甘肅負(fù)80度冰箱驗(yàn)證3Q認(rèn)證誠(chéng)信為本旦霆生物科技供應(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)，甘肅負(fù)80度冰箱驗(yàn)證3Q認(rèn)證。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"><meta name="keywords" content="甘肅負(fù)80度冰箱驗(yàn)證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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onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div></div><div id="xrtargh" 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>甘肅負(fù)80度冰箱驗(yàn)證3Q認(rèn)證,3Q認(rèn)證</p><p><span>***更新：</span>2021-01-20 02:04:35</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="rprof7c" 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="hwd7e4f" class="page-proshow02"><p class="title">詳細(xì)說明</p><div id="3jne3km" 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)，甘肅負(fù)80度冰箱驗(yàn)證3Q認(rèn)證。 </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)，甘肅負(fù)80度冰箱驗(yàn)證3Q認(rèn)證。 </p> <p> PQ內(nèi)容：根據(jù)甲方SOP運(yùn)行3次，甘肅負(fù)80度冰箱驗(yàn)證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，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)！甘肅負(fù)80度冰箱驗(yàn)證3Q認(rèn)證</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="甘肅負(fù)80度冰箱驗(yàn)證3Q認(rèn)證,3Q認(rèn)證" src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175309141357421/2337878.jpg"></div><p> 什么是風(fēng)險(xiǎn)評(píng)估，怎么做？ </p> <p> 3Q認(rèn)證過程中風(fēng)險(xiǎn)評(píng)估是為了簡(jiǎn)化驗(yàn)證和減少不必要的確認(rèn)活動(dòng)，應(yīng)通過風(fēng)險(xiǎn)評(píng)估的方法確定待確認(rèn)的設(shè)備或系統(tǒng)以及每個(gè)系統(tǒng)所需要的驗(yàn)證范圍和程度。風(fēng)險(xiǎn)評(píng)估是一種用于評(píng)估并描述系統(tǒng)、設(shè)備或工藝的關(guān)鍵方面，以構(gòu)成編寫驗(yàn)證方案的基礎(chǔ)的方法。在定義關(guān)鍵設(shè)計(jì)控制(CAs/CDEs)后，采用失效模式影響分析（Failure mode effects analysis, FMEA)或其他風(fēng)險(xiǎn)評(píng)估工具來找出可能失效的影響。風(fēng)險(xiǎn)評(píng)估結(jié)果以表格形式提供，每一行分別對(duì)應(yīng)一個(gè)需求或功能可能失效的風(fēng)險(xiǎn)，每個(gè)風(fēng)險(xiǎn)具有對(duì)應(yīng)編號(hào)。在表格中應(yīng)結(jié)合URS要求，以及設(shè)計(jì)確認(rèn)結(jié)果列出關(guān)鍵設(shè)計(jì)控制(CAs/CDEs)所有失效模式，并分析其失效的可能性，危害嚴(yán)重性以及失效的可檢測(cè)性，將失效模式分為高中低三級(jí)，并制定相應(yīng)的風(fēng)險(xiǎn)降低策略。風(fēng)險(xiǎn)降低策略可包含驗(yàn)證策略的提出，制作針對(duì)系統(tǒng)的檢查表，制定相應(yīng)的SOP（如設(shè)備/儀器操作，人員管理，對(duì)關(guān)鍵功能模塊進(jìn)行定期維護(hù)，定期再驗(yàn)證等）。浙江細(xì)胞分選系統(tǒng)3Q認(rèn)證旦霆科技配備專業(yè)的質(zhì)量部，進(jìn)行驗(yàn)證審核、報(bào)告審核等質(zhì)量監(jiān)管，專業(yè)提供3Q認(rèn)證及咨詢服務(wù)，值得信賴！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="甘肅負(fù)80度冰箱驗(yàn)證3Q認(rèn)證,3Q認(rèn)證" src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175309137695312/441838.png"></div><p> 生物反應(yīng)器3Q認(rèn)證包括： </p> <p> PQ：性能確認(rèn) 是對(duì) 設(shè) 備總體的檢驗(yàn) ，是對(duì) 照用戶需求說明中對(duì) 性能描述進(jìn) 行的 *** 確認(rèn) ，在 P Q 執(zhí)行時(shí) ，需要使用一定的模擬物料，需要考慮設(shè) 備比較大 </p> <p> <p> OQ內(nèi)容：設(shè) 備正常啟動(dòng) 、運(yùn) 行、關(guān) 閉和重啟， </p> <p> 溫度、pH 、DO2、溶二氧化碳 DC O2 等控制功能和控制曲線，同時(shí)考察各控制器如電動(dòng)或氣動(dòng) 閥門的動(dòng) 作，進(jìn) 料和出料的功能，稱重系統(tǒng) 或液位控制，攪拌槳控制和轉(zhuǎn) 速的調(diào) 節(jié)，控制系統(tǒng) 功能的確認(rèn) ，包括登陸、權(quán) 限、報(bào) 警、記錄、報(bào) 表等功能的確認(rèn)，C I P 和 s i p 功能的確認(rèn)，安全防護(hù) 功能的確認(rèn)等： </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), 圖紙確認(rèn)（管道連接，包括管件的安裝順序和方向）部件安裝確認(rèn)（包括罐的尺寸、安裝方式、水平，與產(chǎn) 品直接接觸的部件的材質(zhì)，各種控制、監(jiān) 視用的傳感器的品牌、型號(hào) 、材質(zhì) 和安裝位置）, 公用系統(tǒng)連接確認(rèn)，控制軟件的名稱、版木號(hào)和標(biāo)識(shí)確認(rèn)，IO測(cè)試（數(shù) 字量/模擬量輸入和輸出的檢査，可引用SAT中IO測(cè)試結(jié)果） </p> </p><p> 二氧化碳培養(yǎng)箱3Q驗(yàn)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)。 </p> <p> PQ內(nèi)容：根據(jù)甲方SOP運(yùn)行3次。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="甘肅負(fù)80度冰箱驗(yàn)證3Q認(rèn)證,3Q認(rèn)證" src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175309147939453/5125649.jpg"></div><p> 驗(yàn)證總計(jì)劃內(nèi)容 </p> <p> PIC/S對(duì)于3Q認(rèn)證文件中驗(yàn)證總計(jì)劃應(yīng)包含內(nèi)容該如何做出具體的指導(dǎo)，指出一個(gè)驗(yàn)證主計(jì)劃應(yīng)包含以下幾方面的資料:1.簡(jiǎn)介：公司的驗(yàn)證方針，驗(yàn)證項(xiàng)目所包含操作的概述，地點(diǎn)和時(shí)間安排（包括先后順序）；2如下驗(yàn)證活動(dòng)組織機(jī)構(gòu)：起草VMP，項(xiàng)目負(fù)責(zé)，驗(yàn)證工作，報(bào)告/文件的控制和準(zhǔn)備，文件審批，審核和索引系統(tǒng)，培訓(xùn)需求管理人員;3工廠/工藝/產(chǎn)品描述：提供對(duì)其他文檔的交叉引用。包含或排除驗(yàn)證的基本原理。對(duì)于驗(yàn)證方法和驗(yàn)證的范圍應(yīng)該包括在內(nèi);4與其他文件的相互引用關(guān)系說明;5特殊工藝說明：簡(jiǎn)要說明工廠和工藝的特殊性質(zhì)和要求;6需驗(yàn)證的產(chǎn)品/工藝/系統(tǒng)的列表：驗(yàn)證計(jì)劃中的所有驗(yàn)證活動(dòng)應(yīng)以矩陣的形式進(jìn)行概述和編排，包括對(duì)驗(yàn)證所需的程序進(jìn)行描述，如DQ，IQ，OQ，PQ，用于確定工藝和系統(tǒng)的驗(yàn)證狀態(tài)所用的分析技術(shù)的驗(yàn)證，對(duì)驗(yàn)證方法的概述（如前瞻性驗(yàn)證，回顧性驗(yàn)證和再驗(yàn)證），再驗(yàn)證活動(dòng)，產(chǎn)品/工藝/系統(tǒng)當(dāng)前的驗(yàn)證狀態(tài)以及驗(yàn)證安排;7.關(guān)鍵合格標(biāo)準(zhǔn)概述：包括第6挑中項(xiàng)目的關(guān)鍵合格標(biāo)準(zhǔn)的概述;8.文件格式要求;9.相關(guān)的SOP清單;10驗(yàn)證項(xiàng)目的規(guī)劃和安排：包括驗(yàn)證所需的人員、設(shè)備和其他特殊要求的估計(jì)，項(xiàng)目的時(shí)間安排，子項(xiàng)目的詳細(xì)規(guī)劃;11變更控制旦霆科技不但擁有龐大的驗(yàn)證及檢測(cè)團(tuán)隊(duì)，同時(shí)配備幾百套驗(yàn)證及檢測(cè)儀器，專業(yè)開展3Q認(rèn)證服務(wù)！浙江細(xì)胞分選系統(tǒng)3Q認(rèn)證</p><p style="text-indent:25px">旦霆科技作為國(guó)內(nèi)**大中型規(guī)模綜合性咨詢服務(wù)公司，專業(yè)提供3Q認(rèn)證服務(wù)，值得信賴！甘肅負(fù)80度冰箱驗(yàn)證3Q認(rèn)證</p><p> 冰箱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.開啟/關(guān)閉確認(rèn)，4.報(bào)警功能確認(rèn)，5空載溫度分布確認(rèn) 。 </p> <p> PQ內(nèi)容：1.預(yù)確認(rèn)(確認(rèn)運(yùn)行確認(rèn)是否完成，2.安裝運(yùn)行確認(rèn)中出現(xiàn)的偏差是否已關(guān)閉)，3. 滿載溫度分布確認(rèn)，4.開門挑戰(zhàn)試驗(yàn)，5.斷電挑戰(zhàn)試驗(yàn)。甘肅負(fù)80度冰箱驗(yàn)證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>文章來源地址: http://www.cdcfah.com/cp/2921541.html</p></div></div></div></div></div><div id="ap738hy" class="page-right twoColRt"><div id="ncebdmo" class="box01 margin10 clearfix"><h3><a href="http://www.cdcfah.com/cp/">猜你喜歡</a></h3><div id="mwtacoq" class="recomPic likePro"><a href="http://www.cdcfah.com/cp/814588.html"><div><img src="http://tyunfile.71360.com/UpLoadFile/2019/11/1/14/637082168864691056_lgpj_5374157.jpg" alt="福建ZF配件哪家強(qiáng) 信息推薦自業(yè)物資供應(yīng)" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></div><p>福建ZF配件哪家強(qiáng) 信息推薦自業(yè)物資供應(yīng)</p></a></div><div id="uevxugs" class="recomPic likePro"><a href="http://www.cdcfah.com/cp/846569.html"><div><img src="https://tyunfile.71360.com/WaterMark/UploadFile/nbzxsw/637298235378037109/764794.png" alt="寧波寧海直接考A2有幾個(gè)科目真誠(chéng)推薦寧波助學(xué)商務(wù)信息咨詢供應(yīng)" 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