河北區(qū)計(jì)算機(jī)驗(yàn)證怎么做值得信賴旦霆生物科技供應(yīng)-b2b網(wǎng)站_b2b電子商務(wù)平臺【買產(chǎn)品】-上?？谄蚴称酚邢薰?/title><meta name="description" content="旦霆科技為企業(yè)提供生物制品工藝驗(yàn)證GMP驗(yàn)證咨詢，按照工藝流程：生物制品生產(chǎn)設(shè)備和系統(tǒng)中一般被定義為直接影響系統(tǒng)的有：1.配液罐系統(tǒng)2.反應(yīng)罐系統(tǒng)3.超濾系統(tǒng)4.離心機(jī)系統(tǒng)細(xì)胞庫制備及保存設(shè)備：液氮罐，超低溫冰箱，搖床，培養(yǎng)箱，倒置顯微鏡，"><meta name="keywords" content="河北區(qū)計(jì)算機(jī)驗(yàn)證怎么做,計(jì)算機(jī)驗(yàn)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" href="/static/new_net_01/css/404.css"> <meta 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class="container clearfix tcPro"><section class="home-main container clearfix"><div id="8hos9vs" class="twoCol"><div id="ptiu9fx" class="page-proshow clearfix"><p class="current"> 當(dāng)前位置:<a href="http://www.cdcfah.com/">首頁?<a href="http://www.cdcfah.com/cp/">產(chǎn)品供應(yīng)</a>?<a href="http://www.cdcfah.com/cp/first-_yyby/">醫(yī)藥健康</a>?<a href="http://www.cdcfah.com/cp/second-yyby_yiliaoqiju/">醫(yī)療器具</a>?<a href="http://www.cdcfah.com/cp/third-yiliaoqiju_qtylqj/">其他醫(yī)療器具</a>?河北區(qū)計(jì)算機(jī)驗(yàn)證怎么做值得信賴旦霆生物科技供應(yīng)</p><div id="8bdfkbi" class="leftbox clearfix"><h1>河北區(qū)計(jì)算機(jī)驗(yàn)證怎么做值得信賴旦霆生物科技供應(yīng)</h1><div id="jd7iah8" class="proBig"><div id="koykevs" class="bigimg"><div><p class="pic"><img src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637174845529443360/3597871.jpg" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div><div id="hgnfuv8" class="smallimg"><div><p class="pic"><img src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637174845529443360/3597871.jpg" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div></div><div id="ftv7724" 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>河北區(qū)計(jì)算機(jī)驗(yàn)證怎么做,計(jì)算機(jī)驗(yàn)證</p><p><span>***更新：</span>2020-08-18 01:13:29</p><p><span id="click" >瀏覽次數(shù)：0次</span></p><a rel="nofollow" class="button">聯(lián)系我們</a></div></div><div id="7su2x99" 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="vulic3w" class="page-proshow02"><p class="title">詳細(xì)說明</p><div id="lf73obc" class="box"><p><p> 旦霆科技為企業(yè)提供生物制品工藝驗(yàn)證GMP驗(yàn)證咨詢，按照工藝流程： </p> <p> 生物制品生產(chǎn)設(shè)備和系統(tǒng)中一般被定義為直接影響系統(tǒng)的有： </p> <p> 1. 配液罐系統(tǒng) </p> <p> 2. 反應(yīng)罐系統(tǒng) </p> <p> 3. 超濾系統(tǒng) </p> <p> 4.離心機(jī)系統(tǒng) </p> <p> <br /> </p> <p> 細(xì)胞庫制備及保存設(shè)備：液氮罐，超低溫冰箱，搖床，培養(yǎng)箱，倒置顯微鏡，生化分析儀，細(xì)胞計(jì)數(shù)儀，流式細(xì)胞儀，程序降溫儀等； </p> <p> <br /> </p> <p> 細(xì)胞復(fù)蘇過程：水浴鍋，生物安全柜，恒溫培養(yǎng)箱，搖床，CO2培養(yǎng)箱等； </p> <p> <br /> </p> <p> 細(xì)胞培養(yǎng)、傳代過程：生物反應(yīng)器； </p> <p> <br /> </p> <p> 收貨過程：過濾系統(tǒng)，收集罐，中轉(zhuǎn)罐等； </p> <p> <br /> </p> <p> 純化和精制過程：離心機(jī)，層析系統(tǒng)（蛋白純化柱，GE AKTA蛋白純化儀等）過濾系統(tǒng)，除菌過濾系統(tǒng)； </p> <p> <br /> </p> <p> 生物制品生產(chǎn)設(shè)備和系統(tǒng)中一般被定義為直接影響系統(tǒng)的有： </p> <p> <br /> </p> <p> 1. 配液罐系統(tǒng) </p> <p> <br /> </p> <p> 2，河北區(qū)計(jì)算機(jī)驗(yàn)證怎么做，河北區(qū)計(jì)算機(jī)驗(yàn)證怎么做. 反應(yīng)罐系統(tǒng) </p> <p> <br /> </p> <p> 3. 超濾系統(tǒng) </p> <p> <br /> </p> <p> 離心機(jī)系統(tǒng)" </p> <p> <br /> </p> <p> <br /> 旦霆科技可提供CSV認(rèn)證等驗(yàn)證檢測服務(wù)。廣納良言，河北區(qū)計(jì)算機(jī)驗(yàn)證怎么做，吸取客戶有效意見、致力于為客戶更好的服務(wù)。河北區(qū)計(jì)算機(jī)驗(yàn)證怎么做</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="河北區(qū)計(jì)算機(jī)驗(yàn)證怎么做,計(jì)算機(jī)驗(yàn)證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637174845529443360/3597871.jpg"></div><p> "什么是驗(yàn)證與確認(rèn)？ </p> <p> <br /> </p> <p> 3Q驗(yàn)證/3Q認(rèn)證/驗(yàn)證與確認(rèn)是證明任何程序、生產(chǎn)過程、設(shè)備、物料、活動(dòng)或系統(tǒng)確實(shí)能達(dá)到預(yù)期結(jié)果的有文件證明的一系列活動(dòng)，PIC/s中將驗(yàn)證與確認(rèn)的關(guān)系闡釋如下：設(shè)計(jì)確認(rèn)-安裝確認(rèn)-運(yùn)行確認(rèn)-工藝驗(yàn)證(性能確認(rèn))-變更控制-設(shè)計(jì)確認(rèn)。 </p> <p> <br /> </p> <p> 設(shè)備/系統(tǒng)的確認(rèn)/驗(yàn)證工作應(yīng)按照驗(yàn)證生命周期（Life cycle）設(shè)計(jì)出一套完整的驗(yàn)證計(jì)劃（VP）及有效的測試策略，旦霆科技為您提供GMP驗(yàn)證咨詢服務(wù)，從制定用戶需求說明為起點(diǎn)，經(jīng)過設(shè)計(jì)階段，建造實(shí)施階段，安裝確認(rèn)，運(yùn)行確認(rèn)，**終通過性能確認(rèn)來證實(shí)用戶需求說明是否完成。" </p> <p> <br /> </p> <p> <br /> 河北區(qū)計(jì)算機(jī)驗(yàn)證怎么做旦霆科技提供技術(shù)咨詢、3Q認(rèn)證、驗(yàn)證及檢測服務(wù)。在您不知道具體項(xiàng)目需求時(shí)為您擇優(yōu)推薦！</p> <span style="display:none;"></span><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="河北區(qū)計(jì)算機(jī)驗(yàn)證怎么做,計(jì)算機(jī)驗(yàn)證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637174846292871094/5703031.jpg"></div><p> 我司目前已提供以下常見實(shí)驗(yàn)室儀器{3Q驗(yàn)GMP驗(yàn)證咨詢服務(wù)： </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: </p> <p> 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，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> <p> 生化檢測類：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> 制藥用水系統(tǒng)驗(yàn)證內(nèi)容 </p> <p> 旦霆科技為企業(yè)提供制藥用水系統(tǒng)GMP驗(yàn)證咨詢，驗(yàn)證交付物包括VP，SC，SRA，IQ，OQ，PQ，RTM以及VSR文件，其中IQ內(nèi)容包括：文件確認(rèn)（圖紙確認(rèn)/技術(shù)文件確認(rèn)/材質(zhì)證明類文件確認(rèn)/施工記錄/報(bào)告確認(rèn)）, 系統(tǒng)安全確認(rèn), 系統(tǒng)安裝環(huán)境確認(rèn), 公用介質(zhì)連接確認(rèn), 儀器儀表校準(zhǔn)確認(rèn), 機(jī)械部件安裝確認(rèn)，HMI及PLC確認(rèn)，標(biāo)識確認(rèn)，I/O測試確認(rèn)；OQ內(nèi)容包括：系統(tǒng)啟動(dòng)和關(guān)閉確認(rèn)，登錄權(quán)限確認(rèn)，HMI界面和基本功能確認(rèn)，用戶權(quán)限確認(rèn)，控制柜急停功能確認(rèn)，電機(jī)轉(zhuǎn)向確認(rèn)，罐體排空確認(rèn)，核黃素覆蓋率確認(rèn)，預(yù)處理清洗、消毒功能確認(rèn)，軟化器自動(dòng)再生功能確認(rèn)，反滲透自動(dòng)沖洗功能確認(rèn)，自動(dòng)程序運(yùn)行確認(rèn)，純化水流速及產(chǎn)能確認(rèn)，電加熱空氣呼吸器（保溫純化水箱）加熱功能確認(rèn)，紫外滅菌器計(jì)時(shí)功能確認(rèn)，反滲透系統(tǒng)消毒功能確認(rèn)，純化水分配系統(tǒng)消毒功能確認(rèn)，純化水關(guān)鍵控制點(diǎn)取樣確認(rèn)，用戶權(quán)限確認(rèn)，互鎖/安全確認(rèn)，報(bào)警確認(rèn)，斷電恢復(fù)確認(rèn)，數(shù)據(jù)打印功能確認(rèn)；PQ內(nèi)容包括：第1階段（評價(jià)階段），第2階段（短期質(zhì)量控制階段），第三階段（長期質(zhì)量控制階段）分別對制備系統(tǒng)各過程控制點(diǎn)和分配系統(tǒng)各取樣點(diǎn)進(jìn)行取樣檢測 </p> <p> <br /> 旦霆科技服務(wù)面向全國、CSV項(xiàng)目均安排項(xiàng)目經(jīng)理，對項(xiàng)目質(zhì)量、質(zhì)量、進(jìn)度及時(shí)監(jiān)督。保證項(xiàng)目質(zhì)量！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="河北區(qū)計(jì)算機(jī)驗(yàn)證怎么做,計(jì)算機(jī)驗(yàn)證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637174842336787110/9975836.jpg"></div><p> 什么是設(shè)計(jì)確認(rèn)，怎么做？ </p> <p> GMP驗(yàn)證咨詢服務(wù)過程中設(shè)計(jì)確認(rèn)是指在安裝/運(yùn)行/性能確認(rèn)之前，按照用戶提出的需求，通過文件記錄的方式證明所提出的廠房、系統(tǒng)和設(shè)備的設(shè)計(jì)適用于其預(yù)期用途和GxP的要求，用科學(xué)的理論和實(shí)際的數(shù)據(jù)證明設(shè)計(jì)結(jié)果滿足用戶需求說明。設(shè)計(jì)確認(rèn)執(zhí)行過程中可通過表格的方式對用戶需求是否在設(shè)計(jì)文件中得以實(shí)現(xiàn)進(jìn)行詳細(xì)的比對，且詳細(xì)記錄設(shè)計(jì)文件如何滿足相應(yīng)的用戶需求，并對相應(yīng)的設(shè)計(jì)文件進(jìn)行詳細(xì)索引，設(shè)計(jì)確認(rèn)過程中對于不能滿足的用戶需求應(yīng)進(jìn)行記錄，并通過評估以及與供應(yīng)商溝通的方式，確認(rèn)需求是否關(guān)鍵或者設(shè)備/系統(tǒng)是否需要進(jìn)行升級。經(jīng)過批準(zhǔn)的設(shè)計(jì)確認(rèn)報(bào)告是后續(xù)確認(rèn)活動(dòng)（如安裝確認(rèn)、運(yùn)行確認(rèn)、性能確認(rèn)）的基礎(chǔ)。 </p> <p> <br /> </p> <p> <br /> 旦霆科技布局藥企行業(yè)，目前為20余家相關(guān)行業(yè)的公司提供計(jì)算機(jī)化系統(tǒng)驗(yàn)證及咨詢等服務(wù)。河北區(qū)計(jì)算機(jī)驗(yàn)證怎么做</p><p style="text-indent:25px">旦霆科技不斷強(qiáng)化團(tuán)隊(duì)管理、品牌價(jià)值及服務(wù)升級，以質(zhì)量的理念為企業(yè)提供高水準(zhǔn)的CSV驗(yàn)證服務(wù)！河北區(qū)計(jì)算機(jī)驗(yàn)證怎么做</p><p> 驗(yàn)證過程中對于儀表校準(zhǔn)常見問題 </p> <p> 旦霆科技為企業(yè)提供GMP驗(yàn)證咨詢中發(fā)現(xiàn)驗(yàn)證過程中儀表校準(zhǔn)常見偏差問題如下： </p> <p> 1．儀器 /儀表精密度不符合要求；2. 需要校準(zhǔn) 的儀器 /儀表卻未進(jìn) 行校準(zhǔn)；3. 校準(zhǔn)證書的校準(zhǔn)范圍不符合用戶使用需求；4.新購儀器 /儀表無相應(yīng) 的校準(zhǔn) 報(bào) 告或供應(yīng) 商提供的桕關(guān) 校準(zhǔn) 記錄5. 儀器 /儀表超過校準(zhǔn) 日期，尚未校準(zhǔn) 仍在現(xiàn) 場使用，未做任何處置；6. 校準(zhǔn)合格儀器/儀表無標(biāo) 識或標(biāo) 識破損、模糊，無法識別； 7.為儀器/儀表出具校準(zhǔn)證書的第三方機(jī)構(gòu)資質(zhì)不全或者資質(zhì)造假。 </p> <p> <br /> </p> <p> <br /> 河北區(qū)計(jì)算機(jī)驗(yàn)證怎么做</p><p style="text-indent:25px">旦霆生物科技（上海）有限公司屬于醫(yī)藥、保養(yǎng)的高新企業(yè)，技術(shù)力量雄厚。公司是一家私營有限責(zé)任公司企業(yè)，以誠信務(wù)實(shí)的創(chuàng)業(yè)精神、質(zhì)量高效的管理團(tuán)隊(duì)、精悍的職工隊(duì)伍，努力為廣大用戶提供***的產(chǎn)品。公司業(yè)務(wù)涵蓋[ "GMP驗(yàn)證咨詢與服務(wù)", "計(jì)算機(jī)化系統(tǒng)驗(yàn)證", "壓縮空氣檢測", "潔凈室檢測" 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