{"id":5192,"date":"2026-04-22T15:24:17","date_gmt":"2026-04-22T07:24:17","guid":{"rendered":"https:\/\/www.jianpaitech.com\/?post_type=blog&#038;p=5192"},"modified":"2026-04-22T15:24:17","modified_gmt":"2026-04-22T07:24:17","slug":"choosing-a-tablet-coating-machine-the-ultimate-fda-21-cfr-part-11-compliance-guide","status":"publish","type":"blog","link":"https:\/\/www.jianpaitech.com\/zh\/blog\/choosing-a-tablet-coating-machine-the-ultimate-fda-21-cfr-part-11-compliance-guide\/","title":{"rendered":"\u9009\u62e9\u7247\u5242\u5305\u8863\u673a\uff1aFDA 21 CFR Part 11 \u5408\u89c4\u7ec8\u6781\u6307\u5357"},"content":{"rendered":"<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u5728\u73b0\u4ee3\u836f\u54c1\u751f\u4ea7\u4e2d\uff0c\u91c7\u8d2d\u00a0<\/span><a href=\"https:\/\/www.jianpaitech.com\/zh\/product_category\/tablet-coating\/\" target=\"_blank\" rel=\"noopener\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u7247\u5242\u5305\u8863\u673a<\/span><\/strong><\/a><span class=\"ng-star-inserted\">\u00a0\u4e0d\u518d\u4ec5\u4ec5\u5173\u4e4e\u673a\u68b0\u6027\u80fd\u3001\u4e0d\u9508\u94a2\u724c\u53f7\u6216\u55b7\u67aa\u7cbe\u5ea6\u3002\u5bf9\u4e8e\u7784\u51c6\u6b27\u6d32\u548c\u5317\u7f8e\u5e02\u573a\u7684\u53e3\u670d\u56fa\u4f53\u5236\u5242 (OSD) \u5236\u9020\u5546\u6765\u8bf4\uff0c\u8fd0\u884c\u673a\u5668\u7684\u8f6f\u4ef6\u540c\u6837\u91cd\u8981\uff0c\u751a\u81f3\u66f4\u91cd\u8981\u3002<\/span><\/p>\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u5982\u679c\u6d82\u5c42\u7cfb\u7edf\u4e0d\u80fd\u4fdd\u8bc1\u7edd\u5bf9\u7684\u6570\u636e\u5b8c\u6574\u6027\uff0c\u5b83\u5c06\u65e0\u6cd5\u901a\u8fc7 FDA \u6216 EU-GMP \u68c0\u67e5\u3002\u8fd9\u662f\u54ea\u91cc\u00a0<\/span><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">FDA 21 CFR \u7b2c 11 \u90e8\u5206<\/span><\/strong><span class=\"ng-star-inserted\">\u00a0\u53d1\u6325\u4f5c\u7528\u3002<\/span><\/p>\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u5728\u672c\u7efc\u5408\u6307\u5357\u4e2d\uff0c\u6211\u4eec\u5c06\u63a2\u8ba8 21 CFR \u7b2c 11 \u90e8\u5206\u662f\u4ec0\u4e48\u3001\u4e3a\u4ec0\u4e48\u5b83\u5bf9\u60a8\u7684\u5305\u8863\u5de5\u827a\u81f3\u5173\u91cd\u8981\uff0c\u4ee5\u53ca\u5982\u4f55\u9009\u62e9\u7247\u5242\u5305\u8863\u673a\u4ee5\u786e\u4fdd\u60a8\u7684\u8bbe\u65bd\u4fdd\u6301 100% \u5ba1\u6838\u5c31\u7eea\u72b6\u6001\u3002<\/span><\/p>\n<p><img fetchpriority=\"high\" decoding=\"async\" class=\"alignleft size-full wp-image-3239\" src=\"https:\/\/i1.wp.com\/www.jianpaitech.com\/wp-content\/uploads\/2025\/05\/Model-JGB-Series-High-efficient-Sugar-Flim-Coating-Machine.png?quality=85&strip=all\" alt=\"\" width=\"968\" height=\"968\" srcset=\"https:\/\/i1.wp.com\/www.jianpaitech.com\/wp-content\/uploads\/2025\/05\/Model-JGB-Series-High-efficient-Sugar-Flim-Coating-Machine.png?quality=85&strip=all 968w, https:\/\/i1.wp.com\/www.jianpaitech.com\/wp-content\/uploads\/2025\/05\/Model-JGB-Series-High-efficient-Sugar-Flim-Coating-Machine-300x300.png?quality=85&strip=all 300w, https:\/\/i1.wp.com\/www.jianpaitech.com\/wp-content\/uploads\/2025\/05\/Model-JGB-Series-High-efficient-Sugar-Flim-Coating-Machine-150x150.png?quality=85&strip=all 150w, https:\/\/i1.wp.com\/www.jianpaitech.com\/wp-content\/uploads\/2025\/05\/Model-JGB-Series-High-efficient-Sugar-Flim-Coating-Machine-768x768.png?quality=85&strip=all 768w\" sizes=\"(max-width: 968px) 100vw, 968px\" \/><\/p>\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_76 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">\u76ee\u5f55<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"\u5207\u6362\u76ee\u5f55\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">\u5207\u6362<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewbox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewbox=\"0 0 24 24\" version=\"1.2\" baseprofile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.jianpaitech.com\/zh\/blog\/choosing-a-tablet-coating-machine-the-ultimate-fda-21-cfr-part-11-compliance-guide\/#What_Is_FDA_21_CFR_Part_11\" >\u4ec0\u4e48\u662f FDA 21 CFR \u7b2c 11 \u90e8\u5206\uff1f<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.jianpaitech.com\/zh\/blog\/choosing-a-tablet-coating-machine-the-ultimate-fda-21-cfr-part-11-compliance-guide\/#Why_Part_11_is_Critical_for_the_Tablet_Coating_Process\" >\u4e3a\u4ec0\u4e48\u7b2c 11 \u90e8\u5206\u5bf9\u4e8e\u7247\u5242\u5305\u8863\u5de5\u827a\u81f3\u5173\u91cd\u8981<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.jianpaitech.com\/zh\/blog\/choosing-a-tablet-coating-machine-the-ultimate-fda-21-cfr-part-11-compliance-guide\/#4_Core_Part_11_Features_to_Look_for_in_a_Tablet_Coater\" >\u7247\u5242\u5305\u8863\u673a\u9700\u8981\u5177\u5907\u7684\u7b2c 11 \u90e8\u5206\u7684 4 \u4e2a\u6838\u5fc3\u529f\u80fd<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.jianpaitech.com\/zh\/blog\/choosing-a-tablet-coating-machine-the-ultimate-fda-21-cfr-part-11-compliance-guide\/#Strict_Audit_Trails\" >\u4e25\u683c\u7684\u5ba1\u8ba1\u8ffd\u8e2a<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.jianpaitech.com\/zh\/blog\/choosing-a-tablet-coating-machine-the-ultimate-fda-21-cfr-part-11-compliance-guide\/#Role-Based_Access_Control_RBAC\" >\u57fa\u4e8e\u89d2\u8272\u7684\u8bbf\u95ee\u63a7\u5236 (RBAC)<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.jianpaitech.com\/zh\/blog\/choosing-a-tablet-coating-machine-the-ultimate-fda-21-cfr-part-11-compliance-guide\/#Secure_Electronic_Signatures\" >\u5b89\u5168\u7535\u5b50\u7b7e\u540d<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.jianpaitech.com\/zh\/blog\/choosing-a-tablet-coating-machine-the-ultimate-fda-21-cfr-part-11-compliance-guide\/#Data_Integrity_Retrieval\" >\u6570\u636e\u5b8c\u6574\u6027\u548c\u68c0\u7d22<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/www.jianpaitech.com\/zh\/blog\/choosing-a-tablet-coating-machine-the-ultimate-fda-21-cfr-part-11-compliance-guide\/#The_JianPai_Advantage_Compliant_Automated_Coating_Systems\" >\u5efa\u724c\u4f18\u52bf\uff1a\u5408\u89c4\u4e14\u81ea\u52a8\u5316\u7684\u6d82\u88c5\u7cfb\u7edf<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/www.jianpaitech.com\/zh\/blog\/choosing-a-tablet-coating-machine-the-ultimate-fda-21-cfr-part-11-compliance-guide\/#Conclusion\" >\u7ed3\u8bba<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/www.jianpaitech.com\/zh\/blog\/choosing-a-tablet-coating-machine-the-ultimate-fda-21-cfr-part-11-compliance-guide\/#Frequently_Asked_Questions_FAQ\" >\u5e38\u89c1\u95ee\u9898 (FAQ)<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"ng-star-inserted\"><span class=\"ez-toc-section\" id=\"What_Is_FDA_21_CFR_Part_11\"><\/span><span class=\"ng-star-inserted\">\u4ec0\u4e48\u662f FDA 21 CFR \u7b2c 11 \u90e8\u5206\uff1f<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u7b80\u800c\u8a00\u4e4b\uff0c\u00a0<\/span><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">21 CFR \u7b2c 11 \u90e8\u5206<\/span><\/strong><span class=\"ng-star-inserted\">\u00a0\u662f\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u7269\u7ba1\u7406\u5c40 (FDA) \u7684\u6cd5\u89c4\uff0c\u8be5\u6cd5\u89c4\u5236\u5b9a\u4e86\u7535\u5b50\u8bb0\u5f55\u548c\u7535\u5b50\u7b7e\u540d\u88ab\u8ba4\u4e3a\u503c\u5f97\u4fe1\u8d56\u3001\u53ef\u9760\u4e14\u901a\u5e38\u7b49\u540c\u4e8e\u7eb8\u8d28\u8bb0\u5f55\u7684\u6807\u51c6\u3002<\/span><\/p>\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u7b2c 11 \u90e8\u5206\u4e0d\u518d\u4f9d\u8d56\u5bb9\u6613\u4e22\u5931\u6216\u7be1\u6539\u7684\u7eb8\u8d28\u65e5\u5fd7\uff0c\u800c\u662f\u786e\u4fdd\u63a7\u5236\u5236\u836f\u673a\u68b0\u7684\u6570\u5b57\u7cfb\u7edf\u9ad8\u5ea6\u5b89\u5168\u3002\u5b83\u89c4\u5b9a\u4e86\u4e25\u683c\u7684\u53ef\u8ffd\u6eaf\u6027\u3001\u8bbf\u95ee\u63a7\u5236\u548c\u6570\u636e\u9a8c\u8bc1\u89c4\u5219\uff0c\u4ece\u800c\u5b9e\u73b0\u5236\u836f\u8fd0\u8425\u7684\u5b89\u5168\u6570\u5b57\u5316\u8f6c\u578b\u3002<\/span><\/p>\n<h2 class=\"ng-star-inserted\"><span class=\"ez-toc-section\" id=\"Why_Part_11_is_Critical_for_the_Tablet_Coating_Process\"><\/span><span class=\"ng-star-inserted\">\u4e3a\u4ec0\u4e48\u7b2c 11 \u90e8\u5206\u5bf9\u4e8e\u7247\u5242\u5305\u8863\u5de5\u827a\u81f3\u5173\u91cd\u8981<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u4e0e\u66f4\u7b80\u5355\u7684\u5236\u9020\u6b65\u9aa4\u4e0d\u540c\uff0c\u00a0<\/span><a href=\"https:\/\/www.jianpaitech.com\/zh\/product_category\/tablet-coating\/\" target=\"_blank\" rel=\"noopener\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u5e73\u677f\u7535\u8111\u6d82\u6599<\/span><\/strong><\/a><span class=\"ng-star-inserted\">\u00a0\u662f\u4e00\u4e2a\u9ad8\u5ea6\u590d\u6742\u7684\u70ed\u529b\u5b66\u8fc7\u7a0b\u3002\u8584\u819c\u8863\u6216\u80a0\u6eb6\u7247\u7684\u8d28\u91cf\u5b8c\u5168\u53d6\u51b3\u4e8e\u7cbe\u786e\u7684\u5b9e\u65f6\u53c2\u6570\uff0c\u5305\u62ec\uff1a<\/span><\/p>\n<ul class=\"ng-star-inserted\">\n<li class=\"ng-star-inserted\">\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u8fdb\u6c14\u548c\u6392\u6c14\u6e29\u5ea6<\/span><\/p>\n<\/li>\n<li class=\"ng-star-inserted\">\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u96fe\u5316\u538b\u529b\u548c\u55b7\u96fe\u901f\u7387<\/span><\/p>\n<\/li>\n<li class=\"ng-star-inserted\">\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u5305\u8863\u9505\uff08\u6eda\u7b52\uff09\u901f\u5ea6<\/span><\/p>\n<\/li>\n<li class=\"ng-star-inserted\">\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u60ac\u6d6e\u6db2\u8f93\u9001<\/span><\/p>\n<\/li>\n<\/ul>\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u5982\u679c\u672a\u7ecf\u6388\u6743\u7684\u64cd\u4f5c\u5458\u5728\u6279\u6b21\u4e2d\u610f\u5916\u6539\u53d8\u55b7\u96fe\u901f\u7387\uff0c\u6216\u8005\u4ece\u7cfb\u7edf\u4e2d\u5220\u9664\u6e29\u5ea6\u8b66\u62a5\uff0c\u5219\u53ef\u80fd\u4f1a\u5bfc\u81f4\u4e25\u91cd\u7684\u6279\u6b21\u5931\u8d25\u6216\u76d1\u7ba1\u5904\u7f5a\u3002\u4e00\u4e2a\u00a0<\/span><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u7b26\u5408 21 CFR Part 11 \u6807\u51c6\u7684\u7247\u5242\u5305\u8863\u673a<\/span><\/strong><span class=\"ng-star-inserted\">\u00a0\u786e\u4fdd\u6c38\u4e45\u8bb0\u5f55\u6bcf\u4e00\u4e2a\u53c2\u6570\u53d8\u5316\u3001\u8b66\u62a5\u548c\u914d\u65b9\u8c03\u6574\uff0c\u4ece\u800c\u786e\u4fdd\u60a8\u7684\u4ea7\u54c1\u8d28\u91cf\u548c\u516c\u53f8\u58f0\u8a89\u3002<\/span><\/p>\n<h2 class=\"ng-star-inserted\"><span class=\"ez-toc-section\" id=\"4_Core_Part_11_Features_to_Look_for_in_a_Tablet_Coater\"><\/span><span class=\"ng-star-inserted\">\u7247\u5242\u5305\u8863\u673a\u9700\u8981\u5177\u5907\u7684\u7b2c 11 \u90e8\u5206\u7684 4 \u4e2a\u6838\u5fc3\u529f\u80fd<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u5728\u8bc4\u4f30\u836f\u7269\u5305\u8863\u7cfb\u7edf\u65f6\uff0c\u4e0d\u8981\u53ea\u8be2\u95ee\u4f9b\u5e94\u5546\u4ed6\u4eec\u7684\u8f6f\u4ef6\u662f\u5426\u201c\u5408\u89c4\u201d\u3002\u786e\u4fdd\u4ed6\u4eec\u7684 PLC\/HMI \u7cfb\u7edf\u5177\u6709\u4ee5\u4e0b\u56db\u4e2a\u6838\u5fc3\u529f\u80fd\uff1a<\/span><\/p>\n<h3 class=\"ng-star-inserted\"><span class=\"ez-toc-section\" id=\"Strict_Audit_Trails\"><\/span><span class=\"ng-star-inserted\">\u4e25\u683c\u7684\u5ba1\u8ba1\u8ffd\u8e2a<\/span><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u5ba1\u8ba1\u8ddf\u8e2a\u662f\u6570\u636e\u5b8c\u6574\u6027\u7684\u652f\u67f1\u3002\u60a8\u7684\u6d82\u5c42\u673a\u5fc5\u987b\u81ea\u52a8\u751f\u6210\u6240\u6709\u64cd\u4f5c\u5458\u64cd\u4f5c\u7684\u5b89\u5168\u7684\u3001\u8ba1\u7b97\u673a\u751f\u6210\u7684\u3001\u5e26\u65f6\u95f4\u6233\u7684\u8bb0\u5f55\u3002\u5982\u679c\u6709\u4eba\u5c06\u5165\u53e3\u6e29\u5ea6\u4ece 60\u00b0C \u66f4\u6539\u4e3a 65\u00b0C\uff0c\u7cfb\u7edf\u5fc5\u987b\u8bb0\u5f55\u00a0<\/span><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">WHO<\/span><\/strong><span class=\"ng-star-inserted\">\u00a0\u505a\u5230\u4e86\uff0c\u00a0<\/span><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u4ec0\u4e48\u65f6\u5019<\/span><\/strong><span class=\"ng-star-inserted\">\u00a0\u4e8b\u60c5\u53d1\u751f\u4e86\uff0c\u00a0<\/span><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u65e7\u503c<\/span><\/strong><span class=\"ng-star-inserted\">\uff0c \u8fd9\u00a0<\/span><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u65b0\u4ef7\u503c<\/span><\/strong><span class=\"ng-star-inserted\">\uff0c\u4ee5\u53ca\u00a0<\/span><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u539f\u56e0<\/span><\/strong><span class=\"ng-star-inserted\">\u00a0\u4e3a\u4e86\u6539\u53d8\u3002\u8fd9\u4e9b\u65e5\u5fd7\u5fc5\u987b\u662f\u4e0d\u53ef\u7f16\u8f91\u7684\u3002<\/span><\/p>\n<h3 class=\"ng-star-inserted\"><span class=\"ez-toc-section\" id=\"Role-Based_Access_Control_RBAC\"><\/span><span class=\"ng-star-inserted\">\u57fa\u4e8e\u89d2\u8272\u7684\u8bbf\u95ee\u63a7\u5236 (RBAC)<\/span><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u5408\u89c4\u7684\u6d82\u5e03\u673a\u5fc5\u987b\u9632\u6b62\u672a\u7ecf\u6388\u6743\u7684\u8bbf\u95ee\u3002\u8be5\u8f6f\u4ef6\u5e94\u8be5\u5141\u8bb8\u60a8\u5206\u914d\u4e0d\u540c\u7684\u6743\u9650\u7ea7\u522b\u3002\u4f8b\u5982\uff1a<\/span><\/p>\n<ul class=\"ng-star-inserted\">\n<li class=\"ng-star-inserted\">\n<p class=\"ng-star-inserted\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u8fd0\u8425\u5546\uff1a<\/span><\/strong><span class=\"ng-star-inserted\">\u00a0\u53ea\u80fd\u542f\u52a8\/\u505c\u6b62\u6279\u6b21\u5e76\u786e\u8ba4\u8b66\u62a5\u3002<\/span><\/p>\n<\/li>\n<li class=\"ng-star-inserted\">\n<p class=\"ng-star-inserted\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u76d1\u4e8b\uff1a<\/span><\/strong><span class=\"ng-star-inserted\">\u00a0\u53ef\u4ee5\u7f16\u8f91\u548c\u6279\u51c6\u6d82\u5c42\u914d\u65b9\u3002<\/span><\/p>\n<\/li>\n<li class=\"ng-star-inserted\">\n<p class=\"ng-star-inserted\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u7ba1\u7406\u5458\/IT\uff1a<\/span><\/strong><span class=\"ng-star-inserted\">\u00a0\u53ef\u4ee5\u7ba1\u7406\u7528\u6237\u5e10\u6237\u548c\u7cfb\u7edf\u914d\u7f6e\u3002<\/span><br class=\"ng-star-inserted\" \/><span class=\"ng-star-inserted\">\u5171\u4eab\u5bc6\u7801\u5e94\u8be5\u53d7\u5230\u7cfb\u7edf\u67b6\u6784\u7684\u7269\u7406\u9650\u5236\u3002<\/span><\/p>\n<\/li>\n<\/ul>\n<h3 class=\"ng-star-inserted\"><span class=\"ez-toc-section\" id=\"Secure_Electronic_Signatures\"><\/span><span class=\"ng-star-inserted\">\u5b89\u5168\u7535\u5b50\u7b7e\u540d<\/span><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u5f53\u53d1\u751f\u5173\u952e\u64cd\u4f5c\u65f6\uff08\u4f8b\u5982\u6279\u51c6\u65b0\u7684\u6d82\u5c42\u914d\u65b9\u6216\u53d1\u5e03\u6279\u6b21\u62a5\u544a\uff09\uff0c\u7cfb\u7edf\u5fc5\u987b\u8981\u6c42\u7535\u5b50\u7b7e\u540d\u3002\u6839\u636e\u7b2c 11 \u90e8\u5206\uff0c\u6b64\u7b7e\u540d\u5fc5\u987b\u7531\u81f3\u5c11\u4e24\u4e2a\u4e0d\u540c\u7684\u7ec4\u6210\u90e8\u5206\uff08\u4f8b\u5982\uff0c\u552f\u4e00 ID \u548c\u79c1\u4eba\u5bc6\u7801\uff09\u7ec4\u6210\uff0c\u5e76\u6c38\u4e45\u94fe\u63a5\u5230\u76f8\u5e94\u7684\u7535\u5b50\u8bb0\u5f55\u3002<\/span><\/p>\n<h3 class=\"ng-star-inserted\"><span class=\"ez-toc-section\" id=\"Data_Integrity_Retrieval\"><\/span><span class=\"ng-star-inserted\">\u6570\u636e\u5b8c\u6574\u6027\u548c\u68c0\u7d22<\/span><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u6d82\u5c42\u8fc7\u7a0b\u4e2d\u751f\u6210\u7684\u6240\u6709\u6279\u6b21\u62a5\u544a\u3001\u8b66\u62a5\u65e5\u5fd7\u548c\u5ba1\u8ba1\u8ddf\u8e2a\u5fc5\u987b\u5b89\u5168\u5b58\u50a8\u3002\u8be5\u673a\u5668\u5e94\u63d0\u4f9b\u81ea\u52a8\u6570\u636e\u5907\u4efd\u89e3\u51b3\u65b9\u6848\uff08\u4f8b\u5982\uff0c\u5c06\u52a0\u5bc6\u7684 PDF \u5bfc\u51fa\u5230\u5b89\u5168\u7684\u5de5\u5382\u670d\u52a1\u5668\uff09\u5e76\u4fdd\u8bc1\u8bb0\u5f55\u5728\u6574\u4e2a\u4fdd\u7559\u671f\u5185\u4fdd\u6301\u53ef\u8bfb\u548c\u53ef\u68c0\u7d22\u3002<\/span><\/p>\n<h2 class=\"ng-star-inserted\"><span class=\"ez-toc-section\" id=\"The_JianPai_Advantage_Compliant_Automated_Coating_Systems\"><\/span><span class=\"ng-star-inserted\">\u5efa\u724c\u4f18\u52bf\uff1a\u5408\u89c4\u4e14\u81ea\u52a8\u5316\u7684\u6d82\u88c5\u7cfb\u7edf<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u9009\u62e9\u80fd\u591f\u5c06\u5353\u8d8a\u7684\u673a\u68b0\u6027\u80fd\u4e0e\u5148\u8fdb\u7684\u8f6f\u4ef6\u5408\u89c4\u6027\u65e0\u7f1d\u8fde\u63a5\u8d77\u6765\u7684\u8bbe\u5907\u81f3\u5173\u91cd\u8981\u3002\u6210\u7acb\u4e8e1997\u5e74\uff0c\u00a0<\/span><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u667a\u683c\u6c5f\u6280\u672f\u6709\u9650\u516c\u53f8<\/span><\/strong><span class=\"ng-star-inserted\">\u00a0\u662f\u5168\u7403\u516c\u8ba4\u7684\u201c\u4e2d\u56fd\u5236\u836f\u88c5\u5907\u5236\u9020\u5546\u5341\u5f3a\u201d\uff0c\u4e13\u6ce8\u4e8e\u4e2d\u9ad8\u7aefOSD\u89e3\u51b3\u65b9\u6848\u3002<\/span><\/p>\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u6211\u4eec\u7684\u65d7\u8230\u00a0<\/span><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u4f18\u8d28\u7247\u5242\u5305\u8863\u673a<\/span><\/strong><span class=\"ng-star-inserted\">\u00a0\u4e13\u4e3a\u9ad8\u5ea6\u76d1\u7ba1\u7684\u5e02\u573a\uff08FDA\/EU-GMP\uff09\u800c\u8bbe\u8ba1\u3002<\/span><\/p>\n<ul class=\"ng-star-inserted\">\n<li class=\"ng-star-inserted\">\n<p class=\"ng-star-inserted\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u7ecf\u9a8c\u8bc1\u7684\u63a7\u5236\u7cfb\u7edf\uff1a<\/span><\/strong><span class=\"ng-star-inserted\">\u00a0\u6211\u4eec\u5148\u8fdb\u7684 PLC\/HMI \u67b6\u6784\u5b8c\u5168\u7b26\u5408 21 CFR Part 11 \u6807\u51c6\uff0c\u5177\u6709\u5f3a\u5927\u7684\u5ba1\u8ba1\u8ddf\u8e2a\u3001\u591a\u7ea7\u5bc6\u7801\u4fdd\u62a4\u548c\u81ea\u52a8\u6279\u91cf\u62a5\u544a\u529f\u80fd\u3002<\/span><\/p>\n<\/li>\n<li class=\"ng-star-inserted\">\n<p class=\"ng-star-inserted\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u6570\u636e\u5b8c\u6574\u6027\u7684\u6838\u5fc3\uff1a<\/span><\/strong><span class=\"ng-star-inserted\">\u00a0\u6211\u4eec\u901a\u8fc7\u5b89\u5168\u7684\u5bfc\u51fa\u529f\u80fd\u786e\u4fdd\u96f6\u6570\u636e\u4e22\u5931\uff0c\u4f7f\u60a8\u7684\u4e0b\u4e00\u6b21\u76d1\u7ba1\u5ba1\u6838\u987a\u5229\u4e14\u65e0\u538b\u529b\u3002<\/span><\/p>\n<\/li>\n<\/ul>\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u6b64\u5916\uff0c\u5065\u724c\u8fd8\u4e3a\u56fa\u4f53\u5236\u5242\u5236\u9020\u63d0\u4f9b\u4e86\u5b8c\u6574\u7684\u751f\u6001\u7cfb\u7edf\u3002\u901a\u8fc7\u6574\u5408\u6211\u4eec\u7684\u5408\u89c4\u00a0<\/span><a href=\"https:\/\/www.jianpaitech.com\/zh\/product_category\/high-shear-mixer\/\" target=\"_blank\" rel=\"noopener\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u9ad8\u526a\u5207\u6df7\u5408\u5668<\/span><\/strong><\/a><span class=\"ng-star-inserted\">\u00a0\u548c\u00a0<\/span><a href=\"https:\/\/www.jianpaitech.com\/zh\/product_category\/fluid-bed-dryer\/\" target=\"_blank\" rel=\"noopener\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u6d41\u5316\u5e8a\u5e72\u71e5\u673a<\/span><\/strong><\/a><span class=\"ng-star-inserted\">\u00a0\u501f\u52a9\u6211\u4eec\u7684\u5305\u8863\u673a\uff0c\u60a8\u53ef\u4ee5\u786e\u4fdd\u6574\u4e2a\u9020\u7c92\u548c\u5305\u8863\u751f\u4ea7\u7ebf\u7684\u7aef\u5230\u7aef\u6570\u636e\u5b8c\u6574\u6027\u3002<\/span><\/p>\n<h2 class=\"ng-star-inserted\"><span class=\"ez-toc-section\" id=\"Conclusion\"><\/span><span class=\"ng-star-inserted\">\u7ed3\u8bba<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u7406\u89e3\u548c\u5b9e\u65bd FDA 21 CFR Part 11 \u4e0d\u4ec5\u4ec5\u662f\u4e3a\u4e86\u907f\u514d\u76d1\u7ba1\u7f5a\u6b3e\uff1b\u5b83\u662f\u5173\u4e8e\u6784\u5efa\u66f4\u667a\u80fd\u3001\u66f4\u5b89\u5168\u3001\u66f4\u9ad8\u6548\u7684\u5236\u9020\u6d41\u7a0b\u3002\u901a\u8fc7\u6295\u8d44\u5b8c\u5168\u5408\u89c4\u7684\u7247\u5242\u5305\u8863\u673a\uff0c\u60a8\u53ef\u4ee5\u4fdd\u62a4\u60a8\u7684\u6570\u636e\u3001\u4ea7\u54c1\u8d28\u91cf\u548c\u60a3\u8005\u3002<\/span><\/p>\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u51c6\u5907\u597d\u5347\u7ea7\u60a8\u7684\u836f\u7269\u5305\u8863\u64cd\u4f5c\u4e86\u5417\uff1f\u00a0<\/span><a class=\"ng-star-inserted\" href=\"https:\/\/www.jianpaitech.com\/zh\/product_category\/tablet-coating\/\" target=\"_blank\" rel=\"noopener\"><span class=\"ng-star-inserted\">\u63a2\u7d22\u5065\u6d3e\u79d1\u6280\u5148\u8fdb\u7684\u7247\u5242\u5305\u8863\u89e3\u51b3\u65b9\u6848<\/span><\/a><span class=\"ng-star-inserted\">\u00a0\u5efa\u8bbe\u8d85\u8d8a\u5168\u7403GMP\u9884\u671f\u7684\u751f\u4ea7\u7ebf\u3002<\/span><\/p>\n<h2 class=\"ng-star-inserted\"><span class=\"ez-toc-section\" id=\"Frequently_Asked_Questions_FAQ\"><\/span><span class=\"ng-star-inserted\">\u5e38\u89c1\u95ee\u9898 (FAQ)<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p class=\"ng-star-inserted\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">1. 21 CFR Part 11 \u662f\u5426\u5bf9\u6240\u6709\u7247\u5242\u5305\u8863\u673a\u5f3a\u5236\u6267\u884c\uff1f<\/span><\/strong><br class=\"ng-star-inserted\" \/><span class=\"ng-star-inserted\">\u662f\u7684\uff0c\u5982\u679c\u60a8\u7684\u5236\u836f\u5382\u4f7f\u7528\u7535\u5b50\u7cfb\u7edf\u6765\u521b\u5efa\u3001\u4fee\u6539\u3001\u7ef4\u62a4\u6216\u4f20\u8f93 FDA \u8981\u6c42\u7684\u8bb0\u5f55\uff0c\u5219\u673a\u5668\u7684\u63a7\u5236\u7cfb\u7edf\u5fc5\u987b\u7b26\u5408\u7b2c 11 \u90e8\u5206\u7684\u89c4\u5b9a\u3002<\/span><\/p>\n<p class=\"ng-star-inserted\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">2. \u65e7\u7684\u3001\u4e0d\u5408\u89c4\u7684\u6d82\u5e03\u673a\u53ef\u4ee5\u5347\u7ea7\u5417\uff1f<\/span><\/strong><br class=\"ng-star-inserted\" \/><span class=\"ng-star-inserted\">\u5728\u5f88\u591a\u60c5\u51b5\u4e0b\uff0c\u662f\u7684\u3002\u867d\u7136\u53ef\u80fd\u6ca1\u6709\u5fc5\u8981\u5347\u7ea7\u673a\u68b0\u7ec4\u4ef6\uff0c\u4f46\u63a7\u5236\u9762\u677f\uff08PLC\/HMI \u8f6f\u4ef6\uff09\u901a\u5e38\u53ef\u4ee5\u7531\u5efa\u6d3e\u79d1\u6280\u7b49\u4e13\u4e1a\u5236\u9020\u5546\u8fdb\u884c\u6539\u88c5\uff0c\u4ee5\u6ee1\u8db3 21 CFR Part 11 \u7684\u8981\u6c42\u3002<\/span><\/p>\n<p class=\"ng-star-inserted\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">3. \u7b2c 11 \u90e8\u5206\u5408\u89c4\u6027\u5728 FDA \u68c0\u67e5\u671f\u95f4\u6709\u4f55\u5e2e\u52a9\uff1f<\/span><\/strong><br class=\"ng-star-inserted\" \/><span class=\"ng-star-inserted\">\u5408\u89c4\u7cfb\u7edf\u5177\u6709\u4e0d\u53ef\u7f16\u8f91\u7684\u5ba1\u8ba1\u8ddf\u8e2a\u548c\u5b89\u5168\u7684\u7535\u5b50\u7b7e\u540d\u3002\u5f53\u68c0\u67e5\u5458\u8981\u6c42\u67e5\u770b\u7279\u5b9a\u7247\u5242\u5305\u8863\u8fd0\u884c\u7684\u6279\u6b21\u5386\u53f2\u8bb0\u5f55\u65f6\uff0c\u60a8\u53ef\u4ee5\u7acb\u5373\u68c0\u7d22\u51c6\u786e\u3001\u9632\u7be1\u6539\u7684\u6570\u5b57\u62a5\u544a\uff0c\u5c55\u793a\u5bf9\u5236\u9020\u8fc7\u7a0b\u7684\u5b8c\u5168\u63a7\u5236\u3002<\/span><\/p>","protected":false},"excerpt":{"rendered":"<p>\u5728\u73b0\u4ee3\u5236\u836f\u5236\u9020\u4e2d\uff0c\u8d2d\u4e70\u7247\u5242\u5305\u8863\u673a\u4e0d\u518d\u4ec5\u4ec5\u8003\u8651\u673a\u68b0\u6027\u80fd\u3001\u4e0d\u9508\u94a2\u7b49\u7ea7\u6216\u55b7\u67aa\u7cbe\u5ea6\u3002\u5bf9\u4e8e\u7784\u51c6\u6b27\u6d32\u548c\u5317\u7f8e\u5e02\u573a\u7684\u53e3\u670d\u56fa\u4f53\u5236\u5242 (OSD) \u5236\u9020\u5546\u6765\u8bf4\uff0c\u8fd0\u884c\u673a\u5668\u7684\u8f6f\u4ef6\u540c\u6837\u91cd\u8981\uff0c\u751a\u81f3\u66f4\u91cd\u8981\u3002\u5982\u679c\u6d82\u5c42\u7cfb\u7edf\u4e0d\u80fd\u4fdd\u8bc1\u7edd\u5bf9\u7684\u6570\u636e\u5b8c\u6574\u6027\uff0c\u5b83[...]<\/p>","protected":false},"featured_media":5193,"template":"","meta":{"_acf_changed":false,"footnotes":""},"blog_category":[16],"class_list":["post-5192","blog","type-blog","status-publish","has-post-thumbnail","hentry","blog_category-industry-news"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.jianpaitech.com\/zh\/wp-json\/wp\/v2\/blog\/5192","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.jianpaitech.com\/zh\/wp-json\/wp\/v2\/blog"}],"about":[{"href":"https:\/\/www.jianpaitech.com\/zh\/wp-json\/wp\/v2\/types\/blog"}],"version-history":[{"count":1,"href":"https:\/\/www.jianpaitech.com\/zh\/wp-json\/wp\/v2\/blog\/5192\/revisions"}],"predecessor-version":[{"id":5194,"href":"https:\/\/www.jianpaitech.com\/zh\/wp-json\/wp\/v2\/blog\/5192\/revisions\/5194"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.jianpaitech.com\/zh\/wp-json\/wp\/v2\/media\/5193"}],"wp:attachment":[{"href":"https:\/\/www.jianpaitech.com\/zh\/wp-json\/wp\/v2\/media?parent=5192"}],"wp:term":[{"taxonomy":"blog_category","embeddable":true,"href":"https:\/\/www.jianpaitech.com\/zh\/wp-json\/wp\/v2\/blog_category?post=5192"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}