{"id":31484,"date":"2026-08-07T13:34:27","date_gmt":"2026-08-07T04:34:27","guid":{"rendered":"https:\/\/www.ripla.co.jp\/blog\/?p=31484"},"modified":"2026-08-09T15:38:05","modified_gmt":"2026-08-09T06:38:05","slug":"validation-management-complete-guide","status":"publish","type":"post","link":"https:\/\/www.ripla.co.jp\/blog\/system\/validation-management-complete-guide\/","title":{"rendered":"\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u958b\u767a\u306e\u5b8c\u5168\u30ac\u30a4\u30c9"},"content":{"rendered":"\n

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\u25bc\u95a2\u9023\u8a18\u4e8b\u4e00\u89a7<\/strong>
\n\u30fb\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u958b\u767a\u306e\u9032\u3081\u65b9\/\u3084\u308a\u65b9\/\u6d41\u308c\u3084\u65b9\u6cd5\/\u624b\u6cd5\/\u5de5\u7a0b\/\u624b\u9806<\/a>
\n\u30fb\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u958b\u767a\u3067\u304a\u3059\u3059\u3081\u306e\u958b\u767a\u4f1a\u793e\/\u30d9\u30f3\u30c0\u30fc6\u9078\u3068\u9078\u3073\u65b9<\/a>
\n\u30fb\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u958b\u767a\u306e\u898b\u7a4d\u76f8\u5834\u3084\u8cbb\u7528\/\u30b3\u30b9\u30c8\/\u5024\u6bb5\u306b\u3064\u3044\u3066<\/a>
\n\u30fb\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u958b\u767a\u306e\u767a\u6ce8\/\u5916\u6ce8\/\u4f9d\u983c\/\u59d4\u8a17\u65b9\u6cd5\u306b\u3064\u3044\u3066<\/a><\/p>\n\n\n\n

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\n
\n
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\n

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\n

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\n

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\n
\n
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\n

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\n

\u30c6\u30b9\u30c8\u5b9f\u884c\u30fb\u627f\u8a8d\u30fb\u518d\u5b9f\u884c\u3092\u4e00\u3064\u306b\u307e\u3068\u3081\u307e\u3059<\/strong><\/strong><\/strong><\/h3>\n<\/div>\n\n\n\n

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\n

\u76e3\u67fb\u8a3c\u8de1\u30fb\u6a29\u9650\u30fb\u9023\u643a\u3092\u8a2d\u8a08\u3057\u307e\u3059<\/strong><\/strong><\/strong><\/h3>\n<\/div>\n\n\n\n

\u76e3\u67fb\u8a3c\u8de1\u306f\u300c\u753b\u9762\u306b\u30ed\u30b0\u30a4\u30f3\u3057\u305f\u8a18\u9332\u300d\u3060\u3051\u3067\u306f\u8db3\u308a\u307e\u305b\u3093\u3002GxP\u8a18\u9332\u306e\u4f5c\u6210\u3001\u5909\u66f4\u3001\u524a\u9664\u3001\u627f\u8a8d\u306b\u5bfe\u3057\u3066\u3001\u8ab0\u304c\u3001\u4f55\u3092\u3001\u3044\u3064\u3001\u306a\u305c\u884c\u3063\u305f\u304b\u3092\u518d\u69cb\u6210\u3067\u304d\u308b\u3053\u3068\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002\u6700\u5c0f\u6a29\u9650\u3001\u8077\u52d9\u5206\u96e2\u3001\u5b9a\u671f\u7684\u306a\u30a2\u30af\u30bb\u30b9\u6a29\u30ec\u30d3\u30e5\u30fc\u3001\u30d0\u30c3\u30af\u30a2\u30c3\u30d7\u3001\u30c7\u30fc\u30bf\u4fdd\u6301\u3001\u30a8\u30af\u30b9\u30dd\u30fc\u30c8\u3001\u691c\u7d22\u3001\u6642\u523b\u306e\u57fa\u6e96\u3082\u78ba\u8a8d\u3057\u307e\u3059\u3002QMS\u3001\u6587\u66f8\u7ba1\u7406\u3001LIMS\u3001MES\u3001ERP\u3001\u30c1\u30b1\u30c3\u30c8\u7ba1\u7406\u306a\u3069\u3068\u9023\u643a\u3059\u308b\u5834\u5408\u306f\u3001API\u306e\u5931\u6557\u6642\u3001\u518d\u9001\u6642\u3001\u30de\u30b9\u30bf\u5909\u66f4\u6642\u306b\u539f\u672c\u6027\u3068\u5c65\u6b74\u3092\u3069\u3046\u4fdd\u3064\u304b\u307e\u3067\u8a2d\u8a08\u3057\u307e\u3059\u3002<\/p>\n\n\n\n

\u5c0e\u5165\u30fb\u958b\u767a\u306e\u9032\u3081\u65b9\uff5c\u8981\u4ef6\u5b9a\u7fa9\u304b\u3089\u904b\u7528\u307e\u3067\u306e8\u30b9\u30c6\u30c3\u30d7<\/strong><\/h2>\n\n\n\n
\n
\n
\"\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u306e\u5c0e\u5165\u624b\u9806\"<\/figure>\n<\/div>\n<\/div>\n\n\n\n

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\u25b6 \u8a73\u7d30\u306f\u3053\u3061\u3089\uff1a\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u958b\u767a\u306e\u9032\u3081\u65b9\/\u3084\u308a\u65b9\/\u6d41\u308c\u3084\u65b9\u6cd5\/\u624b\u6cd5\/\u5de5\u7a0b\/\u624b\u9806<\/a><\/p>\n\n\n

1. \u5bfe\u8c61\u7bc4\u56f2\u3068\u30ac\u30d0\u30ca\u30f3\u30b9\u3092\u6c7a\u3081\u307e\u3059<\/strong><\/strong><\/strong><\/h3>\n<\/div>\n\n\n\n

\u6700\u521d\u306b\u3001\u5bfe\u8c61\u30b5\u30a4\u30c8\u3001\u696d\u52d9\u3001\u30b7\u30b9\u30c6\u30e0\u3001\u30c7\u30fc\u30bf\u3001\u5229\u7528\u8005\u3001\u5916\u90e8\u59d4\u8a17\u5148\u3092\u4e00\u89a7\u5316\u3057\u307e\u3059\u3002\u6b21\u306b\u3001GxP\u5f71\u97ff\u3001\u60a3\u8005\u3084\u88fd\u54c1\u54c1\u8cea\u3078\u306e\u5f71\u97ff\u3001\u30c7\u30fc\u30bf\u5b8c\u5168\u6027\u3078\u306e\u5f71\u97ff\u3001\u696d\u52d9\u505c\u6b62\u6642\u306e\u5f71\u97ff\u3092\u8a55\u4fa1\u3057\u3001\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306e\u6df1\u3055\u3092\u6c7a\u3081\u307e\u3059\u3002QA\u3001IT\u3001\u696d\u52d9\u30aa\u30fc\u30ca\u30fc\u3001\u30b7\u30b9\u30c6\u30e0\u30aa\u30fc\u30ca\u30fc\u3001\u627f\u8a8d\u8005\u3001\u59d4\u8a17\u5148\u306e\u5f79\u5272\u3092RACI\u306a\u3069\u3067\u660e\u78ba\u306b\u3057\u3001\u8ab0\u304cURS\u3092\u627f\u8a8d\u3057\u3001\u8ab0\u304c\u30c6\u30b9\u30c8\u3092\u5b9f\u884c\u3057\u3001\u8ab0\u304c\u9038\u8131\u3092\u5224\u5b9a\u3059\u308b\u304b\u3092\u5148\u306b\u6c7a\u3081\u308b\u3068\u3001\u5f8c\u5de5\u7a0b\u306e\u624b\u623b\u308a\u3092\u6291\u3048\u3089\u308c\u307e\u3059\u3002<\/p>\n\n\n\n

\n

2. URS\u3068Fit\u30fbGap\u3092\u6574\u7406\u3057\u307e\u3059<\/strong><\/strong><\/strong><\/h3>\n<\/div>\n\n\n\n

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\n

3. \u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u3067\u8a66\u9a13\u3092\u8a2d\u8a08\u3057\u307e\u3059<\/strong><\/strong><\/strong><\/h3>\n<\/div>\n\n\n\n

\u5168\u6a5f\u80fd\u3092\u540c\u3058\u6df1\u3055\u3067\u8a66\u9a13\u3059\u308b\u306e\u3067\u306f\u306a\u304f\u3001\u610f\u56f3\u3057\u305f\u7528\u9014\u3001\u30c7\u30fc\u30bf\u306e\u91cd\u8981\u5ea6\u3001\u5931\u6557\u6642\u306e\u5f71\u97ff\u3001\u691c\u51fa\u53ef\u80fd\u6027\u3001\u65e2\u5b58\u306e\u7ba1\u7406\u7b56\u304b\u3089\u8a66\u9a13\u306e\u7bc4\u56f2\u3092\u6c7a\u3081\u307e\u3059\u3002ICH Q9(R1)\u306f\u54c1\u8cea\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u3092\u3001\u30ea\u30b9\u30af\u8a55\u4fa1\u3001\u30ea\u30b9\u30af\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u3001\u30ea\u30b9\u30af\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u3001\u30ec\u30d3\u30e5\u30fc\u3068\u3044\u3046\u7d99\u7d9a\u7684\u306a\u30d7\u30ed\u30bb\u30b9\u3068\u3057\u3066\u6574\u7406\u3057\u3066\u3044\u307e\u3059\uff08\u51fa\u5178: ICH Q9(R1) Quality Risk Management\u30012021\u5e74\uff09\u3002\u3053\u306e\u8003\u3048\u65b9\u3092\u8981\u4ef6\u3068\u30c6\u30b9\u30c8\u306b\u53cd\u6620\u3057\u3001\u91cd\u8981\u306a\u6a5f\u80fd\u306b\u306f\u8ca0\u8377\u30fb\u7570\u5e38\u7cfb\u30fb\u6a29\u9650\u30fb\u76e3\u67fb\u8a3c\u8de1\u30fb\u30d0\u30c3\u30af\u30a2\u30c3\u30d7\u5fa9\u65e7\u3082\u542b\u3081\u307e\u3059\u3002<\/p>\n\n\n\n

\n

4. \u8a2d\u5b9a\u30fb\u69cb\u7bc9\u30fb\u6587\u66f8\u5316\u3092\u9032\u3081\u307e\u3059<\/strong><\/strong><\/strong><\/h3>\n<\/div>\n\n\n\n

\u74b0\u5883\u3092\u5206\u3051\u3001\u8a2d\u5b9a\u5024\u3001\u30de\u30b9\u30bf\u3001\u6a29\u9650\u30ed\u30fc\u30eb\u3001\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u3001\u901a\u77e5\u3001\u4fdd\u6301\u671f\u9593\u3001\u9023\u643a\u8a2d\u5b9a\u3092\u7ba1\u7406\u3057\u307e\u3059\u3002\u8a2d\u5b9a\u3092\u672c\u756a\u753b\u9762\u3067\u76f4\u63a5\u5909\u66f4\u3059\u308b\u3068\u3001\u8ab0\u304c\u3044\u3064\u4f55\u3092\u5909\u3048\u305f\u304b\u3092\u8aac\u660e\u3067\u304d\u306a\u304f\u306a\u308b\u305f\u3081\u3001\u958b\u767a\u30fb\u691c\u8a3c\u30fb\u672c\u756a\u306e\u79fb\u9001\u624b\u9806\u3068\u627f\u8a8d\u3092\u7528\u610f\u3057\u307e\u3059\u3002\u30d1\u30c3\u30b1\u30fc\u30b8\u3084SaaS\u3067\u3082\u3001\u4f1a\u793e\u5074\u306e\u8a2d\u5b9a\u3001\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\u3001\u30de\u30b9\u30bf\u3001\u904b\u7528\u624b\u9806\u306f\u81ea\u793e\u306e\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u5bfe\u8c61\u306b\u306a\u308a\u5f97\u307e\u3059\u3002\u30d9\u30f3\u30c0\u30fc\u306e\u6a19\u6e96\u6587\u66f8\u3092\u4f7f\u3046\u5834\u5408\u3082\u3001\u5bfe\u8c61\u30d0\u30fc\u30b8\u30e7\u30f3\u3068\u81ea\u793e\u306e\u610f\u56f3\u3057\u305f\u7528\u9014\u306b\u7167\u3089\u3057\u3066\u9069\u7528\u7bc4\u56f2\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002<\/p>\n\n\n\n

\n

5\u301c6. \u8a66\u9a13\u3001\u9038\u8131\u3001\u627f\u8a8d\u3001\u30ea\u30ea\u30fc\u30b9\u3092\u8a18\u9332\u3057\u307e\u3059<\/strong><\/strong><\/strong><\/h3>\n<\/div>\n\n\n\n

\u30c6\u30b9\u30c8\u306f\u3001\u627f\u8a8d\u6e08\u307f\u306e\u30b9\u30af\u30ea\u30d7\u30c8\u3068\u30c7\u30fc\u30bf\u3092\u4f7f\u3063\u3066\u5b9f\u884c\u3057\u3001\u7d50\u679c\u3068\u8a3c\u8de1\u3092\u305d\u306e\u5834\u3067\u8a18\u9332\u3057\u307e\u3059\u3002\u671f\u5f85\u7d50\u679c\u3068\u5b9f\u6e2c\u7d50\u679c\u304c\u7570\u306a\u308b\u3068\u304d\u306f\u3001\u9038\u8131\u3084\u8ab2\u984c\u3068\u3057\u3066\u8d77\u7968\u3057\u3001\u5f71\u97ff\u3001\u539f\u56e0\u3001\u662f\u6b63\u3001\u518d\u8a66\u9a13\u3001\u6700\u7d42\u5224\u5b9a\u3092\u6b8b\u3057\u307e\u3059\u3002\u5408\u683c\u7387\u3060\u3051\u3092KPI\u306b\u3059\u308b\u3068\u3001\u8a18\u9332\u306e\u4e0d\u5099\u3084\u518d\u8a66\u9a13\u306e\u96a0\u308c\u305f\u8ca0\u62c5\u304c\u898b\u3048\u307e\u305b\u3093\u3002\u30ea\u30ea\u30fc\u30b9\u5224\u5b9a\u3067\u306f\u3001\u672a\u89e3\u6c7a\u306e\u9038\u8131\u3001\u6559\u80b2\u3001\u624b\u9806\u3001\u30d0\u30c3\u30af\u30a2\u30c3\u30d7\u3001\u6a29\u9650\u3001\u30b5\u30dd\u30fc\u30c8\u7a93\u53e3\u3001\u5207\u308a\u623b\u3057\u6761\u4ef6\u307e\u3067\u78ba\u8a8d\u3057\u307e\u3059\u3002<\/p>\n\n\n\n

\n

7\u301c8. \u79fb\u884c\u30fb\u6559\u80b2\u5f8c\u306b\u5b9a\u671f\u30ec\u30d3\u30e5\u30fc\u3078\u79fb\u308a\u307e\u3059<\/strong><\/strong><\/strong><\/h3>\n<\/div>\n\n\n\n

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\n
\n
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\n

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\n

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\n
\n
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\n

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\n

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\n

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\n
\n
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\n

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\n

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\n

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\n
\n
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\n

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\n

\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8\u3092\u7121\u6761\u4ef6\u306b\u9069\u7528\u3059\u308b<\/strong><\/strong><\/strong><\/h3>\n<\/div>\n\n\n\n

SaaS\u3084\u30d1\u30c3\u30b1\u30fc\u30b8\u306e\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8\u306f\u3001\u30bb\u30ad\u30e5\u30ea\u30c6\u30a3\u3084\u6a5f\u80fd\u6539\u5584\u306e\u305f\u3081\u306b\u5fc5\u8981\u3067\u3059\u304c\u3001\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u3001\u6a29\u9650\u3001\u5e33\u7968\u3001API\u3001\u76e3\u67fb\u8a3c\u8de1\u3001\u30c6\u30b9\u30c8\u30b9\u30af\u30ea\u30d7\u30c8\u3078\u5f71\u97ff\u3059\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002\u30ea\u30ea\u30fc\u30b9\u30ce\u30fc\u30c8\u3092\u53d7\u3051\u53d6\u3063\u305f\u3089\u3001\u5909\u66f4\u306e\u91cd\u8981\u5ea6\u3092\u8a55\u4fa1\u3057\u3001\u5f71\u97ff\u3092\u53d7\u3051\u308b\u8981\u6c42\u30fb\u30c6\u30b9\u30c8\u30fb\u624b\u9806\u30fb\u6559\u80b2\u3092\u7279\u5b9a\u3057\u307e\u3059\u3002\u91cd\u8981\u306a\u5909\u66f4\u3060\u3051\u56de\u5e30\u30c6\u30b9\u30c8\u3092\u884c\u3046\u306a\u3069\u3001\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u306e\u518d\u8a55\u4fa1\u3092\u6c7a\u3081\u3066\u304a\u304f\u3068\u3001\u6bce\u56de\u3059\u3079\u3066\u3092\u3084\u308a\u76f4\u3059\u8ca0\u62c5\u3092\u6291\u3048\u3089\u308c\u307e\u3059\u3002<\/p>\n\n\n\n

\n

AI\u306e\u51fa\u529b\u3092\u691c\u8a3c\u305b\u305a\u8a3c\u8de1\u306b\u4f7f\u3046<\/strong><\/strong><\/strong><\/h3>\n<\/div>\n\n\n\n

AI\u3067\u30c6\u30b9\u30c8\u30b1\u30fc\u30b9\u3001\u30ea\u30b9\u30af\u306e\u5019\u88dc\u3001\u6587\u66f8\u306e\u4e0b\u66f8\u304d\u3092\u4f5c\u308b\u3068\u3001\u4f5c\u696d\u6642\u9593\u3092\u77ed\u7e2e\u3067\u304d\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002\u3057\u304b\u3057\u3001\u51fa\u529b\u306e\u8aa4\u308a\u3001\u6839\u62e0\u306e\u4e0d\u660e\u78ba\u3055\u3001\u5b66\u7fd2\u30fb\u5165\u529b\u30c7\u30fc\u30bf\u306e\u6f0f\u3048\u3044\u3001\u30e2\u30c7\u30eb\u66f4\u65b0\u306b\u3088\u308b\u7d50\u679c\u306e\u5909\u5316\u3001\u518d\u73fe\u6027\u306e\u4e0d\u8db3\u304c\u3042\u308b\u305f\u3081\u3001\u6700\u7d42\u5224\u65ad\u3092AI\u306b\u59d4\u306d\u307e\u305b\u3093\u3002\u5229\u7528\u76ee\u7684\u3001\u5165\u529b\u30c7\u30fc\u30bf\u3001\u30e2\u30c7\u30eb\u3084\u30d7\u30ed\u30f3\u30d7\u30c8\u306e\u7248\u3001\u51fa\u529b\u3001\u30ec\u30d3\u30e5\u30fc\u8005\u3001\u63a1\u7528\u30fb\u4e0d\u63a1\u7528\u306e\u7406\u7531\u3092\u7ba1\u7406\u3057\u3001\u5909\u66f4\u6642\u306b\u518d\u8a55\u4fa1\u3057\u307e\u3059\u3002EMA\u3068FDA\u304c2026\u5e741\u6708\u306b\u516c\u8868\u3057\u305f\u533b\u85ac\u54c1\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u5411\u3051AI\u306e\u826f\u597d\u306a\u5b9f\u8df5\u539f\u5247\u3082\u3001\u30ea\u30b9\u30af\u306b\u5fdc\u3058\u305f\u4eba\u306e\u76e3\u7763\u3068\u54c1\u8cea\u7ba1\u7406\u3092\u91cd\u8996\u3059\u308b\u65b9\u5411\u6027\u3067\u3059\uff08\u51fa\u5178: EMA\u30fbFDA\u30012026\u5e74\uff09\u3002<\/p>\n\n\n\n

\u898f\u5236\u30fb\u30af\u30e9\u30a6\u30c9\u30fbAI\u306e\u6700\u65b0\u52d5\u5411\u3092\u3069\u3046\u53d6\u308a\u8fbc\u3080\u304b<\/strong><\/h2>\n\n\n\n
\n
\n
\"\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u306e\u6700\u65b0\u52d5\u5411\"<\/figure>\n<\/div>\n<\/div>\n\n\n\n

\u898f\u5236\u5bfe\u5fdc\u3067\u306f\u3001\u7279\u5b9a\u306e\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u3092\u6e80\u305f\u3059\u3053\u3068\u3060\u3051\u3092\u76ee\u6a19\u306b\u305b\u305a\u3001\u9069\u7528\u3055\u308c\u308b\u898f\u5247\u3001\u30ac\u30a4\u30c0\u30f3\u30b9\u3001\u793e\u5185SOP\u3001\u610f\u56f3\u3057\u305f\u7528\u9014\u3092\u7d50\u3073\u4ed8\u3051\u307e\u3059\u3002\u898f\u5236\u3084\u30ac\u30a4\u30c0\u30f3\u30b9\u304c\u6539\u8a02\u3055\u308c\u308b\u53ef\u80fd\u6027\u3092\u524d\u63d0\u306b\u3001\u60c5\u5831\u6e90\u3001\u5f71\u97ff\u8a55\u4fa1\u3001\u5bfe\u5fdc\u65b9\u91dd\u3001\u627f\u8a8d\u3001\u5b9f\u65bd\u72b6\u6cc1\u3092\u5909\u66f4\u7ba1\u7406\u306b\u767b\u9332\u3067\u304d\u308b\u4ed5\u7d44\u307f\u3092\u4f5c\u308a\u307e\u3059\u3002<\/p>\n\n\n\n

\n

Part 11\u3068\u30c7\u30fc\u30bf\u5b8c\u5168\u6027\u3092\u5bfe\u8c61\u8a18\u9332\u304b\u3089\u5224\u65ad\u3057\u307e\u3059<\/strong><\/strong><\/strong><\/h3>\n<\/div>\n\n\n\n

FDA\u306ePart 11\u30ac\u30a4\u30c0\u30f3\u30b9\u3067\u306f\u3001\u6cd5\u4ee4\u4e0a\u4fdd\u5b58\u307e\u305f\u306f\u63d0\u51fa\u304c\u5fc5\u8981\u306a\u8a18\u9332\u3092\u96fb\u5b50\u5f62\u5f0f\u3067\u7dad\u6301\u3057\u3001\u305d\u306e\u96fb\u5b50\u8a18\u9332\u3092\u898f\u5236\u696d\u52d9\u3067\u4fe1\u983c\u3059\u308b\u5834\u5408\u306a\u3069\u306b\u9069\u7528\u7bc4\u56f2\u3092\u5224\u65ad\u3059\u308b\u8003\u3048\u65b9\u304c\u793a\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u307e\u305f\u3001\u30a2\u30af\u30bb\u30b9\u5236\u5fa1\u3001\u6a29\u9650\u78ba\u8a8d\u3001\u6559\u80b2\u8a13\u7df4\u3001\u96fb\u5b50\u7f72\u540d\u3001\u6587\u66f8\u7ba1\u7406\u306a\u3069\u306e\u7ba1\u7406\u3082\u91cd\u8981\u3067\u3059\uff08\u51fa\u5178: FDA, Part 11 Electronic Records; Electronic Signatures – Scope and Application\u30012003\u5e74\uff09\u3002\u81ea\u793e\u306e\u3059\u3079\u3066\u306e\u30c7\u30fc\u30bf\u306b\u4e00\u5f8b\u306e\u7ba1\u7406\u3092\u8db3\u3059\u306e\u3067\u306f\u306a\u304f\u3001\u3069\u306e\u8a18\u9332\u304c\u5bfe\u8c61\u304b\u3001\u4f55\u3092\u6b63\u672c\u3068\u3059\u308b\u304b\u3001\u3069\u306e\u696d\u52d9\u3067\u96fb\u5b50\u8a18\u9332\u3092\u4fe1\u983c\u3059\u308b\u304b\u3092\u6587\u66f8\u5316\u3057\u307e\u3059\u3002<\/p>\n\n\n\n

\n

Annex 11\u3068AI\u306e\u52d5\u304d\u3092\u78ba\u5b9a\u8981\u4ef6\u3068\u6df7\u540c\u3057\u307e\u305b\u3093<\/strong><\/strong><\/strong><\/h3>\n<\/div>\n\n\n\n

\u6b27\u5dde\u59d4\u54e1\u4f1a\u306f2025\u5e747\u6708\u3001GMP\u306eChapter 4\u3068Annex 11\u306e\u6539\u8a02\u3001AI\u3092\u6271\u3046\u65b0\u3057\u3044Annex 22\u306b\u3064\u3044\u3066\u610f\u898b\u52df\u96c6\u3092\u958b\u59cb\u3057\u3001\u540c\u5e7410\u6708\u306b\u7de0\u3081\u5207\u308a\u307e\u3057\u305f\u3002\u3053\u308c\u306f\u30c7\u30b8\u30bf\u30eb\u6280\u8853\u3068AI\u306e\u9032\u5c55\u3092\u8e0f\u307e\u3048\u305f\u6539\u8a02\u306e\u65b9\u5411\u6027\u3092\u793a\u3059\u5354\u8b70\u3067\u3042\u308a\u3001\u8a18\u4e8b\u57f7\u7b46\u6642\u70b9\u3067\u78ba\u5b9a\u3057\u305f\u6700\u7d42\u8981\u4ef6\u3068\u540c\u4e00\u8996\u3057\u306a\u3044\u3053\u3068\u304c\u5927\u5207\u3067\u3059\uff08\u51fa\u5178: European Commission, Stakeholders\u2019 Consultation on EudraLex Volume 4\u30012025\u5e74\uff09\u3002\u30b7\u30b9\u30c6\u30e0\u8a2d\u8a08\u3067\u306f\u3001\u73fe\u884c\u306e\u9069\u7528\u898f\u5236\u3092\u6e80\u305f\u3057\u3064\u3064\u3001AI\u306e\u610f\u56f3\u3057\u305f\u7528\u9014\u3001\u30c7\u30fc\u30bf\u306e\u51fa\u6240\u3001\u30e2\u30c7\u30eb\u5909\u66f4\u3001\u51fa\u529b\u30ec\u30d3\u30e5\u30fc\u3001\u76e3\u67fb\u53ef\u80fd\u6027\u3092\u7ba1\u7406\u3067\u304d\u308b\u4f59\u5730\u3092\u6b8b\u3057\u307e\u3059\u3002<\/p>\n\n\n\n

\n

\u76e3\u67fb\u8a3c\u8de1\u3092\u300c\u4fdd\u5b58\u300d\u304b\u3089\u300c\u30ec\u30d3\u30e5\u30fc\u300d\u3078\u5e83\u3052\u307e\u3059<\/strong><\/strong><\/strong><\/h3>\n<\/div>\n\n\n\n

MHRA\u306eGxP\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u30ac\u30a4\u30c0\u30f3\u30b9\u306f\u3001\u76e3\u67fb\u8a3c\u8de1\u3092\u8a18\u9332\u306e\u4f5c\u6210\u30fb\u5909\u66f4\u30fb\u524a\u9664\u306a\u3069\u306e\u5c65\u6b74\u3068\u3057\u3066\u6271\u3044\u3001\u8ab0\u304c\u3001\u4f55\u3092\u3001\u3044\u3064\u3001\u306a\u305c\u884c\u3063\u305f\u304b\u3092\u518d\u69cb\u6210\u3067\u304d\u308b\u3053\u3068\u3092\u8aac\u660e\u3057\u3066\u3044\u307e\u3059\uff08\u51fa\u5178: MHRA, Guidance on GxP Data Integrity\u30012018\u5e74\u30fb\u6700\u7d42\u66f4\u65b02021\u5e74\uff09\u3002\u305d\u306e\u305f\u3081\u3001\u30ed\u30b0\u3092\u4fdd\u5b58\u3059\u308b\u3060\u3051\u3067\u306a\u304f\u3001\u91cd\u8981\u306a\u8a18\u9332\u306b\u5bfe\u3059\u308b\u30ec\u30d3\u30e5\u30fc\u306e\u983b\u5ea6\u3001\u30ec\u30d3\u30e5\u30fc\u62c5\u5f53\u8005\u3001\u78ba\u8a8d\u89b3\u70b9\u3001\u7570\u5e38\u6642\u306e\u30a8\u30b9\u30ab\u30ec\u30fc\u30b7\u30e7\u30f3\u3001\u30ec\u30d3\u30e5\u30fc\u7d50\u679c\u306e\u627f\u8a8d\u307e\u3067\u3092\u904b\u7528\u306b\u7d44\u307f\u8fbc\u307f\u307e\u3059\u3002<\/p>\n\n\n\n

\u3088\u304f\u3042\u308b\u8cea\u554f\uff08FAQ\uff09<\/strong><\/h2>\n\n\n\n
\n
\n
\"\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u306eFAQ\"<\/figure>\n<\/div>\n<\/div>\n\n\n\n

\u6700\u5f8c\u306b\u3001\u5c0e\u5165\u524d\u306b\u7279\u306b\u591a\u3044\u7591\u554f\u3092\u6574\u7406\u3057\u307e\u3059\u3002\u898f\u5236\u306e\u9069\u7528\u7bc4\u56f2\u3084\u8cbb\u7528\u306f\u5bfe\u8c61\u696d\u52d9\u306b\u3088\u3063\u3066\u5909\u308f\u308b\u305f\u3081\u3001\u4e00\u822c\u8ad6\u3067\u5224\u65ad\u305b\u305a\u3001\u81ea\u793e\u306e\u8a18\u9332\u3001\u30c7\u30fc\u30bf\u30d5\u30ed\u30fc\u3001SOP\u3001\u30ea\u30b9\u30af\u8a55\u4fa1\u306b\u5f53\u3066\u306f\u3081\u3066\u78ba\u8a8d\u3057\u307e\u3059\u3002<\/p>\n\n\n\n

\n

\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u306f\u3059\u3079\u3066\u306e\u696d\u52d9\u30b7\u30b9\u30c6\u30e0\u306b\u5fc5\u8981\u3067\u3059\u304b\uff1f<\/strong><\/strong><\/strong><\/h3>\n<\/div>\n\n\n\n

\u3059\u3079\u3066\u306e\u696d\u52d9\u30b7\u30b9\u30c6\u30e0\u306b\u540c\u3058\u6df1\u3055\u306e\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u304c\u5fc5\u8981\u3068\u306f\u9650\u308a\u307e\u305b\u3093\u3002GxP\u5f71\u97ff\u3001\u54c1\u8cea\u30fb\u60a3\u8005\u3078\u306e\u5f71\u97ff\u3001\u30c7\u30fc\u30bf\u5b8c\u5168\u6027\u3001\u696d\u52d9\u306e\u91cd\u8981\u5ea6\u3001\u4ee3\u66ff\u624b\u6bb5\u3092\u8a55\u4fa1\u3057\u3001\u5bfe\u8c61\u7bc4\u56f2\u3068\u8a66\u9a13\u306e\u6df1\u3055\u3092\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u3067\u6c7a\u3081\u307e\u3059\u3002\u5bfe\u8c61\u5916\u3068\u5224\u65ad\u3057\u305f\u5834\u5408\u3082\u3001\u7406\u7531\u3068\u627f\u8a8d\u3092\u53f0\u5e33\u306b\u6b8b\u3059\u3053\u3068\u304c\u91cd\u8981\u3067\u3059\u3002<\/p>\n\n\n\n

\n

\u30af\u30e9\u30a6\u30c9\u306a\u3089CSV\u3084\u5b9a\u671f\u30ec\u30d3\u30e5\u30fc\u306f\u4e0d\u8981\u3067\u3059\u304b\uff1f<\/strong><\/strong><\/strong><\/h3>\n<\/div>\n\n\n\n

\u4e0d\u8981\u306b\u306f\u306a\u308a\u307e\u305b\u3093\u3002\u30af\u30e9\u30a6\u30c9\u30b5\u30fc\u30d3\u30b9\u306e\u57fa\u76e4\u3084\u6a19\u6e96\u6a5f\u80fd\u306b\u3064\u3044\u3066\u63d0\u4f9b\u8005\u306e\u8cc7\u6599\u3092\u6d3b\u7528\u3067\u304d\u3066\u3082\u3001\u81ea\u793e\u306e\u8a2d\u5b9a\u3001\u6a29\u9650\u3001\u30c7\u30fc\u30bf\u3001\u610f\u56f3\u3057\u305f\u7528\u9014\u3001\u696d\u52d9\u624b\u9806\u3001UAT\u3001\u6559\u80b2\u3001\u5909\u66f4\u5f71\u97ff\u8a55\u4fa1\u306f\u5229\u7528\u8005\u5074\u306e\u7ba1\u7406\u304c\u5fc5\u8981\u3067\u3059\u3002\u30b5\u30fc\u30d3\u30b9\u306e\u66f4\u65b0\u3001\u9023\u643a\u3001\u969c\u5bb3\u3001\u30a2\u30af\u30bb\u30b9\u6a29\u3001\u76e3\u67fb\u8a3c\u8de1\u3092\u5b9a\u671f\u7684\u306b\u30ec\u30d3\u30e5\u30fc\u3057\u307e\u3059\u3002<\/p>\n\n\n\n

\n

Excel\u904b\u7528\u304b\u3089\u79fb\u884c\u3059\u308b\u3068\u4f55\u304c\u5909\u308f\u308a\u307e\u3059\u304b\uff1f<\/strong><\/strong><\/strong><\/h3>\n<\/div>\n\n\n\n

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