{"id":11810,"date":"2023-07-20T09:36:24","date_gmt":"2023-07-20T09:36:24","guid":{"rendered":"https:\/\/grafiti.com\/%e3%82%b7%e3%82%b0%e3%83%9e%e3%83%97%e3%83%ad%e3%83%83%e3%83%88%e3%81%ae%e8%a9%b3%e7%b4%b0\/21-cfr-11\/"},"modified":"2025-12-05T11:59:46","modified_gmt":"2025-12-05T11:59:46","slug":"21-cfr-11","status":"publish","type":"page","link":"https:\/\/grafiti.com\/ja\/%e3%82%b7%e3%82%b0%e3%83%9e%e3%83%97%e3%83%ad%e3%83%83%e3%83%88%e3%81%ae%e8%a9%b3%e7%b4%b0\/21-cfr-11\/","title":{"rendered":"21 CFR 11"},"content":{"rendered":"\t\t
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FDA\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Grafiti LLC\u306f\u3001\u79d1\u5b66\u7814\u7a76\u306e\u8cea\u3092\u9ad8\u3081\u3001\u5411\u4e0a\u3055\u305b\u308b\u6700\u5148\u7aef\u306e\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u958b\u767a\u306b\u53d6\u308a\u7d44\u3093\u3067\u3044\u307e\u3059\u3002 Grafiti LLC\u306f\u3001\u7814\u7a76\u79d1\u5b66\u8005\u3084\u30a8\u30f3\u30b8\u30cb\u30a2\u306e\u7279\u5225\u306a\u30cb\u30fc\u30ba\u3092\u6e80\u305f\u3059\u3088\u3046\u306b\u8a2d\u8a08\u3055\u308c\u305f\u79d1\u5b66\u7684\u30fb\u5de5\u5b66\u7684\u30c4\u30fc\u30eb\u306e\u30d5\u30eb\u30ec\u30f3\u30b8\u3092\u63d0\u4f9b\u3059\u308b\u552f\u4e00\u306e\u79d1\u5b66\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u4f1a\u793e\u3067\u3059\u3002\n\n<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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SigmaPlot\u304a\u3088\u3073\u95a2\u9023\u88fd\u54c1\u306e\u9ad8\u54c1\u8cea\u306a\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u3092\u958b\u767a\u3057\u3001\u4fdd\u8a3c\u3059\u308b\u305f\u3081\u306b\u4f7f\u7528\u3055\u308c\u308b\u624b\u9806\u306e\u8a73\u7d30\u306b\u3064\u3044\u3066\u306f\u3001\u5f0a\u793e\u307e\u3067\u304a\u554f\u3044\u5408\u308f\u305b\u304f\u3060\u3055\u3044\u3002\n\n<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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SigmaPlot\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u6587\u66f8 (PDF)<\/a><\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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HTML\u30d5\u30a1\u30a4\u30eb\u306b\u30a8\u30af\u30b9\u30dd\u30fc\u30c8\u3057\u305f\u30b0\u30e9\u30d5\u306f\u3001\u30a4\u30f3\u30bf\u30fc\u30cd\u30c3\u30c8\u4e0a\u3067\u95b2\u89a7\u3059\u308b\u969b\u306b\u95b2\u89a7\u8005\u304c\u5165\u529b\u3059\u308b\u30d1\u30b9\u30ef\u30fc\u30c9\u3092\u8a2d\u5b9a\u3059\u308b\u3053\u3068\u3067\u3001\u30c7\u30fc\u30bf\u3092\u4fdd\u8b77\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002 \u30d1\u30b9\u30ef\u30fc\u30c9\u3092\u8a2d\u5b9a\u3059\u308b\u3068\u3001\u3053\u306e\u30d5\u30a1\u30a4\u30eb\u3092\u958b\u3044\u305f\u308a\u30c0\u30a6\u30f3\u30ed\u30fc\u30c9\u3057\u305f\u308a\u3059\u308b\u3053\u3068\u3082\u3067\u304d\u306a\u304f\u306a\u308b\u3002\n\n<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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    SigmaPlot Auditing \u3092\u4f7f\u3063\u3066\u3001\u8ab0\u304c\u30ce\u30fc\u30c8\u30d6\u30c3\u30af\u30d5\u30a1\u30a4\u30eb\u3092\u5909\u66f4\u30fb\u4fdd\u5b58\u3057\u305f\u304b\u3001\u307e\u305f\u3001\u305d\u306e\u4eba\u304c\u4e00\u5b9a\u671f\u9593\u306b\u3069\u306e\u3088\u3046\u306a\u64cd\u4f5c\u3092\u884c\u3063\u305f\u304b\u3092\u793a\u3059\u8a18\u9332\u3092\u4f5c\u6210\u3057\u307e\u3059\u3002<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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    21 CFR Part 11\u306f\u3001\u7c73\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5c40(FDA)\u306e\u96fb\u5b50\u8a18\u9332\u306b\u95a2\u3059\u308b\u8981\u6c42\u4e8b\u9805\u3067\u3042\u308b\u3002 \u3053\u308c\u306f\u3001\u96fb\u5b50\u6587\u66f8\u304c\u7d19\u6587\u66f8\u3068\u540c\u7b49\u3068\u307f\u306a\u3055\u308c\u308b\u305f\u3081\u306e\u30eb\u30fc\u30eb\u3067\u3042\u308b\u3002 \u3053\u308c\u306b\u306f\u4e00\u90e8\u3001\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u691c\u8a3c\u3001\u30c7\u30fc\u30bf\u3084\u30de\u30af\u30ed\u306e\u30d1\u30b9\u30ef\u30fc\u30c9\u4fdd\u8b77\u3001\u30bf\u30a4\u30e0\u30b9\u30bf\u30f3\u30d7\u4ed8\u304d\u76e3\u67fb\u8a3c\u8de1\u6a5f\u80fd\u3001\u3055\u307e\u3056\u307e\u306a\u30d1\u30b9\u30ef\u30fc\u30c9\u3084\u30bb\u30ad\u30e5\u30ea\u30c6\u30a3\u5bfe\u7b56\u304c\u542b\u307e\u308c\u308b\u3002\n\n<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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    SigmaPlot\u306f\u3001\u624b\u52d5\u30c6\u30b9\u30c8\u306b\u3088\u308b\u793e\u5185\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306e\u8981\u4ef6\u3092\u3059\u3067\u306b\u6e80\u305f\u3057\u3066\u3044\u307e\u3059\u3002 \u307e\u305f\u3001\u30de\u30af\u30ed\u8a00\u8a9e\u306f\u3001\u8a08\u6e2c\u30c7\u30fc\u30bf\u3092\u7e70\u308a\u8fd4\u3057 \"\u30cf\u30f3\u30ba\u30aa\u30d5 \"\u5206\u6790\u3059\u308b\u305f\u3081\u306e\u30e1\u30ab\u30cb\u30ba\u30e0\u3092\u63d0\u4f9b\u3059\u308b\u3002\n\n<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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