{"id":52609,"date":"2018-09-28T01:00:00","date_gmt":"2018-09-30T01:35:37","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/09\/30\/%e8%a7%a3%e8%af%bb%ef%bd%9c%e6%97%a0%e8%8f%8c%e5%b7%a5%e8%89%ba%e6%a8%a1%e6%8b%9f%e8%af%95%e9%aa%8c%ef%bc%88%e6%97%a0%e8%8f%8c%e5%88%b6%e5%89%82%ef%bc%89%e7%9a%84%e6%ad%a3%e5%bc%8f%e7%89%88%e4%b8%8e\/"},"modified":"2018-09-30T09:35:38","modified_gmt":"2018-09-30T01:35:38","slug":"%e8%a7%a3%e8%af%bb%ef%bd%9c%e6%97%a0%e8%8f%8c%e5%b7%a5%e8%89%ba%e6%a8%a1%e6%8b%9f%e8%af%95%e9%aa%8c%ef%bc%88%e6%97%a0%e8%8f%8c%e5%88%b6%e5%89%82%ef%bc%89%e7%9a%84%e6%ad%a3%e5%bc%8f%e7%89%88%e4%b8%8e","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/52609\/","title":{"rendered":"\u89e3\u8bfb\uff5c\u65e0\u83cc\u5de5\u827a\u6a21\u62df\u8bd5\u9a8c\uff08\u65e0\u83cc\u5236\u5242\uff09\u7684\u6b63\u5f0f\u7248\u4e0e\u5f81\u6c42\u610f\u89c1\u7a3f\u7684\u53d8\u5316"},"content":{"rendered":"
\n

\"\u89e3\u8bfb\uff5c\u65e0\u83cc\u5de5\u827a\u6a21\u62df\u8bd5\u9a8c\uff08\u65e0\u83cc\u5236\u5242\uff09\u7684\u6b63\u5f0f\u7248\u4e0e\u5f81\u6c42\u610f\u89c1\u7a3f\u7684\u53d8\u5316\"<\/p>\n

\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u81ea<\/span>2016\u5e7410\u6708\u53d1\u5e03\u300a\u65e0\u83cc\u5de5\u827a\u6a21\u62df\u8bd5\u9a8c\u300b\uff08\u65e0\u83cc\u5236\u5242\uff09\u548c\uff08\u65e0\u83cc\u539f\u6599\u836f\uff09\u7684\u5f81\u6c42\u610f\u89c1\u7a3f\u4ee5\u6765\uff0c2018\u5e7409\u670811\u65e5\u6b63\u5f0f\u53d1\u5e03\uff0c<\/span><\/strong>10\u670801\u65e5\u5f00\u59cb\u5b9e\u65bd\uff0c<\/span><\/strong>\u7ecf\u5386\u4e86\u6574\u6574\u4e24\u5e74\u7684\u65f6\u95f4\uff0c\u73b0\u6211\u5c31<\/span><\/strong>\u6b63\u5f0f\u7248\u4e0e\u5f81\u6c42\u610f\u89c1\u7a3f\u505a\u4e2a\u6bd4\u8f83<\/span><\/strong>\uff1a<\/span><\/strong><\/span><\/p>\n

\u4e00\u3001\u6574\u4f53\u7ed3\u6784\uff0c\u7565\u6709\u53d8\u5316,<\/span>\u5171<\/span>14\u8282  \u5982\u4e0b\uff1a<\/span><\/strong><\/p>\n

    \n
  1. \n

    \u76ee\u7684
    <\/p>\n<\/li>\n

  2. \n

    \u5b9a\u4e49<\/p>\n<\/li>\n

  3. \n

    \u8303\u56f4<\/p>\n<\/li>\n

  4. \n

    \u539f\u5219<\/p>\n<\/li>\n

  5. \n

    \u65e0\u83cc\u5236\u5242\u751f\u4ea7\u5de5\u827a\u53ca\u6a21\u62df\u8303\u56f4<\/p>\n<\/li>\n

  6. \n

    \u6a21\u62df\u8bd5\u9a8c\u65b9\u6848\u7684\u8bbe\u8ba1\u53ca\u5b9e\u65bd\u8fc7\u7a0b\u8981\u6c42<\/p>\n

    6.1\u65e0\u83cc\u5de5\u827a\u6a21\u62df\u8bd5\u9a8c\u7684\u524d\u63d0\u6761\u4ef6<\/p>\n

    6.2\u57fa\u4e8e\u98ce\u9669\u7684\u65b9\u6848\u8bbe\u8ba1<\/p>\n

    6.3\u6a21\u62df\u4ecb\u8d28\u7684\u9009\u62e9\u4e0e\u8bc4\u4ef7<\/p>\n

    6.4\u704c\u88c5\u6570\u91cf\u53ca\u6a21\u62df\u6301\u7eed\u65f6\u95f4<\/p>\n

    6.5\u5bb9\u5668\u88c5\u91cf<\/p>\n

    6.6\u6a21\u62df\u8bd5\u9a8c\u65b9\u6cd5\u7684\u9009\u62e9<\/p>\n

    6.7\u6700\u5dee\u6761\u4ef6\u7684\u9009\u62e9<\/p>\n

    6.8\u5e72\u9884<\/p>\n

    6.9\u5bb9\u5668\u89c4\u683c<\/p>\n

    6.10\u57f9\u517b\u4e0e\u89c2\u5bdf<\/p>\n

    6.11\u8ba1\u6570\u4e0e\u6570\u91cf\u5e73\u8861<\/p>\n

    6.12\u73af\u5883\uff08\u5305\u62ec\u4eba\u5458\uff09\u76d1\u63a7<\/p>\n

    6.13\u4eba\u5458\u56e0\u7d20<\/p>\n

    6.14\u4e0d\u540c\u5242\u578b\u5e94\u8003\u8651\u7684\u7279\u6b8a\u56e0\u7d20<\/p>\n

    6.15\u65b9\u6848\u7684\u5b9e\u65bd<\/p>\n<\/li>\n

  7. \n

    \u53ef\u63a5\u53d7\u6807\u51c6\u4e0e\u7ed3\u679c\u8bc4\u4ef7<\/p>\n<\/li>\n

  8. \n

    \u6c61\u67d3\u8c03\u67e5\u53ca\u7ea0\u6b63\u63aa\u65bd<\/p>\n<\/li>\n

  9. \n

    \u6a21\u62df\u8bd5\u9a8c\u7684\u5468\u671f\u4e0e\u518d\u9a8c\u8bc1<\/p>\n<\/li>\n

  10. \n

    \u65e0\u83cc\u5de5\u827a\u6a21\u62df\u8bd5\u9a8c\u7684\u5c40\u9650\u6027<\/p>\n<\/li>\n

  11. \n

    \u672f\u8bed<\/p>\n<\/li>\n

  12. \n

    \u53c2\u8003\u6cd5\u89c4\u4e0e\u6307\u5357<\/p>\n


    <\/p>\n<\/li>\n<\/ol>\n

    \u4e8c\u3001\u4fee\u6539\u5904<\/span> <\/span> \u589e\u52a0\u3001\u5220\u9664\u548c\u4fee\u6539<\/span>3\u4e2a\u65b9\u9762   \u6c47\u603b\u5982\u4e0b\uff1a<\/span><\/strong><\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
    \n

    \u4fee\u6539\u7ae0\u8282<\/span><\/p>\n<\/td>\n

    		\n

    \u9898\u76ee<\/span><\/p>\n<\/td>\n

    		\n

    \u53d8\u5316\u5185\u5bb9<\/span><\/p>\n<\/td>\n<\/tr>\n

    \n

    3.<\/span> <\/span><\/p>\n<\/td>\n

    		\n

    \u8303\u56f4<\/span><\/p>\n<\/td>\n

    		\n

    \u589e\u52a0\uff1a\u7ed3\u679c\u8bc4\u4ef7<\/span><\/p>\n<\/td>\n<\/tr>\n

    \n

           4.<\/span><\/p>\n<\/td>\n

    		\n

    \u539f\u5219<\/span><\/p>\n<\/td>\n

    		\n

    \u5220\u51cf\uff1a\u540c\u65f6\u4e5f\u4e3a\u4f01\u4e1a\u53ca\u65f6\u8bc6\u522b\u98ce\u9669\uff0c\u8fdb\u800c\u6539\u8fdb\u65e0\u83cc\u63a7\u5236\u63aa\u65bd\u63d0\u4f9b\u6570\u636e\u652f\u6301<\/span><\/strong><\/p>\n<\/td>\n<\/tr>\n

    \n

          4.2<\/span><\/p>\n<\/td>\n

    		\n

    \u589e\u52a0\uff1a<\/span><\/strong>\u5e94\u7279\u522b\u5173\u6ce8\u66b4\u9732\u64cd\u4f5c\u3001\u4eba\u5de5\u5e72\u9884\u7b49\u9ad8\u98ce\u9669\u8fc7\u7a0b\u3002<\/span><\/strong>\u91c7\u7528\u826f\u597d\u8bbe\u8ba1\u4e14\u53d7\u63a7\u7684\u65e0\u83cc\u704c\u88c5\u7cfb\u7edf\uff0c\u7279\u522b\u662f\u81ea\u52a8\u5316\u7684\u7cfb\u7edf\u5982\u5439\u704c\u5c01\u3001\u9694\u79bb\u5668\u7b49\uff0c\u6c61\u67d3\u7387\u53ef\u5927\u5e45\u5ea6\u964d\u4f4e\u3002<\/span><\/p>\n<\/td>\n<\/tr>\n

    \n

    4.3<\/span><\/p>\n<\/td>\n

    		\n

    \u589e\u52a0\uff1a<\/span><\/strong>\u91c7\u7528\u98ce\u9669\u8bc4\u4f30\u7684\u65b9\u5f0f\u7edf\u7b79<\/span>\u8003\u8651\u8be5\u751f\u4ea7\u7ebf\u751f\u4ea7\u4f7f\u7528\u7684\u5bb9\u5668\u7c7b\u578b\u3001\u89c4\u683c\u5927\u5c0f\uff0c\u4ea7\u54c1\u7c7b\u522b\uff0c\u704c\u88c5\u901f\u5ea6\u3001\u8fc7\u7a0b\u4e2d\u65ad\u7b49\u73af\u8282\uff0c<\/span><\/strong>\u8fdb\u884c\u8bd5\u9a8c\u65b9\u6848\u7684\u8bbe\u8ba1\u3002<\/span><\/p>\n<\/td>\n<\/tr>\n

    \n

    6.<\/span><\/p>\n<\/td>\n

    		\n

    \u6a21\u62df\u8bd5\u9a8c\u65b9\u6848\u7684\u8bbe\u8ba1\u53ca\u5b9e\u65bd\u8fc7\u7a0b\u8981\u6c42<\/span><\/p>\n<\/td>\n<\/tr>\n

    \n

    6.1.4<\/span><\/p>\n<\/td>\n

    		\n

    \u589e\u52a0\uff1a<\/span><\/strong>\u4f46<\/span>\u4e0d\u5f97\u91c7\u7528\u5bf9\u73af\u5883\u6216\u8005\u5668\u5177\u8fdb\u884c\u8fc7\u5ea6\u706d\u83cc\u6216\u6d88\u6bd2<\/span><\/strong>\u7684\u65b9\u5f0f\u63d0\u9ad8\u65e0\u83cc\u4fdd\u8bc1\u6c34\u5e73\u3002<\/span><\/p>\n<\/td>\n<\/tr>\n

    \n

    6.3.2<\/span><\/p>\n<\/td>\n

    		\n

    \u57f9\u517b\u57fa\u7684\u9009\u62e9<\/span><\/p>\n<\/td>\n<\/tr>\n

    \n

    6.3.2.2<\/span><\/p>\n<\/td>\n

    		\n

    \u589e\u52a0\uff1a<\/span>\u6216\u5176\u4ed6\u9002\u5b9c\u7684\u57f9\u517b\u57fa<\/span>\u3002<\/span><\/p>\n<\/td>\n<\/tr>\n

    \n

    6.3.2.4<\/span><\/p>\n<\/td>\n

    		\n

    \u589e\u52a0\uff1b<\/span>\u4ea6\u53ef\u9009\u7528\u690d\u7269\u6765\u6e90\u7684\u57f9\u517b\u57fa\u3002<\/span><\/p>\n<\/td>\n<\/tr>\n

    \n

    6.3.3<\/span><\/p>\n<\/td>\n

    		\n

    \u57f9\u517b\u57fa\u7684\u914d\u5236<\/span><\/p>\n<\/td>\n<\/tr>\n

    \n

    6.3.3.1<\/span><\/p>\n<\/td>\n

    		\n

    \u4fee\u6539\uff1a<\/span><\/p>\n

    \uff081\uff09 <\/span>\u5728\u63a7\u5236\u533a\u4fee\u6539\u4e3a\u63a7\u5236\u533a<\/span><\/p>\n

    \uff082\uff09 <\/span>\u901a\u5e38\u6309\u7167\u6700\u7ec8\u57f9\u517b\u6d53\u5ea6<\/span>3%<\/span>\u7684\u8981\u6c42\u914d\u5236\u57f9\u517b\u57fa\u4fee\u6539\u4e3a<\/span>\u901a\u5e38\u6309\u7167\u836f\u5178\u8981\u6c42\u6216\u5382\u5546\u63d0\u4f9b\u7684\u914d\u5236\u65b9\u6cd5\u914d\u5236\u57f9\u517b\u57fa<\/span><\/strong>\u3002<\/span><\/p>\n<\/td>\n<\/tr>\n

    \n

    6.3.4<\/span><\/p>\n<\/td>\n

    		\n

    \u57f9\u517b\u57fa\u7684\u9664\u83cc\u4e0e\u706d\u83cc<\/span><\/p>\n<\/td>\n<\/tr>\n

    \n

    6.3.4.1<\/span><\/p>\n<\/td>\n

    		\n

    \u9664\u83cc\u8fc7\u6ee4<\/span><\/p>\n<\/td>\n

    		\n

    \u589e\u52a0\uff1a<\/span>\u6e7f\u70ed\u706d\u83cc\u6216\u8f90\u7167\u706d\u83cc\u6709\u52a9\u4e8e\u964d\u4f4e\u8be5\u6f5c\u5728\u98ce\u9669<\/span><\/strong>\uff0c\u5fc5\u8981\u65f6\u53ef\u914d\u5408\u9664\u83cc\u8fc7\u6ee4\u8054\u5408\u4f7f\u7528\u3002<\/span><\/p>\n<\/td>\n<\/tr>\n

    \n

    6.3.4.2<\/span><\/p>\n<\/td>\n

    		\n

    \u6e7f\u70ed\u706d\u83cc<\/span><\/p>\n<\/td>\n

    		\n

    \u589e\u52a0\uff1a<\/span>\u4ea6\u53ef\u4f7f\u7528\u65e0\u83cc\u5e72\u7c89\u6216\u6db2\u4f53\u6210\u54c1\u57f9\u517b\u57fa\u3002<\/span><\/p>\n<\/td>\n<\/tr>\n

    \n

    6.3.6<\/span><\/p>\n<\/td>\n

    		\n

    \u5176\u4ed6\u6a21\u62df\u4ecb\u8d28\u7684\u9009\u62e9\u4e0e\u8bc4\u4ef7<\/span><\/p>\n<\/td>\n<\/tr>\n

    \n

    6.3.6.1<\/span><\/p>\n<\/td>\n

    		\n

    \u5176\u4ed6\u6a21\u62df\u4ecb\u8d28\u7684\u9009\u62e9<\/span><\/p>\n<\/td>\n

    		\n

    \u589e\u52a0\uff1a<\/span>\u6a21\u62df\u4ecb\u8d28\u7684\u5305\u88c5\u5f62\u5f0f\u5e94\u4e0e\u88ab\u6a21\u62df\u7269\u7684<\/span>\u5305\u88c5\u5f62\u5f0f\u4e00\u81f4\u6216\u80fd\u5145\u5206\u4ee3\u8868\u8be5\u79cd\u5305\u88c5\u5f62\u5f0f<\/span><\/strong>\u3002<\/span><\/p>\n<\/td>\n<\/tr>\n

    \n

    6.4<\/span><\/p>\n<\/td>\n

    		\n

    \u704c\u88c5\u6570\u91cf\u53ca\u6a21\u62df\u7ef4\u6301\u65f6\u95f4<\/span><\/p>\n<\/td>\n<\/tr>\n

    \n

    6.4.2<\/span><\/p>\n<\/td>\n

    		\n

    \u4fee\u6539\uff1a<\/span>\u751f\u4ea7\u6279\u91cf\u5927\u4e8e10000\u652f\uff0c<\/span>\u53bb\u6389\uff1a\u4e14\u4e00\u822c\u4e0d\u4f4e\u4e8e\u4ea7\u54c1\u5b9e\u9645\u751f\u4ea7\u6279\u91cf\u7684<\/span><\/strong>10%<\/span><\/strong>\u3002<\/span><\/strong><\/p>\n

    \u589e\u52a0\uff1a<\/span>\u5bf9\u4e8e\u8d85\u5927\u6279\u91cf\u7684\u751f\u4ea7\u89c4\u6a21\uff0c<\/span>\u4f8b\u5982\u5927\u4e8e100000\u652f\uff0c\u5219\u5e94\u8003\u8651\u9002\u5f53\u589e\u52a0\u6a21\u62df\u7684\u704c\u88c5\u6570\u91cf<\/span><\/strong>\uff1b<\/span><\/p>\n<\/td>\n<\/tr>\n

    \n

    6.6<\/span><\/p>\n<\/td>\n

    		\n

    \u6a21\u62df\u8bd5\u9a8c\u65b9\u6cd5\u7684\u9009\u62e9<\/span><\/p>\n<\/td>\n

    		\n

    \u589e\u52a0\uff1a<\/span>\u5927\u89c4\u6a21\u751f\u4ea7\u65f6\uff0c\u6a21\u62df\u8bd5\u9a8c\u65b9\u6cd5\u53ef\u91c7\u7528\u4f46\u4e0d\u9650\u4e8e\u4ee5\u4e0b\u51e0\u79cd\u65b9\u5f0f\uff1a<\/span><\/p>\n<\/td>\n<\/tr>\n

    \n

    6.5.4<\/span><\/p>\n<\/td>\n

    		\n

    \u751f\u4ea7\u7ed3\u675f\u540e\u6a21\u62df<\/span><\/p>\n<\/td>\n

    		\n

    \u589e\u52a0\uff1a<\/span>\u4e0d\u63a8\u8350\u4f7f\u7528\u672c\u65b9\u5f0f\u3002<\/span><\/p>\n<\/td>\n<\/tr>\n

    \n

    6.7.2<\/span><\/p>\n<\/td>\n

    		\n

    \u65f6\u9650<\/span><\/p>\n<\/td>\n

    		\n

    \u4fee\u6539\uff1a\u7531<\/span>\u5de5\u827a\u65f6\u95f4\u4fee\u6539\u4e3a\u65f6\u9650\u3002<\/span><\/strong><\/p>\n

    \u589e\u52a0\uff1a<\/span>\u5728\u6761\u4ef6\u5141\u8bb8\u7684\u60c5\u51b5\u4e0b<\/span>\uff0c<\/span><\/p>\n<\/td>\n<\/tr>\n

    \n

    6.7.4<\/span><\/p>\n<\/td>\n

    		\n

     <\/span><\/p>\n

    \u73af\u5883<\/span><\/p>\n<\/td>\n

    		\n

    \u5220\u9664\uff1a<\/span>\u6a21\u62df\u8bd5\u9a8c\u6311\u6218\u7684\u6700\u5dee\u73af\u5883\u5e94\u8003\u8651\u9009\u62e9\u5355\u6279\u4ea7\u54c1\u65e0\u83cc\u751f\u4ea7\u5468\u671f\u672b\u7aef\u3001\u95f4\u6b47\u5f0f\u751f\u4ea7\u7684\u7a7a\u8c03\u7cfb\u7edf\u91cd\u65b0\u5f00\u542f\u540e\u6216\u8fde\u7eed\u751f\u4ea7\u671f\u95f4\u5468\u671f\u6027\u706d\u83cc\u6700\u957f\u7684\u65f6\u95f4\u95f4\u9694\u3002<\/span><\/p>\n<\/td>\n<\/tr>\n

    \n

    6.7.5<\/span><\/p>\n<\/td>\n

    		\n

    \u5220\u9664\uff1a<\/span><\/strong>\u5982\u662f\u518d\u9a8c\u8bc1\uff0c\u5e94\u8003\u8651\u6311\u6218\u65e0\u83cc\u751f\u4ea7\u5468\u671f\u7684\u672b\u7aef\u3002<\/span><\/strong>\u65e5\u5e38\u751f\u4ea7\u4e2d\uff0c\u9488\u5bf9\u5fae\u751f\u7269\u6c61\u67d3\u4e8b\u4ef6\u800c\u5236\u5b9a\u4e86\u7ea0\u6b63\u63aa\u65bd\u3002\u5728\u6a21\u62df\u8bd5\u9a8c\u65f6\uff0c\u53ef\u5bf9\u7ea0\u6b63\u63aa\u65bd\u7684\u6709\u6548\u6027\u7ed9\u4e88\u786e\u8ba4\u3002<\/span><\/p>\n<\/td>\n<\/tr>\n

    \n

    6.8<\/span><\/p>\n<\/td>\n

    		\n

    \u5e72\u9884<\/span><\/p>\n<\/td>\n<\/tr>\n

    \n

    6.8.1<\/span><\/p>\n<\/td>\n

    		\n

    \u6982\u5ff5<\/span><\/p>\n<\/td>\n

    		\n

    \u5220\u9664\uff1a\u624b\u5de5\u52a0\u585e<\/span><\/p>\n<\/td>\n<\/tr>\n

    \n

    6.12<\/span><\/p>\n<\/td>\n

    		\n

    \u73af\u5883\uff08\u5305\u62ec\u4eba\u5458\uff09\u76d1\u63a7<\/span><\/p>\n<\/td>\n<\/tr>\n

    \n

    6.12.1<\/span><\/p>\n<\/td>\n

    		\n

    \u73af<\/span>\u5883\u76d1\u63a7\u65b9\u6848\u8bbe\u8ba1<\/span><\/p>\n<\/td>\n

    		\n

    \u589e\u52a0\uff1a\u5982\u4eba\u5458\u76d1\u6d4b<\/span><\/p>\n<\/td>\n<\/tr>\n

    \n

    6.14<\/span><\/p>\n<\/td>\n

    		\n

    \u4e0d\u540c\u5242\u578b\u5e94\u8003\u8651\u7684\u7279\u6b8a\u56e0\u7d20<\/span><\/p>\n<\/td>\n<\/tr>\n

    \n

    6.14.1<\/span><\/p>\n<\/td>\n

    		\n

    \u51bb\u5e72\u5236\u5242<\/span><\/p>\n<\/td>\n<\/tr>\n

    \n

    6.14.1.2.1<\/span><\/p>\n<\/td>\n

    		\n

    \u7f29\u77ed\u7ef4\u6301\u65f6\u95f4\u6a21\u62df<\/span><\/p>\n<\/td>\n

    		\n

    \u589e\u52a0\uff1a<\/span>\u5e94\u5f53\u6709\u9884\u9632\u6027\u63aa\u65bd\u786e\u4fdd\u57f9\u517b\u57fa<\/span>\u4fdd\u6301\u5728\u6709\u6c27\u72b6\u6001\u4ee5\u514d\u963b\u788d\u5fae\u751f\u7269\u751f\u957f<\/span><\/strong>\u7684\u60c5\u51b5\u53d1\u751f\u3002<\/span><\/p>\n<\/td>\n<\/tr>\n

    \n

    6.14.2<\/span><\/p>\n<\/td>\n

    		\n

    \u60ac\u6d4a\u6db2<\/span><\/p>\n<\/td>\n<\/tr>\n

    \n

    6.14.2.1<\/span><\/p>\n<\/td>\n

    		\n

    \u589e\u52a0\uff1a<\/span>\u5176\u4ed6\u5177\u6709\u7279\u6b8a\u5de5\u827a\u7684\u60ac\u6d4a\u6db2\uff0c\u6a21\u62df\u7a0b\u5e8f\u5e94\u8be5\u8003\u8651\u5176\u7279\u6b8a\u6027<\/span>\u3002<\/span><\/span><\/p>\n<\/td>\n<\/tr>\n

    \n

    7\uff0e<\/span><\/p>\n<\/td>\n

    		\n

    \u53ef\u63a5\u53d7\u6807\u51c6\u4e0e\u7ed3\u679c\u8bc4\u4ef7<\/span><\/p>\n<\/td>\n<\/tr>\n

    \n

    7.2<\/span><\/p>\n<\/td>\n

    		\n

    \u5220\u9664\uff1a\u91c7\u7528\u826f\u597d\u8bbe\u8ba1\u4e14\u53d7\u63a7\u7684\u65e0\u83cc\u704c\u88c5\u7cfb\u7edf\uff0c\u7279\u522b\u662f\u81ea\u52a8\u5316\u7684\u7cfb\u7edf\u5982\u5439\u704c\u5c01\u3001\u9694\u79bb\u5668\uff0c\u6c61\u67d3\u7387\u53ef\u5927\u5e45\u5ea6\u964d\u4f4e\u3002<\/span><\/p>\n<\/td>\n<\/tr>\n

    \n

    9.<\/span><\/p>\n<\/td>\n

    		\n

    \u6a21\u62df\u8bd5\u9a8c\u7684\u5468\u671f\u4e0e\u518d\u9a8c\u8bc1<\/span><\/p>\n<\/td>\n<\/tr>\n

    \n

    9.1<\/span><\/p>\n<\/td>\n

    		\n

    \u589e\u52a0\uff1a<\/span>\u5982\u662f\u518d\u9a8c\u8bc1\uff0c\u65e5\u5e38\u751f\u4ea7\u4e2d\uff0c\u9488\u5bf9\u5fae\u751f\u7269\u6c61\u67d3\u4e8b\u4ef6\u800c\u5236\u5b9a\u4e86\u7ea0\u6b63\u63aa\u65bd\uff0c\u5728\u6a21\u62df\u8bd5\u9a8c\u65f6\uff0c\u53ef\u5bf9\u7ea0\u6b63\u63aa\u65bd\u7684\u6709\u6548\u6027\u7ed9\u4e88\u786e\u8ba4\u3002<\/span>\u672c\u6307\u5357\u63a8\u8350\u5728\u67d0\u4e9b\u60c5\u51b5\u4e0b\uff0c\u53ef\u9002\u5f53\u8003\u8651\u6311\u6218\u65e0\u83cc\u751f\u4ea7\u5468\u671f\u7684\u672b\u7aef\u3002<\/span><\/strong><\/p>\n<\/td>\n<\/tr>\n

    \n

    12.<\/span><\/p>\n<\/td>\n

    		\n

    \u4fee\u6539\uff1a<\/span><\/p>\n

    \uff081\uff09 <\/span>\u7531\u53c2\u8003\u6587\u732e\u4fee\u6539\u4e3a\u53c2\u8003\u6cd5\u89c4\u4e0e\u6307\u5357\u3002<\/span><\/p>\n

    \uff082\uff09 <\/span>\u5e8f\u53f7\u7531\u3008\u3009\u6539\u4e3a<\/span>[<\/span> <\/span>]<\/span>\u3002<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

    \n
    \n
    \n
    \n
    \n
    <\/section>\n<\/section>\n


    <\/section>\n<\/section>\n<\/section>\n<\/section>\n

    \n
    \n
    \n
    \n


    <\/p>\n

    \u5b9e\u9a8c\u5ba4\u6570\u636e\u5b8c\u6574\u6027\u6307\u5357\uff1a\u5355\u673a\u7248\u4eea\u5668\u7ba1\u7406\u8981\u6c42\u89e3\u8bfb<\/span><\/h2>\n


    <\/span><\/span><\/p>\n

    PDA TR80\u300aData Integrity Management System for Pharmaceutical Laboratories<\/span>\u5236\u836f\u5b9e\u9a8c\u5ba4\u6570\u636e\u5b8c\u6574\u6027\u7ba1\u7406\u4f53\u7cfb<\/span>\u300b\u7ed9\u51fa\u4e86\u5173\u4e8e<\/span><\/span>\u5b9e\u9a8c\u5ba4\u5355\u673a\u7248\u4eea\u5668<\/span><\/strong>\uff08\u4f8b\u5982\uff0c\u7d2b\u5916\u5206\u5149\u5149\u5ea6\u8ba1\uff0c\u5085\u91cc\u53f6\u53d8\u6362\u7ea2\u5916\u5149\u8c31\u4eea\uff08FTIR\uff09\uff0c\u539f\u5b50\u5438\u6536\u5149\u8c31\u4eea\uff0cX\u5c04\u7ebf\u5149\u8c31\u4eea\u6216\u6ef4\u5b9a\u4eea\uff09<\/span>\u7684\u6570\u636e\u7ba1\u7406\u6307\u5357\u3002\u7ffb\u8bd1\u5982\u4e0b\uff1a<\/span><\/p>\n


    <\/p>\n


    <\/p>\n<\/section>\n

    \n
    \n
    <\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n
    \n
    \n
    \n

    Due to the increasing number of citations about HPLC and GC instruments that have led to FDA Warning Letters, laboratory management may underestimate the importance of other equipment (e.g., UV, FTIR) being in compliance with 21 CFR Part 11. Because not all laboratory equipment is available in both a hybrid-system and a computer operated system (e.g., UV spectrophotometer, Fourier transform infrared spectrometer (FTIR), atomic absorption spectrometer, X-ray spectrometer, or titrator), there could be a mix of formats in the laboratory. As a result, some laboratories have adopted \u201cscientific data management systems,\u201d which can capture data from all instruments that generate signals and are equipped with RS 232 or local area network ports. If used, this scientific data management system needs to be qualified as laboratory data management software and should be compliant with 21 CFR Part 11 requirements.
    \u7531\u4e8eHPLC\u548cGC\u4eea\u5668\u5f15\u53d1FDA \u8b66\u544a\u4fe1\u7684\u6b21\u6570\u8d8a\u6765\u8d8a\u591a\uff0c\u5b9e\u9a8c\u5ba4\u7ba1\u7406\u4eba\u5458\u53ef\u80fd\u4f1a\u4f4e\u4f30\u5176\u4ed6\u8bbe\u5907\uff08\u4f8b\u5982UV\uff0cFTIR\uff09\u7b26\u540821 CFR Part 11\u7684\u91cd\u8981\u6027\u3002\u56e0\u4e3a\u5e76\u975e\u6240\u6709\u5b9e\u9a8c\u5ba4\u8bbe\u5907\u53ef\u5e94\u7528\u6df7\u5408\u7cfb\u7edf\u548c\u8ba1\u7b97\u673a\u64cd\u4f5c\u7cfb\u7edf\uff08\u4f8b\u5982\uff0c\u7d2b\u5916\u5206\u5149\u5149\u5ea6\u8ba1\uff0c\u5085\u91cc\u53f6\u53d8\u6362\u7ea2\u5916\u5149\u8c31\u4eea\uff08FTIR\uff09\uff0c\u539f\u5b50\u5438\u6536\u5149\u8c31\u4eea\uff0cX\u5c04\u7ebf\u5149\u8c31\u4eea\u6216\u6ef4\u5b9a\u4eea\uff09\uff0c\u5b9e\u9a8c\u5ba4\u4e2d\u53ef\u80fd\u4f1a\u540c\u65f6\u6709\u5f88\u591a\u79cd\u6570\u636e\u7ba1\u7406\u5f62\u5f0f\u3002 \u56e0\u6b64\uff0c\u4e00\u4e9b\u5b9e\u9a8c\u5ba4\u91c7\u7528\u4e86\u201c\u79d1\u5b66\u6570\u636e\u7ba1\u7406\u7cfb\u7edf\u201d\uff0c\u5b83\u53ef\u4ee5\u4ece\u6240\u6709\u4ea7\u751f\u4fe1\u53f7\u7684\u4eea\u5668\u4e2d\u6536\u96c6\u6570\u636e\uff0c\u5e26\u6709RS 232\u901a\u8baf\u63a5\u53e3\u6216\u5c40\u57df\u7f51\u7aef\u53e3\u3002 \u5982\u679c\u4f7f\u7528\uff0c\u8be5\u79d1\u5b66\u6570\u636e\u7ba1\u7406\u7cfb\u7edf\u9700\u8981\u88ab\u8ba4\u5b9a\u4e3a\u5b9e\u9a8c\u5ba4\u6570\u636e\u7ba1\u7406\u8f6f\u4ef6\uff0c\u5e76\u4e14\u5e94\u7b26\u540821 CFR Part 11\u7684\u8981\u6c42\u3002<\/span><\/p>\n

     <\/p>\n

    Although the software supplied for UV and FTIR instruments may not have the same applications HPLC or GC software, similar observations have been listed as deficiencies in audits and FDA Warning Letters, for example: (55)<\/p>\n

    \u5c3d\u7ba1\u4e3aUV\u548cFTIR\u4eea\u5668\u63d0\u4f9b\u7684\u8f6f\u4ef6\u53ef\u80fd\u4e0eHPLC\u6216GC\u8f6f\u4ef6\u7684\u5e94\u7528\u7a0b\u5e8f\u4e0d\u540c\uff0c\u4f46GxP\u68c0\u67e5\u548cFDA\u8b66\u544a\u4fe1\u4e2d\u4e5f\u6709\u7c7b\u4f3c\u7f3a\u9677\uff0c\u4f8b\u5982\uff1a\uff0855\uff09<\/span><\/p>\n

     <\/p>\n

      \n
    • \n

      Lack of audit trails<\/p>\n

      \u7f3a\u4e4f\u5ba1\u8ba1\u8ffd\u8e2a<\/span><\/p>\n<\/li>\n

    • \n

      No unique user IDs and passwords<\/p>\n

      \u7528\u6237\u8d26\u53f7\u548c\u5bc6\u7801\u4e0d\u552f\u4e00<\/span><\/p>\n<\/li>\n

    • \n

      Data can be deleted<\/p>\n

      \u6570\u636e\u53ef\u4ee5\u88ab\u5220\u9664<\/span><\/p>\n<\/li>\n

    • \n

      Data files can be saved as new data files using “save as” function<\/p>\n

      \u53ef\u4ee5\u4f7f\u7528\u201c\u53e6\u5b58\u4e3a\u201d\u529f\u80fd\u5c06\u6570\u636e\u6587\u4ef6\u53e6\u5b58\u4e3a\u65b0\u6570\u636e\u6587\u4ef6<\/span><\/p>\n<\/li>\n

    • \n

      Not all changes to data captured in audit trails<\/p>\n

      \u5ba1\u8ba1\u8ffd\u8e2a\u4e2d\u672a\u5305\u62ec\u6570\u636e\u7684\u6240\u6709\u66f4\u6539<\/span><\/p>\n<\/li>\n

    • \n

      Processing parameters not saved or not captured as metadata<\/p>\n

      \u5904\u7406\u53c2\u6570\u672a\u4fdd\u5b58\u6216\u672a\u6355\u83b7\u4e3a\u5143\u6570\u636e<\/span><\/p>\n<\/li>\n

    • \n

      Not enabling, reviewing, or printing\/publishing audit trails<\/p>\n

      \u672a\u6fc0\u6d3b\uff0c\u5ba1\u6838\u6216\u6253\u5370\/\u53d1\u5e03\u5ba1\u8ba1\u8ffd\u8e2a<\/span><\/p>\n<\/li>\n

    • \n

      All user IDs and passwords treated as “administrator” for the majority of stand-alone systems<\/p>\n

      \u5927\u591a\u6570\u5355\u673a\u7248\u7cfb\u7edf\u7684\u6240\u6709\u7528\u6237ID\u548c\u5bc6\u7801\u5747\u4e3a\u201c\u7ba1\u7406\u5458\u201d<\/span><\/p>\n<\/li>\n

    • \n

      Failure to establish and exercise adequate controls over computers to prevent unauthorized access, changes to, or omission of electronic data<\/p>\n

      \u672a\u80fd\u5bf9\u8ba1\u7b97\u673a\u5efa\u7acb\u548c\u5b9e\u65bd\u5145\u5206\u7684\u63a7\u5236\uff0c\u4ee5\u9632\u6b62\u672a\u6388\u6743\u7684\u8bbf\u95ee\uff0c\u66f4\u6539\u6216\u4e22\u5931\u7535\u5b50\u6570\u636e<\/span><\/p>\n<\/li>\n

    • \n

      Failure to maintain complete electronic raw data for instruments, Malvern particle-size analyzer, and UV spectrophotometer, e.g., instruments were connected to stand-alone computers that stored the data, which could be deleted at any time<\/p>\n

      \u672a\u80fd\u4fdd\u5b58Malvern\u7c92\u5ea6\u5206\u6790\u4eea\u548c\u7d2b\u5916\u5206\u5149\u5149\u5ea6\u8ba1\u7684\u5b8c\u6574\u7684\u539f\u59cb\u7535\u5b50\u6570\u636e\uff0c\u4f8b\u5982<\/span>\u4eea\u5668\u88ab\u8fde\u63a5\u5230\u4e00\u4e2a\u5355\u673a\u7248\u8ba1\u7b97\u673a\u7528\u4e8e\u5b58\u50a8\u6570\u636e\uff0c\u4f46\u6570\u636e\u53ef\u4ee5\u968f\u65f6\u5220\u9664<\/span><\/p>\n<\/li>\n<\/ul>\n


      <\/p>\n

      Laboratory management should ensure that the following procedures and system design, where possible,  are put in place for UV and FTIR instruments:<\/p>\n

      \u5b9e\u9a8c\u5ba4\u7ba1\u7406\u5c42\u5e94\u786e\u4fdd\u5728\u53ef\u80fd\u7684\u60c5\u51b5\u4e0b\u4e3aUV\u548cFTIR\u8bbe\u65bd\u5236\u5b9a\u4ee5\u4e0b\u89c4\u7a0b\u548c\u7cfb\u7edf\u8bbe\u8ba1\uff1a<\/span><\/p>\n

       <\/p>\n

        \n
      • \n

        Audit trail feature enabled at all times<\/p>\n

        \u59cb\u7ec8\u542f\u7528\u5ba1\u8ba1\u8ffd\u8e2a\u529f\u80fd<\/span><\/p>\n<\/li>\n

      • \n

        System audit trails review, including scope and how to conduct<\/p>\n

        \u7cfb\u7edf\u5ba1\u8ba1\u8ffd\u8e2a\u5ba1\u6838\uff0c\u5305\u62ec\u8303\u56f4\u548c\u5982\u4f55\u8fdb\u884c<\/span><\/p>\n<\/li>\n

      • \n

        Data protection and archival<\/p>\n

        \u6570\u636e\u4fdd\u62a4\u548c\u5b58\u6863<\/span><\/p>\n<\/li>\n

      • \n

        Individual user logins<\/p>\n

        \u4e2a\u4eba\u7528\u6237\u767b\u5f55<\/span><\/p>\n<\/li>\n

      • \n

        Qualification of software<\/p>\n

        \u8f6f\u4ef6\u786e\u8ba4<\/span><\/p>\n<\/li>\n<\/ul>\n


        <\/span><\/p>\n

        \u6709\u5173PDA TR80\u7684\u5176\u4ed6\u90e8\u5206GMP\u529e\u516c\u5ba4\u6b63\u5728\u7ffb\u8bd1\u548c\u6821\u5bf9\u4e2d\uff0c\u5c06\u4e8e\u8fd1\u671f\u9646\u7eed\u53d1\u51fa\uff0c\u656c\u8bf7\u671f\u5f85\u3002<\/span><\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

        \u200d<\/span><\/p>\n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"

        \u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u81ea2016\u5e7410\u6708\u53d1\u5e03\u300a\u65e0\u83cc\u5de5\u827a\u6a21\u62df\u8bd5\u9a8c\u300b\uff08\u65e0\u83cc\u5236\u5242\uff09\u548c\uff08\u65e0\u83cc\u539f\u6599\u836f\uff09\u7684\u5f81\u6c42\u610f\u89c1\u7a3f\u4ee5\u6765\uff0c […]<\/p>\n","protected":false},"author":1,"featured_media":52610,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[2],"tags":[],"_links":{"self":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/52609"}],"collection":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/comments?post=52609"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/52609\/revisions"}],"predecessor-version":[{"id":52612,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/52609\/revisions\/52612"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/52610"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=52609"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=52609"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=52609"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}