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id="maqw0mw" class="leftbox clearfix"><h1>江蘇3Q認證排名誠信服務旦霆生物科技供應</h1><div id="ywuie2s" class="proBig"><div id="uaqgms0" class="bigimg"><div><p class="pic"><img src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175309141357421/925031.jpg" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div><div id="wgmkaoc" class="smallimg"><div><p class="pic"><img src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175309141357421/925031.jpg" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div></div><div id="0a0umcg" 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>江蘇3Q認證排名,3Q認證</p><p><span>***更新：</span>2021-01-21 04:04:19</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="swusi0o" 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="kqw0mmk" class="page-proshow02"><p class="title">詳細說明</p><div id="kqoeki0" class="box"><p><p> 什么是需求追溯矩陣，怎么做？ </p> <p> <br /> </p> <p> ISPE GAMP5《良好自動化生產(chǎn)實踐指南-遵從GxP計算機化系統(tǒng)監(jiān)管的風險管理方法》提到：在系統(tǒng)生命周期的早期就應該識別并糾正系統(tǒng)缺點，設計審査和可追溯性有助于保證系統(tǒng)符合預定用途，并且可以通過在早期識別缺陷并解決問題來降低總體項目成本?！?3Q認證過程中，需求追溯性矩陣（Requirements traceability matrix, RTM)可與標準、要點和成果進行比較，對特定問題點提出必要的糾正措施。 </p> <p> 需求追溯矩陣可起到如下作用： </p> <p> 1.設計需求經(jīng)過了驗證，并可以追溯到表明需求得到滿足的測試或驗證活動； </p> <p> 2.使得風險管理和設計審査流程更有效率； </p> <p> 判斷所提交的變更需求會產(chǎn)生什么樣的影響； </p> <p> 3.有助于對所提交的變更進行風險評估； </p> <p> 4.確認對變更進行測試的范圍； </p> <p> 5，江蘇3Q認證排名.可在檢査和審査時快速準確地反應。 </p> <p> <br /> 旦霆科技作為國內(nèi)為數(shù)不多的中大規(guī)模驗證公司，江蘇3Q認證排名，專業(yè)提供3Q認證服務，江蘇3Q認證排名，擁有幾十人的驗證團隊，值得信賴！江蘇3Q認證排名</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="江蘇3Q認證排名,3Q認證" src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175309141357421/925031.jpg"></div><p> 制藥行業(yè)實驗室常見儀器清單 </p> <p> <p> 我司目前已提供以下常見實驗室儀器3Q認證： </p> <p> 生化檢測類：細胞計數(shù)儀，流式細胞儀實時熒光定量PCR儀，全自動微生物培養(yǎng)系統(tǒng)，酶標儀，凝膠成像系統(tǒng)，倒置顯微鏡，菌落計數(shù)器 </p> <p> 理化檢測類：電泳儀，電導率儀，紫外分光光度計，紅外分光光度計，可見分光光度計，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，分析天平/電子天平，血細胞分析儀 </p> <p> 存儲類：冷藏箱，低溫冰箱，超低溫冰箱，液氮儲存罐，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，電熱鼓風干燥箱，生物安全柜，超凈工作臺，通風櫥、層流罩、手套箱、隔離器，離心機（冷凍，微量，96孔板），水浴槽，全自動蛋白純化儀，純水儀，洗板機，滅菌鍋，干式細胞融化儀，血液分析系統(tǒng) </p> 江蘇3Q認證排名3Q認證服務選旦霆科技，多年的驗證服務經(jīng)驗，成熟的驗證體系，品質(zhì)優(yōu)先，良心推薦。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="江蘇3Q認證排名,3Q認證" src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175309141357421/2337878.jpg"></div><p> 二氧化碳培養(yǎng)箱3Q認證內(nèi)容包括： </p> <p> IQ內(nèi)容: 技術(shù)類文件確認, 設備儀表校準確認, 安裝位置和安裝環(huán)境確認, 部件安裝確認, 公用系統(tǒng)連接確認和標識確認 </p> <p> OQ內(nèi)容：預確認(確認安裝確認是否完成,安裝確認中出現(xiàn)的偏差是否已關(guān)閉，設備操作SOP是否已審批完成)，開啟/關(guān)閉確認，報警功能確認，數(shù)據(jù)記錄功能確認，參數(shù)校準功能確認，空載溫度分布確認，空載CO2濃度確認，斷電挑戰(zhàn)試驗 </p> <p> PQ內(nèi)容：預確認(確認運行確認是否完成，安裝運行確認中出現(xiàn)的偏差是否已關(guān)閉)，滿載溫度分布確認，滿載CO2濃度確認，開門挑戰(zhàn)試驗 </p><p> 制藥行業(yè)公用系統(tǒng)清單 </p> <p> 按照ISPE 基準指南《調(diào)試與確認》第二版,可根據(jù)系統(tǒng)影響產(chǎn)品質(zhì)量的能力將系統(tǒng)分為兩類，直接影響系統(tǒng)和非直接影響系統(tǒng)，我司目前已為多家制藥行業(yè)/醫(yī)療器械行業(yè)提供以下常見公用系統(tǒng)3Q認證服務：凈化空調(diào)系統(tǒng)（HVAC），潔凈廠房，倉庫及稱量間，制藥用水系統(tǒng)（純化水系統(tǒng)，注射用水系統(tǒng)），純蒸汽系統(tǒng)，工藝氣體系統(tǒng)（包括CO2系統(tǒng)，N2系統(tǒng)，壓縮空氣系統(tǒng)，O2系統(tǒng)），樓宇管理系統(tǒng)（BMS），環(huán)境監(jiān)測系統(tǒng)（EMS）系統(tǒng)，倉儲管理系統(tǒng)（WMS）旦霆科技擁有先進的驗證理念，成熟的驗證體系，完善的質(zhì)量體系，為您提供專業(yè)、質(zhì)量的3Q認證服務！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="江蘇3Q認證排名,3Q認證" src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175309137382812/4789865.png"></div><p> 離心機3Q認證內(nèi)容包括： </p> <p> IQ內(nèi)容: 1.技術(shù)類文件確認, 2.設備儀表校準確認, 3.安裝位置和安裝環(huán)境確認, 4.部件安裝確認, 5.公用系統(tǒng)連接確認和標識確認 </p> <p> OQ內(nèi)容：1.預確認(確認安裝確認是否完成,安裝確認中出現(xiàn)的偏差是否已關(guān)閉，2.設備操作SOP是否已審批完成)，3.啟動/關(guān)閉確認，4.按鍵功能確認，5.參數(shù)設置功能確認，6.轉(zhuǎn)速確認，7.計時器比對確認，8.溫度控制功能確認，9.升/降速時間確認，10。噪聲確認，11.報警/安全功能確認 </p> <p> PQ內(nèi)容：1.根據(jù)甲方SOP運行3次旦霆科技提供技術(shù)咨詢、3Q認證、驗證及檢測服務。在您不知道具體項目需求時為您擇優(yōu)推薦！廣東3Q認證服務第三方</p><p style="text-indent:25px">旦霆科技服務面向全國、3Q認證及其他項目均安排項目經(jīng)理，對項目質(zhì)量、質(zhì)量、進度及時監(jiān)督。保證項目質(zhì)量！江蘇3Q認證排名</p><p> 什么是性能確認，怎么做？ </p> <p> <br /> </p> <p> 3Q認證過程中性能確認應在安裝確認和運行確認成功完成之后執(zhí)行。性能確認可通過文件證明當設備、設施等與其他系統(tǒng)完成連接后能夠有效地可重復的發(fā)揮作用，即通過測試設施、設備等的產(chǎn)出物來證明它們的正確性。就工藝設備而言，性能確認實際上是通過實際負載生產(chǎn)的方法，考察其運行的可靠性、關(guān)鍵工藝參數(shù)的穩(wěn)定性和產(chǎn)出的產(chǎn)品的質(zhì)量均一性、重現(xiàn)性的一系列活動進行。 </p> <p> 性能確認前應考慮以下內(nèi)容： </p> <p> ① 確認安裝確認/運行確認報告已完成并審批，沒有未關(guān)閉的偏差或存在的偏差不影響性能確認； </p> <p> ② 用于完成性能確認測試的分析方法已經(jīng)計對其預期用途經(jīng)過了充分的驗證/確認； </p> <p> ③ 用于性能確認測試的所有實驗室設備和儀器均已經(jīng)過了充分的確認或校準。 </p> <p> 性能測試應包含以下內(nèi)容： </p> <p> ?性能測試經(jīng)常包括一些合理的“挑戰(zhàn)”檢測，確保系統(tǒng)“挑戰(zhàn)”后能繼續(xù)滿足工藝要求； </p> <p> ?性能測試將主要涉及工藝相關(guān)的關(guān)鍵工藝參數(shù)，如滅菌/除熱原周期確認、清潔挑戰(zhàn)測試、微生物挑戰(zhàn)測試、滿載熱穿透測試等內(nèi)容。關(guān)鍵工藝參數(shù)設定后，其實際生產(chǎn)運行時應在規(guī)定的范圍內(nèi)波動； </p> <p> ?輸出的質(zhì)量均一行、重現(xiàn)性：對輸出進行取樣檢測，各項質(zhì)量指標均在預定標準之內(nèi)。 </p> <p> <br /> 江蘇3Q認證排名</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、制藥設備等行業(yè)提供GXP合規(guī)咨詢、驗證服務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，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/2938914.html</p></div></div></div></div></div><div id="6wc0qoc" class="page-right twoColRt"><div id="k0igeay" class="box01 margin10 clearfix"><h3><a href="http://www.cdcfah.com/cp/">猜你喜歡</a></h3><div id="0uigmag" 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" 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</p></a></div><div id="ui8iy88" 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