河北區(qū)計(jì)算機(jī)驗(yàn)證咨詢推薦咨詢旦霆生物科技供應(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="旦霆科技為企業(yè)提供{GMP咨詢}/{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：1.校準(zhǔn)合格儀器/儀表無標(biāo)識(shí)或標(biāo)識(shí)破損、模糊，無法識(shí)別； 2.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，河北區(qū)計(jì)算機(jī)驗(yàn)證"><meta name="keywords" content="河北區(qū)計(jì)算機(jī)驗(yàn)證咨詢,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="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)證咨詢,計(jì)算機(jī)驗(yàn)證</p><p><span>***更新：</span>2020-08-17 18:16:04</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="qe8wka0" 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="wsq8kyo" class="page-proshow02"><p class="title">詳細(xì)說明</p><div id="wuaiokq" class="box"><p><p> 旦霆科技為企業(yè)提供{GMP咨詢}/{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. 校準(zhǔn)合格儀器/儀表無標(biāo) 識(shí) 或標(biāo) 識(shí) 破損、模糊，無法識(shí) 別； </p> <p> 2.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，河北區(qū)計(jì)算機(jī)驗(yàn)證咨詢。 </p> <p> 3．儀器 /儀表精密度不符合要求；4. 需要校準(zhǔn) 的儀器 /儀表卻未進(jìn) 行校準(zhǔn)；5. 校準(zhǔn)證書的校準(zhǔn)范圍不符合用戶使用需求；6.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7. 儀器 /儀表超過校準(zhǔn) 日期，河北區(qū)計(jì)算機(jī)驗(yàn)證咨詢，尚未校準(zhǔn) 仍在現(xiàn) 場使用，河北區(qū)計(jì)算機(jī)驗(yàn)證咨詢，未做任何處置； </p> <p> <br /> 旦霆科技專業(yè)為國內(nèi)制藥行業(yè)提供3Q認(rèn)證服務(wù)、第三方測試執(zhí)行以及技術(shù)支持。河北區(qū)計(jì)算機(jī)驗(yàn)證咨詢</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)證咨詢,計(jì)算機(jī)驗(yàn)證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637174846356162110/699390.jpg"></div><p> 什么是風(fēng)險(xiǎn)評估，怎么做？ </p> <p> GMP驗(yàn)證咨詢服務(wù)過程中風(fēng)險(xiǎn)評估是為了簡化驗(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)評估是一種用于評估并描述系統(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 </p> <p> mode effects analysis, FMEA)或其他風(fēng)險(xiǎn)評估工具來找出可能失效的影響。風(fēng)險(xiǎn)評估結(jié)果以表格形式提供，每一行分別對應(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性，將失效模式分為高中低三級，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，對關(guān)鍵功能模塊進(jìn)行定期維護(hù)，定期再驗(yàn)證等）。河北區(qū)實(shí)驗(yàn)室管理軟件計(jì)算機(jī)驗(yàn)證旦霆科技是國內(nèi)無數(shù)不多的為制藥及醫(yī)療器械等相關(guān)行業(yè)提供3Q認(rèn)證服務(wù)的專業(yè)第三方咨詢公司。</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)證咨詢,計(jì)算機(jī)驗(yàn)證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637174845529443360/3597871.jpg"></div><p> 什么是SRA，怎么做（是否與RA合并） </p> <p> GMP驗(yàn)證咨詢服務(wù)過程中系統(tǒng)風(fēng)險(xiǎn)評估（SRA）是通過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）。（對于標(biāo)準(zhǔn)的現(xiàn)成的或簡單的目錄系統(tǒng),一些組織認(rèn)為沒有必要的執(zhí)行系統(tǒng)風(fēng)險(xiǎn)評估；可使用簡單的協(xié)議或報(bào)告（例如，安裝和運(yùn)行驗(yàn)證)來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.過程控制已經(jīng)就位。 </p> <p> <br /> </p> <p> <br /> </p><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 /> 旦霆科技為制藥行業(yè)等企業(yè)提供驗(yàn)證測試服務(wù)。對耗材供應(yīng)商進(jìn)行年審、為項(xiàng)目進(jìn)行及服務(wù)客戶把好關(guān)！</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)證咨詢,計(jì)算機(jī)驗(yàn)證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637174842257265625/5275814.jpg"></div><p> 空調(diào)系統(tǒng)與潔凈室驗(yàn)證內(nèi)容 </p> <p> 旦霆科技為企業(yè)提供空調(diào)系統(tǒng)與潔凈廠房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： </p> <p> 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), 潔凈區(qū)安裝確認(rèn), 空調(diào)系統(tǒng)部件安裝確認(rèn)，PLC及HMI確認(rèn)，標(biāo)識(shí)確認(rèn)以及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)，報(bào)警確認(rèn)，斷電恢復(fù)確認(rèn)，自動(dòng)運(yùn)行確認(rèn)，風(fēng)量及換氣次數(shù)確認(rèn)測，壓差確認(rèn)，高效過濾器及邊框完整性確認(rèn)，溫度/相對濕度確，噪音確認(rèn)測，照度確認(rèn)，氣流流型確認(rèn)，自凈時(shí)間確認(rèn)，懸浮粒子確認(rèn)，浮游菌確認(rèn)，沉降菌確認(rèn)；PQ內(nèi)容包括：溫度/相對濕度確認(rèn)，懸浮粒子確認(rèn)，浮游菌確認(rèn)，沉降菌確認(rèn)測試以及表面微生物，動(dòng)態(tài)執(zhí)行三次。 </p> <p> <br /> </p> <p> <br /> 旦霆科技擁有先進(jìn)的驗(yàn)證理念，成熟的驗(yàn)證體系，為您提供專業(yè)、質(zhì)量的計(jì)算機(jī)化系統(tǒng)驗(yàn)證服務(wù)。河北區(qū)SAP系統(tǒng)計(jì)算機(jī)驗(yàn)證</p><p style="text-indent:25px">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CSV認(rèn)證服務(wù)！河北區(qū)計(jì)算機(jī)驗(yàn)證咨詢</p><p> 制藥行業(yè)實(shí)驗(yàn)室常見儀器清單 </p> <p> 我司目前已提供以下常見實(shí)驗(yàn)室儀器GMP驗(yàn)證咨詢服務(wù)： </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> 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(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) 河北區(qū)計(jì)算機(jī)驗(yàn)證咨詢</p><p style="text-indent:25px">旦霆生物科技（上海）有限公司成立于2014-04-21，是一家服務(wù)型的公司。旦霆科技致力于為客戶提供質(zhì)量的[ "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" ]，一切以用戶需求為中心,深受廣大客戶的歡迎。公司從事醫(yī)藥、保養(yǎng)多年，有著創(chuàng)新的設(shè)計(jì)、強(qiáng)大的技術(shù)，還有一批**的專業(yè)化的隊(duì)伍，確保為客戶提供質(zhì)量的產(chǎn)品及服務(wù)。在社會(huì)各界的鼎力支持下，經(jīng)過公司所有人員的努力，公司自2014-04-21成立以來，年?duì)I業(yè)額達(dá)到700-1000萬元。</p></p><br /><p>文章來源地址: http://www.cdcfah.com/cp/948019.html</p></div></div></div></div></div><div id="imiouk8" class="page-right twoColRt"><div id="u0qgwai" class="box01 margin10 clearfix"><h3><a href="http://www.cdcfah.com/cp/">猜你喜歡</a></h3><div id="koowcqu" 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="m2sym0u" class="recomPic likePro"><a href="http://www.cdcfah.com/cp/846569.html"><div><img 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