{"id":11824,"date":"2023-07-20T09:36:24","date_gmt":"2023-07-20T09:36:24","guid":{"rendered":"https:\/\/grafiti.com\/sigmaplot-%e8%af%a6%e6%83%85\/21-cfr-11\/"},"modified":"2025-05-21T06:14:40","modified_gmt":"2025-05-21T06:14:40","slug":"21-cfr-11","status":"publish","type":"page","link":"https:\/\/grafiti.com\/zh-hans\/sigmaplot-%e8%af%a6%e6%83%85\/21-cfr-11\/","title":{"rendered":"21 CFR 11"},"content":{"rendered":"\t\t
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SigmaPlot \u5408\u89c4\u6027\uff1a\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u7269\u7ba1\u7406\u5c40 21 CFR \u7b2c 11 \u90e8\u5206\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Grafiti LLC \u81f4\u529b\u4e8e\u5f00\u53d1\u6700\u5148\u8fdb\u7684\u8f6f\u4ef6\uff0c\u4ee5\u63d0\u9ad8\u548c\u6539\u5584\u79d1\u5b66\u7814\u7a76\u7684\u8d28\u91cf\u3002 Grafiti LLC \u662f\u552f\u4e00\u4e00\u5bb6\u63d0\u4f9b\u5168\u5957\u79d1\u5b66\u548c\u5de5\u7a0b\u5de5\u5177\u7684\u79d1\u5b66\u8f6f\u4ef6\u516c\u53f8\uff0c\u8fd9\u4e9b\u5de5\u5177\u65e8\u5728\u6ee1\u8db3\u7814\u7a76\u79d1\u5b66\u5bb6\u548c\u5de5\u7a0b\u5e08\u7684\u7279\u6b8a\u9700\u6c42\u3002\n\n<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\u5982\u9700\u8be6\u7ec6\u4e86\u89e3\u7528\u4e8e\u5f00\u53d1\u548c\u786e\u4fdd SigmaPlot \u53ca\u76f8\u5173\u4ea7\u54c1\u7684\u9ad8\u8d28\u91cf\u8f6f\u4ef6\u7684\u7a0b\u5e8f\uff0c\u8bf7\u8054\u7cfb\u6211\u4eec\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 \u8f6f\u4ef6\u9a8c\u8bc1\u6587\u4ef6 (PDF)<\/a><\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\u4e3a\u786e\u4fdd\u7b14\u8bb0\u672c\u5185\u5bb9\u7684\u5b89\u5168\uff0c\u60a8\u53ef\u4ee5\u4f7f\u7528\u5bc6\u7801\u9501\u5b9a\u7b14\u8bb0\u672c\u3002 \u5982\u679c\u4e24\u4e2a\u6216\u591a\u4e2a\u7528\u6237\u4f7f\u7528\u540c\u4e00\u7248\u672c\u7684 SigmaPlot\uff0c\u8fd9\u4e00\u70b9\u5c24\u5176\u6709\u7528\u3002 \u60a8\u8fd8\u53ef\u4ee5\u4f7f\u7528\u5bc6\u7801\u5411\u5176\u4ed6 SigmaPlot \u7528\u6237\u53d1\u9001\u673a\u5bc6\u6570\u636e\u3002\n\n<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\u60a8\u53ef\u4ee5\u4fdd\u5b58\u9ad8\u5206\u8fa8\u7387\u7684\u56fe\u8868\uff0c\u7136\u540e\u4f7f\u7528 SigmaPlot WebViewer \u5c06\u5176\u53d1\u5e03\u5230\u4e92\u8054\u7f51\u4e0a\u3002\n\n<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\u5c06\u56fe\u8868\u4fdd\u5b58\u4e3a\u7f51\u9875\u4f1a\u521b\u5efa HTML \u4ee3\u7801\uff0c\u968f\u540e\u53ef\u5c06\u5176\u5bfc\u5165\u4efb\u4f55 HTML \u7f16\u8f91\u5668\u3002\n\n<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\u5c06\u56fe\u5f62\u5bfc\u51fa\u5230 Web \u65f6\uff0cSigmaPlot \u4f1a\u81ea\u52a8\u521b\u5efa\u4e09\u4e2a\u6587\u4ef6\uff1a\n\n<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\u60a8\u53ef\u4ee5\u4e3a\u5bfc\u51fa\u5230 HTML \u6587\u4ef6\u7684\u56fe\u8868\u8bbe\u7f6e\u5bc6\u7801\uff0c\u4ee5\u4fbf\u67e5\u770b\u8005\u5728\u4e92\u8054\u7f51\u4e0a\u67e5\u770b\u8be5\u56fe\u8868\u65f6\u8f93\u5165\u5bc6\u7801\uff0c\u4ece\u800c\u4fdd\u62a4\u6570\u636e\u5b89\u5168\u3002 \u8bbe\u7f6e\u5bc6\u7801\u8fd8\u53ef\u4ee5\u9632\u6b62\u6253\u5f00\u548c\u4e0b\u8f7d\u8be5\u6587\u4ef6\u3002\n\n<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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  • \n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t<\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\u5305\u542b SigmaPlot \u56fe\u5f62\u548c\u6570\u636e\u5de5\u4f5c\u8868\u7684\u7b14\u8bb0\u672c .JNB \u6587\u4ef6\u3002<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t
  • \n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t<\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\u56fe\u8868\u7684 JPEG \u6587\u4ef6\uff0c\u6ca1\u6709 SigmaPlot WebViewer \u7684\u7528\u6237\u4e5f\u53ef\u67e5\u770b\u3002<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t
  • \n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t<\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\u4e00\u4e2a HTML \u6587\u4ef6\uff0c\u5176\u4e2d\u5f15\u7528\u4e86\u56fe\u5f62\u7684 .JPG \u548c .JNB \u6587\u4ef6\u3002<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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    \u4f7f\u7528 SigmaPlot Auditing \u521b\u5efa\u8bb0\u5f55\uff0c\u663e\u793a\u5728\u7279\u5b9a\u65f6\u95f4\u5185\u8c01\u4fee\u6539\u548c\u4fdd\u5b58\u4e86\u7b14\u8bb0\u672c\u6587\u4ef6\uff0c\u4ee5\u53ca\u6267\u884c\u4e86\u54ea\u4e9b\u64cd\u4f5c\u3002<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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    21 CFR \u7b2c 11 \u90e8\u5206\u662f\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u7269\u7ba1\u7406\u5c40\uff08FDA\uff09\u5bf9\u7535\u5b50\u8bb0\u5f55\u4fdd\u5b58\u7684\u8981\u6c42\u3002 \u6839\u636e\u8fd9\u4e9b\u89c4\u5219\uff0c\u7535\u5b50\u6587\u6863\u53ef\u88ab\u89c6\u4e3a\u7b49\u540c\u4e8e\u7eb8\u8d28\u6587\u6863\u3002 \u8fd9\u90e8\u5206\u5305\u62ec\u8f6f\u4ef6\u9a8c\u8bc1\u3001\u6570\u636e\u548c\u5b8f\u7684\u5bc6\u7801\u4fdd\u62a4\u3001\u65f6\u95f4\u6233\u5ba1\u8ba1\u8ddf\u8e2a\u529f\u80fd\u4ee5\u53ca\u5404\u79cd\u5bc6\u7801\u548c\u5b89\u5168\u63aa\u65bd\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 \u5df2\u7ecf\u6ee1\u8db3\u4e86\u4f7f\u7528\u4eba\u5de5\u6d4b\u8bd5\u8fdb\u884c\u5185\u90e8\u9a8c\u8bc1\u7684\u8981\u6c42\u3002 \u6b64\u5916\uff0c\u5b8f\u8bed\u8a00\u8fd8\u4e3a\u4eea\u5668\u6570\u636e\u7684\u53ef\u91cd\u590d \"\u653e\u624b \"\u5206\u6790\u63d0\u4f9b\u4e86\u673a\u5236\u3002\n\n<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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    9.0 \u53ca\u4ee5\u4e0a\u7248\u672c\u7684 SigmaPlot \u53ef\u4ece\u5404\u79cd ODBC \u517c\u5bb9\u6570\u636e\u5e93\u5bfc\u5165\u6570\u636e\u5e76\u8fd0\u884c SQL \u67e5\u8be2\u3002 \u65b0\u7248\u672c\u8fd8\u63d0\u4f9b\u4e86\u5bc6\u7801\u4fdd\u62a4\u7b14\u8bb0\u672c\u7684\u529f\u80fd\uff0c\u4ee5\u4fbf\u63d0\u4ea4\u7ed9 FDA \u6216\u5176\u4ed6\u8981\u6c42\u9075\u5b88\u5b89\u5168\u51c6\u5219\u7684\u653f\u5e9c\u673a\u6784\u3002\n\n<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"

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