湖北層流罩3Q認(rèn)證創(chuàng)新服務(wù) 旦霆生物科技供應(yīng)-b2b網(wǎng)站_b2b電子商務(wù)平臺(tái)【買產(chǎn)品】-上?？谄蚴称酚邢薰?/title><meta name="description" content="二氧化碳培養(yǎng)箱3Q認(rèn)證內(nèi)容包括已下：IQ內(nèi)容:技術(shù)類文件確認(rèn),設(shè)備儀表校準(zhǔn)確認(rèn),，安裝位置和安裝環(huán)境確認(rèn),部件安裝確認(rèn),公用系統(tǒng)連接確認(rèn)和標(biāo)識(shí)確認(rèn)。OQ內(nèi)容：預(yù)確認(rèn)(確認(rèn)安裝確認(rèn)是否完成,安裝確認(rèn)中出現(xiàn)的偏差是否已關(guān)閉，設(shè)備操作SOP是否已"><meta name="keywords" content="湖北層流罩3Q認(rèn)證,3Q認(rèn)證"><link rel="canonical" href="http://www.cdcfah.com/"/><meta name="applicable-device" content="pc"><link rel="shortcut icon" href="/static/new_net_01/images/favicon.ico"><link rel="stylesheet" href="/static/new_net_01/css/slick.css" /><link rel="stylesheet" href="/static/new_net_01/css/addnew.css"><link rel="stylesheet" href="/static/new_net_01/css/sidenav.css"><link rel="stylesheet" href="/static/new_net_01/css/style.css" /><link rel="stylesheet" href="/static/new_net_01/css/tab.css"><link rel="stylesheet" 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旦霆生物科技供應(yīng)</p><div id="furovcj" class="leftbox clearfix"><h1>湖北層流罩3Q認(rèn)證創(chuàng)新服務(wù) 旦霆生物科技供應(yīng)</h1><div id="jd29vjf" class="proBig"><div id="jysjqx7" class="bigimg"><div><p class="pic"><img src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175309149550781/2262639.png" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div><div id="xwdf7ta" class="smallimg"><div><p class="pic"><img src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175309149550781/2262639.png" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div></div><div id="2lx8tvu" class="content"><p><span>需求數(shù)量：</span>0</p><p><span>價(jià)格要求：</span>面議</p><p><span>所在地：</span>上海市</p><p><span>包裝要求：</span><span style="color: #f30;"></span></p><p><span>產(chǎn)品關(guān)鍵詞：</span>湖北層流罩3Q認(rèn)證,3Q認(rèn)證</p><p><span>***更新：</span>2021-01-11 05:05:34</p><p><span id="click" >瀏覽次數(shù)：1次</span></p><a rel="nofollow" class="button">聯(lián)系我們</a></div></div><div id="7ld82tq" class="rightbox"><h3>公司基本資料信息</h3><p style="border:0;"><a rel="nofollow">旦霆生物科技（上海）有限公司</a></p><p><span>聯(lián)系人：</span>楊玲玲</p><p><span>郵箱: </span>847678360@qq.com</p><p><span>電話: </span>18918043358</p><p><span>傳真: </span>021_</p><p><span>網(wǎng)址: </span></p><p><span>手機(jī): </span>021-59882315</p><p><span>地址: </span>上海市青浦區(qū)華徐公路966號(hào)法姬娜大廈B323室，325室</p><p>[當(dāng)前離線] <a rel="nofollow"> [加為商友] </a><a rel="nofollow"> [發(fā)送信件] </a></p></div></div><div id="qfxurd2" class="page-proshow02"><p class="title">詳細(xì)說(shuō)明</p><div id="8b3eo2v" class="box"><p><p> 二氧化碳培養(yǎng)箱3Q認(rèn)證內(nèi)容包括已下： </p> <p> IQ內(nèi)容: 技術(shù)類文件確認(rèn), 設(shè)備儀表校準(zhǔn)確認(rèn),，安裝位置和安裝環(huán)境確認(rèn), 部件安裝確認(rèn), 公用系統(tǒng)連接確認(rèn)和標(biāo)識(shí)確認(rèn)。 </p> <p> OQ內(nèi)容：預(yù)確認(rèn)(確認(rèn)安裝確認(rèn)是否完成,安裝確認(rèn)中出現(xiàn)的偏差是否已關(guān)閉，設(shè)備操作SOP是否已審批完成)，啟動(dòng)/關(guān)閉確認(rèn)，按鍵功能確認(rèn)，參數(shù)設(shè)置功能確認(rèn)，轉(zhuǎn)速確認(rèn)，計(jì)時(shí)器比對(duì)確認(rèn)，溫度控制功能確認(rèn)，升/降速時(shí)間確認(rèn)，噪聲確認(rèn)，報(bào)警/安全功能確認(rèn)，湖北層流罩3Q認(rèn)證。 </p> <p> PQ內(nèi)容：根據(jù)甲方SOP運(yùn)行3次，湖北層流罩3Q認(rèn)證。旦霆科技擁有先進(jìn)的驗(yàn)證理念，成熟的驗(yàn)證體系，湖北層流罩3Q認(rèn)證，完善的質(zhì)量體系，為您提供專業(yè)、質(zhì)量的3Q認(rèn)證服務(wù)！湖北層流罩3Q認(rèn)證</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="湖北層流罩3Q認(rèn)證,3Q認(rèn)證" src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175309149550781/2262639.png"></div><p> 二氧化碳培養(yǎng)箱3Q認(rèn)證內(nèi)容包括如下： </p> <p> PQ內(nèi)容：根據(jù)甲方SOP運(yùn)行、3次。 </p> <p> OQ內(nèi)容：預(yù)確認(rèn)(確認(rèn)安裝確認(rèn)是否完成,安裝確認(rèn)中出現(xiàn)的偏差是否已關(guān)閉，設(shè)備操作SOP是否已審批完成)，啟動(dòng)/關(guān)閉確認(rèn)，按鍵功能確認(rèn)，參數(shù)設(shè)置功能確認(rèn)，轉(zhuǎn)速確認(rèn)，計(jì)時(shí)器比對(duì)確認(rèn)，溫度控制功能確認(rèn)，升/降速時(shí)間確認(rèn)，噪聲確認(rèn)，報(bào)警/安全功能確認(rèn)。 </p> <p> IQ內(nèi)容: 技術(shù)類文件確認(rèn), 設(shè)備儀表校準(zhǔn)確認(rèn), 安裝位置和安裝環(huán)境確認(rèn), 部件安裝確認(rèn), 公用系統(tǒng)連接確認(rèn)和標(biāo)識(shí)確認(rèn)。 </p> <p> <br /> </p> <p> <br /> 湖北層流罩3Q認(rèn)證旦霆科技作為專業(yè)驗(yàn)證檢測(cè)供應(yīng)商，具備CMA資質(zhì)，檢測(cè)報(bào)告國(guó)家認(rèn)可，專業(yè)提供3Q認(rèn)證服務(wù)，是您放心的選擇！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="湖北層流罩3Q認(rèn)證,3Q認(rèn)證" src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175309141064453/8232012.jpg"></div><p> 什么是SRA，怎么做（是否與RA合并） </p> <p> <br /> </p> <p> 3Q認(rèn)證過(guò)程中系統(tǒng)風(fēng)險(xiǎn)評(píng)估（SRA）是通過(guò)QRM檢驗(yàn)直接影響系統(tǒng)的產(chǎn)品質(zhì)量風(fēng)險(xiǎn)控制措施的應(yīng)用，執(zhí)行系統(tǒng)風(fēng)險(xiǎn)評(píng)估的項(xiàng)目團(tuán)隊(duì)?wèi)?yīng)包含能理解工藝和相關(guān)CQAs的相關(guān)風(fēng)險(xiǎn)的主題技術(shù)**（SMEs）。（對(duì)于標(biāo)準(zhǔn)的現(xiàn)成的或簡(jiǎn)單的目錄系統(tǒng),一些組織認(rèn)為沒(méi)有必要的執(zhí)行系統(tǒng)風(fēng)險(xiǎn)評(píng)估；可使用簡(jiǎn)單的協(xié)議或報(bào)告（例如，安裝和運(yùn)行驗(yàn)證)來(lái)提供安裝和操作滿足系統(tǒng)需求的書面證據(jù)）。 </p> <p> 系統(tǒng)風(fēng)險(xiǎn)評(píng)估完成后，應(yīng)檢查 URS 以確保 CAs/CDEs 已包括在內(nèi)；若未包括在內(nèi)，則應(yīng)修訂 URS，將其加入。過(guò)程控制元素應(yīng)該添加到 C&Q 范圍中。系統(tǒng)的驗(yàn)收和放行涉及確認(rèn)系統(tǒng)風(fēng)險(xiǎn)評(píng)估中確定的控制措施如下: </p> <p> 1.已經(jīng)證明設(shè)計(jì)控件(CAs/CDEs)按照指定的方式運(yùn)行； </p> <p> 2.過(guò)程控制已經(jīng)就位。 </p> <p> <br /> </p><p> 制藥行業(yè)實(shí)驗(yàn)室常見儀器清單 </p> <p> <p> 我司目前已提供以下常見實(shí)驗(yàn)室儀器3Q認(rèn)證： </p> <p> 生化檢測(cè)類：細(xì)胞計(jì)數(shù)儀，流式細(xì)胞儀實(shí)時(shí)熒光定量PCR儀，全自動(dòng)微生物培養(yǎng)系統(tǒng)，酶標(biāo)儀，凝膠成像系統(tǒng)，倒置顯微鏡，菌落計(jì)數(shù)器 </p> <p> 理化檢測(cè)類：電泳儀，電導(dǎo)率儀，紫外分光光度計(jì)，紅外分光光度計(jì)，可見分光光度計(jì)，高效液相色譜儀，氣相色譜儀，原子吸收光譜儀、質(zhì)譜儀，液質(zhì)聯(lián)用/氣質(zhì)聯(lián)用，滲透壓儀，pH計(jì)，分析天平/電子天平，血細(xì)胞分析儀 </p> <p> 存儲(chǔ)類：冷藏箱，低溫冰箱，超低溫冰箱，液氮儲(chǔ)存罐，程序降溫儀 </p> <p> 其他類: CO2培養(yǎng)箱，生化培養(yǎng)箱，震蕩培養(yǎng)箱，電熱鼓風(fēng)干燥箱，生物安全柜，超凈工作臺(tái)，通風(fēng)櫥、層流罩、手套箱、隔離器，離心機(jī)（冷凍，微量，96孔板），水浴槽，全自動(dòng)蛋白純化儀，純水儀，洗板機(jī)，滅菌鍋，干式細(xì)胞融化儀，血液分析系統(tǒng) </p> 旦霆科技在提供高質(zhì)量服務(wù)的同時(shí)為眾多客戶解決項(xiàng)目偏差、驗(yàn)證偏差等問(wèn)題。以保證3Q認(rèn)證服務(wù)的順利進(jìn)行。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="湖北層流罩3Q認(rèn)證,3Q認(rèn)證" src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175309142753906/1736200.jpg"></div><p> 生物安全柜3Q認(rèn)證內(nèi)容包括： </p> <p> PQ內(nèi)容：預(yù)確認(rèn)(確認(rèn)運(yùn)行確認(rèn)是否完成,安裝運(yùn)行確認(rèn)中出現(xiàn)的偏差是否已關(guān)閉)，懸浮粒子測(cè)試，沉降菌測(cè)試，浮游菌測(cè)試以及表面微生物測(cè)試，動(dòng)態(tài)下測(cè)試三次 </p> <p> OQ內(nèi)容：預(yù)確認(rèn)(確認(rèn)安裝確認(rèn)是否完成,安裝確認(rèn)中出現(xiàn)的偏差是否已關(guān)閉，設(shè)備操作SOP是否已審批完成)，開啟/關(guān)閉確認(rèn)，系統(tǒng)按鍵功能確認(rèn)，參數(shù)設(shè)置確認(rèn)，高效過(guò)濾器及其邊框完整性確認(rèn)，下降氣流流速確認(rèn)，流入氣流流速確認(rèn)，噪聲確認(rèn)，照度確認(rèn)，氣流流型確認(rèn)，溫升確認(rèn)，紫外線輻射強(qiáng)度確認(rèn)，報(bào)警及互鎖功能確認(rèn)，懸浮粒子確認(rèn)，沉降菌確認(rèn)，浮游菌確認(rèn) </p> <p> IQ內(nèi)容: 技術(shù)類文件確認(rèn), 設(shè)備儀表校準(zhǔn)確認(rèn), 安裝位置和安裝環(huán)境確認(rèn), 部件安裝確認(rèn), 公用系統(tǒng)連接確認(rèn)和標(biāo)識(shí)確認(rèn) </p> <p> <br /> </p> <p> <br /> 旦霆科技以高質(zhì)量、高性價(jià)比作為服務(wù)宗旨，為國(guó)內(nèi)制藥行業(yè)、醫(yī)療器械行業(yè)等眾多行業(yè)提供3Q認(rèn)證及咨詢服務(wù).湖北層流罩3Q認(rèn)證</p><p style="text-indent:25px">旦霆科技可提供3Q認(rèn)證等驗(yàn)證檢測(cè)服務(wù)。廣納良言，吸取客戶有效意見、致力于為客戶更好的服務(wù)。湖北層流罩3Q認(rèn)證</p><p> 離心機(jī)3Q認(rèn)證內(nèi)容包括： </p> <p> IQ內(nèi)容: 1.技術(shù)類文件確認(rèn), 2.設(shè)備儀表校準(zhǔn)確認(rèn), 3.安裝位置和安裝環(huán)境確認(rèn), 4.部件安裝確認(rèn), 5.公用系統(tǒng)連接確認(rèn)和標(biāo)識(shí)確認(rèn) </p> <p> OQ內(nèi)容：1.預(yù)確認(rèn)(確認(rèn)安裝確認(rèn)是否完成,安裝確認(rèn)中出現(xiàn)的偏差是否已關(guān)閉，2.設(shè)備操作SOP是否已審批完成)，3.啟動(dòng)/關(guān)閉確認(rèn)，4.按鍵功能確認(rèn)，5.參數(shù)設(shè)置功能確認(rèn)，6.轉(zhuǎn)速確認(rèn)，7.計(jì)時(shí)器比對(duì)確認(rèn)，8.溫度控制功能確認(rèn)，9.升/降速時(shí)間確認(rèn)，10。噪聲確認(rèn)，11.報(bào)警/安全功能確認(rèn) </p> <p> PQ內(nèi)容：1.根據(jù)甲方SOP運(yùn)行3次湖北層流罩3Q認(rèn)證</p><p> 旦霆生物科技（上海）有限公司是一家為制藥、化工、化妝品、保健食品、制藥設(shè)備等行業(yè)提供GXP合規(guī)咨詢、驗(yàn)證服務(wù)以及培訓(xùn)的綜合性咨詢公司； </p> <p> 旦霆公司長(zhǎng)期致力于幫助企業(yè)順利通過(guò)FDA EU TGA WHO CFDA等機(jī)構(gòu)的GMP認(rèn)證檢查； </p> <p> 公司成員多來(lái)自于**外資制藥企業(yè)、外資GMP咨詢公司、及國(guó)內(nèi)**的第三方檢測(cè)公司。 </p> <p> 作為以慈善事業(yè)為使命的旦霆公司堅(jiān)持以超值的品質(zhì)為客戶提供服務(wù)，同時(shí)公司每年利潤(rùn)的10%捐獻(xiàn)給中國(guó)貧困兒童，持久資助中國(guó)貧困兒童的教育。 </p></p><br /><p>文章來(lái)源地址: http://www.cdcfah.com/cp/2795172.html</p></div></div></div></div></div><div id="peli77o" class="page-right 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