河北區(qū)ELN系統(tǒng)計算機驗證歡迎來電旦霆生物科技供應(yīng)-b2b網(wǎng)站_b2b電子商務(wù)平臺【買產(chǎn)品】-上?？谄蚴称酚邢薰?/title><meta name="description" content="空調(diào)系統(tǒng)與潔凈室驗證內(nèi)容旦霆科技為企業(yè)提供空調(diào)系統(tǒng)與潔凈廠房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"><meta name="keywords" content="河北區(qū)ELN系統(tǒng)計算機驗證,計算機驗證"><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 name="baidu-site-verification" content="OBVzrC9aaQ" /> <meta http-equiv="Cache-Control" 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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)ELN系統(tǒng)計算機驗證歡迎來電旦霆生物科技供應(yīng)</p><div id="a26gomy" class="leftbox clearfix"><h1>河北區(qū)ELN系統(tǒng)計算機驗證歡迎來電旦霆生物科技供應(yīng)</h1><div id="oo2oqgu" class="proBig"><div id="s44m2ay" class="bigimg"><div><p class="pic"><img src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637174846787929688/6186335.jpg" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div><div id="4aqcioo" class="smallimg"><div><p class="pic"><img src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637174846787929688/6186335.jpg" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div></div><div id="w2oq6oy" 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>河北區(qū)ELN系統(tǒng)計算機驗證,計算機驗證</p><p><span>***更新：</span>2020-08-18 08:13:19</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="mm2ouww" 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="k2qsake" class="page-proshow02"><p class="title">詳細說明</p><div id="agm4gaw" class="box"><p><p> 空調(diào)系統(tǒng)與潔凈室驗證內(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： </p> <p> 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)安全確認, 系統(tǒng)安裝環(huán)境確認, 公用介質(zhì)連接確認, 儀器儀表校準確認, 潔凈區(qū)安裝確認, 空調(diào)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(nèi)容包括：系統(tǒng)啟動和關(guān)閉確認，登錄權(quán)限確認，HMI界面和基本功能確認，用戶權(quán)限確認，報警確認，斷電恢復確認，自動運行確認，河北區(qū)ELN系統(tǒng)計算機驗證，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，河北區(qū)ELN系統(tǒng)計算機驗證，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，河北區(qū)ELN系統(tǒng)計算機驗證，浮游菌確認，沉降菌確認；PQ內(nèi)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> <br /> </p> <p> <br /> 旦霆科技短時間內(nèi)快速發(fā)展為國內(nèi)**的GMP咨詢公司，持續(xù)為新老客戶提供質(zhì)量專業(yè)的CSV認證服務(wù)！河北區(qū)ELN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)ELN系統(tǒng)計算機驗證,計算機驗證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637174846787929688/6186335.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(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)安全確認, 系統(tǒng)安裝環(huán)境確認, 公用介質(zhì)連接確認, 儀器儀表校準確認, 潔凈區(qū)安裝確認, 空調(diào)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(nèi)容包括：系統(tǒng)啟動和關(guān)閉確認，登錄權(quán)限確認，HMI界面和基本功能確認，用戶權(quán)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(nèi)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(diào)系統(tǒng)與潔凈廠房GMP驗證咨詢河北區(qū)ERP系統(tǒng)計算機驗證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="河北區(qū)ELN系統(tǒng)計算機驗證,計算機驗證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637174842157939454/5189243.jpg"></div><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> 常見驗證文件并釋意 </p> <p> GMP驗證咨詢服務(wù)常見驗證交付物釋意如下：用戶需求（URS）：指使用方對廠房、設(shè)施、設(shè)備或其他系統(tǒng)提出的要求及期望；驗證總計劃（VMP）：是對整個驗證計劃的概述；驗證計劃（VP）：針對于大型復雜項目，驗證總計劃將整個項目再劃分成多個小項目，按照其特點來編寫驗證計劃和方案；風險評估（RA）：一種用于評估并描述系統(tǒng)、設(shè)備或工藝的關(guān)鍵方面（CQA/CPP），以確定系統(tǒng)、設(shè)備驗證的范圍和程度的方法；設(shè)計確認（DQ）：在設(shè)備建造前，對設(shè)備設(shè)計文件（用戶需求說明、功能設(shè)計說明、詳細設(shè)計說明等）進行檢査確保能夠完全滿足用戶需求說明及GMP中的所有要求；安裝確認（IQ）：為確認安裝或改造后的設(shè)施、系統(tǒng)和設(shè)備符合已批準的設(shè)計及制造商建議所作的各種查證及文件記錄，新的或改造的廠房、設(shè)施、設(shè)備需進行安裝確認；運行確認（OQ）：應(yīng)當證明廠房、設(shè)施、設(shè)備的運行符合設(shè)計標準；性能確認（PQ）：性能確認目的在于證明廠房、設(shè)施、設(shè)備在正常操作方法和工藝條件下能夠持續(xù)符合標準，性能確認方案的制定應(yīng)依據(jù)已有的生產(chǎn)工藝、設(shè)施和設(shè)備的相關(guān)知識，使用生產(chǎn)物料、適當?shù)奶娲坊蛘吣M產(chǎn)品來進行試驗/測試；需求追溯矩陣。 </p> <p> <br /> 旦霆科技配備專業(yè)的質(zhì)量部，進行驗證審核、報告審核等質(zhì)量監(jiān)管，專業(yè)提供CSV驗證及咨詢服務(wù)，值得信賴！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="河北區(qū)ELN系統(tǒng)計算機驗證,計算機驗證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637174846131826172/197945.jpg"></div><p> 驗證參考的法規(guī)文獻有哪些？ </p> <p> <br /> </p> <p> GMP驗證咨詢服務(wù)參考的法規(guī)/指南文件如下： </p> <p> <br /> </p> <p> (NMPA) 2010年版GMP及附錄確認與驗證 </p> <p> <br /> </p> <p> (NMPA) 2003藥品生產(chǎn)驗證指南 </p> <p> <br /> </p> <p> (EU) 歐盟GMP附錄15:《確認與驗證》2015.10 </p> <p> <br /> </p> <p> (EMA)《制劑工藝驗證指南-監(jiān)管性遞交需提供的信息和數(shù)據(jù)》2014.08 </p> <p> <br /> </p> <p> (FDA) 聯(lián)邦法規(guī)第21篇第210 211部分，成品藥的現(xiàn)行生產(chǎn)質(zhì)量管理規(guī)范 </p> <p> <br /> </p> <p> (FDA)《工藝驗證：一般原則與慣例》2011.01 </p> <p> <br /> </p> <p> (PIC/S)GMP指南，藥用產(chǎn)品良好生產(chǎn)實踐指南 </p> <p> <br /> </p> <p> (PIC/S) 驗證指南文件 </p> <p> <br /> </p> <p> (TGA)GMP，藥用產(chǎn)品良好生產(chǎn)實踐指南 </p> <p> <br /> </p> <p> (PDA)第60號技術(shù)報告：《工藝驗證-一個生命周期方式》2013.02 </p> <p> <br /> </p> <p> (ISPE)指南第5卷：調(diào)試與確認（2nd）2019.06 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！河北區(qū)ELN系統(tǒng)計算機驗證</p><p style="text-indent:25px">CSV認證服務(wù)選旦霆科技，多年的驗證服務(wù)經(jīng)驗，成熟的驗證體系，品質(zhì)優(yōu)先，良心推薦。河北區(qū)ELN系統(tǒng)計算機驗證</p><p> 冷鏈運輸系統(tǒng)驗證 </p> <p> 旦霆科技為企業(yè)提供冷鏈運輸系統(tǒng)GMP驗證咨詢冷鏈運輸倉儲物流系統(tǒng)中一般確定為直接影響系統(tǒng)的有：庫房、設(shè) 施、設(shè) 備、保溫包裝、運輸工具和監(jiān)控儀器等系統(tǒng)驗證，對于物流系統(tǒng)的風險評估，首先需要確定運輸的環(huán)境，分析運輸過程中可能對產(chǎn) 品（藥品或包材）產(chǎn)生的危害，驗證應(yīng)重點考慮環(huán)境溫度變化、冷藏藥品穩(wěn) 定性數(shù)據(jù)、運輸或配送的相關(guān)信息、包裝部件的設(shè)計等。冷鏈運輸車的安裝確認主要是冷藏車的確認，包括制冷系統(tǒng)的安裝，自動控制系統(tǒng)的安裝，以及設(shè)備狀態(tài)及關(guān)鍵儀表的校準狀態(tài)的確認；運行確認一般在實驗室內(nèi) 完成，這些測試應(yīng)該能夠保證包裝和運輸方案能夠維持產(chǎn)品所處的內(nèi)部環(huán)境。測試應(yīng)該包括冷點和熱點的確認，震蕩測試，受壓測試等。一般包括以下測試項：安裝確認報告以及運行確認方案已完成，冬季、夏季溫度曲線確認，產(chǎn) 品 ** 大 /**小裝載/季節(jié)測試，溫度比對測試以及按照風險評估結(jié)果的其他測試項目；性能測試包括以下內(nèi)容：確認安裝確認和運行確認已經(jīng)完成，性能確認方案得到批準，SOP狀態(tài)應(yīng)為已批準，測試儀器儀表校準確認，典型產(chǎn)品裝載按照運輸路線、運輸類型、運輸季節(jié)及運輸時間等運輸條件確認，溫度監(jiān)測和計算機系統(tǒng)數(shù)據(jù)備份的確認。 </p> <p> <br /> 河北區(qū)ELN系統(tǒng)計算機驗證</p><p style="text-indent:25px">旦霆生物科技（上海）有限公司屬于醫(yī)藥、保養(yǎng)的高新企業(yè)，技術(shù)力量雄厚。公司致力于為客戶提供安全、質(zhì)量有保障的質(zhì)量產(chǎn)品及服務(wù)，是一家私營有限責任公司企業(yè)。公司業(yè)務(wù)涵蓋[ "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" ]，價格合理，品質(zhì)有保證，深受廣大客戶的歡迎。旦霆科技自成立以來，一直堅持走正規(guī)化、專業(yè)化路線，得到了廣大客戶及社會各界的普遍認可與大力支持。</p></p><br /><p>文章來源地址: http://www.cdcfah.com/cp/954136.html</p></div></div></div></div></div><div id="y2oagig" class="page-right twoColRt"><div id="2uwao4e" class="box01 margin10 clearfix"><h3><a href="http://www.cdcfah.com/cp/">猜你喜歡</a></h3><div id="umygay2" 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="mws86wg" class="recomPic likePro"><a 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