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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>湖北CSV驗證咨詢公司,驗證咨詢公司</p><p><span>***更新：</span>2021-01-30 06:05:07</p><p><span id="click" >瀏覽次數(shù)：2次</span></p><a rel="nofollow" class="button">聯(lián)系我們</a></div></div><div id="wvxproq" 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="odfsubd" class="page-proshow02"><p class="title">詳細說明</p><div id="b7hbypw" class="box"><p><p> 什么是需求追溯矩陣，怎么做？ </p> <p> ISPE </p> <p> 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(fēng)險管理方法》提到：在系統(tǒng)生命周期的早期就應(yīng)該識別并糾正系統(tǒng)缺點，設(shè)計審査和可追溯性有助于保證系統(tǒng)符合預(yù)定用途，并且可以通過在早期識別缺點并解決問題來降低總體項目成本?！盙MP驗證咨詢服務(wù)過程中，需求追溯性矩陣（Requirements </p> <p> 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，湖北CSV驗證咨詢公司。 </p> <p> 需求追溯矩陣可起到如下作用： </p> <p> 1.設(shè)計需求經(jīng)過了驗證，湖北CSV驗證咨詢公司，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(fēng)險管理和設(shè)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(fēng)險評估； </p> <p> 4，湖北CSV驗證咨詢公司.確認對變更進行測試的范圍； </p> <p> 5.可在檢査和審査時快速準確地反應(yīng)。旦霆科技專業(yè)提供3Q認證、驗證服務(wù)及第三方檢測，技術(shù)實力雄厚，值得信賴！湖北CSV驗證咨詢公司</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="湖北CSV驗證咨詢公司,驗證咨詢公司" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637188431490947265/1428486.jpg"></div><p> 各項驗證與測試 </p> <p> <br /> </p> <p> 在各項驗證中，確認儀器的個別或整體性能，必須對儀器進行各項測試，測試是指系統(tǒng)中誤差的鑒定，當我們用已知(亦即可回溯)的標準品對儀器進行測試時，這個過程就稱之為校正。 </p> <p> <br /> </p> <p> 倘若鑒定后的誤差超出容許的范圍，就必須視情況對儀器進行調(diào)整的動作，并將原來偏差的部分調(diào)回標準的規(guī)格，這個過程我們可稱之為標準化。 </p> <p> <br /> </p> <p> 因此，儀器在驗證的過程中必須作哪些測試，必須選擇什么樣的標準品，就成為相當重要的課題。 </p> <p> <br /> </p> <p> 在各類檢測規(guī)范中，雖然對于分析儀器驗證的項目及其標準，有部分建議及規(guī)范供使用者遵循，但規(guī)范多是概念性的指引，對于詳細的驗證程序著墨不多，在驗證中，需根據(jù)現(xiàn)實情況做調(diào)整。 </p> <p> <br /> </p> <p> <br /> 湖北CSV驗證咨詢公司旦霆科技團隊成員掌握國內(nèi)為GMP、國標、ISO等相關(guān)法規(guī)，可為相關(guān)企業(yè)開展CSV認證等服務(wù)。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="湖北CSV驗證咨詢公司,驗證咨詢公司" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637188431524511718/1685851.jpg"></div><p> 同步驗證怎么做? </p> <p> GMP驗證咨詢服務(wù)中，同步驗證是在工藝常規(guī)運行的同時進行的驗證，即從工藝實際運行過程中獲得的數(shù)據(jù)來確立文件的依據(jù)，以證明某項工藝達到預(yù)計要求的活動。以水系統(tǒng)驗證為例，人們很難制造一個原水污染變化的環(huán)境條件來考察水系統(tǒng)的處理能力并根據(jù)原水污染程度來確定系統(tǒng)運行參數(shù)的調(diào)控范圍，這種條件下，同步驗證成了合理的選擇。這種情況下，工藝驗證的實際概念是特殊監(jiān)控條件下的試生產(chǎn)，而在試生產(chǎn)性的工藝驗證過程中，可以同時獲得兩方面的結(jié)果：一是合格的產(chǎn)品，二是驗證的結(jié)果，即“工藝重現(xiàn)性及可靠性”的證據(jù)。由于同步驗證與生產(chǎn)同時進行，因此該驗證方式可能帶來產(chǎn)品質(zhì)量方面的風(fēng)險，因此，企業(yè)應(yīng)根據(jù)自己的實際情況作出適當?shù)倪x擇，且在制定驗證方案并實施驗證時，特別注意這種方式的先決條件，分析主客觀的情況并預(yù)計驗證結(jié)果對保證質(zhì)量可靠性的風(fēng)險程度。 </p><p> OQ（運行確認）其主要是驗證儀器在空轉(zhuǎn)的情況下，在儀器設(shè)計的限度方位內(nèi)都能完成良好的運行，也就是一個較小限和較大限試驗的驗證。在這里需要使用到很多計量設(shè)備來確認儀器的一些功能。比如溫度，我們需要利用一個外界的溫度設(shè)備來驗證儀器本身設(shè)計的較高溫度和較低溫度，是否在設(shè)計范圍內(nèi)。還比如進樣體積，如果進樣量大可以使用已校正好的量具來確認；如果是體積較小，就需要通過間接方法來確認，如液相的進樣準確性，可以通過標準樣品連續(xù)進樣來確認。實驗室儀器設(shè)備--3Q驗證方案如果是一套完整的儀器（或設(shè)備）驗證方案，將包括4個部分，即4Q，分別為：DQ，3Q驗證咨詢中心，設(shè)計確認（DesignQualification），3Q驗證咨詢機構(gòu)，確認設(shè)備的設(shè)計符合用戶需求規(guī)范及相關(guān)法規(guī)。IQ，安裝確認（InstallationQualification），確認儀器文件、部件及安裝過程。OQ，運行確認（OperationalQualification），確認儀器在空轉(zhuǎn)狀態(tài)下，3Q驗證機構(gòu)，在操作的極限范圍內(nèi)能作正常的運轉(zhuǎn)。PQ，性能確認（PerformanceQualification），確認儀器載樣運行下是否符合標準規(guī)定。由于實驗室所用儀器均有儀器廠家研發(fā)設(shè)計而成，因此DQ（設(shè)計確認）在儀器驗證中可以不做，所以本帖所提3Q。旦霆科技不斷強化團隊管理、品牌價值及服務(wù)升級，以質(zhì)量的理念為企業(yè)提供高水準的CSV驗證服務(wù)！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="湖北CSV驗證咨詢公司,驗證咨詢公司" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637188431512958984/46711.jpg"></div><p> 驗證過程中對于儀表校準常見問題 </p> <p> 旦霆科技為企業(yè)提供GMP驗證咨詢中發(fā)現(xiàn)驗證過程中儀表校準常見偏差問題如下： </p> <p> 1．儀器 /儀表精密度不符合要求； </p> <p> 2. 需要校準的儀器 /儀表卻未進行校準； </p> <p> 3.校準證書的校準范圍不符合用戶使用需求； </p> <p> 4.新購儀器 /儀表無相應(yīng) 的校準報告或供應(yīng) 商提供的桕關(guān) 校準記錄 </p> <p> 5.儀器 /儀表超過校準日期，尚未校準仍在現(xiàn) 場使用，未做任何處置； </p> <p> 6. 校準合格儀器/儀表無標識或標識破損、模糊，無法識別； </p> <p> 7.為儀器/儀表出具校準證書的第三方機構(gòu)資質(zhì)不全或者資質(zhì)造假。旦霆科技擁有專業(yè)的驗證及檢測服務(wù)團隊、專業(yè)提供CSV證等服務(wù)，因為專業(yè)所以值得信賴！湖北CSV驗證咨詢公司</p><p style="text-indent:25px">旦霆科技作為專業(yè)的CSV驗證及第三方檢測供應(yīng)商，取得良好的客戶口碑，我們繼續(xù)保持高水準服務(wù)全國。湖北CSV驗證咨詢公司</p><p> 壓縮空氣系統(tǒng)驗證內(nèi)容 </p> <p> 旦霆科技為企業(yè)提供壓縮空氣系統(tǒng)GMP驗證咨詢，驗證交付物包括VP，SC，SRA，IQ，OQ，PQ，RTM以及VSR文件,其中IQ內(nèi)容包括：文件確認（圖紙確認/技術(shù)文件確認/材質(zhì)證明類文件確認/施工記錄/報告確認）,系統(tǒng)安裝環(huán)境確認, 儀器儀表校準確認,部件信息及安裝確認，公用介質(zhì)連接確認, 標識確認；OQ內(nèi)容包含：系統(tǒng)啟動和關(guān)閉，系統(tǒng)安全確認，權(quán)限確認，按鍵確認，參數(shù)設(shè)置功能確認，噪聲確認，歷史故障記錄確認，斷電/恢復(fù)確認；PQ內(nèi)容包括：水分測試，含油量測試，固體顆粒測試以及微生物測試，測試執(zhí)行3次 </p> <p> <br /> </p> <p> <br /> 湖北CSV驗證咨詢公司</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(xùn)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://m.cdcfah.com/cp/3076426.html</p></div></div></div></div></div><div id="aphuw8w" class="page-right twoColRt"><div id="i87mrd8" class="box01 margin10 clearfix"><h3><a href="http://m.cdcfah.com/cp/">猜你喜歡</a></h3><div id="wqn8jb8" class="recomPic likePro"><a href="http://m.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="smzr3ia" class="recomPic likePro"><a 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