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href="http://www.cdcfah.com/cp/second-yyby_yiliaoqiju/">醫(yī)療器具</a>?<a href="http://www.cdcfah.com/cp/third-yiliaoqiju_qtylqj/">其他醫(yī)療器具</a>?河北區(qū)SAP系統(tǒng)計算機驗證值得信賴旦霆生物科技供應</p><div id="okiyyec" class="leftbox clearfix"><h1>河北區(qū)SAP系統(tǒng)計算機驗證值得信賴旦霆生物科技供應</h1><div id="imu2sqe" class="proBig"><div id="aqgmca2" class="bigimg"><div><p class="pic"><img src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637174844711513672/4726673.jpg" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div><div id="2ucsqec" class="smallimg"><div><p class="pic"><img src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637174844711513672/4726673.jpg" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div></div><div id="kyw240c" 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>產品關鍵詞：</span>河北區(qū)SAP系統(tǒng)計算機驗證,計算機驗證</p><p><span>***更新：</span>2020-08-18 14:18:00</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="wmca4ea" 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="siyweky" class="page-proshow02"><p class="title">詳細說明</p><div id="kqoecyw" class="box"><p><p> 分析方法驗證怎么做？ </p> <p> 旦霆科技為企業(yè)提供分析方法驗證GMP驗證咨詢。分析方法驗證的目的是證明所采用的方法達到相應的檢測要求，河北區(qū)SAP系統(tǒng)計算機驗證，驗證的內容主要包括準確度、精密度、專屬性、檢測限、定量限、線性、范圍、粗放性（重現(xiàn)性）和耐用性 9 個方面。某一方法需到底須進行哪些項目的驗證，應根據(jù)實際情況而定，一般可分一下3種情況對待： </p> <p> 1. 對于直接引用有法定依據(jù)的方法，如藥典標準和部頒標準，*做系統(tǒng)適用性試驗即可。但若將法定方法用于測定新藥，或將某一品種的法定測定方法用于另一品種，就需進行系統(tǒng)的方法驗證。 </p> <p> 2. 對于已在一實驗室驗證過但需在另一個實驗室使用的分析方法，可采用對照試驗法。即取同一批樣品，按此方法在兩實驗室分別進行檢驗，將結果進行比較 ( 如用 t 檢驗法計算 ) ，河北區(qū)SAP系統(tǒng)計算機驗證，判斷是否有性差異。 </p> <p> 其他分析方法又分為4種類型，有不同的驗證要求：用于測定原料藥中主要成分或制劑中活性組分 ( 包括防腐劑 ) 的定量分析方法；用于測定原料藥中雜質或制劑中降解產物的分析方法，包括定量分析和限度試驗；用于測定性能特性 ( 如溶解度、溶出度 ) 的分析方法以及鑒別試驗，河北區(qū)SAP系統(tǒng)計算機驗證。 </p> <p> <br /> </p> <p> <br /> 旦霆科技擁有專業(yè)的驗證及檢測服務團隊、專業(yè)提供CSV證等服務，因為專業(yè)所以值得信賴！河北區(qū)SAP系統(tǒng)計算機驗證</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="河北區(qū)SAP系統(tǒng)計算機驗證,計算機驗證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637174844711513672/4726673.jpg"></div><p> 什么是需求追溯矩陣，怎么做？ </p> <p> ISPE GAMP5《良好自動化生產實踐指南-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點并解決問題來降低總體項目成本?！盙MP驗證咨詢服務過程中，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> <br /> </p> <p> 需求追溯矩陣可起到如下作用： </p> <p> <br /> </p> <p> 1.設計需求經過了驗證，并可以追溯到表明需求得到滿足的測試或驗證活動； </p> <p> <br /> </p> <p> 2.使得風險管理和設計審査流程更有效率； </p> <p> <br /> </p> <p> 判斷所提交的變更需求會產生什么樣的影響； </p> <p> <br /> </p> <p> 3.有助于對所提交的變更進行風險評估； </p> <p> <br /> </p> <p> 4.確認對變更進行測試的范圍； </p> <p> <br /> </p> <p> 5.可在檢査和審査時快速準確地反應。 </p> <p> <br /> </p> <p> <br /> 河北區(qū)電子監(jiān)管碼系統(tǒng)計算機驗證旦霆科技配備幾百套驗證及檢測儀器，專業(yè)的驗證及檢測服務團隊，專業(yè)提供驗證服務，服務區(qū)域覆蓋全國。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="河北區(qū)SAP系統(tǒng)計算機驗證,計算機驗證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637174843361640625/3264996.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；2. 需要校準的儀器 /儀表卻未進行校準；3. 校準證書的校準范圍不符合用戶使用需求；4.新購儀器 /儀表無相應的校準報告或供應商提供的桕關校準記錄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；6. 校準合格儀器/儀表無標識或標識破損、模糊，無法識別； 7.為儀器/儀表出具校準證書的第三方機構資質不全或者資質造假。 </p> <p> <br /> </p> <p> <br /> </p><p> 什么是運行確認，怎么做？ </p> <p> <br /> </p> <p> GMP驗證咨詢服務過程中運行確認是通過檢査、檢測等測試方式，用文件的形式證明設備的運行狀況符合設備出廠技術參數(shù)，能滿足設備的用戶需求說明和設計確認中的功能技術指標，是證明系統(tǒng)或設備各項技術參數(shù)能否達到設定要求的一系列活動。運行確認應包含以下內容： </p> <p> <br /> </p> <p> a.先決條件確認：確認安裝確認是否完成，設備/系統(tǒng)的操作/維護保養(yǎng)SOP是否完成； </p> <p> <br /> </p> <p> b.人員培訓確認：確認所有參與該方案執(zhí)行的人員經過培訓，掌握方案測試內容和方法，確保方案實施過程正確無誤； </p> <p> <br /> </p> <p> c.功能測試。設備的功能測試應依據(jù)設施、設備的設計標準制定，必須關注影響產品質量的關鍵參數(shù)，應在一種或一組運行條件之下進行，包括設備運行的上下限，必要時選擇“**差條件”測試應證實設備的功能滿足預定的運行范圍。 </p> <p> <br /> 旦霆科技作為專業(yè)的CSV驗證及第三方檢測供應商，取得良好的客戶口碑，我們繼續(xù)保持高水準服務全國。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="河北區(qū)SAP系統(tǒng)計算機驗證,計算機驗證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637174846292871094/5703031.jpg"></div><p> 驗證交付物包括VP，SC，SRA，IQ，OQ，PQ，RTM以及VSR文件，其中IQ內容包括：文件確認（圖紙確認/技術文件確認/材質證明類文件確認/施工記錄/報告確認）, 系統(tǒng)安全確認, 系統(tǒng)安裝環(huán)境確認, 公用介質連接確認, 儀器儀表校準確認, 潔凈區(qū)安裝確認, 空調系統(tǒng)部件安裝確認，PLC及HMI確認，標識確認以及I/O測試確認，OQ內容包括：系統(tǒng)啟動和關閉確認，登錄權限確認，HMI界面和基本功能確認，用戶權限確認，報警確認，斷電恢復確認，自動運行確認，風量及換氣次數(shù)確認測，壓差確認，高效過濾器及邊框完整性確認，溫度/相對濕度確，噪音確認測，照度確認，氣流流型確認，自凈時間確認，懸浮粒子確認，浮游菌確認，沉降菌確認；PQ內容包括：溫度/相對濕度確認，懸浮粒子確認，浮游菌確認，沉降菌確認測試以及表面微生物，動態(tài)執(zhí)行三次。旦霆科技可提供CSV認證等驗證檢測服務。廣納良言，吸取客戶有效意見、致力于為客戶更好的服務。河北區(qū)SAP系統(tǒng)計算機驗證</p><p style="text-indent:25px">旦霆科技保證測試驗證數(shù)據(jù)真實、測試人員專業(yè)、性價比高。為客戶提供CSV驗證服務及技術咨詢！河北區(qū)SAP系統(tǒng)計算機驗證</p><p> 驗證交付物包括VP，SC，SRA，IQ，OQ，PQ，RTM以及VSR文件，其中IQ內容包括：文件確認（圖紙確認/技術文件確認/材質證明類文件確認/施工記錄/報告確認）, 系統(tǒng)安全確認, 系統(tǒng)安裝環(huán)境確認, 公用介質連接確認, 儀器儀表校準確認, 潔凈區(qū)安裝確認, 空調系統(tǒng)部件安裝確認，PLC及HMI確認，標識確認以及I/O測試確認，OQ內容包括：系統(tǒng)啟動和關閉確認，登錄權限確認，HMI界面和基本功能確認，用戶權限確認，報警確認，斷電恢復確認，自動運行確認，風量及換氣次數(shù)確認測，壓差確認，高效過濾器及邊框完整性確認，溫度/相對濕度確，噪音確認測，照度確認，氣流流型確認，自凈時間確認，懸浮粒子確認，浮游菌確認，沉降菌確認；PQ內容包括：溫度/相對濕度確認，懸浮粒子確認，浮游菌確認，沉降菌確認測試以及表面微生物，動態(tài)執(zhí)行三次。 </p> <p> 旦霆科技為企業(yè)提供空調系統(tǒng)與潔凈廠房GMP驗證咨詢河北區(qū)SAP系統(tǒng)計算機驗證</p><p style="text-indent:25px">旦霆生物科技（上海）有限公司成立于2014-04-21，是一家服務型的公司。公司業(yè)務分為[ "GMP驗證咨詢與服務", "計算機化系統(tǒng)驗證", "壓縮空氣檢測", "潔凈室檢測" ]等，目前不斷進行創(chuàng)新和服務改進，為客戶提供質量的產品和服務。公司秉持誠信為本的經營理念，在醫(yī)藥、保養(yǎng)深耕多年，以技術為先導，以自主產品為**，發(fā)揮人才優(yōu)勢，打造醫(yī)藥、保養(yǎng)質量品牌。公司自成立以來發(fā)展迅速，業(yè)務不斷發(fā)展壯大，年營業(yè)額度達到700-1000萬元，未來我們將不斷進行創(chuàng)新和改進，讓企業(yè)發(fā)展再上新高。</p></p><br /><p>文章來源地址: http://www.cdcfah.com/cp/957098.html</p></div></div></div></div></div><div id="usqgm4u" class="page-right twoColRt"><div id="ou20eci" class="box01 margin10 clearfix"><h3><a href="http://www.cdcfah.com/cp/">猜你喜歡</a></h3><div id="4o2wca2" 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="2ywuiom" class="recomPic likePro"><a 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