安徽96孔板離心機3Q認證誠信服務旦霆生物科技供應-b2b網(wǎng)站_b2b電子商務平臺【買產(chǎn)品】-上?？谄蚴称酚邢薰?/title><meta name="description" content="倉庫Q認證內(nèi)容包括：PQ內(nèi)容：1.預確認(確認運行確認是否完成，2.安裝運行確認中出現(xiàn)的偏差是否已關(guān)閉)，3，安徽96孔板離心機3Q認證.滿載溫濕度分布確認，4.開門挑戰(zhàn)試驗，5.斷電挑戰(zhàn)試驗OQ內(nèi)容：1.預確認(確認安裝確認是否完成,安裝"><meta name="keywords" content="安徽96孔板離心機3Q認證"><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" content="no-transform" /> <meta 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clearfix"><h1>安徽96孔板離心機3Q認證誠信服務旦霆生物科技供應</h1><div id="xwyf8n3" class="proBig"><div id="tzby3uo" class="bigimg"><div><p class="pic"><img src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175309141064453/8232012.jpg" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div><div id="2f2zt8b" class="smallimg"><div><p class="pic"><img src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175309141064453/8232012.jpg" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div></div><div id="2auqs4h" 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>安徽96孔板離心機3Q認證</p><p><span>***更新：</span>2020-05-22 18:29:11</p><p><span id="click" >瀏覽次數(shù)：5次</span></p><a rel="nofollow" class="button">聯(lián)系我們</a></div></div><div id="vphjl9q" 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="ujgn2o8" class="page-proshow02"><p class="title">詳細說明</p><div id="wlsuwvu" class="box"><p><p> 倉庫Q認證內(nèi)容包括： </p> <p> PQ內(nèi)容：1.預確認(確認運行確認是否完成，2.安裝運行確認中出現(xiàn)的偏差是否已關(guān)閉)，3，安徽96孔板離心機3Q認證. 滿載溫濕度分布確認，4.開門挑戰(zhàn)試驗，5.斷電挑戰(zhàn)試驗 </p> <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.空調(diào)系統(tǒng)開啟/關(guān)閉確認，4.空載溫濕度分布確認 <span style="font-size:12px;"></span> </p> </p> <p> IQ內(nèi)容: 1，安徽96孔板離心機3Q認證.文件確認（圖紙確認，技術(shù)文件確認）,2，安徽96孔板離心機3Q認證.儀器/儀表校準確認，3.部件安裝確認，4.公用系統(tǒng)連接確認和標識確認 </p> <p> <br /> </p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="安徽96孔板離心機3Q認證" src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175309141064453/8232012.jpg"></div><p> 什么是風險評估，怎么做？ </p> <p> 3Q認證過程中風險評估是為了簡化驗證和減少不必要的確認活動，應通過風險評估的方法確定待確認的設備或系統(tǒng)以及每個系統(tǒng)所需要的驗證范圍和程度。風險評估是一種用于評估并描述系統(tǒng)、設備或工藝的關(guān)鍵方面，以構(gòu)成編寫驗證方案的基礎(chǔ)的方法。在定義關(guān)鍵設計控制(CAs/CDEs)后，采用失效模式影響分析（Failure mode effects analysis, FMEA)或其他風險評估工具來找出可能失效的影響。風險評估結(jié)果以表格形式提供，每一行分別對應一個需求或功能可能失效的風險，每個風險具有對應編號。在表格中應結(jié)合URS要求，以及設計確認結(jié)果列出關(guān)鍵設計控制(CAs/CDEs)所有失效模式，并分析其失效的可能性，危害嚴重性以及失效的可檢測性，將失效模式分為高中低三級，并制定相應的風險降低策略。風險降低策略可包含驗證策略的提出，制作針對系統(tǒng)的檢查表，制定相應的SOP（如設備/儀器操作，人員管理，對關(guān)鍵功能模塊進行定期維護，定期再驗證等）。 </p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="安徽96孔板離心機3Q認證" src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637188431513144531/7614493.jpg"></div><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點并解決問題來降低總體項目成本。” </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(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> <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(chǎn)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> 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> <br /> </p> <p> <br /> </p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="安徽96孔板離心機3Q認證" src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175309149550781/2262639.png"></div></p><br /><p>文章來源地址: http://www.cdcfah.com/cp/7198.html</p></div></div></div></div></div><div id="3t7k7rg" class="page-right twoColRt"><div id="fvs2x2e" class="box01 margin10 clearfix"><h3><a 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