{"id":3833,"date":"2025-08-18T19:53:45","date_gmt":"2025-08-18T12:53:45","guid":{"rendered":"http:\/\/biogroupvietnam-worldpress.local\/product\/import-placeholder-for-135\/"},"modified":"2025-12-17T14:34:27","modified_gmt":"2025-12-17T07:34:27","slug":"adamii-cdx","status":"publish","type":"product","link":"https:\/\/biogroupvietnam.com\/vi\/san-pham\/adamii-cdx\/","title":{"rendered":"M\u00e1y Ph\u00e2n T\u00edch T\u1ebf B\u00e0o Mi\u1ec5n D\u1ecbch ADAMII\u2122-CDx"},"content":{"rendered":"<h3><strong>ADAMII\u2122 CDx \u2013 Gi\u1ea3i ph\u00e1p ki\u1ec3m so\u00e1t ch\u1ea5t l\u01b0\u1ee3ng to\u00e0n di\u1ec7n cho li\u1ec7u ph\u00e1p t\u1ebf b\u00e0o mi\u1ec5n d\u1ecbch<\/strong><\/h3>\n<h4><strong>T\u1ed5ng quan m\u00e1y ADAMII\u2122 CDx ph\u00e2n t\u00edch t\u1ebf b\u00e0o mi\u1ec5n d\u1ecbch<\/strong><\/h4>\n<p><strong>ADAMII\u2122 CDx<\/strong> l\u00e0 thi\u1ebft b\u1ecb <strong>ph\u00e2n t\u00edch mi\u1ec5n d\u1ecbch hu\u1ef3nh quang d\u1ef1a tr\u00ean h\u00ecnh \u1ea3nh (image-based immunophenotyping)<\/strong> do <strong>NanoEntek (H\u00e0n Qu\u1ed1c)<\/strong> ph\u00e1t tri\u1ec3n, \u0111\u01b0\u1ee3c thi\u1ebft k\u1ebf chuy\u00ean bi\u1ec7t cho <strong>ki\u1ec3m so\u00e1t ch\u1ea5t l\u01b0\u1ee3ng (QC) trong s\u1ea3n xu\u1ea5t v\u00e0 nghi\u00ean c\u1ee9u li\u1ec7u ph\u00e1p t\u1ebf b\u00e0o<\/strong>.<br \/>\nThi\u1ebft b\u1ecb n\u00e0y gi\u00fap c\u00e1c ph\u00f2ng lab v\u00e0 c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t <strong>\u0111\u1ecbnh danh, \u0111\u1ebfm tuy\u1ec7t \u0111\u1ed1i v\u00e0 ph\u00e2n t\u00edch t\u1ec9 l\u1ec7 c\u00e1c qu\u1ea7n th\u1ec3 t\u1ebf b\u00e0o mi\u1ec5n d\u1ecbch<\/strong> (T cell, NK cell, B cell, Monocyte) m\u1ed9t c\u00e1ch <strong>ch\u00ednh x\u00e1c, nhanh ch\u00f3ng v\u00e0 d\u1ec5 v\u1eadn h\u00e0nh<\/strong><\/p>\n<h4><strong>T\u00ednh n\u0103ng n\u1ed5i b\u1eadt c\u1ee7a m\u00e1y ADAMII\u2122 CDx<\/strong><\/h4>\n<ul>\n<li><strong>\u0110\u1ebfm tuy\u1ec7t \u0111\u1ed1i t\u1ebf b\u00e0o d\u01b0\u01a1ng t\u00ednh v\u1edbi CD marker<\/strong> (Absolute CD marker positive cell counting)<\/li>\n<li><strong>H\u1ed7 tr\u1ee3 nhi\u1ec1u panel CD marker kh\u00e1c nhau<\/strong>: T cell (CD4\/CD8\/CD3), NK cell (CD3\/CD56&amp;16\/CD45), B cell (CD3\/CD19\/CD45), Monocyte (CD3\/CD14\/CD45)<\/li>\n<li><strong>Ph\u00e2n t\u00edch t\u1ed5ng s\u1ed1 t\u1ebf b\u00e0o, t\u1ef7 l\u1ec7 s\u1ed1ng\/ch\u1ebft, k\u00edch th\u01b0\u1edbc t\u1ebf b\u00e0o, \u0111\u01b0\u1eddng cong t\u0103ng tr\u01b0\u1edfng<\/strong><\/li>\n<li><strong>\u0110o v\u00e0 \u0111\u1ecbnh l\u01b0\u1ee3ng apoptosis (ch\u1ebft t\u1ebf b\u00e0o theo ch\u01b0\u01a1ng tr\u00ecnh)<\/strong><\/li>\n<li><strong>D\u1ec5 d\u00e0ng s\u1eed d\u1ee5ng, thao t\u00e1c \u0111\u01a1n gi\u1ea3n<\/strong>, ph\u00f9 h\u1ee3p c\u1ea3 v\u1edbi ng\u01b0\u1eddi kh\u00f4ng chuy\u00ean v\u1ec1 flow cytometry<\/li>\n<li><strong>T\u01b0\u01a1ng quan cao v\u1edbi k\u1ebft qu\u1ea3 flow cytometry<\/strong> \u2013 R\u00b2 &gt; 0.98 \u1edf t\u1ea5t c\u1ea3 c\u00e1c panel<\/li>\n<li><strong>Tu\u00e2n th\u1ee7 21 CFR Part 11<\/strong>: ki\u1ec3m so\u00e1t truy c\u1eadp, nh\u1eadt k\u00fd ho\u1ea1t \u0111\u1ed9ng v\u00e0 ch\u1eef k\u00fd \u0111i\u1ec7n t\u1eed \u0111\u00e1p \u1ee9ng y\u00eau c\u1ea7u GMP \/ GLP.<\/li>\n<\/ul>\n<h4><strong>\u1ee8ng d\u1ee5ng c\u1ee7a m\u00e1y ADAMII\u2122 CDx trong s\u1ea3n xu\u1ea5t li\u1ec7u ph\u00e1p t\u1ebf b\u00e0o<\/strong><\/h4>\n<p>ADAMII\u2122 CDx \u0111\u01b0\u1ee3c \u1ee9ng d\u1ee5ng \u1edf nhi\u1ec1u giai \u0111o\u1ea1n trong quy tr\u00ecnh ph\u00e1t tri\u1ec3n v\u00e0 s\u1ea3n xu\u1ea5t t\u1ebf b\u00e0o mi\u1ec5n d\u1ecbch:<br \/>\n<strong>Leukapheresis \u2192 Isolation \u2192 Gene transfer \u2192 Cell expansion \u2192 Harvest \u2192 Formulation \u2192 Product QC<\/strong>.<\/p>\n<p>C\u1ee5 th\u1ec3:<\/p>\n<ul>\n<li><strong>R&amp;D<\/strong>: \u0110\u1ecbnh danh v\u00e0 \u0111\u1ecbnh l\u01b0\u1ee3ng t\u1ebf b\u00e0o trong qu\u00e1 tr\u00ecnh nghi\u00ean c\u1ee9u li\u1ec7u ph\u00e1p mi\u1ec5n d\u1ecbch (CAR-T, NK, TCR-T\u2026).<\/li>\n<li><strong>QC s\u1ea3n xu\u1ea5t<\/strong>: Ki\u1ec3m tra \u0111\u1eb7c t\u00ednh t\u1ebf b\u00e0o sau khi nu\u00f4i c\u1ea5y, chuy\u1ec3n n\u1ea1p gen ho\u1eb7c thu ho\u1ea1ch.<\/li>\n<li><strong>Ki\u1ec3m tra an to\u00e0n sinh h\u1ecdc<\/strong>: Theo d\u00f5i t\u00ecnh tr\u1ea1ng s\u1ed1ng\/ch\u1ebft c\u1ee7a t\u1ebf b\u00e0o tr\u01b0\u1edbc khi \u0111\u01b0a v\u00e0o \u1ee9ng d\u1ee5ng l\u00e2m s\u00e0ng ho\u1eb7c l\u01b0u tr\u1eef.<\/li>\n<\/ul>\n<h4><strong>Hi\u1ec7u n\u0103ng v\u00e0 \u0111\u1ed9 ch\u00ednh x\u00e1c v\u01b0\u1ee3t tr\u1ed9i m\u00e1y ADAMII\u2122 CDx<\/strong><\/h4>\n<p>Theo d\u1eef li\u1ec7u th\u1eed nghi\u1ec7m, ADAMII\u2122 CDx th\u1ec3 hi\u1ec7n <strong>m\u1ee9c \u0111\u1ed9 t\u01b0\u01a1ng quan g\u1ea7n nh\u01b0 tuy\u1ec7t \u0111\u1ed1i v\u1edbi flow cytometer<\/strong> (R\u00b2 &gt; 0.98) khi so s\u00e1nh c\u00e1c marker nh\u01b0 CD3, CD4, CD8, CD19, CD14, CD56\/16 v\u00e0 CD45.<br \/>\nNh\u1edd s\u1eed d\u1ee5ng <strong>h\u1ec7 th\u1ed1ng LED \u0111a k\u00eanh (UV, Green)<\/strong> v\u00e0 <strong>\u1ed1ng k\u00ednh 10x \u0111\u1ed9 ph\u00e2n gi\u1ea3i cao<\/strong>, thi\u1ebft b\u1ecb mang l\u1ea1i k\u1ebft qu\u1ea3 \u1ed5n \u0111\u1ecbnh, t\u00e1i l\u1eadp v\u00e0 ph\u00f9 h\u1ee3p cho c\u00e1c y\u00eau c\u1ea7u <strong>QC tu\u00e2n th\u1ee7 GMP<\/strong><\/p>\n<h4><strong>\u0110\u1ebfm t\u1ebf b\u00e0o &amp; Ph\u00e2n t\u00edch Apoptosis ch\u00ednh x\u00e1c<\/strong><\/h4>\n<p>ADAMII\u2122 CDx kh\u00f4ng ch\u1ec9 \u0111\u1ebfm t\u1ed5ng s\u1ed1 t\u1ebf b\u00e0o m\u00e0 c\u00f2n x\u00e1c \u0111\u1ecbnh \u0111\u01b0\u1ee3c <strong>giai \u0111o\u1ea1n s\u1edbm \u2013 mu\u1ed9n c\u1ee7a apoptosis v\u00e0 necrosis<\/strong>.<br \/>\nK\u1ebft qu\u1ea3 ki\u1ec3m ch\u1ee9ng v\u1edbi t\u1ebf b\u00e0o Jurkat x\u1eed l\u00fd camptothecin cho th\u1ea5y <strong>sai s\u1ed1 nh\u1ecf h\u01a1n 2% so v\u1edbi FACS<\/strong>, gi\u00fap c\u00e1c ph\u00f2ng lab d\u1ec5 d\u00e0ng ki\u1ec3m tra s\u1ee9c kh\u1ecfe v\u00e0 \u0111\u1ed9 \u1ed5n \u0111\u1ecbnh c\u1ee7a m\u1eabu t\u1ebf b\u00e0o<\/p>\n<h4><strong>Tu\u00e2n th\u1ee7 21 CFR Part 11 \u2013 \u0110\u00e1p \u1ee9ng chu\u1ea9n GMP qu\u1ed1c t\u1ebf<\/strong><\/h4>\n<p>ADAMII\u2122 CDx \u0111\u01b0\u1ee3c thi\u1ebft k\u1ebf <strong>ph\u00f9 h\u1ee3p v\u1edbi quy tr\u00ecnh qu\u1ea3n l\u00fd d\u1eef li\u1ec7u \u0111i\u1ec7n t\u1eed theo chu\u1ea9n 21 CFR Part 11<\/strong>, \u0111\u1ea3m b\u1ea3o:<\/p>\n<ul>\n<li>Ghi nh\u1eadn to\u00e0n b\u1ed9 l\u1ecbch s\u1eed thao t\u00e1c ng\u01b0\u1eddi d\u00f9ng (audit trail)<\/li>\n<li>Ch\u1ec9 cho ph\u00e9p ng\u01b0\u1eddi \u0111\u01b0\u1ee3c ph\u00e2n quy\u1ec1n ch\u1ec9nh s\u1eeda d\u1eef li\u1ec7u<\/li>\n<li>Hi\u1ec3n th\u1ecb ng\u00e0y, gi\u1edd v\u00e0 chi ti\u1ebft thao t\u00e1c c\u1ee5 th\u1ec3<br \/>\n\u0110i\u1ec1u n\u00e0y \u0111\u1eb7c bi\u1ec7t quan tr\u1ecdng \u0111\u1ed1i v\u1edbi c\u00e1c ph\u00f2ng lab <strong>\u0111\u1ea1t chu\u1ea9n GMP, GLP, ISO 17025<\/strong>.<\/li>\n<\/ul>\n<h4><strong>Th\u00f4ng s\u1ed1 k\u1ef9 thu\u1eadt ch\u00ednh c\u1ee7a m\u00e1y ADAMII\u2122 CDx<\/strong><\/h4>\n<table>\n<thead>\n<tr>\n<td><strong>Th\u00f4ng s\u1ed1<\/strong><\/td>\n<td><strong>Gi\u00e1 tr\u1ecb<\/strong><\/td>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>K\u00eanh quan s\u00e1t<\/td>\n<td>Bright field, BV510 (405 nm), PE (525 nm), PerCP (525 nm)<\/td>\n<\/tr>\n<tr>\n<td>\u0110\u1ed9 ph\u00f3ng \u0111\u1ea1i<\/td>\n<td>10x<\/td>\n<\/tr>\n<tr>\n<td>Th\u1ec3 t\u00edch \u0111o<\/td>\n<td>\u2264 7.8 \u03bcL<\/td>\n<\/tr>\n<tr>\n<td>Kho\u1ea3ng n\u1ed3ng \u0111\u1ed9 \u0111o<\/td>\n<td>5\u00d710\u2074 \u2013 5\u00d710\u2076 cells\/mL<\/td>\n<\/tr>\n<tr>\n<td>Th\u1eddi gian ph\u00e2n t\u00edch<\/td>\n<td>4 ph\u00fat 20 gi\u00e2y \/ m\u1eabu<\/td>\n<\/tr>\n<tr>\n<td>K\u00edch th\u01b0\u1edbc m\u00e1y<\/td>\n<td>300 \u00d7 420 \u00d7 370 mm<\/td>\n<\/tr>\n<tr>\n<td>Tr\u1ecdng l\u01b0\u1ee3ng<\/td>\n<td>19.3 kg<\/td>\n<\/tr>\n<tr>\n<td>Tu\u00e2n th\u1ee7<\/td>\n<td>21 CFR Part 11 Ready<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h4><strong>L\u1ee3i \u00edch cho ph\u00f2ng lab v\u00e0 nh\u00e0 s\u1ea3n xu\u1ea5t t\u1ebf b\u00e0o<\/strong><\/h4>\n<ul>\n<li><strong>Gi\u1ea3m 60\u201370% th\u1eddi gian ph\u00e2n t\u00edch<\/strong> so v\u1edbi flow cytometry truy\u1ec1n th\u1ed1ng<\/li>\n<li><strong>Kh\u00f4ng c\u1ea7n k\u1ef9 thu\u1eadt vi\u00ean chuy\u00ean s\u00e2u<\/strong>, thao t\u00e1c \u0111\u01a1n gi\u1ea3n, \u00edt b\u01b0\u1edbc<\/li>\n<li><strong>T\u0103ng n\u0103ng su\u1ea5t ki\u1ec3m so\u00e1t ch\u1ea5t l\u01b0\u1ee3ng<\/strong> cho c\u00e1c c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t t\u1ebf b\u00e0o, biobank v\u00e0 trung t\u00e2m nghi\u00ean c\u1ee9u mi\u1ec5n d\u1ecbch<\/li>\n<li><strong>T\u1ed1i \u01b0u chi ph\u00ed v\u1eadn h\u00e0nh<\/strong>, \u0111\u1eb7c bi\u1ec7t cho ph\u00f2ng QC trong c\u00e1c \u0111\u01a1n v\u1ecb s\u1ea3n xu\u1ea5t li\u1ec7u ph\u00e1p t\u1ebf b\u00e0o.<\/li>\n<\/ul>\n<h4><strong>\u0110\u1ed1i t\u01b0\u1ee3ng \u1ee9ng d\u1ee5ng m\u00e1y ADAMII\u2122 CDx<\/strong><\/h4>\n<ul>\n<li>Trung t\u00e2m <strong>nghi\u00ean c\u1ee9u &amp; s\u1ea3n xu\u1ea5t t\u1ebf b\u00e0o mi\u1ec5n d\u1ecbch (CAR-T, NK, MSC, TCR-T)<\/strong><\/li>\n<li><strong>Biobank, GMP cell processing lab, CRO\/CMO trong l\u0129nh v\u1ef1c cell &amp; gene therapy<\/strong><\/li>\n<li><strong>Ph\u00f2ng QC &amp; R&amp;D<\/strong> t\u1ea1i b\u1ec7nh vi\u1ec7n, vi\u1ec7n nghi\u00ean c\u1ee9u, c\u00f4ng ty c\u00f4ng ngh\u1ec7 sinh h\u1ecdc.<\/li>\n<\/ul>\n<h4><strong>K\u1ebft lu\u1eadn<\/strong><\/h4>\n<p>V\u1edbi kh\u1ea3 n\u0103ng \u0111\u1ecbnh danh t\u1ebf b\u00e0o ch\u00ednh x\u00e1c, thao t\u00e1c nhanh g\u1ecdn, v\u00e0 tu\u00e2n th\u1ee7 ti\u00eau chu\u1ea9n qu\u1ea3n l\u00fd d\u1eef li\u1ec7u qu\u1ed1c t\u1ebf, <strong>ADAMII\u2122 CDx<\/strong> l\u00e0 <strong>gi\u1ea3i ph\u00e1p QC t\u1ed1i \u01b0u<\/strong> cho c\u00e1c ph\u00f2ng lab s\u1ea3n xu\u1ea5t v\u00e0 ki\u1ec3m so\u00e1t ch\u1ea5t l\u01b0\u1ee3ng li\u1ec7u ph\u00e1p t\u1ebf b\u00e0o.<br \/>\nThi\u1ebft b\u1ecb mang \u0111\u1ebfn <strong>hi\u1ec7u su\u1ea5t, t\u00ednh t\u00e1i l\u1eadp v\u00e0 \u0111\u1ed9 tin c\u1eady cao<\/strong>, gi\u00fap <strong>Biogroup Vietnam<\/strong> \u0111\u1ed3ng h\u00e0nh c\u00f9ng c\u00e1c \u0111\u01a1n v\u1ecb trong h\u00e0nh tr\u00ecnh <strong>chuy\u1ec3n \u0111\u1ed5i sang quy tr\u00ecnh s\u1ea3n xu\u1ea5t t\u1ebf b\u00e0o \u0111\u1ea1t chu\u1ea9n GMP<\/strong>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p><strong data-start=\"73\" data-end=\"88\">ADAMII\u2122 CDx<\/strong> l\u00e0 thi\u1ebft b\u1ecb <strong data-start=\"101\" data-end=\"154\" data-is-only-node=\"\">ph\u00e2n t\u00edch mi\u1ec5n d\u1ecbch hu\u1ef3nh quang d\u1ef1a tr\u00ean h\u00ecnh \u1ea3nh<\/strong> (image-based immunophenotyping) d\u00e0nh cho <strong data-start=\"196\" data-end=\"225\">ki\u1ec3m so\u00e1t ch\u1ea5t l\u01b0\u1ee3ng (QC)<\/strong> trong <strong data-start=\"232\" data-end=\"261\">s\u1ea3n xu\u1ea5t li\u1ec7u ph\u00e1p t\u1ebf b\u00e0o<\/strong>. Thi\u1ebft b\u1ecb cho ph\u00e9p \u0111\u1ebfm v\u00e0 ph\u00e2n t\u00edch ch\u00ednh x\u00e1c <strong data-start=\"308\" data-end=\"345\">T cell, NK cell, B cell, Monocyte<\/strong>, \u0111\u1ed3ng th\u1eddi \u0111o <strong data-start=\"360\" data-end=\"392\">t\u1ef7 l\u1ec7 s\u1ed1ng\/ch\u1ebft v\u00e0 apoptosis<\/strong>. V\u1edbi \u0111\u1ed9 ch\u00ednh x\u00e1c t\u01b0\u01a1ng \u0111\u01b0\u01a1ng <strong data-start=\"423\" data-end=\"441\">flow cytometry<\/strong> v\u00e0 tu\u00e2n th\u1ee7 <strong data-start=\"454\" data-end=\"472\">21 CFR Part 11<\/strong>, ADAMII\u2122 CDx gi\u00fap ph\u00f2ng lab v\u00e0 nh\u00e0 s\u1ea3n xu\u1ea5t \u0111\u1ea1t chu\u1ea9n <strong data-start=\"527\" data-end=\"534\">GMP<\/strong> nhanh ch\u00f3ng, hi\u1ec7u qu\u1ea3 v\u00e0 ti\u1ebft ki\u1ec7m chi ph\u00ed.<br data-start=\"578\" data-end=\"581\" \/>\u27a1\ufe0f <em data-start=\"584\" data-end=\"646\" data-is-last-node=\"\">Li\u00ean h\u1ec7 Biogroup Vietnam \u0111\u1ec3 \u0111\u0103ng k\u00fd demo v\u00e0 t\u01b0 v\u1ea5n k\u1ef9 thu\u1eadt.<\/em><\/p>\n","protected":false},"featured_media":8971,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false},"product_brand":[134],"product_cat":[111,175],"product_tag":[],"class_list":{"0":"post-3833","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_brand-nanoentek","7":"product_cat-dem-phan-tich-te-bao","8":"product_cat-phan-tich-te-bao-mien-dich","10":"first","11":"outofstock","12":"shipping-taxable","13":"product-type-simple"},"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>M\u00e1y Ph\u00e2n T\u00edch T\u1ebf B\u00e0o Mi\u1ec5n D\u1ecbch ADAMII\u2122-CDx<\/title>\n<meta name=\"description\" content=\"Kh\u00e1m ph\u00e1 ADAMII\u2122 CDx \u2013 thi\u1ebft b\u1ecb QC \u0111a n\u0103ng d\u1ef1a tr\u00ean h\u00ecnh \u1ea3nh d\u00e0nh cho li\u1ec7u ph\u00e1p t\u1ebf b\u00e0o mi\u1ec5n d\u1ecbch. \u0110\u1ebfm v\u00e0 ph\u00e2n t\u00edch t\u1ebf b\u00e0o T, NK, B v\u00e0 Monocyte v\u1edbi \u0111\u1ed9 ch\u00ednh x\u00e1c cao, tu\u00e2n th\u1ee7 ti\u00eau chu\u1ea9n 21 CFR Part 11. Ph\u00e2n ph\u1ed1i \u0111\u1ed9c quy\u1ec1n b\u1edfi Biogroup Vietnam.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/biogroupvietnam.com\/vi\/san-pham\/adamii-cdx\/\" \/>\n<meta property=\"og:locale\" content=\"vi_VN\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"M\u00e1y Ph\u00e2n T\u00edch T\u1ebf B\u00e0o Mi\u1ec5n D\u1ecbch ADAMII\u2122-CDx\" \/>\n<meta property=\"og:description\" content=\"Kh\u00e1m ph\u00e1 ADAMII\u2122 CDx \u2013 thi\u1ebft b\u1ecb QC \u0111a n\u0103ng d\u1ef1a tr\u00ean h\u00ecnh \u1ea3nh d\u00e0nh cho li\u1ec7u ph\u00e1p t\u1ebf b\u00e0o mi\u1ec5n d\u1ecbch. \u0110\u1ebfm v\u00e0 ph\u00e2n t\u00edch t\u1ebf b\u00e0o T, NK, B v\u00e0 Monocyte v\u1edbi \u0111\u1ed9 ch\u00ednh x\u00e1c cao, tu\u00e2n th\u1ee7 ti\u00eau chu\u1ea9n 21 CFR Part 11. 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