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href="http://www.cdcfah.com/cp/third-yyby_qtflft/">其他未分類</a>?重慶QMS系統(tǒng)滅菌柜驗證第三方誠信服務(wù) 旦霆生物科技供應(yīng)</p><div id="jsfhel7" class="leftbox clearfix"><h1>重慶QMS系統(tǒng)滅菌柜驗證第三方誠信服務(wù) 旦霆生物科技供應(yīng)</h1><div id="8tc3daj" class="proBig"><div id="f3td2zb" class="bigimg"><div><p class="pic"><img src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335293616376954/1769054.png" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div><div id="c2rebt8" class="smallimg"><div><p class="pic"><img src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335293616376954/1769054.png" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div></div><div id="vjb88k2" class="content"><p><span>需求數(shù)量：</span>0</p><p><span>價格要求：</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>重慶QMS系統(tǒng)滅菌柜驗證第三方,滅菌柜驗證</p><p><span>***更新：</span>2021-01-26 00:14:41</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="3xkxzg9" 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: </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="js8h4gk" class="page-proshow02"><p class="title">詳細說明</p><div id="mgyacjd" class="box"><p><p> ***百四十四條確認和驗證不是一次性的行為。***確認或驗證后，應(yīng)根據(jù)產(chǎn)品質(zhì)量回顧分析的情況進行再確認或再驗證。關(guān)鍵的生產(chǎn)工藝和操作規(guī)程應(yīng)定期進行再驗證，確保其能夠達到預(yù)期結(jié)果。 </p> <p> ***百四十八條確認或驗證應(yīng)按照預(yù)先確定和批準的方案實施，并有記錄。確認或驗證工作完成后，重慶QMS系統(tǒng)滅菌柜驗證第三方，應(yīng)寫出報告，重慶QMS系統(tǒng)滅菌柜驗證第三方，并經(jīng)審核、批準。確認或驗證的結(jié)果和結(jié)論（包括評價和建議）應(yīng)有記錄并存檔。 </p> <p> ***百四十九條應(yīng)根據(jù)驗證的結(jié)果確認工藝規(guī)程和操作規(guī)程。旦霆科技專業(yè)提供計算機化系統(tǒng)驗證，重慶QMS系統(tǒng)滅菌柜驗證第三方、空調(diào)系統(tǒng)及潔凈室驗證、生產(chǎn)設(shè)備驗證、滅菌柜驗證等驗證咨詢與服務(wù)。重慶QMS系統(tǒng)滅菌柜驗證第三方</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="重慶QMS系統(tǒng)滅菌柜驗證第三方,滅菌柜驗證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335293616376954/1769054.png"></div><p> 壓力消毒器驗證報告 </p> <p> 概述 </p> <p> 本次驗證通過對高壓滅菌器進行安裝確認、空載、滿載滅菌效果的確認證明在121°C20分鐘的滅菌條件下能達到滅菌效果。 </p> <p> 驗證相關(guān)文件 </p> <p> 文件名稱： </p> <p> 壓力容器管理規(guī)程 </p> <p> 計量器具校驗管理規(guī)程 </p> <p> 電熱式蒸汽消毒器操作標準操作程序 </p> <p> 壓力消毒器驗證方案 </p> <p> 驗證組織和職責 </p> <p> 驗證組織 </p> <p> 驗證小組，由以下部門及人員參加 </p> <p> 驗證組長 </p> <p> 生產(chǎn)部 </p> <p> 設(shè)備部 </p> <p> 職責與分工 </p> <p> 驗證組長：負責驗證方案的起草，并負責組織實施進行壓力消毒器驗證。負責驗證期間各項工作的協(xié)調(diào)。 </p> <p> 生產(chǎn)部：負責按照要求對壓力容器進行操作和日常保養(yǎng)。 </p> <p> 綜保部：負責壓力容器的指導(dǎo)和驗證物品的準備。福建倉庫管理軟件滅菌柜驗證誠信為先旦霆科技為提升各項目質(zhì)量水平，成立質(zhì)量部門。為滅菌柜驗證等驗證及檢測服務(wù)保駕護航！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="重慶QMS系統(tǒng)滅菌柜驗證第三方,滅菌柜驗證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335296157607422/4527074.png"></div><p> 每個行業(yè)公司為啥要校準，測量，檢測，驗證？哪些儀器需要強檢？什么是CNAS認證？ </p> <p> <br /> </p> <p> 為什么要校準，測量，檢測儀器設(shè)備？ </p> <p> <br /> </p> <p> 本質(zhì)原因：全球經(jīng)濟一體化，企業(yè)生產(chǎn)、貿(mào)易、結(jié)算等都需要統(tǒng)一標準。測量儀器用于生產(chǎn)制造的品質(zhì)控制，對它進行校準，滿足了生產(chǎn)制造統(tǒng)一標準的要求。 </p> <p> <br /> </p> <p> 表面原因：客戶審廠需要查看測量儀器是否有校準，審廠一般有ISO、CCC、UL、TUV、以及其它的客戶審廠。 </p> <p> <br /> </p> <p> 全世界的測量儀器都要驗證，所以說，校準是剛需，一年至少一次。 </p> <p> <br /> </p><p style="text-indent:25px">設(shè)備運行確認，就是設(shè)備各個功能的依次確認，在設(shè)備管理中，為設(shè)備的試機，或試運行。概括來講，設(shè)備主要包括四個方面的功能確認：操作功能、安全功能、警示功能和生產(chǎn)功能。操作功能指設(shè)備的可操作性、操作的方便性，安全功能指設(shè)備有防護人身傷害的功能，警示功能指設(shè)備使用過程中超出規(guī)定限度時的報警功能，生產(chǎn)功能是指設(shè)備能夠生產(chǎn)出合格的產(chǎn)品。當設(shè)備的功能齊全后，方可進行下一步的工作。對部分設(shè)備而言，生產(chǎn)功能試驗須有參數(shù)的確認（如梯度試驗），以及基本確定設(shè)備的操作方法、維護方法等，人員應(yīng)經(jīng)過操作、維護的基本培訓。旦霆科技針對于中大型驗證均配備項目經(jīng)理，在為提供滅菌柜驗證服務(wù)時及時匯報進、嚴格控制質(zhì)量！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="重慶QMS系統(tǒng)滅菌柜驗證第三方,滅菌柜驗證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335295380234375/3887825.png"></div><p> 滅菌柜的原理： </p> <p> <br /> </p> <p> 1 干熱滅菌柜，結(jié)合國外制造經(jīng)驗優(yōu)勢，精心設(shè)計開發(fā)，為國內(nèi)制藥企業(yè)采用，符合GMP改造要求。 </p> <p> <br /> </p> <p> 2 干熱滅菌柜采用PLC控制，具備手/自動功能，觸摸屏人機界面，有雙重加熱保護功能。 </p> <p> <br /> </p> <p> 3 設(shè)計比較高工作溫度可達350℃，設(shè)備空載熱分布可以達到±3℃，高效通過DOP測試，塵埃粒子測試，箱內(nèi)達到百級狀態(tài)。 </p> <p> <br /> </p> <p> 4 干熱滅菌柜設(shè)備采用滿焊結(jié)構(gòu)，內(nèi)部拋光，Ra≤0.4 ，無死角，無銳角。 </p> <p> <br /> </p> <p> 5 裝置上留有GMP驗證接口。 </p> <p> <br /> </p> <p> 6 干熱滅菌柜產(chǎn)品可供用戶選擇，在配置和尺寸方面也可根據(jù)用戶用途、場地、產(chǎn)量等定制。 </p> <p> <br /> 旦霆科技為制藥行業(yè)等企業(yè)提供驗證測試服務(wù)。對耗材供應(yīng)商進行年審、為項目進行及服務(wù)客戶把好關(guān)！福建倉庫管理軟件滅菌柜驗證誠信為先</p><p style="text-indent:25px">計算機化系統(tǒng)驗證服務(wù)選旦霆科技，服務(wù)專業(yè)到位，值得信賴！重慶QMS系統(tǒng)滅菌柜驗證第三方</p><p style="text-indent:25px">隨著2020年離我們已經(jīng)越來越近，遵循政策導(dǎo)向，調(diào)整企業(yè)布局將成為未來企業(yè)戰(zhàn)略布局的重中之重。隨著我國醫(yī)藥健康深入推進、“兩票制”進一步推行，以及各項行業(yè)政策的出臺，使得我國冷鏈物流市場規(guī)模不斷擴大。對于冷鏈物流行業(yè)而言，“十三五”規(guī)劃時期是冷鏈物流調(diào)整和發(fā)展的關(guān)鍵時期。新增內(nèi)容體現(xiàn)了我國醫(yī)藥產(chǎn)業(yè)技術(shù)升級的方向，有助于引導(dǎo)企業(yè)緊跟國際前沿技術(shù)，加快開發(fā)具有國際競爭力的新產(chǎn)品，提高產(chǎn)業(yè)化水平。既是GMP驗證咨詢與服務(wù)，計算機化系統(tǒng)驗證，壓縮空氣檢測，潔凈室檢測當前發(fā)展的重要方向，也是我國重視中醫(yī)藥傳承與創(chuàng)新發(fā)展的重要體現(xiàn)。自2015年以來，健康科技成為醫(yī)藥健康私營有限責任公司增長**快的領(lǐng)域。事實上，根據(jù)硅谷銀行的分析，有風投支持的健康科技行業(yè)募資次數(shù)在這段時間增長了25%，硅谷銀行與其中大約40%的歐美公司進行了合作。加之旦霆生物科技（上海）有限公司位于上海市青浦區(qū)徐涇鎮(zhèn)華徐公路966號323室、325室，成立于2014年04月21日的私營/民營企業(yè)，目前公司的主要經(jīng)營范圍是從事生物科技、計算機領(lǐng)域內(nèi)的技術(shù)開發(fā)、技術(shù)咨詢,企業(yè)管理咨詢,檢測領(lǐng)域內(nèi)的技術(shù)咨詢和技術(shù)服務(wù)。【依法須經(jīng)批準的項目,經(jīng)相關(guān)部門批準后方可開展經(jīng)營活動】“兩票制”壓縮流通渠道層級，減少中間環(huán)節(jié)層層加價；反商業(yè)賄賂、稅務(wù)改進等一系列政策的落地，迫使產(chǎn)業(yè)從不規(guī)范、低水平的商業(yè)化向規(guī)范的、高水平成熟的商業(yè)化進化。重慶QMS系統(tǒng)滅菌柜驗證第三方</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、驗證服務(wù)以及培訓的綜合性咨詢公司； </p> <p> 旦霆公司長期致力于幫助企業(yè)順利通過FDA EU TGA WHO CFDA等機構(gòu)的GMP認證檢查； </p> <p> 公司成員多來自于**外資制藥企業(yè)、外資GMP咨詢公司、及國內(nèi)**的第三方檢測公司。 </p> <p> 作為以慈善事業(yè)為使命的旦霆公司堅持以超值的品質(zhì)為客戶提供服務(wù)，同時公司每年利潤的10%捐獻給中國貧困兒童，持久資助中國貧困兒童的教育。 </p></p><br /><p>文章來源地址: http://www.cdcfah.com/cp/3007386.html</p></div></div></div></div></div><div id="poac2y3" class="page-right twoColRt"><div id="mf83i8t" class="box01 margin10 clearfix"><h3><a href="http://www.cdcfah.com/cp/">猜你喜歡</a></h3><div id="tnkmj7y" 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配件哪家強信息推薦自業(yè)物資供應(yīng)</p></a></div><div id="gvczwvu" class="recomPic likePro"><a 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