9<\/li>\n<\/ul>\n\n\n\n<figure class=\"wp-block-table aligncenter\"><table><tbody><tr><td>Attributable<br>\u5e30\u5c5e\u6027<\/td><td>\u5e30\u5c5e\/\u8cac\u4efb\u306e\u6240\u5728\u304c\u660e\u78ba\u3067\u3042\u308b\u3002 \u30c7\u30fc\u30bf\u306e\u8a18\u9332\u8005\u304c\u660e\u78ba\u3067\u3042\u308b\u3002<br>\u30c7\u30fc\u30bf\u3092\u89b3\u6e2c\u3001\u8a18\u9332\u3001\u8a02\u6b63\u3057\u305f\u500b\u4eba\u3092\u7279\u5b9a\u3057\u3001?\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3002<\/td><\/tr><tr><td>Legible<br>\u5224\u8aad\u6027<\/td><td>\u5224\u8aad\/\u7406\u89e3\u3067\u304d\u308b\u3002\u8ab0\u3082\u304c\u9593\u9055\u3044\u306a\u304f\u7c21\u5358\u306b\u8aad\u307f\u53d6\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3002<\/td><\/tr><tr><td>Contemporaneous<br>\u540c\u6642\u6027<\/td><td>\u540c\u6642\u3067\u3042\u308b\u3002\u30c7\u30fc\u30bf\u304c\u767a\u751f\u3057\u3066\u304b\u3089\u3067\u304d\u308b\u3060\u3051\u901f\u3084\u304b\u306b\u8a18\u9332\u3059\u308b\u3002\u65e5\u4ed8\u3092?\u3063\u3066\u8a18\u9332\u3057\u3066\u306f\u306a\u3089\u306a\u3044\u3002 <br><\/td><\/tr><tr><td>Original<br>\u539f\u672c\u6027<\/td><td>\u3059\u3079\u3066\u306e\u539f\u672c\u3082\u4fdd\u5b58\u3059\u308b\u3002\u6700\u521d\u306b\u8a18\u9332\u3057\u305f\u3082\u306e\u3002\u8907\u88fd\u7269\u3084\u8ee2\u8a18\u3057\u305f\u3082\u306e\u3067\u306f\u306a\u3044\u3002<\/td><\/tr><tr><td>Accurate<br>\u6b63\u78ba\u6027<\/td><td>\u6b63\u78ba\u3067\u3042\u308b\u3002\u8aa4\u308a\u304c\u306a\u304f\u3001\u5b8c\u5168\u3067\u3042\u308b\u3002<\/td><\/tr><tr><td>Complete<br>\u5b8c\u5168\u6027<\/td><td>\u5b8c\u7d50\u3057\u3066\u3044\u308b\u3002<\/td><\/tr><tr><td>Consistent<br>\u4e00\u8cab\u6027<\/td><td>\u77db\u76fe\u304c\u306a\u3044\u3002 \u539f\u8cc7\u6599\u5185\u306e\u8a18\u9332\u306b\u77db\u76fe\u304c\u306a\u3044\u3002\u4ed6\u306e\u539f\u8cc7\u6599\u3068\u306e\u77db\u76fe\u304c\u306a\u3044\u3002<\/td><\/tr><tr><td>Enduring<br>\u8010\u4e45\u6027\u3001\u666e\u904d\u6027<\/td><td>\u6c38\u7d9a\u7684\u3067\u3042\u308b\u3002 \u6d88\u53bb\u3067\u304d\u306a\u3044\u7b46\u8a18\u5177\u3067\u8a18\u9332\u3059\u308b\u3002<br>\u7d1b\u5931\u3092\u907f\u3051\u3001\u640d\u50b7\u3084\u52a3\u5316\u304c\u6700\u5c0f\u9650\u3067\u3042\u308b\u9069\u5207\u306a\u74b0\u5883\u3067\u3001\u5b9a \u3081\u3089\u308c\u305f\u671f\u9593\u3001\u4fdd\u5b58\u3059\u308b\u3002<\/td><\/tr><tr><td>Available when needed<br>\u8981\u6642\u5229\u7528\u53ef\u80fd<\/td><td>\u5fc5\u8981\u6642\u306b\u53d6\u308a\u51fa\u305b\u308b\u3002 \u4fdd\u5b58\u671f\u9593\u4e2d\u3092\u901a\u3057\u3066\u3001\u5fc5\u8981\u306a\u3068\u304d\u306b\u901f\u3084\u304b\u306b\u53d6\u308a\u51fa\u305b\u308b\u3002<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<ul id=\"block-9b3a0772-cd0d-4fe2-89e9-0a42caafb45d\" class=\"is-style-vk-default wp-block-list\">\n<li>Attributable\u3000\u5e30\u5c5e\u6027\uff5c\u5e30\u5c5e\uff0f\u8cac\u4efb\u306e\u6240\u5728\u304c\u660e\u78ba\u3067\u3042\u308b\u3002<br>\u30c7\u30fc\u30bf\u306e\u8a18\u9332\u8005\u304c\u660e\u78ba\u3067\u3042\u308b\u3002\u30c7\u30fc\u30bf\u3092\u89b3\u6e2c\u3001\u8a18\u9332\u3001\u8a02\u6b63\u3057\u305f\u500b\u4eba\u3092\u7279\u5b9a\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3002<br>\u76e3\u67fb\u8a3c\u8de1\u30c7\u30fc\u30bf\u306b\u304a\u3044\u3066\u3082\u305d\u306e\u30c7\u30fc\u30bf\u306e\u5e30\u5c5e\u6027\u3092\u4fdd\u8a3c\u3059\u308b\u3053\u3068<\/li>\n\n\n\n<li>Legible\u3000\u5224\u8aad\u6027\u3000\u5224\u8aad\uff0f\u7406\u89e3\u3067\u304d\u308b\u3002<br>\u8ab0\u3082\u304c\u9593\u9055\u3044\u306a\u304f\u7c21\u5358\u306b\u8aad\u307f\u53d6\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3002\u30e1\u30bf\u30c7\u30fc\u30bf\uff08\u30e9\u30d9\u30eb\uff09\u3068\u3068\u3082\u306b\u30c7\u30fc\u30bf\u306e\u4fdd\u5b58\u304c\u5fc5\u8981\u3002\u307e\u305f\u3001\u30c6\u30ad\u30b9\u30c8\u4ee5\u5916\u306e\u65b9\u6cd5\u3067\u4fdd\u5b58\u3055\u308c\u3066\u3044\u308b\u60c5\u5831\u3084\u30cf\u30fc\u30c9\u30c7\u30a3\u30b9\u30af\u304c\u6697\u53f7\u5316\u3055\u308c\u3066\u3044\u308b\u3068\u304d\u306f\u6ce8\u610f<br>\u5370\u5237\u304c\u3067\u304d\u308b\u3088\u3046\u306b\u3057\u3066\u304a\u304f\u306e\u3082\u4e00\u624b\u3002\u305f\u3060\u3057\u3001\u305d\u306e\u5370\u5237\u7269\u306f\u53c2\u7167\u7528\u3068\u3044\u3046\u53d6\u308a\u6271\u3044\u3002<\/li>\n\n\n\n<li>Contemporaneous\u3000\u540c\u6642\u6027\u3000\u540c\u6642\u3067\u3042\u308b\u3002<br>\u30c7\u30fc\u30bf\u304c\u767a\u751f\u3057\u3066\u304b\u3089\u3067\u304d\u308b\u3060\u3051\u901f\u3084\u304b\u306b\u8a18\u9332\u3059\u308b\u3002\u65e5\u4ed8\u3092\u9061\u3063\u3066\u8a18\u9332\u3057\u3066\u306f\u306a\u3089\u306a\u3044\u3002<br>\u30b7\u30b9\u30c6\u30e0\u6642\u523b\u306b\u306f\u6ce8\u610f\u3002\u65e5\u5e38\u70b9\u691c\u3067\u81ea\u793e\u6a19\u6e96\u6642\u3068\u306e\u30c1\u30a7\u30c3\u30af\u3092\u3002\uff08\u624b\u8a18\u9332\u7528\u306e\u6642\u8a08\u306a\u3069\u3068\u306e\u540c\u671f\u3082\uff09<\/li>\n\n\n\n<li>Original\u3000\u539f\u672c\u6027\u3000\u3059\u3079\u3066\u306e\u539f\u672c\u3082\u4fdd\u5b58\u3059\u308b\u3002\u6700\u521d\u306b\u8a18\u9332\u3057\u305f\u3082\u306e\u3002\u8907\u88fd\u7269\u3084\u8ee2\u8a18\u3057\u305f\u3082\u306e\u3067\u306f\u306a\u3044\u3002<br>\u4fd7\u306b\u8a00\u3046\u300c\u751f\u30c7\u30fc\u30bf\u300d\u3002\u6a5f\u5668\u9593\u3001\u30b7\u30b9\u30c6\u30e0\u9593\u3067\u30c7\u30fc\u30bf\u9023\u643a\u3059\u308b\u5834\u5408\u306f\u3069\u308c\u304c\u539f\u672c\u3068\u898f\u5b9a\u3059\u308b\u304b\u3002CSV\u304c\u306a\u3055\u308c\u305f\u6a5f\u5668\u3001\u30b7\u30b9\u30c6\u30e0\u9593\u306b\u304a\u3044\u3066\u3001\u4eba\u9593\u304c\u95a2\u4e0e\u305b\u305a\u306b\u81ea\u52d5\u7684\u306b\u9023\u643a\u3055\u308c\u308b\u30c7\u30fc\u30bf\u3067\u3042\u308c\u3070\u3001\u3069\u308c\u3082\u751f\u30c7\u30fc\u30bf\u3068\u898f\u5b9a\u3067\u304d\u308b\u3002\u3002\u3002\u304b\u306a\uff1f<\/li>\n\n\n\n<li>Accurate\u3000\u6b63\u78ba\u6027\u3000\u6b63\u78ba\u3067\u3042\u308b\u3002\u8aa4\u308a\u304c\u306a\u304f\u3001\u5b8c\u5168\u3067\u3042\u308b\u3002<br>\u30b7\u30b9\u30c6\u30e0\u304c\u6b63\u3057\u304f\u52d5\u3044\u3066\u3044\u308c\u3070\u9593\u9055\u3044\u306a\u3044\u3088\u3046\u306b\u601d\u3046\u304c\u3001\u5c0f\u6570\u70b9\u6841\u3084\u30a2\u30ca\u30ed\u30b0\u30c7\u30fc\u30bf\u3092\u3069\u306e\u7cbe\u5ea6\u3067\u30c7\u30b8\u30bf\u30eb\u5316\u3059\u308b\u304b\u3068\u3044\u3046\u4ed5\u69d8\u3092\u691c\u8a0e\u3059\u308b\u969b\u306b\u306f\u3001\u304b\u306a\u308a\u306e\u8003\u616e\u304c\u5fc5\u8981\u3060\u3068\u8003\u3048\u3089\u308c\u308b\u3002<\/li>\n\n\n\n<li>Complete\u3000\u5b8c\u5168\u6027 \u5b8c\u7d50\u3057\u3066\u3044\u308b\u3002<\/li>\n\n\n\n<li>Consistent\u3000\u4e00\u8cab\u6027 \u77db\u76fe\u304c\u306a\u3044\u3002\u539f\u8cc7\u6599\u5185\u306e\u8a18\u9332\u306b\u77db\u76fe\u304c\u306a\u3044\u3002\u4ed6\u306e\u539f\u8cc7\u6599\u3068\u306e\u77db\u76fe\u304c\u306a\u3044\u3002<br>\u95a2\u9023\u3042\u308b\u30c7\u30fc\u30bf\u3092\u4e00\u89a7\u3067\u304d\u308b\u3001\u305d\u306e\u95a2\u9023\u6027\u3082\u793a\u3057\u3066\u304f\u308c\u308b\u69d8\u306b\u5de5\u592b\u3057\u3066\u304a\u304f\u3079\u304d\u3067\u3059\u3002\u54c1\u8cea\u8a66\u9a13\u6bce\u306b\u5fc5\u8981\u306a\u8a66\u9a13\u30c7\u30fc\u30bf\u306f\u63c3\u3063\u3066\u3044\u308b\u306e\u304b\uff1f\u8a18\u8f09\u5185\u5bb9\u306b\u6f0f\u308c\u306f\u306a\u3044\u306e\u304b\uff1f\u305d\u306e\u5224\u5b9a\u306e\u57fa\u6e96\u3068\u306a\u3063\u305f\u3082\u306e\u306f\u63c3\u3063\u3066\u3044\u308b\u304b\uff1f\u5b9f\u65bd\u3001\u8a18\u9304\u6642\u523b\u306e\u6574\u5408\u6027\u306f\u53d6\u308c\u3066\u3044\u308b\u304b\uff1f\u7d44\u7e54\u3068\u627f\u8a8d\u8005\u3001\u5b9f\u65bd\u8005\u306e\u95a2\u4fc2\u6027\u306b\u6574\u5408\u6027\u306f\u3042\u308b\u304b\uff1f<\/li>\n\n\n\n<li>Enduring\u3000\u8010\u4e45\u6027\u3001\u666e\u904d\u6027 \u6c38\u7d9a\u7684\u3067\u3042\u308b\u3002<br>\u6d88\u53bb\u3067\u304d\u306a\u3044\u7b46\u8a18\u5177\u3067\u8a18\u9332\u3059\u308b\u3002\u7d1b\u5931\u3092\u907f\u3051\u3001\u640d\u50b7\u3084\u52a3\u5316\u304c\u6700\u5c0f\u9650\u3067\u3042\u308b\u9069\u5207\u306a\u74b0\u5883\u3067\u5b9a\u3081\u3089\u308c\u305f\u671f\u9593\u3001\u4fdd\u5b58\u3059\u308b\u3002<br>\u78c1\u6c17\u3084\u5149\u30e1\u30c7\u30a3\u30a2\u3067\u3042\u3063\u3066\u3082\u54c1\u8cea\u52a3\u5316\u3059\u308b\u53ef\u80fd\u6027\u304c\u9ad8\u3044\u306e\u3067\u5341\u5206\u306b\u6ce8\u610f\u304c\u5fc5\u8981\u3067\u3059\u3002\u305f\u3060\u3057\u3001\u30d0\u30c3\u30af\u30a2\u30c3\u30d7\u306e\u30d0\u30c3\u30af\u30a2\u30c3\u30d7\u306a\u3069\u3068\u3057\u3066\u3044\u304f\u3068\u539f\u672c\u88fd\u306e\u62c5\u4fdd\u3084\u3001\u307b\u3093\u3068\u306b\u30ea\u30b9\u30c8\u30a2\u3067\u304d\u308b\u306e\u304b\u306e\u30c6\u30b9\u30c8\u306a\u3069\u304b\u306a\u308a\u306e\u624b\u9593\u304c\u304b\u304b\u308b\u3053\u3068\u304c\u96e3\u3057\u3044\u3068\u3053\u308d\u3067\u3059\u3002<\/li>\n\n\n\n<li>Available when needed\u3000\u8981\u6642\u5229\u7528\u53ef\u80fd \u5fc5\u8981\u6642\u306b\u53d6\u308a\u51fa\u305b\u308b\u3002<br>\u4fdd\u5b58\u671f\u9593\u4e2d\u3092\u901a\u3057\u3066\u3001\u5fc5\u8981\u306a\u3068\u304d\u306b\u901f\u3084\u304b\u306b\u53d6\u308a\u51fa\u305b\u308b\u3002<br>\u67fb\u5bdf\u3067\u306f30\u5206\u4ee5\u5185\u306b\u63d0\u51fa\u3057\u306a\u3044\u3068\u30ef\u30fc\u30cb\u30f3\u30b0\u30ec\u30bf\u30fc\u304c\u51fa\u308b\uff01\u306a\u3069\u3068\u5642\u3092\u805e\u3044\u305f\u3053\u3068\u304c\u3042\u308a\u307e\u3059\u304c\u3001\u305d\u3053\u306f\u30c7\u30b8\u30bf\u30eb\u5316\u3059\u308b\u3053\u3068\u3067\u304b\u306a\u308a\u5229\u4fbf\u6027\u304c\u4e0a\u304c\u308b\u3053\u3068\u306f\u9593\u9055\u3044\u3042\u308a\u307e\u305b\u3093\u3002\u305f\u3060\u3057\u3001\u305d\u306e\u691c\u7d22\u6027\u306b\u306f\u8003\u616e\u304c\u5fc5\u8981\u306b\u306a\u308b\u3068\u601d\u3044\u307e\u3059\u3002\u4f1a\u793e\u306e\u898f\u6a21\u306e\u62e1\u5927\u306b\u3088\u3063\u3066\u5de5\u5834\u3084\u7d44\u7e54\u304c\u5897\u3048\u305f\u308a\u3001\u5909\u66f4\u3055\u308c\u305f\u308a\u3057\u307e\u3059\u306e\u3067\u3001\u5c06\u6765\u306e\u5c55\u671b\u3082\u542b\u3081\u305f\u691c\u7d22\u6761\u4ef6\u3092\u8a2d\u5b9a\u3057\u307e\u3057\u3087\u3046\u3002\u307e\u305f\u3001\u5168\u6587\u691c\u7d22\u304c\u975e\u5e38\u306b\u5f79\u306b\u305f\u3061\u307e\u3059\u3002\u3057\u304b\u3082\u6587\u66f8\u306e\u4e2d\u3082\u5408\u308f\u305b\u3066\u691c\u7d22\u3057\u3066\u304f\u308c\u308b\u30c4\u30fc\u30eb\u304c\u3042\u308c\u3070\u6700\u5f37\u3067\u3059\u3002<\/li>\n<\/ul>\n\n\n\n<ul id=\"block-c106ea17-b9e4-4fd9-9f72-eb3ff70ab8d7\" class=\"is-style-vk-triangle-mark wp-block-list\">\n<li>\u57fa\u672c\u7684\u306a\u8003\u3048\u65b9<br>GCP\uff08\u81e8\u5e8a\u8a66\u9a13\uff09\u3001GDP\uff08\u6d41\u901a\uff09\u3001GLP\uff08\u975e\u81e8\u5e8a\u8a66\u9a13\uff09\u3001GMP\uff08\u88fd\u9020\u30fb\u54c1\u8cea\u7ba1\u7406\uff09\u3001GQP\uff08\u54c1\u8cea\u4fdd\u8a3c\uff09\u3001<a rel=\"noreferrer noopener\" href=\"https:\/\/www.pmda.go.jp\/files\/000161616.pdf\" target=\"_blank\">GVP\uff08\u5e02\u8ca9\u5f8c\u5b89\u5168\u7ba1\u7406\uff09\u3001GPSP\uff08\u5e02\u8ca9\u5f8c\u8abf\u67fb\uff09<\/a>\u3000\u696d\u52d9\u306b\u95a2\u308f\u308b\u30b7\u30b9\u30c6\u30e0\u306e\u5c0e\u5165\u306b\u3064\u3044\u3066\u3001\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u3092\u7528\u3044\u3066\u691c\u8a0e\u3059\u308b\u3002\u4e0a\u8a18\u5bfe\u5fdc\u8981\u4ef6\u306b\u5bfe\u3057\u3066\u306e\u5bfe\u5fdc\u53ef\u80fd\u3001\u4e00\u90e8\u5bfe\u5fdc\u53ef\u80fd\u3001\u5bfe\u5fdc\u4e0d\u53ef\u7b49\u305d\u308c\u305e\u308c\u3067\u30ea\u30b9\u30af\u3092\u6d17\u3044\u51fa\u3057\u3001\u5bfe\u5fdc\u3067\u304d\u306a\u3044\u30ea\u30b9\u30af\u3092\u8a31\u5bb9\u3067\u304d\u308b\u306e\u304b\u3092\u81ea\u793e\u3067\u691c\u8a0e\u3059\u308b\u3002<\/li>\n<\/ul>\n\n\n\n<ul class=\"is-style-vk-triangle-mark wp-block-list\">\n<li><span style=\"color: initial;\">\u5bfe\u5fdc\u8981\u4ef6<\/span><br>\u30fb<a rel=\"noreferrer noopener\" href=\"https:\/\/elaws.e-gov.go.jp\/document?lawid=335AC0000000145\" target=\"_blank\">\u85ac\u6a5f\u6cd5\uff08\u533b\u85ac\u54c1\u3001\u533b\u7642\u6a5f\u5668\u7b49\u306e\u54c1\u8cea\u3001\u6709\u52b9\u6027\u53ca\u3073\u5b89\u5168\u6027\u306e\u78ba\u4fdd\u7b49\u306b\u95a2\u3059\u308b\u6cd5\u5f8b\uff09<\/a><br>\u30fb<a rel=\"noreferrer noopener\" href=\"https:\/\/www.mhlw.go.jp\/web\/t_doc?dataId=00tb6573&amp;dataType=1&amp;pageNo=1\" target=\"_blank\">CSV\uff08Computerized System Validation\uff09\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3<\/a>       <a rel=\"noreferrer noopener\" href=\"https:\/\/www.fsz.co.jp\/wp-content\/uploads\/2018\/05\/214007bc3be1126cb2b15d9aab1c8562.pdf\" target=\"_blank\">PDF\u7248\u306f\u3053\u3061\u3089<\/a><br>\u30fb<a rel=\"noreferrer noopener\" href=\"https:\/\/www.ispe.gr.jp\/ISPE\/07_public\/07_01_19.htm\" target=\"_blank\">GAMP5<\/a><br>\u30fb<a href=\"https:\/\/www.pmda.go.jp\/files\/000158308.pdf\">ER\/ES\u6307\u91dd<\/a>\u3000\u30dd\u30a4\u30f3\u30c8\u306f3\u3064\uff08<span data-color=\"#fcb900\" style=\"background: linear-gradient(transparent 60%,rgba(252, 185, 0, 0.7) 0);\" class=\"vk_highlighter\">\u771f\u6b63\u6027\u3001\u898b\u8aad\u6027\u3001\u4fdd\u5b58\u6027<\/span>\uff09 \u203b\u4e0b\u8a18\u300cER\/ES\u6307\u91dd\u304c\u3053\u306e\u8a71\u306e\u5143\u7956\u3067\u3059\u306d\u300d\u53c2\u7167<br>\u30fb<a rel=\"noreferrer noopener\" href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/CFRSearch.cfm?CFRPart=11\" target=\"_blank\">FDA Part11<\/a><br>\u30fb<a rel=\"noreferrer noopener\" href=\"https:\/\/www.ispe.gr.jp\/ISPE\/07_public\/07_01_41.htm\" target=\"_blank\">\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\uff08Data <\/a>Integrity\uff09<br>\u30fbGMP- manufacturing &#8211; \u533b\u85ac\u54c1\u3001\u533b\u85ac\u90e8\u5916\u54c1\u306e\u88fd\u9020\u7ba1\u7406\u30fb\u54c1\u8cea\u7ba1\u7406\u306e\u57fa\u6e96\u3000<a href=\"https:\/\/www.mhlw.go.jp\/web\/t_doc?dataId=81aa6647&amp;dataType=0&amp;pageNo=1\">\u539a\u52b4\u7701\u30b5\u30a4\u30c8<\/a><br>\u30fbGDP &#8211; Distribution &#8211; \u533b\u85ac\u54c1\u306e\u9069\u6b63\u6d41\u901a\u57fa\u6e96\u3000<a href=\"https:\/\/www.mhlw.go.jp\/content\/11120000\/000466215.pdf\">\u539a\u52b4\u7701\u30b5\u30a4\u30c8<\/a><br>\u30fbGQP &#8211; quality &#8211; \u533b\u85ac\u54c1\u3001\u533b\u85ac\u90e8\u5916\u54c1\u3001\u5316\u7ca7\u54c1\u53ca\u3073\u533b\u7642\u6a5f\u5668\u306e\u54c1\u8cea\u7ba1\u7406\u306e\u57fa\u6e96\u3000<a href=\"https:\/\/www.mhlw.go.jp\/web\/t_doc?dataId=81aa6392&amp;dataType=0&amp;pageNo=1\">\u539a\u52b4\u7701\u30b5\u30a4\u30c8<\/a><br>\u30fbGCP &#8211; clinical &#8211; \u533b\u85ac\u54c1\u30fb\u533b\u7642\u6a5f\u5668\u306e\u81e8\u5e8a\u8a66\u9a13\u306e\u5b9f\u65bd\u57fa\u6e96<br>\u30fbGLP &#8211; laboratory &#8211; \u533b\u85ac\u54c1\u30fb\u533b\u7642\u6a5f\u5668\u306e\u975e\u81e8\u5e8a\u8a66\u9a13\u306e\u5b9f\u65bd\u57fa\u6e96<br>\u30fbGVP &#8211; vigilance &#8211; \u533b\u85ac\u54c1\u3001\u533b\u85ac\u90e8\u5916\u54c1\u3001\u5316\u7ca7\u54c1\u53ca\u3073\u533b\u7642\u6a5f\u5668\u306e\u88fd\u9020\u8ca9\u58f2\u5f8c\u5b89\u5168\u7ba1\u7406\u306e\u57fa\u6e96 <a rel=\"noreferrer noopener\" href=\"http:\/\/law.e-gov.go.jp\/htmldata\/H16\/H16F19001000135.html\" target=\"_blank\">\u539a\u52b4\u7701\u30b5\u30a4\u30c8<\/a><br>\u30fbGPSP &#8211; Post-marketing Study &#8211; \u88fd\u9020\u8ca9\u58f2\u5f8c\u306e\u8abf\u67fb\u30fb\u8a66\u9a13\u306e\u5b9f\u65bd\u57fa\u6e96<br>\u30fbQMS\u7701\u4ee4 &#8211; \u533b\u85ac\u54c1\u3001\u533b\u85ac\u90e8\u5916\u54c1\u3001\u5316\u7ca7\u54c1\u3001\u533b\u7642\u6a5f\u5668\u53ca\u3073\u518d\u751f\u533b\u7642\u7b49\u88fd\u54c1\u306e\u88fd\u9020\u8ca9\u58f2\u5f8c\u5b89\u5168\u7ba1\u7406\u306e\u57fa\u6e96\u306b\u95a2\u3059\u308b\u7701\u4ee4\u3000<a rel=\"noreferrer noopener\" href=\"http:\/\/law.e-gov.go.jp\/htmldata\/H16\/H16F19001000135.html\" target=\"_blank\">\u539a\u52b4\u7701\u30b5\u30a4\u30c8<\/a><br>\u30fbISO27001<br>\u30fbISO27017<br>\u30fbISO13485<\/li>\n<\/ul>\n\n\n\n<ul class=\"is-style-vk-triangle-mark wp-block-list\">\n<li>\u30b7\u30b9\u30c6\u30e0\u306e\u5229\u7528\u7528\u9014\u306f\uff1f<\/li>\n<\/ul>\n\n\n\n<figure class=\"wp-block-table has-small-font-size\"><table><thead><tr><th>\u30b7\u30b9\u30c6\u30e0\u7a2e\u5225<\/th><th>\u88fd\u54c1\u4f8b<\/th><\/tr><\/thead><tbody><tr><td>\u751f\u7523\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0<\/td><td>SAP\u3001MCFrame\u3001ASTROM\u3001SMRi\u3001JIPROS\u3001tsPharma\u3001CIMVisionPMS\uff08MCFrame\uff09\u3001FutureStage\u3001<\/td><\/tr><tr><td>MES\uff5c\u88fd\u9020\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0<\/td><td>HITPHAMS\u3001CIMVisionPharms\u3001Pharmanage\u3001PAS-X\u3001Pharma Suite\u3001EasyT@ct\u3001ASTROM-MES\u3001FactoryTalk\u3001<\/td><\/tr><tr><td>\u5728\u5eab\u7ba1\u7406\uff08\u88fd\u54c1\u3001\u539f\u6750\u6599\uff09\u30b7\u30b9\u30c6\u30e0<\/td><td><\/td><\/tr><tr><td>\u8cfc\u8cb7\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0<\/td><td><\/td><\/tr><tr><td>\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\uff0fLIMS<\/td><td>CIMVisionLIMS\u3001Thermo&nbsp;Scientific&nbsp;SampleManager&nbsp;LIMS\u3001tsPharma qcLIMS\u3001ADME LIMS Debra\u3001Discoverant\u3001<\/td><\/tr><tr><td>\u88fd\u54c1\u60c5\u5831\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\uff0fPLM<\/td><td>Windchill\u3001BIOVIA Discoverant\u3001Aras Innovator\u3001Knowledge Explorer\u3001MCFrame PLM<\/td><\/tr><tr><td>\u54c1\u8cea\u4fdd\u8a3c\u30ef\u30fc\u30af\u30d5\u30ed\u30fc<\/td><td>Trackwise\u3001MasterControl\u3001Agatha\u3001\u696d\u52d9\u30c7\u30b6\u30a4\u30ca\u30fc<br><a href=\"https:\/\/www.fsz.co.jp\/?fszblog=11872\">\u203bQA\u90e8\u9580\u306b\u304a\u3051\u308b\u30a4\u30d9\u30f3\u30c8\u7ba1\u7406\u81ea\u52d5\u5316\u306e\u5fc5\u8981\u6027<\/a><\/td><\/tr><tr><td>\u6587\u66f8\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0<\/td><td>Perma Document\u3001Documentum\u3001HITQUAA\u3001Agatha<\/td><\/tr><tr><td>\u81e8\u5e8a\u8a66\u9a13\u30fb\u6cbb\u9a13\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0<\/td><td>DDworks<\/td><\/tr><tr><td>\u30b5\u30d7\u30e9\u30a4\u30e4\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0<\/td><td><\/td><\/tr><tr><td>\u54c1\u8cea\u60c5\u5831\u3001\u9038\u8131\u3001CAPA\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0<\/td><td><\/td><\/tr><tr><td>\u8ca9\u58f2\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0<\/td><td><\/td><\/tr><tr><td>MR\u652f\u63f4\u30b7\u30b9\u30c6\u30e0<\/td><td><a rel=\"noreferrer noopener\" href=\"https:\/\/www.fsz.co.jp\/?page_id=6728\" target=\"_blank\">JUST.SFA<\/a>\u3001Veeva\u3001Saleforce<\/td><\/tr><tr><td>\u7269\u6d41\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0<\/td><td><\/td><\/tr><tr><td>\u5009\u5eab\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\uff0fWMS<\/td><td>PARCKs -WMS\u3001<\/td><\/tr><tr><td>\u914d\u9001\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0<\/td><td><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<ul class=\"is-style-vk-triangle-mark wp-block-list\">\n<li>\u5c0e\u5165\u30b7\u30b9\u30c6\u30e0\u304c\u78ba\u304b\u306a\u3082\u306e\u3060\u3068\u3044\u3046\u8cc7\u6599\u306f\u63c3\u3063\u3066\u3044\u308b\u304b\uff1f<br>\u30b5\u30d7\u30e9\u30a4\u30e4\u304b\u3089\u8cc7\u6599\u3092\u63d0\u51fa\u3001\u53ce\u96c6\u3057\u3066\u691c\u8a0e\u3059\u308b<br>\u4f8b\uff09\u5229\u7528\u898f\u7d04\u3001SLA<br>\u3000\u3000\u54c1\u8cea\u7ba1\u7406\u57fa\u6e96\u3001\u958b\u767a\u7ba1\u7406\u57fa\u6e96\u3001\u904b\u7528\u7ba1\u7406\u57fa\u6e96<br>\u3000\u3000\u6587\u66f8\u7ba1\u7406\u898f\u5b9a\u3001\u8a18\u9332<br>\u3000\u3000\u904b\u7528\u4f1a\u793e\u304c\u53d6\u5f97\u3057\u3066\u3044\u308b\u7b2c3\u8005\u8a8d\u8a3c<br>\u3000\u3000\u8981\u54e1\u7ba1\u7406\u3001\u6559\u80b2\u8a08\u753b\u3001\u8a18\u9332\u306a\u3069<br>\u3000\u3000\u5909\u66f4\u7ba1\u7406\uff08\u30d0\u30fc\u30b8\u30e7\u30f3\u30a2\u30c3\u30d7\uff09\u306e\u958b\u793a\uff08\u904b\u7528\u30fb\u958b\u767a\u74b0\u5883\uff09<br>\u3000\u3000\u904b\u7528\u4f53\u5236\uff08\u30cf\u30fc\u30c9\u3001\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\uff09\u2192\u30c7\u30fc\u30bf\u5909\u66f4\u30fb\u524a\u9664\u306e\u30ea\u30b9\u30af\u306a\u3069<br>\u3000\u3000\u30b5\u30d7\u30e9\u30a4\u30e4\u304b\u3089\u306e\u59d4\u8a17\u5148\u3001\u305d\u306e\u7ba1\u7406<\/li>\n<\/ul>\n\n\n\n<ul id=\"block-d3502ec2-c80a-4310-b163-0f09e6606699\" class=\"is-style-vk-triangle-mark wp-block-list\">\n<li>\u30b5\u30d7\u30e9\u30a4\u30e4\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\u306f\u5b9f\u65bd\u3057\u305f\u304b\uff1f<br>\u4ee5\u4e0b\u306e\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306b\u5bfe\u3057\u3066\u3001\u30b7\u30b9\u30c6\u30e0\u9078\u5b9a\u6642\u70b9\u3067\u5b9f\u65bd\u3059\u308b\u3002<br>\u4f8b\uff09<br>\u30fb\u30d1\u30c3\u30b1\u30fc\u30b8\u958b\u767a\u30fb\u8ca9\u58f2\u4f1a\u793e \uff08SAP\uff09<br>\u30fb\u30d1\u30c3\u30b1\u30fc\u30b8\u5c0e\u5165\u4f01\u696d          \uff08\u65e5\u7acb\u88fd\u4f5c\u6240\uff09<br>\u30fbIT\u30a4\u30f3\u30d5\u30e9\u63d0\u4f9b\u4f01\u696d          \uff08AWS\uff09<br>\u5b9f\u5730\u3001\u6587\u66f8\u306b\u3064\u3044\u3066\u306f\u3069\u3061\u3089\u3067\u3082\u826f\u3044<br><a rel=\"noreferrer noopener\" href=\"https:\/\/www.fsz.co.jp\/?page_id=212\" target=\"_blank\">\u53c2\u8003\u8cc7\u6599<\/a><\/li>\n<\/ul>\n\n\n\n<ul class=\"is-style-vk-triangle-mark wp-block-list\">\n<li>\u30b7\u30b9\u30c6\u30e0\u306e\u30d0\u30fc\u30b8\u30e7\u30f3\u30a2\u30c3\u30d7\u306f\u81ea\u793e\u3067\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u3067\u304d\u308b\u304b\uff1f<br><strong><span data-color=\"#fcb900\" style=\"background: linear-gradient(transparent 60%,rgba(252, 185, 0, 0.7) 0);\" class=\"vk_highlighter\">\u30dd\u30a4\u30f3\u30c8<\/span><\/strong><br>\u30af\u30e9\u30a6\u30c9\u306e\u5834\u5408\u3001\u81ea\u793e\u5c02\u7528\u9818\u57df\uff08\u30b5\u30fc\u30d0\u3001\u30a4\u30f3\u30b9\u30bf\u30f3\u30b9\uff09\u306a\u3069\u3092\u8a2d\u7f6e\u3057\u3066\u3044\u5834\u5408\u306b\u306f\u3001\u30b5\u30fc\u30d3\u30b9\u5168\u4f53\u3067\u30d0\u30fc\u30b8\u30e7\u30f3\u30a2\u30c3\u30d7\u3055\u308c\u3066\u3057\u307e\u3046\u5834\u5408\u304c\u3042\u308b\u3002\u4e8b\u524d\u306b\u9023\u7d61\u304c\u3042\u308b\u3068\u306f\u3044\u3048\u3001\u30b7\u30b9\u30c6\u30e0\u5909\u66f4\u7ba1\u7406\u306e\u89b3\u70b9\u304b\u3089\u8a00\u3046\u3068\u3001\u81ea\u793e\u306e\u610f\u56f3\u3057\u306a\u3044\u30b7\u30b9\u30c6\u30e0\u5909\u66f4\u306f\u5272\u3051\u305f\u3044\u3068\u3053\u308d\u3067\u3042\u308b\u3002\u63d0\u4f9b\u4f1a\u793e\u306e\u4fe1\u983c\u5ea6\u306a\u3069\u5341\u5206\u306a\u691c\u8a0e\u304c\u5fc5\u8981\u3067\u3042\u308b\u3002<\/li>\n<\/ul>\n\n\n\n<ul class=\"is-style-vk-triangle-mark wp-block-list\">\n<li>\u30b7\u30b9\u30c6\u30e0\u5229\u7528\u898f\u7d04\u3092\u78ba\u8a8d\u3057\u305f\u304b\uff1f<br>\u8a8d\u8a3c\u306e\u6709\u7121<br>\u63d0\u4f9b\u8cc7\u6599\u306e\u5145\u5b9f<br>\u696d\u754c\uff08\u898f\u5236\uff09\u3078\u306e\u7406\u89e3\u5ea6<br>\u5165\u529b\u30c7\u30fc\u30bf\u306e\u9694\u96e2\u6027<br>\u5165\u529b\u30c7\u30fc\u30bf\u306e\u53d6\u6271\u3044\u30fb\u30fb\u904b\u7528\u4f1a\u793e\u304c\u30c7\u30fc\u30bf\u306b\u89e6\u308c\u308b\u5834\u5408\u306e\u78ba\u8a8d<br>\u30b5\u30fc\u30d3\u30b9\u306e\u505c\u6b62\u30fb\u30fb\u30fb\u30fb\u30b5\u30fc\u30d3\u30b9\u304c\u505c\u6b62\u3055\u308c\u308b\u53ef\u80fd\u6027\u306e\u78ba\u8a8d<br>\u30b5\u30fc\u30d3\u30b9\u306e\u5ec3\u6b62\u30fb\u30fb\u30fb\u30fb\u30b5\u30fc\u30d3\u30b9\u5ec3\u6b62\u3055\u308c\u308b\u53ef\u80fd\u6027\u306e\u78ba\u8a8d<br>\u4fdd\u8a3c\u7bc4\u56f2\u30fb\u30fb\u30fb\u30fb\u30fb\u30fb\u30fb\u6700\u7d42\u7684\u306a\u30c7\u30fc\u30bf\u4fdd\u5168\u306f\u57fa\u672c\u7684\u306b\u4fdd\u8a3c\u3055\u308c\u306a\u3044<br>\u59d4\u8a17\u30fb\u30fb\u30fb\u30fb\u30fb\u30fb\u30fb\u30fb\u30fb\u7b2c\uff13\u8005\u306b\u958b\u767a\u3001\u904b\u7528\u306a\u3069\u3092\u59d4\u8a17\u3059\u308b\u53ef\u80fd\u6027<\/li>\n<\/ul>\n\n\n\n<ul class=\"is-style-vk-triangle-mark wp-block-list\">\n<li>\u30b7\u30b9\u30c6\u30e0\u306eSLA\uff08Service Level Agreement\uff09\u30b5\u30fc\u30d3\u30b9\u54c1\u8cea\u4fdd\u8a3c\u3092\u78ba\u8a8d\u3057\u305f\u304b\uff1f<br><a rel=\"noreferrer noopener\" href=\"https:\/\/www.meti.go.jp\/policy\/netsecurity\/secdoc\/contents\/downloadfils\/080121saasgl.pdf\" target=\"_blank\">SaaS\u5411\u3051SLA\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\uff5c\u7d4c\u7523\u7701<\/a><br>\u4f8b\uff09<br><strong><span data-color=\"#00d084\" style=\"background: linear-gradient(transparent 60%,rgba(0, 208, 132, 0.7) 0);\" class=\"vk_highlighter\">\u30fb\u53ef\u7528\u6027<\/span><\/strong><br>\u3000\u30b5\u30fc\u30d2\u3099\u30b9\u6642\u9593\u3001\u8a08\u753b\u505c\u6b62\u4e88\u5b9a\u901a\u77e5\u3001\u30b5\u30fc\u30d3\u30b9\u7a3c\u50cd\u7387\u3001\u30c7\u30a3\u30b6\u30b9\u30bf\u30ea\u30ab\u30d0\u30ea\u3001<br>\u3000\u91cd\u5927\u969c\u5bb3\u6642\u306e\u4ee3\u66ff\u624b\u6bb5\u3001\u4ee3\u66ff\u63aa\u7f6e\u3067\u63d0\u4f9b\u3059\u308b\u30c7\u30fc\u30bf\u5f62\u5f0f\u3001\u30a2\u30c3\u30d7\u30b0\u30ec\u30fc\u30c9\u65b9\u91dd<br><strong><span data-color=\"#7bdcb5\" style=\"background: linear-gradient(transparent 60%,rgba(123, 220, 181, 0.7) 0);\" class=\"vk_highlighter\">\u30fb\u4fe1\u983c\u6027<\/span><\/strong><br>\u3000\u5e73\u5747\u5fa9\u65e7\u6642\u9593\u3001\u30b7\u30b9\u30c6\u30e0\u76e3\u8996\u57fa\u6e96\u3001\u969c\u5bb3\u901a\u77e5\u30d7\u30ed\u30bb\u30b9\u3001\u969c\u5bb3\u901a\u77e5\u6642\u9593\u3001<br>\u3000\u969c\u5bb3\u76e3\u8996\u9593\u9694\u3001\u30b5\u30fc\u30d3\u30b9\u63d0\u4f9b\u72b6\u6cc1\u306e\u5831\u544a\u65b9\u6cd5\u3001\u30ed\u30b0\u53d6\u5f97<br><strong><span data-color=\"#7bdcb5\" style=\"background: linear-gradient(transparent 60%,rgba(123, 220, 181, 0.7) 0);\" class=\"vk_highlighter\">\u30fb\u6027\u80fd<\/span><\/strong><br>\u3000\u30aa\u30f3\u30e9\u30a4\u30f3\u5fdc\u7b54\u6642\u9593\u3001\u30d0\u30c3\u30c1\u51e6\u7406\u6642\u9593\u3001\u540c\u6642\u63a5\u7d9a\u5229\u7528\u8005\u6570<br><strong><span data-color=\"#7bdcb5\" style=\"background: linear-gradient(transparent 60%,rgba(123, 220, 181, 0.7) 0);\" class=\"vk_highlighter\">\u30fb\u30b5\u30dd\u30fc\u30c8<\/span><\/strong><br>\u3000\u63d0\u4f9b\u6642\u9593\u5e2f\uff08\u969c\u5bb3\u5bfe\u5fdc\uff09\u3001\u63d0\u4f9b\u6642\u9593\u5e2f\uff08\u4e00\u822c\u554f\u5408\uff09<br><strong><span data-color=\"#7bdcb5\" style=\"background: linear-gradient(transparent 60%,rgba(123, 220, 181, 0.7) 0);\" class=\"vk_highlighter\">\u30fb\u30c7\u30fc\u30bf\u7ba1\u7406<\/span><\/strong><br>\u3000\u30d0\u30c3\u30af\u30a2\u30c3\u30d7\u306e\u65b9\u6cd5\u3001\u30d0\u30c3\u30af\u30a2\u30c3\u30d7\u30c7\u30fc\u30bf\u306e\u4fdd\u5b58\u671f\u9593\u3001\u30c7\u30fc\u30bf\u6d88\u53bb\u306e\u8981\u4ef6<br><strong><span data-color=\"#7bdcb5\" style=\"background: linear-gradient(transparent 60%,rgba(123, 220, 181, 0.7) 0);\" class=\"vk_highlighter\">\u30fb\u30bb\u30ad\u30e5\u30ea\u30c6\u30a3<\/span><\/strong><br>\u3000\u516c\u7684\u8a8d\u8a3c\u53d6\u5f97\u306e\u8981\u4ef6\u3001\u7b2c\u4e09\u8005\u8a55\u4fa1\u3001\u60c5\u5831\u53d6\u6271\u8005\u306e\u5236\u9650\u3001\u60c5\u5831\u53d6\u6271\u3044\u74b0\u5883\u3001\u901a\u4fe1\u306e\u6697\u53f7\u5316\u30ec\u30d8\u3099\u30eb<\/li>\n<\/ul>\n\n\n\n<ul id=\"block-aaee6c56-66a0-4ce6-a14b-a62c2f7ac93d\" class=\"is-style-vk-triangle-mark wp-block-list\">\n<li>\u30de\u30eb\u30c1\u30af\u30e9\u30a4\u30a2\u30f3\u30c8\u304b\uff1f\u81ea\u793e\u5c02\u7528\u30b5\u30fc\u30d0\u30fc\u304b\u3002<br>\u30cd\u30c3\u30c8\u30ef\u30fc\u30af\u3082\u542b\u3081\u3066\u3001\u81ea\u793e\u5c02\u7528\u306b\u306a\u3063\u3066\u3044\u308b\u65b9\u304c\u8aac\u660e\u3057\u3084\u3059\u3044<br>\u30de\u30eb\u30c1\u30af\u30e9\u30a4\u30a2\u30f3\u30c8\u3067\u3042\u3063\u305f\u3068\u304d\u306f\u3001\u30c7\u30fc\u30bf\u6df7\u5728\u306a\u3069\u306e\u30ea\u30b9\u30af\u3092\u691c\u8a0e<\/li>\n<\/ul>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"alignright size-large is-resized\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/www.fsz.co.jp\/wp-content\/uploads\/2021\/09\/2021-09-19-7.34.38-1-1024x653.png\" alt=\"\" class=\"wp-image-16161\" width=\"276\" height=\"176\" srcset=\"https:\/\/www.fsz.co.jp\/wp-content\/uploads\/2021\/09\/2021-09-19-7.34.38-1-1024x653.png 1024w, https:\/\/www.fsz.co.jp\/wp-content\/uploads\/2021\/09\/2021-09-19-7.34.38-1-300x191.png 300w, https:\/\/www.fsz.co.jp\/wp-content\/uploads\/2021\/09\/2021-09-19-7.34.38-1-1536x979.png 1536w, https:\/\/www.fsz.co.jp\/wp-content\/uploads\/2021\/09\/2021-09-19-7.34.38-1.png 1882w\" sizes=\"auto, (max-width: 276px) 100vw, 276px\" \/><\/figure>\n<\/div>\n\n\n<ul class=\"is-style-vk-triangle-mark wp-block-list\">\n<li>\u5229\u7528\u3059\u308b\u30b7\u30b9\u30c6\u30e0\u306f\u3001SaaS\u3001PaaS\u3001IaaS\u306e\u3069\u308c\u304b\u3002<br><br>\u7c21\u5358\u306b\u8a18\u3059\u308b\u3068<br>\u30fbSaaS<br>\u5229\u7528\u3059\u308b\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u3068\u305d\u306e\u904b\u7528\u3082\u542b\u3081\u3066\u3001\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u3068\u547c\u3070\u308c\u308b\u3002\u6b63\u78ba\u306b\u306f\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u3057\u3066\u304f\u308c\u308b\u30b7\u30b9\u30c6\u30e0\u3002<br>\u30fbPaaS\uff1a\u30cf\u30fc\u30c9\u3068OS \u2192\u3053\u306e\u90e8\u5206\u3060\u3051\u306f\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\uff08\u7dad\u6301\u904b\u7528\uff09\u3057\u3066\u304f\u308c\u308b<br>\u30fbIaaS\uff1a\u30cf\u30fc\u30c9\u3060\u3051 \u2192\u3053\u306e\u90e8\u5206\u3060\u3051\u306f\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\uff08\u7dad\u6301\u904b\u7528\uff09\u3057\u3066\u304f\u308c\u308b<\/li>\n<\/ul>\n\n\n\n<ul id=\"block-a58d31c7-86ac-4a20-b9c5-49cd34ef71d2\" class=\"is-style-vk-triangle-mark wp-block-list\">\n<li>\u30b7\u30b9\u30c6\u30e0\u30ab\u30c6\u30b4\u30ea\u30fc\u306f\u3069\u306e\u3088\u3046\u306b\u3059\u308b\u304b\uff1f<br>\u30b5\u30fc\u30d0\u30fc\u4e0a\u3067\u7a3c\u50cd\u3059\u308b\u30b7\u30b9\u30c6\u30e0\u3067\u30ab\u30c6\u30b4\u30ea\u30fc\uff13\u306f\u975e\u5e38\u306b\u7a00\u3060\u3068\u601d\u308f\u308c\u308b<br>\u30fb\u30ab\u30c6\u30b4\u30ea3\uff1a\u69cb\u6210\u8a2d\u5b9a\u306a\u3057<br>\u30fb\u30ab\u30c6\u30b4\u30ea4\uff1a\u69cb\u6210\u8a2d\u5b9a\u3042\u308a\uff08\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u8a2d\u5b9a\u306a\u3069\uff09<br>\u30fb\u30ab\u30c6\u30b4\u30ea5\uff1a\u30b3\u30fc\u30c6\u30a3\u30f3\u30b0\u3042\u308a\uff08\u30b9\u30af\u30ea\u30d7\u30c8\u3001SQL\u306a\u3069\u542b\u3080\uff09<\/li>\n<\/ul>\n\n\n\n<ul id=\"block-e8d9fd24-ec1e-4b25-b940-939a1ba88e20\" class=\"is-style-vk-triangle-mark wp-block-list\">\n<li>\u7269\u7406\u7684\u30bb\u30ad\u30e5\u30ea\u30c6\u30a3<br>\u30fb\u30c7\u30fc\u30bf\u30bb\u30f3\u30bf\u30fc\u306e\u304a\u304a\u3088\u305d\u306e\u6240\u5728\u5730\uff08\u6fc0\u751a\u707d\u5bb3\u306e\u5834\u5408\u306e\u5f71\u97ff\u5ea6\u628a\u63e1\uff09<br>\u30fb\u8a2d\u5099\u72b6\u6cc1\u3092\u78ba\u8a8d\u3057\u305f\u304b<br>\u3000\u4f8b\uff09\u30b5\u30fc\u30d0\u30fc\u914d\u7f6e\u3001\u51b7\u5374\u88c5\u7f6e\u3001\u30cd\u30c3\u30c8\u30ef\u30fc\u30af\u8a2d\u5099<br>\u30fb\u5165\u9000\u51fa\u7ba1\u7406\u306f\u3069\u306e\u69d8\u306b\u306a\u3063\u3066\u3044\u308b\u304b<br>\u3000\u4f8b\uff09\u5165\u9000\u51fa\u8a8d\u8a3c\uff08\u4eba\u3001\u6642\u523b\uff09\u3001\u7269\u54c1\u6301\u8fbc\u307f\u6301\u3061\u51fa\u3057\u306a\u3069\u306e\u30b7\u30b9\u30c6\u30e0\u3001\u8a18\u9332<\/li>\n<\/ul>\n\n\n\n<ul class=\"is-style-vk-triangle-mark wp-block-list\">\n<li>\u30cd\u30c3\u30c8\u30ef\u30fc\u30af\u69cb\u6210\uff5cER\/ES\u8981\u4ef6\u3000<strong><span data-color=\"#fcb900\" style=\"background: linear-gradient(transparent 60%,rgba(252, 185, 0, 0.7) 0);\" class=\"vk_highlighter\">\u30aa\u30fc\u30d7\u30f3\u30b7\u30b9\u30c6\u30e0\u304b\u3001\u30af\u30ed\u30fc\u30ba\u30c9\u30b7\u30b9\u30c6\u30e0\u304b<\/span><\/strong>  \u203b\u4e0b\u8a18\u300cER\/ES\u6307\u91dd\u304c\u3053\u306e\u8a71\u306e\u5143\u7956\u3067\u3059\u306d\u300d\u53c2\u7167<\/li>\n<\/ul>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p>\u25a0\u30af\u30ed\u30fc\u30ba\u30c9\u30b7\u30b9\u30c6\u30e0<br>\u30b7\u30b9\u30c6\u30e0\u5185\u306e\u96fb\u78c1\u7684\u8a18\u9332\u306b\u8cac\u4efb\u3092\u6301\u3064\u8005\u306b\u3088\u3063\u3066\u3001\u30b7\u30b9\u30c6\u30e0\u3078\u306e\u30a2\u30af\u30bb\u30b9\u3092\u7ba1\u7406\u3055\u308c\u3066\u3044\u308b\u30b7\u30b9\u30c6\u30e0<\/p>\n<cite><meta charset=\"utf-8\"><p>ER\/ES\u6307\u91dd<\/p><\/cite><\/blockquote>\n\n\n\n<p>\u3068\u3044\u3046\u308f\u3051\u3067<br>\u30b7\u30b9\u30c6\u30e0\u307e\u3067\u306e\u30cd\u30c3\u30c8\u30ef\u30fc\u30af\u7d4c\u8def\u3092\u5c02\u7528\u7dda\u3001VPN\u3001IP\u30a2\u30c9\u30ec\u30b9\u56fa\u5b9a\u306a\u3069\u3092\u5b9f\u65bd\u304c\u5fc5\u8981\u3000<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p>\u25a0\u30aa\u30fc\u30d7\u30f3\u30b7\u30b9\u30c6\u30e0<br>\u30b7\u30b9\u30c6\u30e0\u5185\u306e\u96fb\u78c1\u7684\u8a18\u9332\u306b\u8cac\u4efb\u3092\u6301\u3064\u8005\u306b\u3088\u3063\u3066\u3001\u30b7\u30b9\u30c6\u30e0\u3078\u306e\u30a2\u30af\u30bb\u30b9\u3092\u7ba1\u7406\u3055\u308c\u3066\u3044\u306a\u3044\u30b7\u30b9\u30c6\u30e0<br>\u96fb\u78c1\u7684\u8a18\u9332\u304c\u4f5c\u6210\u3055\u308c\u3066\u304b\u3089\u53d7\u3051\u53d6\u3089\u308c\u308b\u307e\u3067\u306e\u9593\u306e\u771f\u6b63\u6027\u3001\u6a5f\u5bc6\u6027\u3092\u78ba\u4fdd\u3059\u308b\u305f\u3081\u306b\u5fc5\u8981\u306a\u624b\u6bb5\u3092\u9069\u5207\u306b\u5b9f\u65bd\u3059\u308b\u3053\u3068\u3002\u8ffd\u52a0\u624b\u6bb5\u306b\u306f\u3001\u96fb\u78c1\u7684\u8a18\u9332\u306e\u6697\u53f7\u5316\u3084\u30c7\u30b8\u30bf\u30eb\u7f72\u540d\u306e\u6280\u8853\u306e\u63a1\u7528\u306a\u3069\u304c\u542b\u307e\u308c\u308b\u3002<\/p>\n<cite><meta charset=\"utf-8\"><p>ER\/ES\u6307\u91dd<\/p><\/cite><\/blockquote>\n\n\n\n<p class=\"has-black-color has-text-color\">\u3000\u3068\u3044\u3046\u3053\u3068\u3067<br>\u3000\u3060\u308c\u3067\u3082<strong>\u30ed\u30b0\u30a4\u30f3\u753b\u9762\u306b\u30a2\u30af\u30bb\u30b9<\/strong>\u3067\u304d\u308b\u3088\u3046\u306a\u30b7\u30b9\u30c6\u30e0\u306f\u30aa\u30fc\u30d7\u30f3\u30b7\u30b9\u30c6\u30e0\u3068\u5b9a\u7fa9\u3055\u308c\u308b\u3002<\/p>\n\n\n\n<ul class=\"is-style-vk-triangle-mark wp-block-list\">\n<li><span style=\"color: initial;\">\u30b7\u30b9\u30c6\u30e0\u306e\u30bb\u30ad\u30e5\u30ea\u30c6\u30a3\u306f\u5341\u5206\u304b\uff1f<\/span><br>\u30fbID\u3001\u30d1\u30b9\u30ef\u30fc\u30c9\u306e\u5229\u7528<br>\u30fb\u30b7\u30b9\u30c6\u30e0\u306e\u5229\u7528\u306f\u500b\u4eba\u6bce\u3067\u306eID\u304c\u5fc5\u8981<br>\u30fb<strong><span data-color=\"#fcb900\" style=\"background: linear-gradient(transparent 60%,rgba(252, 185, 0, 0.7) 0);\" class=\"vk_highlighter\">2\u8981\u7d20\u8a8d\u8a3c<\/span><\/strong><br>\u30fb\u73fe\u5728\u3067\u306f\u30d1\u30b9\u30ef\u30fc\u30c9\u306e\u5b9a\u671f\u7684\u5909\u66f4\u306f\u63a8\u5968\u3055\u308c\u306a\u3044 *1<\/li>\n<\/ul>\n\n\n\n<ul class=\"is-style-vk-triangle-mark wp-block-list\">\n<li>\u7aef\u672b\u306fGMP\u696d\u52d9\u5c02\u7528\u304b\uff1f\u30a4\u30f3\u30bf\u30fc\u30cd\u30c3\u30c8\u306b\u30a2\u30af\u30bb\u30b9\u3067\u304d\u308b\u7aef\u672b\u304b\uff1f<\/li>\n<\/ul>\n\n\n\n<ul class=\"is-style-vk-triangle-mark wp-block-list\">\n<li>\u500b\u4eba\u60c5\u5831\u7ba1\u7406<br>\u57fa\u672c\u7684\u306b\u81ea\u793e\u306e\u500b\u4eba\u60c5\u5831\u4fdd\u8b77\u65b9\u91dd\u306b\u5f93\u3063\u3066\u53d6\u308a\u6271\u3046\u3002<\/li>\n<\/ul>\n\n\n\n<ul class=\"is-style-vk-triangle-mark wp-block-list\">\n<li>\u30ed\u30b0\u30a4\u30f3<br>\u30d1\u30b9\u30ef\u30fc\u30c9\u306e\u66f4\u65b0<br>\u5b9a\u671f\u7684\u306b\u30d1\u30b9\u30ef\u30fc\u30c9\u3092\u66f4\u65b0\u3059\u308b\u3088\u3046\u306a\u30eb\u30fc\u30eb\u3092\u691c\u8a0e\u3055\u308c\u308b\u4f01\u696d\u304c\u591a\u3044\u304c\u3001\u6700\u8fd1\u3067\u306f\u30d1\u30b9\u30ef\u30fc\u30c9\u306e\u5b9a\u671f\u7684\u5909\u66f4\u306f\u63a8\u5968\u3055\u308c\u3066\u307e\u305b\u3093\u3002<br>\u3053\u308c\u306f\u5229\u7528\u8005\u306b\u5b9a\u671f\u7684\u5909\u66f4\u3068\u3044\u3046\u30eb\u30fc\u30eb\u3092\u9069\u7528\u3059\u308b\u3068\u7c21\u5358\u306a\u30d1\u30b9\u30ef\u30fc\u30c9\u3092\u5229\u7528\u3059\u308b\u3068\u3044\u3046\u50be\u5411\u304c\u3042\u308a\u3001\u7d50\u679c\u7684\u306b\u7169\u96d1\u306a\u30d1\u30b9\u30ef\u30fc\u30c9\u904b\u7528\u3068\u306a\u308b\u305f\u3081\u3067\u3059\u3002\u305d\u3082\u305d\u3082\u30d1\u30b9\u30ef\u30fc\u30c9\u3060\u3051\u3067\u306f\u30bb\u30ad\u30e5\u30ea\u30c6\u30a3\u306f\u5b88\u308c\u306a\u3044\u3068\u3044\u3046\u7acb\u5834\u306b\u7acb\u3063\u3066\u30012\u6bb5\u968e\u8a8d\u8a3c\u306a\u3069\u3092\u6d3b\u7528\u3059\u308b\u3079\u304d\u3067\u3059\u3002<br>\u25a0\u53c2\u8003<br><a href=\"https:\/\/www.soumu.go.jp\/main_sosiki\/joho_tsusin\/security\/business\/staff\/01.html\" target=\"_blank\" rel=\"noreferrer noopener\">\u7dcf\u52d9\u7701 \u5b89\u5168\u306a\u30d1\u30b9\u30ef\u30fc\u30c9\u7ba1\u7406<\/a><\/li>\n<\/ul>\n\n\n\n<ul class=\"is-style-vk-triangle-mark wp-block-list\">\n<li>\u76e3\u67fb\u8a3c\u8de1\uff08audit trail\uff09\u3068\u306f<br>\u76e3\u67fb\u8a3c\u8de1\u306f\u3001\u60c5\u5831\u30b7\u30b9\u30c6\u30e0\u3067\u5b9f\u65bd\u3055\u308c\u305f\u6d3b\u52d5\u306e\u8a18\u9332\u3067\u3059\u3002\u4eba\u306e\u4f5c\u696d\u306b\u3088\u308b\u6d3b\u52d5\u3001\u30b7\u30b9\u30c6\u30e0\u304c\u81ea\u52d5\u3067\u5b9f\u65bd\u3059\u308b\u6d3b\u52d5\u306e\u3069\u3061\u3089\u306b\u3082\u9069\u7528\u3055\u308c\u307e\u3059\u3002\u30b7\u30b9\u30c6\u30e0\u306e\u60c5\u5831\u3092\u5229\u7528\u3055\u308c\u308b\u5834\u5408\u306b\u305d\u306e\u4e8b\u5b9f\u305d\u306e\u307e\u307e\u306b\u8a18\u9332\u3055\u308c\u3066\u3044\u308b\u304b\uff08\u771f\u6b63\u6027\uff09\u304c\u4e00\u756a\u306e\u30dd\u30a4\u30f3\u30c8\u3060\u3068\u601d\u3044\u307e\u3059\u3002\u57fa\u672c\u7684\u306b\u306f\u60c5\u5831\u3092\u3001\u767b\u9332\u3001\u5909\u66f4\u3001\u524a\u9664\u3059\u308b\u5834\u5408\u306f\u3001\u3044\u3064\u3001\u8ab0\u304c\u3001\u4f55\u3092\u3001\u7406\u7531\u3092\u6b8b\u3059\u3053\u3068\u3067\u3059\u3002\u5909\u66f4\u524d\u306e\u8a18\u9332\u3001\u5909\u66f4\u5f8c\u306e\u8a18\u9332\u304c\u3042\u308c\u3070\u4e00\u756a\u308f\u304b\u308a\u3084\u3059\u3044\u3068\u3044\u3048\u307e\u3059\u3002<br><br>\u4ee5\u4e0b\u306e\u6587\u7ae0\u306b\u3082\u76e3\u67fb\u8a3c\u8de1\u306b\u95a2\u3059\u308b\u660e\u8a18\u304c\u6709\u308a\u307e\u3059\u3002<br>\u30fb\u533b\u85ac\u54c1\u7b49\u306e\u627f\u8a8d\u53c8\u306f\u8a31\u53ef\u7b49\u306b\u4fc2\u308b\u7533\u8acb\u7b49\u306b\u95a2\u3059\u308b\u96fb\u78c1\u7684\u8a18\u9332\u30fb\u96fb\u5b50\u7f72\u540d\u5229\u7528\u306e\u305f\u3081\u306e\u6307\u91dd\uff08ER\/ES\u6307\u91dd\uff09<br>\u30fb\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u9069\u6b63\u7ba1\u7406\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3(\u6848)\u30d1\u30d6\u30ea\u30c3\u30af\u30b3\u30e1\u30f3\u30c8#22<br>\u30fbPIC\/S\u306eGMP\u3000ANNEX11\u306e10\u7ae0<br><br>\u6700\u4f4e\u9650\u306e\u76e3\u67fb\u8a3c\u8de1\u3068\u3057\u3066\u306f\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u5bfe\u5fdc\u306b\u306a\u308a\u307e\u3059\u3002<br>\u30fb\u3060\u308c\u304c\u3001\u3044\u3064\u3001\u30b7\u30b9\u30c6\u30e0\u3092\u5229\u7528\u3057\u305f\u304b\u304c\u308f\u304b\u308b\u60c5\u5831\u3092\u4fdd\u5b58\u3059\u308b\u3002<br>\u30fb\u30ed\u30b0\u30a4\u30f3\u6642\u306b\u30e6\u30fc\u30b6\u30fcID\u3001\u30d1\u30b9\u30ef\u30fc\u30c9\u3092\u5165\u529b\u3055\u305b\u308b\u3002\u5f53\u7136\u3001\u500b\u4eba\u5225\u306e\u30e6\u30fc\u30b6\u30fcID\u3067\u3042\u308b\u3053\u3068\u304c\u5fc5\u9808\u3002<br>\u30fb\u30c7\u30fc\u30bf\u3092\u767b\u9332\u30fb\u5909\u66f4\u30fb\u524a\u9664\u3059\u308b\u969b\u306b\u305d\u306e\u4f5c\u696d\u306e\u627f\u8a8d\u8005\u3068\u5b9f\u65bd\u8005\u304c\u3001\u3044\u3064\u5b9f\u65bd\u3057\u305f\u304b\u304c\u7279\u5b9a\u3067\u304d\u308b\u60c5\u5831\u3092\u4fdd\u5b58\u3059\u308b\u3002<br>\u30fb\u4e0a\u8a18\u306b\u969b\u3057\u3066\u3001\u7406\u7531\u3082\u4fdd\u5b58\u3059\u308b\u3002<br>\u30fb\u30b7\u30b9\u30c6\u30e0\u3067\u30c7\u30fc\u30bf\u304c\u81ea\u52d5\u7684\u306b\u5909\u66f4\u3055\u308c\u308b\u5834\u5408\u306f\u3001\u305d\u306e\u5185\u5bb9\u3082\u4fdd\u5b58\u3059\u308b\u3002<\/li>\n<\/ul>\n\n\n\n<ul class=\"is-style-vk-triangle-mark wp-block-list\">\n<li>\u76e3\u67fb\u8a3c\u8de1\u304c\u53d6\u308c\u308b\u304b\uff5c\u5909\u66f4\u7ba1\u7406<br>\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u3092\u8003\u3048\u308b\u4e0a\u3067\u306f\u3001\u30b7\u30b9\u30c6\u30e0\u3067\u306f\u300c\u76e3\u67fb\u8a3c\u8de1\u306e\u78ba\u4fdd\u300d\u306f\u57fa\u672c\u4e2d\u306e\u57fa\u672c\u3067\u3059\u3002\u3053\u308c\u304c\u306a\u304f\u3066\u306f\u3001GxP\u696d\u52d9\u306b\u5bfe\u3057\u3066\u306f\u5229\u7528\u3067\u304d\u306a\u3044\u3068\u3044\u3046\u306e\u304c\u4e00\u822c\u7684\u306a\u8a55\u4fa1\u3068\u306a\u3063\u3066\u304d\u3066\u3044\u307e\u3059\u3002\u60c5\u5831\u30b7\u30b9\u30c6\u30e0\u3067\u5b9f\u65bd\u3055\u308c\u305f\u6d3b\u52d5\u306e\u8a18\u9332\u3002\u4eba\u306e\u4f5c\u696d\u306b\u3088\u308b\u6d3b\u52d5\u3001\u30b7\u30b9\u30c6\u30e0\u304c\u81ea\u52d5\u3067\u5b9f\u65bd\u3059\u308b\u6d3b\u52d5\u306e\u3069\u3061\u3089\u306b\u3082\u9069\u7528\u3055\u308c\u307e\u3059\u3002\u30b7\u30b9\u30c6\u30e0\u306e\u60c5\u5831\u3092\u5229\u7528\u3055\u308c\u308b\u5834\u5408\u306b\u305d\u306e\u4e8b\u5b9f\u305d\u306e\u307e\u307e\u306b\u8a18\u9332\u3055\u308c\u3066\u3044\u308b\u304b\uff08\u771f\u6b63\u6027\uff09\u304c\u4e00\u756a\u306e\u30dd\u30a4\u30f3\u30c8\u3002\u57fa\u672c\u7684\u306b\u306f\u60c5\u5831\u3092\u3001\u767b\u9332\u3001\u5909\u66f4\u3001\u524a\u9664\u3059\u308b\u5834\u5408\u306f\u3001\u3044\u3064\u3001\u8ab0\u304c\u3001\u4f55\u3092\u3001\u7406\u7531\u3092\u6b8b\u3059\u3053\u3068\u3067\u3059\u3002\u5909\u66f4\u524d\u306e\u8a18\u9332\u3001\u5909\u66f4\u5f8c\u306e\u8a18\u9332\u304c\u3042\u308c\u3070\u4e00\u756a\u308f\u304b\u308a\u3084\u3059\u3044\u3068\u3044\u3048\u307e\u3059\u3002<br>\u30fb\u81ea\u52d5\u7684\u306b\u53d6\u5f97\u3067\u304d\u3066\u3044\u308b\u304b\u3002<br>\u30fb\u958b\u767a\u3001\u8a2d\u5b9a\u5185\u5bb9\uff08\u904b\u7528\u4f1a\u793e\u3001\u81ea\u793e\uff09\u30fb\u30fb\u30fb\u30d7\u30ed\u30b0\u30e9\u30e0\u5909\u66f4\u3001\u30a4\u30f3\u30d5\u30e9\u5909\u66f4\u306a\u3069<br>\u30fb\u5229\u7528\uff08\u81ea\u793e\uff09\u30fb\u30fb\u30fb\u30fb\u30fb\u30fb\u30fb\u30fb\u30fb\u30fb\u30fb\u30fb\u30fb\u30ed\u30b0\u30a4\u30f3\u3001\u30c7\u30fc\u30bf\u767b\u9332\u30fb\u5909\u66f4\u3001\u30c0\u30a6\u30f3\u30ed\u30fc\u30c9\uff08\u53c2\u7167\u306f\u4e0d\u8981\uff09<br>\u30fb\u904b\u7528\uff08\u904b\u7528\u4f1a\u793e\u3001\u81ea\u793e\uff09\u30fb\u30fb\u30fb\u30fb\u30fb\u30fb\u30fb\u30fb\u30e6\u30fc\u30b6\u30fc\u767b\u9332\u3001\u6a29\u9650\u4ed8\u4e0e\u306a\u3069<br>\u30fb\u5909\u66f4\u524a\u9664\u7b49\u3067\u304d\u306a\u3044\u30b7\u30b9\u30c6\u30e0\u306b\u306a\u3063\u3066\u3044\u308b\u304b<br>\u30fb\u300c\u76e3\u67fb\u8a3c\u8de1\u306e\u78ba\u8a8d\u3057\u305f\u300d\u3068\u3044\u3046\u8a18\u9332\u304c\u5fc5\u8981<br>\u30fb\u76e3\u67fb\u8a3c\u8de1\u30ec\u30d3\u30e5\u30fc\u306f\u3001\u305d\u306e\u627f\u8a8d\u3054\u3068\u304c\u63a8\u5968\u3055\u308c\u3066\u3044\u308b<br>\u30fb\u76e3\u67fb\u8a3c\u8de1\u306f\u5370\u5237\u53ef\u80fd\u306e\u3057\u3066\u304a\u304f<\/li>\n<\/ul>\n\n\n\n<ul class=\"is-style-vk-triangle-mark wp-block-list\">\n<li>\u6642\u523b\u8a2d\u5b9a\uff5c\u30bf\u30a4\u30e0\u30b9\u30bf\u30f3\u30d7<br>\u30fb\u6642\u523b\u8a2d\u5b9a\u306f\u81ea\u52d5\u3067\u6642\u523b\u30b5\u30fc\u30d0\u30fc\u306a\u3069\u3067\u540c\u671f\u3055\u308c\u3066\u3044\u308b\u304b<br>\u30fb\u6642\u523b\u8a2d\u5b9a\u306f\u624b\u52d5\u3067\u5909\u66f4\u3067\u6765\u306a\u3044\u3088\u3046\u306b\u306a\u3063\u3066\u3044\u308b\u304b<br>\u30fb\u65e5\u6642\u3001\u6642\u523b\u306f\u4ed6\u306e\u904b\u7528\u3001\u30b7\u30b9\u30c6\u30e0\u3068\u540c\u671f\u304c\u53d6\u308c\u3066\u3044\u308b\u304b<br>\u30fb\u6642\u523b\u8a2d\u5b9a\u306f\u65e5\u5e38\u70b9\u691c\u306a\u3069\u3055\u308c\u3066\u3044\u308b\u304b<\/li>\n<\/ul>\n\n\n\n<ul class=\"is-style-vk-triangle-mark wp-block-list\">\n<li>\u30ef\u30fc\u30af\u30d5\u30ed\u30fc<br>\u30fb\u96fb\u5b50\u7f72\u540d\u306e\u8981\u4ef6\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u304b\u2192\u627f\u8a8d\u6642\u306bID\u3001\u30d1\u30b9\u30ef\u30fc\u30c9\u5165\u529b<br>\u30fb\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\uff08\u30eb\u30fc\u30c8\uff09\u306f\u30b7\u30b9\u30c6\u30e0\u306b\u8a2d\u5b9a\u3055\u308c\u3066\u3044\u308b\u3082\u306e\u3092\u5229\u7528\u3059\u308b\u3088\u3046\u306b\u306a\u3063\u3066\u3044\u308b\u304b<br>\u30fb\u30eb\u30fc\u30c8\u3092\u5229\u7528\u8005\u304c\u5909\u66f4\u3067\u304d\u306a\u3044\u3088\u3046\u306b\u306a\u3063\u3066\u3044\u308b\u304b<br>\u30fb\u904b\u7528\u4e2d\u306b\u30eb\u30fc\u30c8\u306b\u95a2\u308f\u308b\u5185\u5bb9\u306b\u5909\u66f4\u304c\u51fa\u308b\u5834\u5408\u306e\u5bfe\u5fdc\u691c\u8a0e<br>\u3000\u30eb\u30fc\u30c8\u5909\u66f4\u3001\u7d44\u7e54\u5909\u66f4\u3001\u7533\u8acb\u8005\u30fb\u627f\u8a8d\u8005\u306e\u7570\u52d5<\/li>\n<\/ul>\n\n\n\n<ul class=\"is-style-vk-triangle-mark wp-block-list\">\n<li>\u6587\u66f8\u7ba1\u7406<br>\u30fb\uff11\u756a\u6700\u521d\u304b\u3089\u30b7\u30b9\u30c6\u30e0\u306b\u767b\u9332\u3057\u3066\u3044\u308b\u304b\uff1f<br>\u3000\u7d19\u306b\u8a18\u9332\u3057\u3066\u30b7\u30b9\u30c6\u30e0\u306b\u767b\u9332\u3057\u3066\u3044\u308b\u304b\uff1f\u2192\u751f\u30c7\u30fc\u30bf\u306e\u5b9a\u7fa9<br>\u30fb\u751f\u30c7\u30fc\u30bf\uff08\u6700\u521d\u306b\u8a18\u8f09\u3055\u308c\u305f\u30c7\u30fc\u30bf\uff09\u304c\u7d19\u306e\u5834\u5408\u306f\u7d19\u306e\u4fdd\u5b58\u304c\u5fc5\u8981<\/li>\n<\/ul>\n\n\n\n<ul class=\"is-style-vk-triangle-mark wp-block-list\">\n<li>\u969c\u5bb3<br>\u30fb\u969c\u5bb3\u691c\u77e5<br>\u30fb\u4e00\u6642\u7684\u306b\u7d19\u904b\u7528\u306b\u623b\u3059\u3053\u3068\u3092\u898f\u5b9a\u3057\u3066\u304a\u304f\u3002\u307e\u305f\u3001\u30b7\u30b9\u30c6\u30e0\u5fa9\u65e7\u6642\u306e\u5bfe\u5fdc\u3082\u898f\u5b9a\u3057\u304a\u304f\u3002\u30c7\u30fc\u30bf\u306e\u4e0d\u6b63\u8a9e\u306a\u3069\u5185\u5bb9\u306b\u624b\u6bb5\u304c\u5fc5\u8981\u3002\u30aa\u30ea\u30b8\u30ca\u30eb\u60c5\u5831\u304c\u30b7\u30b9\u30c6\u30e0\u306b\u3057\u304b\u306a\u304f\u3001\u30c7\u30fc\u30bf\u304c\u55aa\u5931\u3057\u3066\u3044\u308b\u53ef\u80fd\u6027\u3082\u8003\u3048\u3089\u308c\u308b\u3002\u307e\u305f\u3001\u7d19\u7ba1\u7406\u3068\u306a\u3063\u3066\u3057\u307e\u3063\u305f\u5de5\u7a0b\u306e\u5185\u5bb9\u3092\u30b7\u30b9\u30c6\u30e0\u306b\u767b\u9332\u3059\u308b\u624b\u9806\u3082\u5fc5\u8981\u3068\u306a\u308b\u3002<\/li>\n<\/ul>\n\n\n\n<ul class=\"is-style-vk-triangle-mark wp-block-list\">\n<li>\u5197\u9577\u6027<br>\u30fb\u30b9\u30bf\u30f3\u30d0\u30a4\uff08\u30db\u30c3\u30c8\u3001\u30b3\u30fc\u30eb\u30c9\uff09\u3092\u78ba\u8a8d\u3059\u308b<\/li>\n\n\n\n<li>\u30d0\u30c3\u30af\u30a2\u30c3\u30d7\u3001\u30ea\u30b9\u30c8\u30a2<br>\u30fb\u85ac\u4e8b\u6cd5\u53ca\u3073\u95a2\u9023\u6cd5\u898f\u3001\u95a2\u9023\u901a\u77e5\u304c\u5b9a\u3081\u308b\u671f\u9593\u4fdd\u5b58\u3067\u304d\u308b\u304b<br>\u30fb\u30d0\u30c3\u30af\u30a2\u30c3\u30d7\u3068\u30a2\u30fc\u30ab\u30a4\u30d6\u3068\u306f\u7570\u306a\u308b<br>\u3000\u30a2\u30fc\u30ab\u30a4\u30d6\u3000\uff1a\u4e00\u5b9a\u671f\u9593\u3092\u8d8a\u3048\u305f\u3001\u901a\u5e38\u5229\u7528\u3057\u306a\u3044\u30c7\u30fc\u30bf\u3092\u5225\u30a8\u30ea\u30a2\u306b\u4fdd\u7ba1\u3059\u308b\u3053\u3068<br>                       \u300c\u3061\u3087\u3063\u3068\u907f\u3051\u3068\u304f\u300d\u3068\u3044\u3046\u611f\u3058<br>\u3000\u30d0\u30c3\u30af\u30a2\u30c3\u30d7\uff1a\u30c7\u30fc\u30bf\u304c\u7834\u640d\u306a\u3069\u3057\u305f\u5834\u5408\u306b\u5fa9\u5143\u3059\u308b\u305f\u3081\u306e\u30c7\u30fc\u30bf<br>                        \u30a2\u30fc\u30ab\u30a4\u30d6\u30c7\u30fc\u30bf\u306e\u30d0\u30c3\u30af\u30a2\u30c3\u30d7\u3082\u5fc5\u8981\u3067\u3042\u308b\u3000<br>\u30fb\u30d0\u30c3\u30af\u30a2\u30c3\u30d7\u53d6\u5f97\u65b9\u6cd5\u3092\u78ba\u8a8d\u3059\u308b<br>\u3000\u3053\u306e\u5358\u4f4d\u3067\u30ea\u30b9\u30c8\u30a2\u3067\u304d\u308b\u7bc4\u56f2\u304c\u6c7a\u307e\u308b\u3002<br>\u3000\u4f8b\uff09\u30c6\u30fc\u30d6\u30eb\u5358\u4f4d\u3001DB\u5358\u4f4d\u3001\u30b7\u30b9\u30c6\u30e0\u307e\u308b\u3054\u3068\u3001\u30b5\u30fc\u30d0\u30fc\u307e\u308b\u3054\u3068\u3001\u8907\u5408<br>\u3000\u3000\u3000\u5358\u4f4d\uff08\u6642\u9593\u3001\u65e5\u3001\u6708\uff09\u3001\u4fdd\u5b58\u671f\u9593\u3001\u4fdd\u5b58\u5a92\u4f53\u3001\u4fdd\u7ba1\u5834\u6240<br>\u30fb\u30d0\u30c3\u30af\u30a2\u30c3\u30d7\u304c\u5909\u66f4\u3055\u308c\u306a\u3044\u3088\u3046\u306b\u4fdd\u7ba1\u3055\u308c\u3066\u3044\u308b\u304b<br>\u30fb\u30c7\u30fc\u30bf\u306f\u30a8\u30c7\u30a3\u30bf\u30fc\u306a\u3069\u3067\u7c21\u5358\u306b\u898b\u308c\u308b\u3082\u306e\u304b\uff08\u4f8b\uff1aCSV\u3068\u304b\uff09<br>\u30fb\u30c7\u30fc\u30bf\u304c\u56fa\u6709\u30b7\u30b9\u30c6\u30e0\u3067\u3042\u308b\u5834\u5408\u3001\u305d\u306e\u30b7\u30b9\u30c6\u30e0\u3092\u30c7\u30fc\u30bf\u4fdd\u6709\u671f\u9593\u306f\u7dad\u6301\u3067\u304d\u308b\u304b<br>\u30fb\u30e1\u30bf\u30c7\u30fc\u30bf\u3001\u76e3\u67fb\u8a3c\u8de1\u3082\u542b\u3081\u3066\u4fdd\u7ba1\u3055\u308c\u3066\u3044\u308b\u304b<br>\u30fb\u30d0\u30c3\u30af\u30a2\u30c3\u30d7\u306f\u771f\u6b63\u30b3\u30d4\u30fc\u3068\u3044\u3046\u6271\u3044\u306b\u306a\u308b<br>\u30fb\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306e\u30d0\u30c3\u30af\u30a2\u30c3\u30d7\u3060\u3051\u3067\u826f\u3044\u304b\u691c\u8a0e\u3059\u308b<br>\u3000\u30b7\u30b9\u30c6\u30e0\u4ee5\u4e0a\u306e\u5834\u5408\u306e\u307f\u5229\u7528\u3055\u308c\u308b\u3082\u306e\u3067\u3001\u901a\u5e38\u306f\u5229\u7528\u8005\u306e\u90fd\u5408\u3067\u306f\u30ea\u30b9\u30c8\u30a2\u3067\u304d\u306a\u3044<br>\u3000\u4f8b\uff09\u3053\u306e\u30c6\u30fc\u30d6\u30eb\u3060\u3051\u623b\u3057\u305f\u3044\u3068\u304b<br>\u30fb\u30b7\u30b9\u30c6\u30e0\u5c0e\u5165\u6642\u306b\u306f\u3001\u30d0\u30c3\u30af\u30a2\u30c3\u30d7\uff0f\u30ea\u30b9\u30c8\u30a2\u30c6\u30b9\u30c8\u3092\u5b9f\u65bd\u3059\u308b<br>\u30fb\u5b9a\u671f\u70b9\u691c\u6642\u306a\u3069\u306b\u6bce\u5e74\u30c6\u30b9\u30c8\u5b9f\u65bd\u304c\u5fc5\u8981<\/li>\n<\/ul>\n\n\n\n<ul class=\"is-style-vk-triangle-mark wp-block-list\">\n<li>\u6fc0\u751a\u707d\u5bb3\u5bfe\u7b56<br>\u30fb\u30b7\u30b9\u30c6\u30e0\u518d\u958b\u306e\u898f\u5b9a<br>\u30fb\u9060\u9694\u5730\u30d0\u30c3\u30af\u30a2\u30c3\u30d7<\/li>\n\n\n\n<li>\u4e8b\u696d\u7d99\u7d9a\u8a08\u753b\uff08BCP\uff09<br>\u4f01\u696d\u304c\u81ea\u7136\u707d\u5bb3\u3001\u5927\u706b\u707d\u3001\u30c6\u30ed\u653b\u6483\u306a\u3069\u306e\u7dca\u6025\u4e8b\u614b\u306b\u906d\u9047\u3057\u305f\u5834\u5408\u306b\u304a\u3044\u3066\u3001\u4e8b\u696d\u8cc7\u7523\u306e\u640d\u5bb3\u3092\u6700\u5c0f\u9650\u306b\u3068\u3069\u3081\u3064\u3064\u3001\u4e2d\u6838\u3068\u306a\u308b\u4e8b\u696d\u306e\u7d99\u7d9a\u3042\u308b\u3044\u306f\u65e9\u671f\u5fa9\u65e7\u3092\u53ef\u80fd\u3068\u3059\u308b\u305f\u3081\u306b\u3001\u5e73\u5e38\u6642\u306b\u884c\u3046\u3079\u304d\u6d3b\u52d5\u3084\u7dca\u6025\u6642\u306b\u304a\u3051\u308b\u4e8b\u696d\u7d99\u7d9a\u306e\u305f\u3081\u306e\u65b9\u6cd5\u3001\u624b\u6bb5\u306a\u3069\u3092\u53d6\u308a\u6c7a\u3081\u3066\u304a\u304f\u8a08\u753b\u306e\u3053\u3068\u3067\u3059\u3002 \u7dca\u6025\u4e8b\u614b\u306f\u7a81\u7136\u767a\u751f\u3057\u307e\u3059\u3002\uff08wikipedia\uff09\u53c2\u8003\u30b5\u30a4\u30c8\uff1a<a href=\"http:\/\/www.meti.go.jp\/policy\/safety_security\/bcp\/\">\u7d4c\u6e08\u7523\u696d\u7701<\/a><\/li>\n\n\n\n<li>\u30c7\u30a3\u30b6\u30b9\u30bf\u30ea\u30ab\u30d0\u30ea\uff08DR\uff09disaster recovery<br>\u4e8b\u696d\u7d99\u7d9a\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u306b\u304a\u3051\u308b\u6982\u5ff5\u306e\u3072\u3068\u3064\u3067\u3001\u707d\u5bb3\u306a\u3069\u306b\u3088\u308b\u88ab\u5bb3\u304b\u3089\u306e\u56de\u5fa9\u63aa\u7f6e\u3001\u3042\u308b\u3044\u306f\u88ab\u5bb3\u3092\u6700\u5c0f\u9650\u306b\u6291\u3048\u308b\u305f\u3081\u306e\u4e88\u9632\u63aa\u7f6e\u306e\u3053\u3068\u3067\u3042\u308b\u3002 \u4e3b\u306b\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u30b7\u30b9\u30c6\u30e0\u3084\u30cd\u30c3\u30c8\u30ef\u30fc\u30af\u306a\u3069IT\u95a2\u9023\u3067\u7528\u3044\u3089\u308c\u308b\u3053\u3068\u304c\u591a\u3044\u3002\uff08wikipedia\uff09<\/li>\n<\/ul>\n\n\n\n<ul class=\"is-style-vk-triangle-mark wp-block-list\">\n<li>\u30b7\u30b9\u30c6\u30e0\u3092\u3084\u3081\u308b\u3068\u304d\uff08\u30ea\u30bf\u30a4\u30e4\u30e1\u30f3\u30c8\uff09\u306b<br>\u30fb\u30c7\u30fc\u30bf\u304c\u53d6\u308a\u51fa\u305b\u308b\u304b\uff1f<br>\u30fb\u540c\u30b7\u30b9\u30c6\u30e0\u4e2d\u3067\u524a\u9664\u3067\u304d\u3066\u3044\u308b\u304b\uff1f\u78ba\u8a8d\u66f8\u306f\u63d0\u51fa\u3044\u305f\u3060\u3051\u308b\u304b\uff1f<\/li>\n<\/ul>\n\n\n\n<ul class=\"is-style-vk-triangle-mark wp-block-list\">\n<li>\u30b5\u30d7\u30e9\u30a4\u30e4\u76e3\u67fb\u306e\u5b9f\u65bd<\/li>\n<\/ul>\n\n\n\n<ul class=\"is-style-vk-triangle-mark wp-block-list\">\n<li>\u65e5\u5e38\u70b9\u691c\u306e\u5b9f\u65bd\u9805\u76ee<br>\u30fb\u30b5\u30fc\u30d0\u3001\u30b7\u30b9\u30c6\u30e0\u7a3c\u50cd\u72b6\u6cc1<br>\u30fb\u30cd\u30c3\u30c8\u30ef\u30fc\u30af\u901a\u4fe1\u72b6\u614b<br>\u30fbCPU\u4f7f\u7528\u7387<br>\u30fb\u30ec\u30b9\u30dd\u30f3\u30b9\u30bf\u30a4\u30e0<br>\u30fb\u30c7\u30a3\u30b9\u30af\u5bb9\u91cf\u4f7f\u7528\u7387<br>\u30fbOS\u30ed\u30b0\u30a4\u30f3\u5c65\u6b74<br>\u30fbDB\u78ba\u4fdd\u5bb9\u91cf\u4f7f\u7528\u7387<br>\u30fbDB\u76e3\u67fb\u30ed\u30b0<br>\u30fb\u30d0\u30c3\u30c1\u51e6\u7406\u7d50\u679c<br>\u30fb\u30b5\u30fc\u30d0\u3001\u30b7\u30b9\u30c6\u30e0\u30a8\u30e9\u30fc\u76e3\u8996<\/li>\n\n\n\n<li>\u81ea\u5df1\u70b9\u691c\u306e\u5b9f\u65bd\u9805\u76ee\uff08\u4f8b\uff09<br>\u30fb\u65e5\u5e38\u70b9\u691c\u306e\u8a18\u9332\u5b9f\u65bd\u72b6\u6cc1<br>\u30fb\u5b9a\u671f\u70b9\u691c\u306e\u8a18\u9332\u5b9f\u65bd\u72b6\u6cc1<br>\u30fb\u5909\u66f4\u7ba1\u7406\u904b\u7528\u306e\u78ba\u8a8d<br>\u30fb\u9038\u8131\u3001\u662f\u6b63\u51e6\u7f6e\u904b\u7528\u306e\u78ba\u8a8d<br>\u30fb\u7ba1\u7406\u8005\u3001\u5229\u7528\u8005\u306e\u6559\u80b2\u8a13\u7df4\u306e\u78ba\u8a8d<\/li>\n<\/ul>\n\n\n\n<ul class=\"is-style-vk-triangle-mark wp-block-list\">\n<li>\u5b9a\u671f\u70b9\u691c\u306e\u5b9f\u65bd\u9805\u76ee\uff08\u4f8b\uff09<br>\u30fb\u30d7\u30ed\u30b0\u30e9\u30e0\u3084\u69cb\u6210\u306e\u5185\u5bb9\u306b\u4e0d\u6b63\u306a\u5909\u66f4\u304c\u52a0\u3048\u3089\u308c\u3066\u3044\u306a\u3044\u304b<br>\u30fb\u5b9a\u3081\u3089\u308c\u305f\u4ed5\u69d8\u901a\u308a\u306e\u30d0\u30fc\u30b8\u30e7\u30f3\u304b<br>\u30fb\u30d0\u30ea\u30c7\u30fc\u30c8\u3055\u308c\u305f\u72b6\u614b\u304c\u7dad\u6301\u3067\u304d\u3066\u3044\u308b\u304b<br>\u30fb\u5909\u66f4\u7ba1\u7406\uff08\u5909\u66f4\u624b\u7d9a\u304d\u3001\u5909\u66f4\u4e8b\u9805\u306e\u691c\u8a3c\u3001\u6559\u80b2\u8a13\u7df4\u3001\uff33OP\u306e\u6539\u8a02\u7b49\uff09\u3001\u30a4\u30f3\u30b7\u30c7\u30f3\u30c8\u7ba1\u7406\u3001\u65e5\u5e38\u70b9\u691c<br>\u30fb\u30bb\u30ad\u30e5\u30ea\u30c6\u30a3\u7ba1\u7406\uff08\u6a29\u9650\u4ed8\u4e0e\u7ba1\u7406\u3092\u542b\u3080\uff09\u304c\u9069\u6b63\u306b\u884c\u308f\u308c\u3066\u3044\u308b\u304b\u3000<br>\u30fb\u5b9a\u671f\u7684\u306b\u4ea4\u63db\u3059\u308b\u3079\u304d\u90e8\u54c1\u7b49\u304c\u9069\u5207\u306b\u4ea4\u63db\u3055\u308c\u3066\u3044\u308b\u304b<br>\u30fb\u30af\u30ed\u30c3\u30af\u3001\u8a08\u6e2c\u6a5f\u5668\u7b49\u306e\u6821\u6b63\u304c\u884c\u308f\u308c\u30ba\u30ec\u306e\u88dc\u6b63\u304c\u884c\u308f\u308c\u3066\u3044\u308b\u304b<br>\u30fb\u81ea\u5df1\u70b9\u691c\u306e\u76ee\u7684\u306fGMP\u306e\u89b3\u70b9\u304b\u3089\u81ea\u793e\u306eGMP\u7ba1\u7406\u65b9\u91dd\uff08\u54c1\u8cea\u30de\u30cb\u30e5\u30a2\u30eb\u3001\u5404\u7a2e\u624b\u9806\u66f8\uff09\u3001\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u7ba1\u7406\u898f\u5b9a\u3092\u9806\u5b88\u3057\u3066\u9069\u5207\u306a\u88fd\u9020\u7ba1\u7406\u53ca\u3073\u54c1\u8cea\u7ba1\u7406\u3092\u78ba\u4fdd\u3057\u3066\u3044\u308b\u304b\u78ba\u8a8d\u3057\u3001\u5fc5\u8981\u306a\u5834\u5408\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30ec\u30d3\u30e5\u30fc\u3092\u901a\u3057\u3066\uff27\uff2d\uff30\u4f53\u5236\uff08\u4eba\u3001\u624b\u9806\u3001\u6a5f\u5668\u3001\u30b7\u30b9\u30c6\u30e0\uff09\u306e\u6539\u5584\u3092\u52e7\u3081\u308b\u305f\u3081\u306b\u884c\u3046\u3067\u3042\u308b<\/li>\n<\/ul>\n\n\n\n<ul class=\"is-style-vk-triangle-mark wp-block-list\">\n<li>EXCEL\u306fGMP\u696d\u52d9\u306b\u5229\u7528\u3067\u304d\u308b\u306e\u304b\uff1f<br>\u57fa\u672c\u7684\u306b\u300c\u3067\u304d\u306a\u3044\u300d\u3068\u3044\u3046\u306e\u304c\u5f0a\u793e\u306e\u898b\u89e3\u3067\u3059\u3002<br>\u30fb\u8ab0\u304c\u8a18\u8f09\u3057\u305f\u304b\u660e\u78ba\u3059\u308b\u306e\u306f\u96e3\u3057\u3044<br>\u30fb\u8a18\u8f09\u65b9\u6cd5\u3092\u5b8c\u5168\u306b\u898f\u5b9a\u3059\u308b\u3053\u3068\u304c\u96e3\u3057\u3044<br>\u30fb\u8a18\u8f09\u3055\u308c\u305f\u65e5\u6642\u3092\u9650\u5b9a\u3059\u308b\u306e\u304c\u96e3\u3057\u3044<br>\u30fb\u7c21\u5358\u306b\u30b3\u30d4\u30fc\u304c\u3067\u304d\u308b<br>\u30fb\u6a29\u9650\u8a2d\u5b9a\u304c\u96e3\u3057\u3044<br>\u30fb\u76e3\u67fb\u8a3c\u8de1\u304c\u53d6\u308c\u306a\u3044<br>\u30fb\u30c7\u30fc\u30bf\u7834\u640d\u306e\u53ef\u80fd\u6027\u304c\u3042\u308b<br>\u306a\u3069\u306a\u3069\u3001\u524d\u8ff0\u3057\u305fALCOA\u306e\u539f\u5247\u306b\u9069\u5408\u3059\u308b\u306e\u306f\u3067\u304d\u306a\u304f\u306f\u306a\u3044\u304c\u3001\u304b\u306a\u308a\u96e3\u3057\u3044\u3068\u8003\u3048\u3066\u3044\u307e\u3059\u3002<br><br>\u307e\u305f\u3001FDA\u304b\u3089\u3082EXCEL\u306b\u95a2\u3059\u308b<a rel=\"noreferrer noopener\" href=\"https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/compliance-actions-and-activities\/warning-letters\" target=\"_blank\"><strong>\u30ef\u30fc\u30cb\u30f3\u30b0\u30ec\u30bf\u30fc\u304c\u591a\u6570\u5831\u544a<\/strong><img loading=\"lazy\" decoding=\"async\" width=\"60\" height=\"43\" class=\"wp-image-3574\" style=\"width: 60px;\" src=\"https:\/\/www.fsz.co.jp\/wp-content\/uploads\/2016\/05\/pixta_10591886_SL120-.jpg\" alt=\"\" srcset=\"https:\/\/www.fsz.co.jp\/wp-content\/uploads\/2016\/05\/pixta_10591886_SL120-.jpg 120w, https:\/\/www.fsz.co.jp\/wp-content\/uploads\/2016\/05\/pixta_10591886_SL120--100x70.jpg 100w\" sizes=\"auto, (max-width: 60px) 100vw, 60px\" \/><\/a>\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u4ee5\u4e0b\u3001\u4e00\u90e8\u4f8b\u3067\u3059\u3002<\/li>\n<\/ul>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p>FDA WARNING LETTER<br>562382 \u2014&nbsp;&nbsp;2019\/2\/19<br>Your response noted the following corrective and preventive actions:holding GLP training for management;<strong><br>\u30fbcreating an <span data-color=\"#fcb900\" class=\"vk_highlighter\" style=\"background: linear-gradient(transparent 60%,rgba(252, 185, 0, 0.7) 0);\">Excel spreadsheet<\/span> to document traceability;<\/strong><br>\u30fb\u4e2d\u7565<br>\u30fbconducting staff training on labeling at the Annual GLP Refresher training session.&nbsp;<\/p>\n<cite><a href=\"https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/warning-letters\/american-preclinical-services-562382-02122019\">https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/warning-letters\/american-preclinical-services-562382-02122019<\/a><\/cite><\/blockquote>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p>FDA WARNING LETTER<br>Tismor Health and Wellness Pty Limited<br>588104 \u2014&nbsp;2019\/12\/5<br><strong><span data-color=\"#fffd6b\" class=\"vk_highlighter\" style=\"background: linear-gradient(transparent 60%,rgba(255, 253, 107, 0.7) 0);\">Your firm failed to validate the Excel spreadsheet<\/span><\/strong> used to perform the assay calculation for your \u201c<strong>(b)(4)<\/strong>.\u201d Your procedures lacked guidance on how to check and manually verify the calculation sheets. During the inspection, our investigator identified a calculation error within the spreadsheet. The incorrect formula for averaging the Internal Standard peak area was used.<\/p>\n<cite><a href=\"https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/warning-letters\/tismor-health-and-wellness-pty-limited-588104-12052019\">https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/warning-letters\/tismor-health-and-wellness-pty-limited-588104-12052019<\/a><\/cite><\/blockquote>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p>FDA WARNING LETTER<br>588104 \u2014&nbsp;2019\/12\/5<br><strong>Your firm failed to validate the <\/strong><span data-color=\"#fcb900\" class=\"vk_highlighter\" style=\"background: linear-gradient(transparent 60%,rgba(252, 185, 0, 0.7) 0);\"><strong>Excel spreadsheet<\/strong>&nbsp;<\/span>used to perform the assay calculation for your \u201c<strong>(b)(4)<\/strong>.\u201d Your procedures lacked guidance on how to check and manually verify the calculation sheets. During the inspection, our investigator identified a <strong>calculation error within the spreadsheet<\/strong>. The incorrect formula for averaging the Internal Standard peak area was used.<\/p>\n<cite><a href=\"https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/warning-letters\/tismor-health-and-wellness-pty-limited-588104-12052019\">https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/warning-letters\/tismor-health-and-wellness-pty-limited-588104-12052019<\/a><\/cite><\/blockquote>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p>FDA WARNING LETTER<br>Kyowa Hakko Bio Co., Ltd.<br>543924 \u2014 2018\/8\/10<br>In your annual product reviews, <span data-color=\"#fffd6b\" class=\"vk_highlighter\" style=\"background: linear-gradient(transparent 60%,rgba(255, 253, 107, 0.7) 0);\"><strong>you used unprotected Excel worksheets<\/strong><\/span> to perform calculations and statistical evaluations of production data, such as standard deviation and process capability. These electronic files were not secured to prevent unauthorized changes, and have no change history.<\/p>\n<cite><a href=\"https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/warning-letters\/kyowa-hakko-bio-co-ltd-543924-08102018\">https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/warning-letters\/kyowa-hakko-bio-co-ltd-543924-08102018<\/a><\/cite><\/blockquote>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p>FDA WARNING LETTER<br>Sichuan Friendly Pharmaceutical Co., Ltd.<br>546990 \u2014 2018\/6\/22<br>Failure to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data, and to have adequate controls to prevent omission of data.&nbsp;You used <strong><span data-color=\"#fffd6b\" class=\"vk_highlighter\" style=\"background: linear-gradient(transparent 60%,rgba(255, 253, 107, 0.7) 0);\">a non-validated Excel spreadsheet<\/span><\/strong> to calculate assay results for&nbsp;(b)(4)&nbsp;USP for product release and stability testing. Our investigator found that this spreadsheet lacked password protection and contained unlocked calculation formulas which were incorrect.&nbsp;During the inspection, your QC manager acknowledged that the formula in the spreadsheet used to calculate assay results was incorrect. Because of these incorrect formulas, multiple certificates of analysis (COA) contained inaccurate data.<\/p>\n<cite><a href=\"https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/warning-letters\/sichuan-friendly-pharmaceutical-co-ltd-546990-06222018\">https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/warning-letters\/sichuan-friendly-pharmaceutical-co-ltd-546990-06222018<\/a><\/cite><\/blockquote>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p>FDA WARNING LETTER<br>Sandoz Private Limited<br>445532 \u2014&nbsp;&nbsp;2015\/10\/22<br>On August 28, 2014, FDA investigators identified instances of non-contemporaneous documentation of batch production activities.&nbsp;<strong><span data-color=\"#fffd6b\" class=\"vk_highlighter\" style=\"background: linear-gradient(transparent 60%,rgba(255, 253, 107, 0.7) 0);\">Two uncontrolled Excel spreadsheets were used to record discrepancies <\/span><\/strong>and certain in-process drug quality data.&nbsp;This data was initially missing in the batch manufacturing record.&nbsp;Your firm later entered this data into batch records and backdated them. &nbsp;<\/p>\n<cite><a href=\"https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/warning-letters\/sandoz-private-limited-445532-10222015\">https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/warning-letters\/sandoz-private-limited-445532-10222015<\/a><\/cite><\/blockquote>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p>\u3059\u3053\u3057\u53e4\u3044\u60c5\u5831\u3067\u3059\u304c\u3001\u30a4\u30fc\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u69d8\u306e\u30b5\u30a4\u30c8\u306b\u306f\u300cMS-Excel\u306b\u95a2\u3059\u308b\u30ef\u30fc\u30cb\u30f3\u30b0\u30ec\u30bf\u30fc\u300d\u3068\u3044\u3046\u60c5\u5831\u304c<a href=\"https:\/\/ecompliance.co.jp\/FDA\/WarningLetters\/excel.html\">\u3053\u3061\u3089\u306b<\/a>\u63b2\u8f09\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n<cite><a href=\"https:\/\/ecompliance.co.jp\/FDA\/WarningLetters\/excel.html\">https:\/\/ecompliance.co.jp\/FDA\/WarningLetters\/excel.html<\/a><\/cite><\/blockquote>\n\n\n\n<p>\u3057\u304b\u3057\uff01\u4fbf\u5229\u3067\u3059\u304b\u3089\u3001\u5229\u7528\u3055\u308c\u3066\u3044\u308b\u30b1\u30fc\u30b9\u3082\u591a\u6570\u3042\u308b\u3088\u3046\u3067\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">ER\/ES\u6307\u91dd\u304c\u3053\u306e\u8a71\u306e\u5143\u7956\u3067\u3059\u306d\u3002<\/h3>\n\n\n\n<p>\u533b\u85ac\u54c1\u7b49\u306e\u627f\u8a8d\u53c8\u306f\u8a31\u53ef\u7b49\u306b\u4fc2\u308b\u7533\u8acb\u7b49\u306b\u304a\u3051\u308b\u96fb\u78c1\u7684\u8a18\u9332\u53ca\u3073\u96fb\u5b50\u7f72\u540d\u306e\u5229\u7528\u306b\u3064\u3044\u3066<\/p>\n\n\n\n<p>\u901a\u79f0\u300cER\/ES\u6307\u91dd\u300d\u306f\u539a\u751f\u52b4\u50cd\u7701\u304b\u3089\u901a\u77e5\u3055\u308c\u305f\u300c\u533b\u85ac\u54c1\u7b49\u306e\u627f\u8a8d\u53c8\u306f\u8a31\u53ef\u7b49\u306b\u4fc2\u308b\u7533\u8acb\u7b49\u306b\u304a\u3051\u308b\u96fb\u78c1\u7684\u8a18\u9332\u53ca\u3073\u96fb\u5b50\u7f72\u540d\u306e\u5229\u7528\u306b\u3064\u3044\u3066\u300d\u306e\u3053\u3068\u3067\u3001\u5185\u5bb9\u306b\u3064\u3044\u3066\u306f\u3001e\u2015\u6587\u66f8\u6cd5 *2\u3092\u524d\u63d0\u3068\u3057\u3066\u4f5c\u6210\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u5185\u5bb9\u3068\u3057\u3066\u306f\u77ed\u3044\u6587\u66f8\u3067\u3059\u304c\u3001\u5185\u5bb9\u306f\u6fc3\u304f\u3001\u3044\u308d\u3044\u308d\u306a\u89e3\u91c8\u304c\u3067\u304d\u308b\u305f\u3081\u3001\u5b9f\u969b\u306b\u96fb\u5b50\u4fdd\u5b58\u3001\u96fb\u5b50\u7f72\u540d\u3092\u63a1\u7528\u3057\u3066\u3044\u308b\u4f01\u696d\u306f\u5c11\u306a\u3044\u306e\u304c\u73fe\u72b6\u3067\u3059\u3002\u3057\u304b\u3057\u3001\u6700\u8fd1\u3067\u306f\u7d19\u3067\u306f\u4fdd\u5b58\u3057\u304d\u308c\u306a\u3044\u30d3\u30c3\u30af\u30c7\u30fc\u30bf\u3084\u518d\u89e3\u6790\u53ef\u80fd\u306a\u751f\u30c7\u30fc\u30bf\u3001\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\uff08DI\uff1aData Integrity\uff09\u306e\u9ad8\u307e\u308a\u304b\u3089\u3001\u518d\u6ce8\u76ee\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>\uff62\u96fb\u78c1\u7684\u8a18\u9332\uff63\u3068\u3044\u3046\u8868\u73fe\u306f\u3001\u5149\u30e1\u30c7\u30a3\u30a2\u3084\u30af\u30e9\u30a6\u30c9\u304c\u4e00\u822c\u7684\u306b\u306a\u3063\u305f\u4eca\u3067\u306f\u3061\u3087\u3063\u3068\u9055\u548c\u611f\u306e\u3042\u308b\u8a00\u8449\u3067\u3059\u304c\u3001\uff62\u96fb\u78c1\u7684\u8a18\u9332\uff63\u306f\u6982\u306d\u300c\u96fb\u5b50\u7684\u65b9\u5f0f\u3001\u78c1\u6c17\u7684\u65b9\u5f0f\u305d\u306e\u4ed6\u306e&nbsp;\u77e5\u899a\u306b\u3088\u3063\u3066\u8a8d\u8b58\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u306a\u3044\u65b9\u5f0f\u3067\u4f5c\u3089\u308c\u305f\u8a18\u9332&nbsp;\u3092\u3044\u3046\u3002\u300d\u3068\u6cd5\u5f8b\u7528\u8a9e\u3067\u5b9a\u7fa9\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u5b9a\u7fa9\u306f\u5e45\u5e83\u3044\u8868\u73fe\u306b\u306a\u3063\u3066\u304a\u308a\u3001\u65b0\u6280\u8853\u304c\u5275\u51fa\u3055\u308c\u3066\u3082\u9069\u7528\u3067\u304d\u308b\u3088\u3046\u306b\u306a\u3063\u3066\u3044\u307e\u3059\u3002\u6cd5\u5f8b\u7528\u8a9e\u306f\u3046\u307e\u3044\u3053\u3068\u5b9a\u7fa9\u3055\u308c\u3066\u3044\u308b\u306a\u3068\u611f\u5fc3\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u85ac\u6a5f\u6cd5\uff08\u5f53\u6642\u306f\u85ac\u4e8b\u6cd5\uff09\u306b\u304b\u304b\u308f\u308b\u7bc4\u56f2\u3067\u306e\u96fb\u78c1\u7684\u8a18\u9332\u3001\u96fb\u5b50\u7f72\u540d\u306b\u3064\u3044\u3066\u66f8\u304b\u308c\u305f\u3082\u306e\u3067\u3001\u88fd\u85ac\u3001\u5316\u7ca7\u54c1\u3001\u533b\u7642\u6a5f\u5668\u306a\u3069\u3092\u88fd\u9020\u3059\u308b\u4f01\u696d\u3092\u5bfe\u8c61\u3068\u306a\u308a\u307e\u3059\u3002\u30a2\u30e1\u30ea\u30ab\u98df\u54c1\u533b\u85ac\u54c1\u5c40\u3000FDA\uff08Food and Drug Administration\uff09\u304c\u51fa\u3057\u3066\u3044\u308b21 CFR Part 11 *1\u3068\u540c\u69d8\u306e\u8981\u4ef6\u304c\u307e\u3068\u3081\u3089\u308c\u3066\u304a\u308a\u3001\u6700\u8fd1\u3067\u306fGDP\uff08Good Distribution Practice\uff09\u306e\u65bd\u884c\u3082\u3042\u3063\u3066\u3001\u88fd\u85ac\u5378\u306a\u3069\u306b\u3082\u5e83\u304c\u308a\u3092\u898b\u305b\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u8981\u6c42\u4e8b\u9805\u3092\u7c21\u5358\u306b\u3044\u3046\u3068\u4ee5\u4e0b\u306e\u3068\u304a\u308a\u3002<\/p>\n\n\n\n<p>\u25a0\u96fb\u78c1\u7684\u8a18\u9332<br>\u30fb\u7ba1\u7406\u306fCSV\u3055\u308c\u305f\u30b7\u30b9\u30c6\u30e0\u3092\u5229\u7528\u3059\u308b\u3053\u3068<br>\u30fb\u4ee5\u4e0b\u306e\uff13\u3064\u3092\u7dad\u6301\u3059\u308b\u3053\u3068<\/p>\n\n\n\n<p>\u2460\u771f\u6b63\u6027<br>\u30fb\u30b7\u30b9\u30c6\u30e0\u30bb\u30ad\u30e5\u30ea\u30c6\u30a3\u306e\u898f\u5247\u3001\u624b\u9806\uff08\u30d0\u30c3\u30af\u30a2\u30c3\u30d7\u542b\u3080\uff09\u304c\u6587\u66f8\u5316\u3055\u308c\u3001\u9069\u5207\u306b\u5b9f\u65bd\u3055\u308c\u3066\u3044\u308b\u3053\u3068<br>\u30fb\u76e3\u67fb\u8a3c\u8de1 *3\uff08\u4f5c\u6210\u3001\u5909\u66f4\u60c5\u5831\u3092\u542b\u3080\uff09\u304c\u81ea\u52d5\u7684\u306b\u8a18\u9332\u3055\u308c\u3001\u4e88\u3081\u5b9a\u3081\u3089\u308c\u305f\u624b\u9806\u3067\u78ba\u8a8d\u3067\u304d\u308b<br>\u30fb\u60c5\u5831\u3092\u5909\u66f4\u3059\u308b\u5834\u5408\u306f\u3001\u5909\u66f4\u524d\u306e\u60c5\u5831\u3082\u4fdd\u5b58\u3055\u308c\u308b\u3068\u3068\u3082\u306b\u3001\u5909\u66f4\u8005\u304c\u660e\u78ba\u306b\u8b58\u5225\u3067\u304d\u308b<\/p>\n\n\n\n<p>\u2461\u898b\u8aad\u6027<br>\u30fb\u4eba\u304c\u8aad\u3081\u308b\u5f62\u5f0f\u3067\u51fa\u529b\u304c\u3067\u304d\u308b\u3053\u3068<\/p>\n\n\n\n<p>\u2462\u4fdd\u5b58\u6027<br>\u30fb\u4fdd\u5b58\u671f\u9593\u5185\u306b\u304a\u3044\u3066\u3001\u771f\u6b63\u6027\u53ca\u3073\u898b\u8aad\u6027\u304c\u78ba\u4fdd\u3055\u308c\u305f\u72b6\u614b\u3067\u4fdd\u5b58\u3067\u304d\u308b<br>\u30fb\u4fdd\u5b58\u6027\u3092\u78ba\u4fdd\u3059\u308b\u305f\u3081\u306e\u624b\u9806\u304c\u6587\u66f8\u5316\u3055\u308c\u3001\u9069\u5207\u306b\u5b9f\u65bd\u3055\u308c\u3066\u3044\u308b\u3053\u3068<br>\u30fb\u4ed6\u306e\u96fb\u78c1\u7684\u8a18\u9332\u5a92\u4f53\u79fb\u884c\u3059\u308b\u5834\u5408\u306b\u3082\u771f\u6b63\u6027\u3001\u898b\u8aad\u6027\u53ca\u3073\u4fdd\u5b58\u6027\u304c\u78ba\u4fdd\u3055\u308c\u3066\u3044\u308b\u3053\u3068<br>\u30fb\u30aa\u30fc\u30d7\u30f3\u30fb\u30b7\u30b9\u30c6\u30e0 *4\u306e\u5229\u7528\u306e\u5834\u5408\u306f\u3001\u96fb\u78c1\u7684\u8a18\u9332\u304c\u4f5c\u6210\u3055\u308c\u3066\u304b\u3089\u53d7\u3051\u53d6\u3089\u308c\u308b\u307e\u3067\u306e\u9593\u306e\u771f\u6b63\u6027\u3001\u6a5f\u5bc6\u6027\u3092\u78ba\u4fdd\u3059\u308b\u305f\u3081\u306b\u8ffd\u52a0\u624b\u6bb5\u3092\u8b1b\u3058\u308b\u3053\u3068<br>\uff08\u96fb\u78c1\u7684\u8a18\u9332\u306e\u6697\u53f7\u5316\u3084\u30c7\u30b8\u30bf\u30eb\u7f72\u540d\u306e\u6280\u8853\u3068\u540c\u69d8\u6280\u8853\u306e\u63a1\u7528\uff09<\/p>\n\n\n\n<p>\u25a0\u96fb\u5b50\u7f72\u540d<br>\u30fb\u96fb\u5b50\u7f72\u540d\u53ca\u3073\u8a8d\u8a3c\u696d\u52d9\u306b\u95a2\u3059\u308b\u6cd5\u5f8b\u306b\u57fa\u3065\u304d\u3001\u7ba1\u7406\u30fb\u904b\u7528\u624b\u9806\u304c\u6587\u66f8\u5316\u3055\u308c\u3066\u3044\u308b\u3053\u3068<br>\u30fb\u5404\u500b\u4eba\u3092\u7279\u5b9a\u3067\u304d\u308b\u552f\u4e00\u306e\u3082\u306e\u3068\u3057\u3001\u4ed6\u306e\u8ab0\u306b\u3082\u518d\u4f7f\u7528\u3001\u518d\u5272\u5f53\u3057\u306a\u3044\u3053\u3068<br>\u30fb\u7f72\u540d\u3068\u3057\u3066\u7f72\u540d\u8005\u306e\u6c0f\u540d\u3001\u7f72\u540d\u304c\u884c\u308f\u308c\u305f\u65e5\u6642\u3001\u7f72\u540d\u306e\u610f\u5473(\u4f5c\u6210\u3001\u78ba\u8a8d\u3001\u627f\u8a8d\u7b49)\u3092\u542b\u3080\u3053\u3068<\/p>\n\n\n\n<p>*1\u300021 CFR Part 11\u3000FDA\u304c\u96fb\u5b50\u8a18\u9332\u3001\u96fb\u5b50\u7f72\u540d\u304a\u3088\u3073\u96fb\u5b50\u8a18\u9332\u3092\u898f\u5236\u5bfe\u8c61\u4f01\u696d\u304b\u3089\u53d7\u3051\u5165\u308c\u308b\u3053\u3068\u3092\u53ef\u80fd\u3068\u3059\u308b\u6cd5\u5f8b<br>*2\u3000e\u2015\u6587\u66f8\u6cd5\u3000\u884c\u653f\u624b\u7d9a\u7b49\u306b\u304a\u3051\u308b\u60c5\u5831\u901a\u4fe1\u306e\u6280\u8853\u306e\u5229\u7528\u306b\u95a2\u3059\u308b\u6cd5\u5f8b(\u5e73\u621014\u5e74\u6cd5\u5f8b\u7b2c151\u53f7)\u53ca\u3073\u6c11\u9593\u4e8b\u696d\u8005\u7b49\u304c\u884c\u3046\u66f8\u9762\u306e\u4fdd\u5b58\u7b49\u306b\u304a\u3051\u308b\u60c5\u5831\u901a\u4fe1\u306e\u6280\u8853\u306e\u5229\u7528\u306b\u95a2\u3059\u308b\u6cd5\u5f8b<br>*3\u3000\u76e3\u67fb\u8a3c\u8de1\u3000\u6b63\u78ba\u306a\u30bf\u30a4\u30e0\u30fb\u30b9\u30bf\u30f3\u30d7(\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u304c\u81ea\u52d5\u7684\u306b\u523b\u5370\u3059\u308b\u65e5\u6642)\u304c\u4ed8\u3051\u3089\u308c\u305f\u4e00\u9023\u306e\u64cd\u4f5c\u8a18\u9332<br>*4\u3000\u30aa\u30fc\u30d7\u30f3\u30fb\u30b7\u30b9\u30c6\u30e0\u3000\u30b7\u30b9\u30c6\u30e0\u5185\u306e\u96fb\u78c1\u7684\u8a18\u9332\u306b\u8cac\u4efb\u3092\u6301\u3064\u8005\u306b\u3088\u3063\u3066\u3001\u30b7\u30b9\u30c6\u30e0\u3078\u306e\u30a2\u30af\u30bb\u30b9\u304c\u7ba1\u7406\u3055\u308c\u3066\u3044\u306a\u3044\u30b7\u30b9\u30c6\u30e0<br>*5\u3000\u30c7\u30b8\u30bf\u30eb\u7f72\u540d\u3000\u7f72\u540d\u8005\u8a8d\u8a3c\u306e\u6697\u53f7\u5316\u6280\u8853\u7b49\u306b\u57fa\u3065\u304f\u96fb\u5b50\u7f72\u540d<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">\u305d\u3082\u305d\u3082\u3001CSV\u3082\u5fc5\u8981\u3067\u3059\u306d<\/h3>\n\n\n\n<p>\u4f5c\u696d\u306e\u5de5\u7a0b\u3001\u5185\u5bb9\u3068\u4f5c\u6210\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u306f\u4ee5\u4e0b\u306e\u901a\u308a<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td><strong>\u4f5c\u696d\u5de5\u7a0b<\/strong><\/td><td><strong>\u4f5c\u696d\u5185\u5bb9<\/strong><\/td><td><strong>\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u5185\u5bb9<\/strong><\/td><\/tr><tr><td>\u4f5c\u696d\u8a08\u753b<\/td><td>WBS\u4f5c\u6210\u3001\u4f5c\u696d\u8abf\u6574<\/td><td><\/td><\/tr><tr><td>\u63d0\u6848<\/td><td>CSV\u9069\u7528\u3092\u524d\u63d0\u306b\u5fa1\u793e\u306e\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u7ba1\u7406\u898f\u5b9a\u306a\u3069\u3092\u7406\u89e3\u3057\u3066\u3001\u958b\u767a\u8a08\u753b\u66f8\u3084\u8981\u6c42\u4ed5\u69d8\u66f8\uff08URS\uff09\u306b\u5bfe\u3057\u3066\u306e\u63d0\u6848<\/td><td><\/td><\/tr><tr><td>\u958b\u767a\u8a08\u753b<\/td><td>\u958b\u767a\u8a08\u753b\u66f8\u306e\u4f5c\u6210<\/td><td>\u76ee\u7684<br>\u30b7\u30b9\u30c6\u30e0\u306e\u6982\u8981<br>\u4f53\u5236\uff08\u7d44\u7e54\u3001\u958b\u767a\u8cac\u4efb\u8005\u3001\u691c\u8a3c\u8cac\u4efb\u8005\uff09<br>\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb<\/td><\/tr><tr><td>CSV\u8a08\u753b<\/td><td>\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u8a08\u753b\u66f8<\/td><td>\u76ee\u7684<br>\u30b7\u30b9\u30c6\u30e0\u306e\u6982\u8981<br>\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u65b9\u91dd<br>\u691c\u8a3c\u3001\u5909\u66f4\u30fb\u9038\u8131\u306e\u7ba1\u7406\u624b\u9806<br>\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306e\u30b9\u30b3\u30fc\u30d7<br>\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u9805\u76ee<br>\u9069\u7528\u3055\u308c\u308b\u6cd5\u898f\u5236\u53ca\u3073\u9069\u7528\u3059\u308b\u898f\u5b9a\u7b49<br>\u4f53\u5236\uff08\u7d44\u7e54\u3001\u958b\u767a\u8cac\u4efb\u8005\u3001\u691c\u8a3c\u8cac\u4efb\u8005\uff09<br>CSV\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb<\/td><\/tr><tr><td>\u8981\u6c42\u4ed5\u69d8\uff08URS\uff09<\/td><td><a href=\"https:\/\/www.fsz.co.jp\/?fszblog=11527\">\u8981\u6c42\u4ed5\u69d8\u66f8\uff08URS\uff09\u306e\u4f5c\u6210<\/a><\/td><td>\u9069\u7528\u3055\u308c\u308b\u6cd5\u898f\u5236\u53ca\u3073\u9069\u7528\u3059\u308b\u898f\u5b9a\u7b49<br>\u30bb\u30ad\u30e5\u30ea\u30c6\u30a3\u8981\u4ef6<br>\u30b7\u30b9\u30c6\u30e0\u57fa\u76e4<br>\u30b7\u30b9\u30c6\u30e0\u6a5f\u80fd<br>\u6027\u80fd\u8981\u4ef6<br>\u904b\u7528\u8981\u4ef6<br>\u969c\u5bb3\u5bfe\u7b56\u6a5f\u80fd<\/td><\/tr><tr><td>\u30b7\u30b9\u30c6\u30e0\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8<\/td><td>\u304a\u5ba2\u69d8\u306e\u30b7\u30b9\u30c6\u30e0\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\u304c\u30b9\u30e0\u30fc\u30ba\u306b\u9032\u3080\u3088\u3046\u306b\u3001\u5fc5\u8981\u306a\u8cc7\u6599\u30fb\u60c5\u5831\u3092\u8fc5\u901f\u306b\u3054\u63d0\u4f9b\u3057\u307e\u3059\u3002<\/td><td>\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u30ab\u30c6\u30b4\u30ea\u5206\u985e<br>\u88fd\u54c1\u54c1\u8cea\u306b\u5bfe\u3059\u308b\u30ea\u30b9\u30af\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8<br>\u4f9b\u7d66\u8005\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8<\/td><\/tr><tr><td>\u6a5f\u80fd\u4ed5\u69d8<\/td><td>\u5177\u4f53\u7684\u306a\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u306e\u6a5f\u80fd\u3068\u6027\u80fd\u3092\u8a18\u8f09\u3057\u305f\u6a5f\u80fd\u4ed5\u69d8\u66f8\u3092\u4f5c\u6210<\/td><td>\u6a5f\u80fd\u4ed5\u69d8\u66f8\uff08FS\uff09\u57fa\u672c\u8a2d\u8a08\u66f8<\/td><\/tr><tr><td>\u8a2d\u8a08\u4ed5\u69d8<\/td><td>\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u306e\u8a73\u7d30\u6a5f\u80fd\u3092\u8a18\u8f09\u3057\u305f\u8a2d\u8a08\u4ed5\u69d8\u66f8\u3092\u4f5c\u6210<\/td><td>\u8a2d\u8a08\u4ed5\u69d8\u66f8\uff08DS\uff09\u8a73\u7d30\u8a2d\u8a08\u66f8<br>\u30b7\u30b9\u30c6\u30e0\u57fa\u76e4\u8a2d\u8a08\u4ed5\u69d8\u30fb\u30fb\u30fb\u30af\u30e9\u30a6\u30c9\u69cb\u6210\u3001\u30cd\u30c3\u30c8\u30ef\u30fc\u30af\u3001\u30b5\u30fc\u30d0\u30fc\u69cb\u6210<br>\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u8a2d\u8a08\u4ed5\u69d8\u30fb\u30fb\u30fb\u753b\u9762\u8a2d\u8a08\u3001\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u30fb\u30d5\u30a1\u30a4\u30eb\u8a2d\u8a08\u3001\u6a5f\u80fd\u30fb\u30e2\u30b8\u30e5\u30fc\u30eb\u8a2d\u8a08\u3001\u30a4\u30f3\u30bf\u30fc\u30d5\u30a7\u30fc\u30b9\u8a2d\u8a08<\/td><\/tr><tr><td>\u8a2d\u8a08\u6642\u9069\u683c\u6027\u8a55\u4fa1\uff08DQ\uff09<\/td><td>\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u30de\u30c8\u30ea\u30c3\u30af\u30b9\uff08TMX\uff09\u306e\u4f5c\u6210<\/td><td>\u8a2d\u8a08\u6642\u9069\u683c\u6027\u8a55\u4fa1\uff08DQ\uff09\u8a08\u753b\uff0f\u8a18\u9332\u66f8<\/td><\/tr><tr><td>\u30d7\u30ed\u30b0\u30e9\u30e0\u306e\u4f5c\u6210\u53ca\u3073\u30d7\u30ed\u30b0\u30e9\u30e0\u30c6\u30b9\u30c8<\/td><td>\u30b7\u30b9\u30c6\u30e0\u30c6\u30b9\u30c8\u8a08\u753b\u66f8\u3092\u4f5c\u6210\u3001\u305d\u308c\u306b\u57fa\u3065\u3044\u3066\u30b7\u30b9\u30c6\u30e0\u30c6\u30b9\u30c8\u3092\u5b9f\u65bd\u3057\u3001\u305d\u306e\u7d50\u679c\u3092\u8a18\u9332<\/td><td><\/td><\/tr><tr><td>\u30b7\u30b9\u30c6\u30e0\u30c6\u30b9\u30c8<\/td><td><\/td><td>\u30b7\u30b9\u30c6\u30e0\u30c6\u30b9\u30c8\u306e\u8a08\u753b\u66f8\uff0f\u5831\u544a\u66f8<\/td><\/tr><tr><td>\u53d7\u5165\u8a66\u9a13<\/td><td>\u5de5\u5834\u53d7\u5165\u8a66\u9a13<br>\u5f0a\u793e\u74b0\u5883\u306b\u304a\u3051\u308b\u6700\u7d42\u8a66\u9a13\u3092\u5b9f\u65bd\u30fb\u73fe\u5730\u53d7\u5165\u308c\u8a66\u9a13<br>\u5fa1\u793e\u74b0\u5883\u306b\u304a\u3051\u308b\u6700\u7d42\u8a66\u9a13\u3092\u5b9f\u65bd<br>\uff08GAMP5\u306b\u5b9a\u7fa9\u304c\u3042\u308a\u307e\u3059\uff09<\/td><td>\u5de5\u5834\u53d7\u5165\u8a66\u9a13\uff08FAT\uff09\u306e\u8a08\u753b\u66f8\uff0f\u5831\u544a\u66f8<br>\u73fe\u5730\u53d7\u5165\u8a66\u9a13\uff08SAT\uff09\u306e\u8a08\u753b\u66f8\uff0f\u5831\u544a\u66f8<\/td><\/tr><tr><td>\u636e\u4ed8\u6642\u9069\u683c\u6027\u8a55\u4fa1\uff08IQ\uff09<\/td><td><\/td><td>\u636e\u4ed8\u6642\u9069\u683c\u6027\u8a55\u4fa1\uff08IQ\uff09\u8a08\u753b\uff0f\u8a18\u9332\u66f8<\/td><\/tr><tr><td>\u904b\u8ee2\u6642\u9069\u683c\u6027\u8a55\u4fa1\uff08OQ\uff09<\/td><td><\/td><td>\u904b\u8ee2\u6642\u9069\u683c\u6027\u8a55\u4fa1\uff08OQ\uff09\u8a08\u753b\uff0f\u8a18\u9332\u66f8<\/td><\/tr><tr><td>\u6027\u80fd\u9069\u683c\u6027\u8a55\u4fa1\uff08PQ\uff09<\/td><td><\/td><td>\u6027\u80fd\u9069\u683c\u6027\u8a55\u4fa1\uff08PQ\uff09\u8a08\u753b\uff0f\u8a18\u9332\u66f8<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><a href=\"https:\/\/www.fsz.co.jp\/?fszblog=2022_medical_devices_qms-csv\">\u203b\u65b0QMS\u7701\u4ee4 \u533b\u7642\u6a5f\u5668\u696d\u754c\u306b\u304a\u3051\u308bCSV\u306e\u8003\u3048\u65b9<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\">\u5404\u56fd\u306e\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u95a2\u9023\u30ac\u30a4\u30c9\uff08Data Integrity\uff09<\/h3>\n\n\n\n<p>\u6700\u8fd1\u3001\u3082\u3063\u3068\u3082\u8a71\u984c\u306b\u306a\u308b\u3053\u3068\u304c\u591a\u3044\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\uff08Data Integrity\uff09\u3067\u3059\u304c\u3001\u65e5\u672c\u306e\u4f01\u696d\u3067\u3082FDA\u3084MHRA\u306a\u3069\u306e\u6d77\u5916\u5f53\u5c40\u304b\u3089\u67fb\u5bdf\u3067\u6307\u6458\u3055\u308c\u308b\u4e8b\u4f8b\u304c\u51fa\u3066\u304d\u3066\u304a\u308a\u3001\u30ef\u30fc\u30cb\u30f3\u30b0\u30ec\u30bf\u30fc\uff08Warning Letter\uff09\u307e\u3067\u3001\u767a\u51fa\u3055\u308c\u308b\u3053\u3068\u304c\u6563\u898b\u3055\u308c\u308b\u3088\u3046\u306b\u306a\u3063\u3066\u304d\u307e\u3057\u305f\u3002\u304b\u306a\u308a\u91cd\u70b9\u7684\u306a\u76e3\u67fb\u30dd\u30a4\u30f3\u30c8\u306b\u306a\u3063\u3066\u3044\u308b\u3053\u3068\u306f\u9593\u9055\u3044\u306a\u3044\u3068\u601d\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u5404\u56fd\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u304c\u767a\u51fa\u3055\u308c\u3001\u305d\u308d\u305d\u308d\u52e2\u63c3\u3044\u3057\u305f\u611f\u3058\u304c\u3042\u308a\u307e\u3059\u3002\u305f\u3060\u3001\u305d\u306e\u30bf\u30a4\u30df\u30f3\u30b0\u3084\u5185\u5bb9\u306f\u30cf\u30fc\u30e2\u30ca\u30a4\u30ba\u3055\u308c\u3066\u3044\u308b\u3088\u3046\u306a\u3001\u3044\u306a\u3044\u3088\u3046\u306a\u3002\u3002\u3002\u3057\u304b\u3057\u3001\u305d\u306e\u5185\u5bb9\u3092\u691c\u8a0e\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3067\u3057\u3087\u3046\u3002<\/p>\n\n\n\n<p>\u305d\u3053\u3067\u3001\u3054\u5b58\u77e5\u3060\u3068\u306f\u601d\u3044\u307e\u3059\u304c\u3001\u3067\u304d\u308b\u304b\u304e\u308a\u60c5\u5831\u3060\u3051\u3092\u96c6\u3081\u3066\u307f\u307e\u3057\u305f\u3002<br>\u304a\u5f79\u306b\u7acb\u3066\u3070\u5e78\u3044\u3067\u3059\u3002<\/p>\n\n\n\n<p><a href=\"https:\/\/www.fda.gov\/media\/161521\/download\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>\u25a0FDA\uff08\u30a2\u30e1\u30ea\u30ab\u98df\u54c1\u533b\u85ac\u5c40\uff09Computer Software Assurance for Production and Quality System Software 2022\/9\/13<\/strong><br><\/a>CSA\u30ac\u30a4\u30c0\u30f3\u30b9\u304c\u516c\u958b\u3055\u308c\u307e\u3057\u305f\u3002<br><br><strong><a rel=\"noreferrer noopener\" href=\"https:\/\/www.fda.gov\/media\/143627\/download\" target=\"_blank\">\u25a0FDA\uff08\u30a2\u30e1\u30ea\u30ab\u98df\u54c1\u533b\u85ac\u54c1\u5c40\uff09Data Modernization Action Plan 2021\/3<\/a><\/strong><br>\u9032\u5316\u3059\u308b\u65b0\u3057\u3044\u79d1\u5b66\u306b\u5bfe\u3059\u308b\u30c7\u30fc\u30bf\u306b\u57fa\u3065\u3044\u305f\u304c\u5fc5\u8981\u3067\u3042\u308b\u3068\u3044\u3046\u898b\u89e3\u3092\u8a18\u8f09\u3055\u308c\u3066\u3044\u307e\u3059<\/p>\n\n\n\n<p><a rel=\"noreferrer noopener\" href=\"https:\/\/picscheme.org\/docview\/4234\" target=\"_blank\"><strong>\u25a0PIC\/S \u30ac\u30a4\u30c0\u30f3\u30b9 2021\/6<\/strong><\/a><br>GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN REGULATED GMP\/GDP ENVIRONMENTS<\/p>\n\n\n\n<p><a rel=\"noreferrer noopener\" href=\"https:\/\/ispe.org\/news\/ispe-publishes-ispe-gampr-rdi-good-practice-guide-data-integrity-design\" target=\"_blank\"><strong>\u25a0ISPE\uff08\u56fd\u969b\u88fd\u85ac\u6280\u8853\u5354\u4f1a\uff09GAMP RDI\u30ac\u30a4\u30c9<\/strong><\/a> <a rel=\"noreferrer noopener\" href=\"https:\/\/ispe.org\/news\/ispe-publishes-ispe-gampr-rdi-good-practice-guide-data-integrity-design\" target=\"_blank\"><strong>2020\/11<\/strong><\/a><br>ISPE GAMP RDI Good Practice Guide: Data Integrity by Design<\/p>\n\n\n\n<p><a rel=\"noreferrer noopener\" href=\"https:\/\/www.who.int\/docs\/default-source\/medicines\/norms-and-standards\/current-projects\/qas19-819-rev1-guideline-on-data-integrity.pdf\" target=\"_blank\"><strong>\u25a0WHO\uff08\u4e16\u754c\u4fdd\u5065\u6a5f\u95a2\uff09\u30ac\u30a4\u30c0\u30f3\u30b9\uff08\u6b63\u5f0f\u7248\uff092020\/6<\/strong><br><\/a>DRAFT WORKING DOCUMENT FOR COMMENTS<br>Guideline on data integrity<\/p>\n\n\n\n<p><strong><a rel=\"noreferrer noopener\" href=\"https:\/\/jiho-contents.s3-ap-northeast-1.amazonaws.com\/s3fs-public\/ptj\/document\/2018\/03\/%E2%80%98GXP%E2%80%99%20Data%20Integrity%20Guidance%20and%20Definitions.pdf\" target=\"_blank\">\u25a0MHRA\uff08\u82f1\u56fd\u898f\u5236\u5f53\u5c40\uff09GxP\u30ac\u30a4\u30c0\u30f3\u30b9 2018\/3<\/a><\/strong><br>MHRA GxP Data Integrity Definitions and Guidance for Industry Draft version for consultation July 2016<br>\u82f1\u56fd\u533b\u85ac\u54c1\u5e81\u304c\u767a\u51fa\u3057\u3066\u3044\u308bGxP\u306b\u304a\u3051\u308b\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u306e\u5b9a\u7fa9\u3068\u696d\u754c\u3078\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u3067\u3059\u3002\u5bfe\u8c61\u306fGLP\u3001GCP\u3001GMP\u3001GDP\u3001GVP\u306a\u3069GxP\u5168\u822c<\/p>\n\n\n\n<p><strong><a rel=\"noreferrer noopener\" href=\"http:\/\/www.who.int\/medicines\/publications\/pharmprep\/WHO_TRS_996_web.pdf?ua=1\" target=\"_blank\">\u25a0WHO\uff08\u4e16\u754c\u4fdd\u5065\u6a5f\u95a2\uff09\u30ac\u30a4\u30c0\u30f3\u30b9\uff08\u6b63\u5f0f\u7248\uff092016\/5<\/a><\/strong><br>Guidance on Good Data and Record Management Practices (GDRP)<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u51fa\u5178<\/h2>\n\n\n\n<p><a rel=\"noreferrer noopener\" href=\"https:\/\/www.soumu.go.jp\/main_sosiki\/joho_tsusin\/security\/business\/staff\/01.html\" target=\"_blank\">*1 \u7dcf\u52d9\u7701\u300c\u56fd\u6c11\u306e\u305f\u3081\u306e\u60c5\u5831\u30bb\u30ad\u30e5\u30ea\u30c6\u30a3\u30b5\u30a4\u30c8\uff1a\u5b89\u5168\u306a\u30d1\u30b9\u30ef\u30fc\u30c9\u7ba1\u7406\u300d<\/a><br><a rel=\"noreferrer noopener\" href=\"https:\/\/www.mhlw.go.jp\/web\/t_doc?dataId=00tb6573&amp;dataType=1&amp;pageNo=1\" target=\"_blank\">*2 \u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u9069\u6b63\u7ba1\u7406 \u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\uff5cCSV<\/a><br><a rel=\"noreferrer noopener\" href=\"https:\/\/www.mhlw.go.jp\/web\/t_doc?dataId=00tb6573&amp;dataType=1&amp;pageNo=1\" target=\"_blank\">\u25a0\u539a\u751f\u52b4\u50cd\u7701 \u533b\u85ac\u54c1\u30fb\u533b\u85ac\u90e8\u5916\u54c1\u88fd\u9020\u8ca9\u58f2\u696d\u8005\u7b49\u306b\u304a\u3051\u308b\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u9069\u6b63\u7ba1\u7406\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u3064\u3044\u3066<\/a><br><a rel=\"noreferrer noopener\" href=\"https:\/\/www.fsz.co.jp\/wp-content\/uploads\/2018\/05\/214007bc3be1126cb2b15d9aab1c8562.pdf\" target=\"_blank\">\u25a0\u539a\u751f\u52b4\u50cd\u7701 \u533b\u85ac\u54c1\u30fb\u533b\u85ac\u90e8\u5916\u54c1\u88fd\u9020\u8ca9\u58f2\u696d\u8005\u7b49\u306b\u304a\u3051\u308b\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u9069\u6b63\u7ba1\u7406\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u3064\u3044\u3066\uff5cPDF\u7248<\/a><br><a rel=\"noreferrer noopener\" href=\"https:\/\/www.fsz.co.jp\/wp-content\/uploads\/2018\/05\/f0cd175cc9ababf257309464409bda9d.pdf\" target=\"_blank\">*3 \u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u9069\u6b63\u7ba1\u7406 \u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u95a2\u3059\u308b\u8cea\u7591\u5fdc\u7b54\u96c6(Q&amp;A)&nbsp;<\/a><br><a href=\"https:\/\/www.pmda.go.jp\/files\/000158308.pdf\">*4 \u533b\u85ac\u54c1\u7b49\u306e\u627f\u8a8d\u53c8\u306f\u8a31\u53ef\u7b49\u306b\u4fc2\u308b\u7533\u8acb\u7b49\u306b\u304a\u3051\u308b\u96fb\u78c1\u7684\u8a18\u9332\u53ca\u3073\u96fb\u5b50\u7f72\u540d\u306e\u5229\u7528\u306b\u3064\u3044\u3066<\/a>\uff08ER\/ES\u6307\u91dd\uff09<br><a rel=\"noreferrer noopener\" href=\"http:\/\/www.pref.kagawa.jp\/yakumukansen\/yakujinotice\/GMP_notice\/250328annex11.pdf\" target=\"_blank\">*5 PIC\/S GMP\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3&nbsp;anex11 &nbsp;\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u30fc\u5316\u30b7\u30b9\u30c6\u30e0<\/a><br><a href=\"http:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/CFRSearch.cfm?CFRPart=11\">*6 FDA 21CFR Part11<\/a>\uff08\u9023\u90a6\u6cd5\u7b2c21\u7ae0\u7b2c11\u6761\uff09<br><a href=\"http:\/\/www.fda.gov\/downloads\/Drugs\/GuidanceComplianceRegulatoryInformation\/Guidances\/UCM495891.pdf\">*7 FDA DI\u30ac\u30a4\u30c0\u30f3\u30b9<\/a>\uff08\u30c9\u30e9\u30d5\u30c8\uff092016\u5e744\u670815\u65e5Guidance for Indsutry Data Integrity and Compliance With CGMP<br>*8 <a href=\"http:\/\/www.it-asso.com\/gxp\/files\/MHRA_Data%20Integrity%20Guide_v1.1_150300.pdf\">MHRA GMP DI\u30ac\u30a4\u30c0\u30f3\u30b9<\/a>\uff08\u6b63\u5f0f\u7248\uff092015\u5e743\u6708MHRA GMP Data Integrity Definitions and Guidance for Industry March 2015<br><a href=\"https:\/\/www.gov.uk\/government\/uploads\/system\/uploads\/attachment_data\/file\/538871\/MHRA_GxP_data_integrity_consultation.pdf\">*9 MHRA GxP DI\u30ac\u30a4\u30c0\u30f3\u30b9<\/a>\uff08\u30d1\u30d6\u30ea\u30c3\u30af\u30b3\u30e1\u30f3\u30c8\u7528\uff092016\u5e747\u6708MHRA GxP Data Integrity Definitions and Guidance for Industry Draft version for consultation July 2016<br><a href=\"http:\/\/www.who.int\/medicines\/publications\/pharmprep\/WHO_TRS_996_web.pdf?ua=1\">*10 WHO DI\u30ac\u30a4\u30c0\u30f3\u30b9<\/a>\uff08\u6b63\u5f0f\u7248\uff092016\u5e745\u670831Guidance on Good Data and Record Management Practices (GDRP)<br><a href=\"http:\/\/www.it-asso.com\/gxp\/files\/PI_041_1_Draft_2.pdf\">*11 PIC\/S GMP\/GDP DI\u30ac\u30a4\u30c0\u30f3\u30b9<\/a>\uff08\u30c9\u30e9\u30d5\u30c8\uff092016\u5e748\u670810\u65e5GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN REGULATED GMP\/GDP ENVIRONMENTS<br>*.   <a href=\"https:\/\/www.jpma.or.jp\/information\/evaluation\/results\/allotment\/rfcmr00000001v1k-att\/handbook_2022_01.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">\u96fb\u5b50\u5316\u60c5\u5831\u306e\u898f\u5236\u8981\u4ef6\u30fb\u767a\u51fa\u7269\u30cf\u30f3\u30c9\u30d6\u30c3\u30af<\/a> \u65e5\u672c\u88fd\u85ac\u5de5\u696d\u5354\u4f1a \u533b\u85ac\u54c1\u8a55\u4fa1\u59d4\u54e1\u4f1a \u96fb\u5b50\u5316\u60c5\u5831\u90e8\u4f1a \u30bf\u30b9\u30af\u30d5\u30a9\u30fc\u30b9<\/p>\n\n\n\n<p><br><\/p>\n\n\n<p><!-- \/wp:post-content --><\/p>\n<p><!-- wp:media-text {\"mediaId\":13500,\"mediaLink\":\"https:\/\/www.fsz.co.jp\/?attachment_id=13500\",\"linkDestination\":\"custom\",\"mediaType\":\"image\",\"mediaWidth\":69} --><\/p>\n<div class=\"wp-block-media-text alignwide is-stacked-on-mobile\" style=\"grid-template-columns:69% auto\">\n<figure class=\"wp-block-media-text__media\"><a href=\"https:\/\/www.fsz.co.jp\/?page_id=11195\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"688\" src=\"https:\/\/www.fsz.co.jp\/wp-content\/uploads\/2019\/12\/dbsforpharma-Cap20191215b-1024x688.png\" alt=\"\" class=\"wp-image-13500 size-full\" srcset=\"https:\/\/www.fsz.co.jp\/wp-content\/uploads\/2019\/12\/dbsforpharma-Cap20191215b-1024x688.png 1024w, https:\/\/www.fsz.co.jp\/wp-content\/uploads\/2019\/12\/dbsforpharma-Cap20191215b-300x201.png 300w, https:\/\/www.fsz.co.jp\/wp-content\/uploads\/2019\/12\/dbsforpharma-Cap20191215b-1536x1031.png 1536w, https:\/\/www.fsz.co.jp\/wp-content\/uploads\/2019\/12\/dbsforpharma-Cap20191215b-2048x1375.png 2048w, https:\/\/www.fsz.co.jp\/wp-content\/uploads\/2019\/12\/dbsforpharma-Cap20191215b-272x182.png 272w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/a><\/figure>\n<div class=\"wp-block-media-text__content\"><!-- wp:paragraph {\"placeholder\":\"\u30b3\u30f3\u30c6\u30f3\u30c4\u2026\"} --><p><\/p>\n<p>Data Integrity\u306e\u5bfe\u5fdc\u306b\u306f<br>\u3053\u3061\u3089\u306e\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\u3092\u30aa\u30b9\u30b9\u30e1\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<p><!-- \/wp:paragraph --><\/p>\n<\/div>\n<\/div>\n<p><!-- \/wp:media-text --><\/p>","protected":false},"featured_media":16492,"template":"","news_category":[79,74],"class_list":["post-15983","news","type-news","status-publish","has-post-thumbnail","hentry","news_category-just-db","news_category-fszblog-pharma"],"_links":{"self":[{"href":"https:\/\/www.fsz.co.jp\/index.php?rest_route=\/wp\/v2\/news\/15983","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.fsz.co.jp\/index.php?rest_route=\/wp\/v2\/news"}],"about":[{"href":"https:\/\/www.fsz.co.jp\/index.php?rest_route=\/wp\/v2\/types\/news"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.fsz.co.jp\/index.php?rest_route=\/wp\/v2\/media\/16492"}],"wp:attachment":[{"href":"https:\/\/www.fsz.co.jp\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=15983"}],"wp:term":[{"taxonomy":"news_category","embeddable":true,"href":"https:\/\/www.fsz.co.jp\/index.php?rest_route=%2Fwp%2Fv2%2Fnews_category&post=15983"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}