<section data-role="outer" label="Powered by 135editor.com" style=""> <p style="vertical-align:inherit;"> <img src="https://bcn.135editor.com/files/users/474/4749834/202206/mF7evdth_PnWF.jpg" style="max-width: 100% !important;box-sizing:border-box;vertical-align: inherit; width: 100%;" alt="公众号首图.jpg" data-ratio="0.42685185185185187" data-w="1080"/> </p> <section class="_135editor" data-tools="135编辑器" data-id="114488"> <section style="margin: 20px auto;"> <section> <section style="padding-right: 10px;"> <section style="display: flex;justify-content: flex-start;margin-bottom: -3px;"> <section style="box-sizing:border-box;width: 70px;height: 6px;background-color: #ec651c;"></section> </section> <section style="padding: 30px 15px 25px;background: linear-gradient(to bottom,#e6f9ff,#ffffff);"> <section data-autoskip="1" class="135brush" style="text-align: justify;line-height:1.75em;letter-spacing: 1.5px;font-size:14px;color:#333;background: transparent;"> <p style="text-align:center;color: #333333; vertical-align: inherit; line-height: 2em;" align="center"> <span style="background-color: transparent; caret-color: red; font-size: 14px; letter-spacing: 1px; color: #323232; font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif;">根据市场行业调查</span> </p> <p style="text-align:center;color: #333333; vertical-align: inherit; line-height: 2em;" align="center"> <span style="background-color: transparent; text-align: justify; caret-color: red;">风险评估需要大约3个月时间</span> </p> <p style="text-align:center;color: #333333; vertical-align: inherit; line-height: 2em;" align="center"> <span style="background-color: transparent; text-align: justify; caret-color: red;">对于很多忙碌的科研人员</span> </p> <p style="text-align:center;color: #333333; vertical-align: inherit; line-height: 2em;" align="center"> <span style="background-color: transparent; text-align: justify; caret-color: red;">3个月的小组会议太过漫长</span> </p> <p style="text-align:center;color: #333333; vertical-align: inherit; line-height: 2em;" align="center"> <br/> </p> <p style="text-align:center;color: #333333; vertical-align: inherit; line-height: 2em;" align="center"> <img src="https://bcn.135editor.com/files/users/474/4749834/202206/eAOvFTbq_mMyU.png" style="vertical-align:inherit;" alt="下载.png" draggable="false" data-ratio="0.6416938110749185" data-w="307"/> </p> <p style="text-align:center;color: #333333; vertical-align: inherit; line-height: 2em;" align="center"> <br/> </p> <p style="text-align:center;color: #333333; vertical-align: inherit; line-height: 2em;" align="center"> <span style="background-color: transparent; caret-color: red; font-size: 14px; letter-spacing: 1px; color: #323232; font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif;">LeanQbd是一款<br/></span> </p> <p style="text-align:center;color: #333333; vertical-align: inherit; line-height: 2em;" align="center"> <span style="background-color: transparent; caret-color: red; font-size: 14px; letter-spacing: 1px; color: #323232; font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif;">智能QbD风险评估工具</span> </p> <p style="text-align:center;color: #333333; vertical-align: inherit; line-height: 2em;" align="center"> <span style="background-color: transparent; caret-color: red; font-size: 14px; letter-spacing: 1px; color: #323232; font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif;">由智能算法提供支持</span> </p> <p style="text-align:center;color: #333333; vertical-align: inherit; line-height: 2em;" align="center"> <span style="background-color: transparent; caret-color: red; font-size: 14px; letter-spacing: 1px; color: #323232; font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif;">可以在很短的时间内进行风险评估</span> </p> <p style="text-align:center;color: #333333; vertical-align: inherit; line-height: 2em;" align="center"> <span style="background-color: transparent; caret-color: red; font-size: 14px; letter-spacing: 1px; color: #323232; font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif;">通过已有Lean QbD™模板</span> </p> <p style="text-align:center;color: #333333; vertical-align: inherit; line-height: 2em;" align="center"> <span style="background-color: transparent; caret-color: red; font-size: 14px; letter-spacing: 1px; color: #323232; font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif;">您可以随时开始风险评估</span> </p> </section> </section> </section> </section> </section> </section> <section data-role="paragraph" class="_135editor"> <p style="vertical-align:inherit;"> <br/> </p> </section> <section class="_135editor" data-role="title" data-tools="135编辑器" data-id="113247"> <section style="margin: 20px auto;"> <section style="display: flex;justify-content: center;"> <section style="padding-bottom: 20px;"> <section style="padding: 0 40px;"> <section style="box-sizing:border-box;width: 65px;height: 65px;background: radial-gradient(circle,#c7e5f8,#ebf6fd,#ffffff);border-radius: 100%;"></section> </section> <section style="margin-top: -45px;"> <section style="display: flex;justify-content: center;align-items: center;" hm_fix="354:322"> <section style="font-size: 20px;text-align: justify;color: #283e66;"> <span style="font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; font-size: 18px;"><strong>开发商介绍</strong></span> </section> </section> </section> </section> </section> </section> </section> <section class="_135editor" data-tools="135编辑器" data-id="114488"> <section style="margin: 20px auto;"> <section> <section style="padding-right: 10px; box-sizing: border-box;"> <section style="display: flex;justify-content: flex-start;margin-bottom: -3px;"> <section style="box-sizing:border-box; width: 70px; height: 6px; background-color: #ec651c; overflow: hidden;"></section> </section> <section style="padding: 30px 15px 25px;background: linear-gradient(to bottom,#e6f9ff,#ffffff);"> <section data-autoskip="1" class="135brush" style="text-align: justify;line-height:1.75em;letter-spacing: 1.5px;font-size:14px;color:#333;background: transparent;"> <p style="text-align:left; color: #333333; vertical-align: inherit; line-height: 2em;" align="left"> <span style="background-color: transparent; caret-color: red; font-size: 14px; letter-spacing: 1px; color: #323232; font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif;"></span><span style="background-color: transparent; text-align: justify; caret-color: red; font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; font-size: 14px; letter-spacing: 1px;">QbDWorks是一个科学家社区，他们在这里分享他们真实的QbD问题和实践。</span><span style="font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; letter-spacing: 1px; background-color: transparent; text-align: justify; caret-color: red;">LeanQbD软件是我们的QbDWorks社区分享的成功与失败经验的结晶。 </span> </p> <p style="text-align:left; color: #333333; vertical-align: inherit; line-height: 2em;" align="left"> <br/> </p> <p style="text-align:center; color: #333333; vertical-align: inherit; line-height: 2em;" align="center"> <img src="https://bcn.135editor.com/files/users/474/4749834/202206/MRPX4Hp2_9PLC.png" style="vertical-align:inherit;" alt="logo3.png" draggable="false" data-ratio="0.285140562248996" data-w="249"/> </p> <p style="text-align:left; color: #333333; vertical-align: inherit; line-height: 2em;" align="left"> <br/> </p> <p style="line-height: 2em;"> <span style="font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; font-size: 14px; letter-spacing: 1px;">LeanQbD使科学家能够轻松的实施QbD (</span><strong><span style="font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; font-size: 14px; letter-spacing: 1px;">质量源于设计</span></strong><span style="font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; font-size: 14px; letter-spacing: 1px;">)。</span> </p> <p style="line-height: 2em;"> <strong><span style="font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; letter-spacing: 1px; background-color: transparent; caret-color: red;">质量源于设计</span></strong><span style="font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; letter-spacing: 1px; background-color: transparent; caret-color: red;">是一种系统的开发方法，它从预先确定的目标开始，强调产品和过程的理解和过程控制，基于健全的科学和质量风险管理。</span><br/> </p> <p style="line-height: 2em;"> <br/> </p> <p style="line-height: 2em;"> <span style="font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; font-size: 14px; letter-spacing: 1px;">LeanQbD是很多</span><strong><span style="font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; font-size: 14px; letter-spacing: 1px;">生物技术</span></strong><span style="font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; font-size: 14px; letter-spacing: 1px;">、</span><strong><span style="font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; font-size: 14px; letter-spacing: 1px;">制药</span></strong><span style="font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; font-size: 14px; letter-spacing: 1px;">、</span><strong><span style="font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; font-size: 14px; letter-spacing: 1px;">医疗器械</span></strong><span style="font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; font-size: 14px; letter-spacing: 1px;">相关企业和组织的绝佳选择，截至目前为止，Merck、Lilly、Medtronic、Dr. Reddy's、Sun Pharma和FDA等著名公司都在使用LeanQbD来进行风险评估。</span> </p> </section> </section> </section> </section> </section> </section> <section data-role="paragraph" class="_135editor"> <p> <br/> </p> </section> <section class="_135editor" data-role="title" data-tools="135编辑器" data-id="113247"> <section style="margin: 20px auto;"> <section style="display: flex;justify-content: center;"> <section style="padding-bottom: 20px; box-sizing: border-box;"> <section style="padding: 0px 40px; box-sizing: border-box;"> <section style="box-sizing:border-box; width: 65px; height: 65px; background: radial-gradient(circle, #c7e5f8, #ebf6fd, #ffffff); border-radius: 100%; overflow: hidden;"></section> </section> <section style="margin-top: -45px;"> <section style="display: flex;justify-content: center;align-items: center;" hm_fix="354:322"> <section style="font-size: 20px;text-align: justify;color: #283e66;"> <span style="font-size: 18px; font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif;"><strong>产品功能</strong></span> </section> </section> </section> </section> </section> </section> </section> <section class="_135editor" data-tools="135编辑器" data-id="114488"> <section style="margin: 20px auto;"> <section> <section style="padding-right: 10px; box-sizing: border-box;"> <section style="display: flex;justify-content: flex-start;margin-bottom: -3px;"> <section style="box-sizing:border-box; width: 70px; height: 6px; background-color: #ec651c; overflow: hidden;"></section> </section> <section style="padding: 30px 15px 25px;background: linear-gradient(to bottom,#e6f9ff,#ffffff);"> <section data-autoskip="1" class="135brush" style="text-align: justify;line-height:1.75em;letter-spacing: 1.5px;font-size:14px;color:#333;background: transparent;"> <section class="_135editor" data-role="title" data-tools="135编辑器" data-id="94125"> <section style="padding: 5px; text-align: center; box-sizing: border-box;" hm_fix="396:754"> <section style="display: inline-block;"> <section class="135brush" data-brushtype="text" style="font-size: 16px; color: #283e66; letter-spacing: 1px; padding: 6px 0px 4px; box-sizing: border-box;"> <p style="vertical-align: inherit; line-height: 1.75em; letter-spacing: 1px;"> <strong><span style="font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif;">产品包含</span></strong> </p> </section> <section style="box-sizing:border-box; width: 3.5em; margin: 4px auto; border-bottom: 1px solid #333333; height: 1px; overflow: hidden;"></section> <section style="box-sizing:border-box; width: 2.5em; margin: 0px auto; border-bottom: 1px solid #333333; height: 1px; overflow: hidden;"> <br/> </section> </section> </section> </section> <section data-role="list" class="_135editor" style="color: #ff0000;"> <ul class="list-paddingleft-2" style="list-style-type: square;"> <li> <p style="line-height: 2em;"> <span style="font-size: 14px; color: #000000; letter-spacing: 1px; font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif;">QbD风险评估软件</span> </p> </li> <li> <p style="line-height: 2em;"> <span style="font-size: 14px; color: #000000; letter-spacing: 1px; font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif;">一个 QTPP-CQA-CPP模板：立即发布的平板电脑模板</span> </p> </li> <li> <p style="line-height: 2em;"> <span style="font-size: 14px; color: #000000; letter-spacing: 1px; font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif;">一个 QTPP-CQA-CPP模板：生物制剂的aMab模板（可购买）</span> </p> </li> <li> <p style="line-height: 2em;"> <span style="font-size: 14px; color: #000000; letter-spacing: 1px; font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif;">更多模板与产品模板定制</span> </p> </li> </ul> </section> <section data-role="paragraph" class="_135editor"> <p style="line-height: 2em;"> <span style="font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; font-size: 14px; letter-spacing: 1px;">这些模板是根据FDA和行业案例研究构建的，您可以轻松地为您的项目进行编辑。通过这些模板将帮助您节省会议时间来收集候选人QTPP、CQA和CPP。</span> </p> </section> <section data-role="paragraph" class="_135editor"> <p> <br/> </p> </section> <section class="_135editor" data-role="title" data-tools="135编辑器" data-id="94125"> <section style="padding: 5px; text-align: center; box-sizing: border-box;" hm_fix="396:754"> <section style="display: inline-block;"> <section class="135brush" data-brushtype="text" style="font-size: 16px; color: #283e66; letter-spacing: 1px; padding: 6px 0px 4px; box-sizing: border-box;"> <p style="vertical-align: inherit; line-height: 1.75em; letter-spacing: 1px;"> <strong><span style="font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif;">QbD风险评估功能</span></strong> </p> </section> <section style="box-sizing:border-box; width: 3.5em; margin: 4px auto; border-bottom: 1px solid #333333; height: 1px; overflow: hidden;"></section> <section style="box-sizing:border-box; width: 2.5em; margin: 0px auto; border-bottom: 1px solid #333333; height: 1px; overflow: hidden;"> <br/> </section> </section> </section> </section> <section data-role="paragraph" class="_135editor"> <p style="text-align:center;" align="center"> <img src="https://bcn.135editor.com/files/users/474/4749834/202206/W9r9yO4L_HTSa.jpg" style="max-width: 100% !important;box-sizing:border-box;vertical-align: inherit; width: 100%;" alt="QbD风险评估.jpg" draggable="false" data-ratio="0.4462890625" data-w="1024"/> </p> </section> <section data-role="list" class="_135editor" style="color: #ff0000;"> <ul class="list-paddingleft-2" style="list-style-type: square;"> <li> <p style="line-height: 2em;"> <span style="font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; font-size: 14px; letter-spacing: 1px; color: #000000;">简化过于复杂的风险评估过程</span> </p> </li> <li> <p style="line-height: 2em;"> <span style="font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; font-size: 14px; letter-spacing: 1px; color: #000000;">消除非增值会议</span> </p> </li> <li> <p style="line-height: 2em;"> <span style="font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; font-size: 14px; letter-spacing: 1px; color: #000000;">通过节省科学家的时间并提出正确的问题来获得科学家的支持。</span> </p> </li> <li> <p style="line-height: 2em;"> <span style="font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; font-size: 14px; letter-spacing: 1px; color: #000000;">轻松促进QbD会议并缩短准备时间</span> </p> </li> <li> <p style="line-height: 2em;"> <span style="font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; font-size: 14px; letter-spacing: 1px; color: #000000;">直观地分享和交流风险评估结果</span> </p> </li> <li> <p style="line-height: 2em;"> <span style="font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; font-size: 14px; letter-spacing: 1px; color: #000000;">在整个开发生命周期中更新风险指数很容易。</span> </p> </li> <li> <p style="line-height: 2em;"> <span style="font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; font-size: 14px; letter-spacing: 1px; color: #000000;">使用实践风险评估模板节省时间。</span> </p> </li> <li> <p style="line-height: 2em;"> <span style="font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; font-size: 14px; letter-spacing: 1px; color: #000000;">……并带领您的QbD计划取得成功”</span> </p> </li> </ul> </section> </section> </section> </section> </section> </section> </section> <section data-role="paragraph" class="_135editor"> <p> <br/> </p> </section> <section class="_135editor" data-role="title" data-tools="135编辑器" data-id="113247"> <section style="margin: 20px auto;"> <section style="display: flex;justify-content: center;"> <section style="padding-bottom: 20px; box-sizing: border-box;"> <section style="padding: 0px 40px; box-sizing: border-box;"> <section style="box-sizing:border-box; width: 65px; height: 65px; background: radial-gradient(circle, #c7e5f8, #ebf6fd, #ffffff); border-radius: 100%; overflow: hidden;"></section> </section> <section style="margin-top: -45px;"> <section style="display: flex;justify-content: center;align-items: center;" hm_fix="354:322"> <section style="font-size: 20px;text-align: justify;color: #283e66;"> <span style="font-size: 18px; font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif;"><strong>产品优势</strong></span> </section> </section> </section> </section> </section> </section> </section> <section class="_135editor" data-tools="135编辑器" data-id="114488"> <section style="margin: 20px auto;"> <section> <section style="padding-right: 10px; box-sizing: border-box;"> <section style="display: flex;justify-content: flex-start;margin-bottom: -3px;"> <section style="box-sizing:border-box; width: 70px; height: 6px; background-color: #ec651c; overflow: hidden;"></section> </section> <section style="padding: 30px 15px 25px;background: linear-gradient(to bottom,#e6f9ff,#ffffff);"> <section data-autoskip="1" class="135brush" style="text-align: justify;line-height:1.75em;letter-spacing: 1.5px;font-size:14px;color:#333;background: transparent;"> <section class="_135editor" data-role="title" data-tools="135编辑器" data-id="94125"> <section style="padding: 5px; text-align: center; box-sizing: border-box;" hm_fix="396:754"> <section style="display: inline-block;"> <section class="135brush" data-brushtype="text" style="font-size: 16px; color: #000000; letter-spacing: 1px; padding: 6px 0px 4px; box-sizing: border-box;"> <p style="vertical-align: inherit; line-height: 1.75em; letter-spacing: 1px;"> <strong><span style="font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif;">易于使用和简化流程</span></strong> </p> </section> <section style="box-sizing:border-box; width: 3.5em; margin: 4px auto; border-bottom: 1px solid #333333; height: 1px; overflow: hidden;"></section> <section style="box-sizing:border-box; width: 2.5em; margin: 0px auto; border-bottom: 1px solid #333333; height: 1px; overflow: hidden;"> <br/> </section> </section> </section> </section> <section data-role="paragraph" class="_135editor"> <p style="text-align:center;" align="center"> <img src="https://bcn.135editor.com/files/users/474/4749834/202206/LX4qOBB4_T8BQ.gif" style="vertical-align:inherit;" alt="易于使用和简化流程.gif" draggable="false" data-ratio="0.5907172995780591" data-w="237"/> </p> </section> <section data-role="list" class="_135editor" style="color: #ff0000;"> <ul class="list-paddingleft-2" style="list-style-type: square;"> <li> <p style="line-height: 2em;"> <span style="font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; font-size: 14px; color: #000000; letter-spacing: 1px;">作为QbD的第一步，风险评估对您的团队来说必须简单且轻松。</span> </p> </li> <li> <p style="line-height: 2em;"> <span style="font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; font-size: 14px; color: #000000; letter-spacing: 1px;">使用LeanQbD很直观，因为它是由科学家设计的，也是为科学家设计的。</span> </p> </li> <li> <p style="line-height: 2em;"> <span style="font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; font-size: 14px; color: #000000; letter-spacing: 1px;">轻松分配和跟踪风险，连接QTPP-CQA-CPP/CMA。</span> </p> </li> <li> <p style="line-height: 2em;"> <span style="font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; font-size: 14px; color: #000000; letter-spacing: 1px;">使用智能仪表板可视化风险参数。</span> </p> </li> </ul> </section> <section data-role="paragraph" class="_135editor"> <p> <br/> </p> </section> <section class="_135editor" data-role="title" data-tools="135编辑器" data-id="94125"> <section style="padding: 5px; text-align: center; box-sizing: border-box;" hm_fix="396:754"> <section style="display: inline-block;"> <section class="135brush" data-brushtype="text" style="font-size: 16px; color: #283e66; letter-spacing: 1px; padding: 6px 0px 4px; box-sizing: border-box;"> <p style="vertical-align: inherit; line-height: 1.75em; letter-spacing: 1px;"> <strong><span style="font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif;">节约时间和自动化</span></strong> </p> </section> <section style="box-sizing:border-box; width: 3.5em; margin: 4px auto; border-bottom: 1px solid #333333; height: 1px; overflow: hidden;"></section> <section style="box-sizing:border-box; width: 2.5em; margin: 0px auto; border-bottom: 1px solid #333333; height: 1px; overflow: hidden;"> <br/> </section> </section> </section> </section> <section data-role="paragraph" class="_135editor"> <p style="text-align:center;" align="center"> <img src="https://bcn.135editor.com/files/users/474/4749834/202206/IVs4VvnY_eTw2.gif" style="vertical-align:inherit;" alt="节省时间和自动化.gif" draggable="false" data-ratio="0.40350877192982454" data-w="228"/> </p> </section> <section data-role="list" class="_135editor" style="color: #ff0000;"> <ul class="list-paddingleft-2" style="list-style-type: square;"> <li> <p style="line-height: 2em;"> <span style="font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; font-size: 14px; color: #000000; letter-spacing: 1px;">延迟1天 = 损失100万美元</span> </p> </li> <li> <p style="line-height: 2em;"> <span style="font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; font-size: 14px; color: #000000; letter-spacing: 1px;">节省3个月的开发时间。</span> </p> </li> <li> <p style="line-height: 2em;"> <span style="font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; font-size: 14px; color: #000000; letter-spacing: 1px;">使用FDA案例研究中的QbD风险评估模板节省时间。</span> </p> </li> <li> <p style="line-height: 2em;"> <span style="font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; font-size: 14px; color: #000000; letter-spacing: 1px;">自动化生成耗时的文档、报告和图表。</span> </p> </li> <li> <p style="line-height: 2em;"> <span style="font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; font-size: 14px; color: #000000; letter-spacing: 1px;">您的同事会认可您为加快QbD项目的开发时间所做的贡献。</span> </p> </li> <li> <p style="line-height: 2em;"> <span style="font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; font-size: 14px; color: #000000; letter-spacing: 1px;">只关注必要的设计空间工作 - 更重要的工作。</span> </p> </li> </ul> </section> <section data-role="paragraph" class="_135editor"> <p> <br/> </p> </section> <section class="_135editor" data-role="title" data-tools="135编辑器" data-id="94125"> <section style="padding: 5px; text-align: center; box-sizing: border-box;" hm_fix="396:754"> <section style="display: inline-block;"> <section class="135brush" data-brushtype="text" style="font-size: 16px; color: #000000; letter-spacing: 1px; padding: 6px 0px 4px; box-sizing: border-box;"> <p style="vertical-align: inherit; line-height: 1.75em; letter-spacing: 1px;"> <strong><span style="font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif;">合作&远程工作</span></strong> </p> </section> <section style="box-sizing:border-box; width: 3.5em; margin: 4px auto; border-bottom: 1px solid #333333; height: 1px; overflow: hidden;"></section> <section style="box-sizing:border-box; width: 2.5em; margin: 0px auto; border-bottom: 1px solid #333333; height: 1px; overflow: hidden;"> <br/> </section> </section> </section> </section> <section data-role="paragraph" class="_135editor"> <p style="text-align:center;" align="center"> <img src="https://bcn.135editor.com/files/users/474/4749834/202206/K4UuAzsA_qKBe.gif" style="vertical-align:inherit;" alt="合作&远程工作.gif" draggable="false" data-ratio="0.5194805194805194" data-w="231"/> </p> </section> <section data-role="list" class="_135editor" style="color: #ff0000;"> <section class="_135editor" data-role="list"> <ul class="list-paddingleft-2" style="list-style-type: square;"> <li> <p style="line-height: 2em;"> <span style="font-size: 14px; color: #000000; letter-spacing: 1px; font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif;">您和您的团队可以在QbD项目上实时协作。</span> </p> </li> <li> <p style="line-height: 2em;"> <span style="font-size: 14px; color: #000000; letter-spacing: 1px; font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif;">易于远程管理项目或客户。</span> </p> </li> <li> <p style="line-height: 2em;"> <span style="font-size: 14px; color: #000000; letter-spacing: 1px; font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif;">消除70%不必要的会议。</span> </p> </li> <li> <p style="line-height: 2em;"> <span style="font-size: 14px; color: #000000; letter-spacing: 1px; font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif;">减少70%的会议并提高生产力和满意度！</span> </p> </li> </ul> </section> </section> </section> </section> </section> </section> </section> </section> <section data-role="paragraph" class="_135editor"> <p> <br/> </p> </section> <section class="_135editor" data-role="title" data-tools="135编辑器" data-id="113247"> <section style="margin: 20px auto;"> <section style="display: flex;justify-content: center;"> <section style="padding-bottom: 20px; box-sizing: border-box;"> <section style="padding: 0px 40px; box-sizing: border-box;"> <section style="box-sizing:border-box; width: 65px; height: 65px; background: radial-gradient(circle, #c7e5f8, #ebf6fd, #ffffff); border-radius: 100%; overflow: hidden;"></section> </section> <section style="margin-top: -45px;"> <section style="display: flex;justify-content: center;align-items: center;" hm_fix="354:322"> <section style="font-size: 20px;text-align: justify;color: #283e66;"> <span style="font-size: 18px; font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif;"><strong>产品特征</strong></span> </section> </section> </section> </section> </section> </section> </section> <section class="_135editor" data-tools="135编辑器" data-id="114488"> <section style="margin: 20px auto;"> <section> <section style="padding-right: 10px; box-sizing: border-box;"> <section style="display: flex;justify-content: flex-start;margin-bottom: -3px;"> <section style="box-sizing:border-box; width: 70px; height: 6px; background-color: #ec651c; overflow: hidden;"></section> </section> <section style="padding: 30px 15px 25px;background: linear-gradient(to bottom,#e6f9ff,#ffffff);"> <section data-autoskip="1" class="135brush" style="text-align: justify;line-height:1.75em;letter-spacing: 1.5px;font-size:14px;color:#333;background: transparent;"> <section class="box-edit _135editor" style="background-color: #ffffff; padding: 8px 15px 25px; margin-top: 20px; box-sizing: border-box;"> <section style="display: flex;justify-content: flex-start;align-items: flex-start;"> <section style="display: inline-block;flex-shrink: 0;"> <section style="font-size: 30px;letter-spacing: 0px;color: #000;"> <span style="font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif;"><strong>0</strong><strong class="autonum" data-original-title="" title="">1</strong></span> </section> <section class="assistant" style="box-sizing:border-box;max-width: 100% !important; width: 100%; height: 3px; background-color: #ff7907; margin-top: -3px; overflow: hidden;" data-width="100%"></section> </section> <section data-autoskip="1" class="135brush" style="flex: 1 1 0%; margin: 7px 0px 0px 10px; text-align: justify; line-height: 1.7em; letter-spacing: 1.5px; color: #fe7806; background: transparent;"> <p style="vertical-align: inherit;" hm_fix="338:412"> <span style="font-size: 16px; letter-spacing: 1px; font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif;"><strong>QbD风险评估</strong></span> </p> </section> </section> <section data-autoskip="1" class="135brush" style="margin-top: 10px; text-align: justify; line-height: 1.7em; font-size: 14px; color: #000000; background: transparent;"> <p style="vertical-align: inherit; line-height: 1.75em;"> <span style="background-color: transparent; caret-color: red; font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; font-size: 14px; letter-spacing: 1px;">QbD风险评估是Quality-by-Design计划的支柱。</span> </p> <p style="vertical-align: inherit; line-height: 1.75em;"> <br/> </p> <p style="vertical-align: inherit; line-height: 1.75em;"> <span style="background-color: transparent; caret-color: red; font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; font-size: 14px; letter-spacing: 1px;">LeanQbD是智能的QbD风险评估工具，可将过程参数与您的患者联系起来。</span> </p> <p style="vertical-align: inherit; line-height: 1.75em;"> <br/> </p> <p style="line-height: 1.75em;"> <span style="font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; font-size: 14px; letter-spacing: 1px;">使用相关矩阵和FMECA来计算质量目标产品概况、关键质量属性、关键工艺参数和关键材料属性的风险，该软件在后台运行，因此您可以专注于重要的事情 - 将科学与患者联系起来。</span> </p> </section> </section> <section class="box-edit _135editor" style="background-color: #ffffff; padding: 8px 15px 25px; margin-top: 20px; box-sizing: border-box;"> <section style="display: flex;justify-content: flex-start;align-items: flex-start;"> <section style="display: inline-block;flex-shrink: 0;"> <section style="font-size: 30px;letter-spacing: 0px;color: #000;"> <span style="font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif;"><strong>0</strong><strong class="autonum" data-original-title="" title="">2</strong></span> </section> <section class="assistant" style="box-sizing:border-box;max-width: 100% !important; width: 100%; height: 3px; background-color: #ff7907; margin-top: -3px; overflow: hidden;" data-width="100%"></section> </section> <section data-autoskip="1" class="135brush" style="flex: 1 1 0%; margin: 7px 0px 0px 10px; text-align: justify; line-height: 1.7em; letter-spacing: 1.5px; color: #fe7806; background: transparent;"> <p style="vertical-align: inherit;" hm_fix="338:412"> <span style="font-size: 16px; letter-spacing: 1px; font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif;"><strong>LeanQbD工作原理</strong></span> </p> </section> </section> <section data-autoskip="1" class="135brush" style="margin-top: 10px; text-align: justify; line-height: 1.7em; font-size: 14px; color: #000000; background: transparent;"> <p style="vertical-align: inherit; line-height: 1.75em;"> <span style="font-size: 16px; color: #283e66;"><strong><span style="font-size: 16px; background-color: transparent; caret-color: red; font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; letter-spacing: 1px;">步骤1—</span></strong><span style="font-size: 16px; background-color: transparent; caret-color: red;"><strong><span style="font-size: 16px; background-color: transparent; caret-color: red; font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; letter-spacing: 1px;">输入参数：</span></strong></span></span> </p> <p style="vertical-align: inherit; line-height: 1.75em;"> <span style="background-color: transparent; caret-color: red; font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; letter-spacing: 1px;">使用Lean QbD™模板， 您可以立即开始，跳过您习惯的大部分繁琐的初始设置。根据您的需要自定义QTPP/CQA/CPP输入。我们还提供导入服务，帮助您从excel或其他数据格式迁移。</span> </p> <p style="line-height: 1.75em;"> <br/> </p> <p style="line-height: 1.75em;"> <span style="font-size: 16px; color: #283e66;"><strong><span style="color: #283e66; font-size: 16px; background-color: transparent; caret-color: red; font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; letter-spacing: 1px;">步骤2：—分配风险：</span></strong></span> </p> <p style="line-height: 1.75em;"> <span style="background-color: transparent; caret-color: red; font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; letter-spacing: 1px;">我们专门的风险评估网格和向导使其变得简单，将科学家的时间和职能解耦。在每个步骤中，记录 并根据需要存储相关的元数据和文件附件。</span> </p> <p style="line-height: 1.75em;"> <br/> </p> <p style="line-height: 1.75em;"> <span style="font-size: 16px; color: #283e66;"><strong><span style="color: #283e66; font-size: 16px; background-color: transparent; caret-color: red; font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; letter-spacing: 1px;">步骤3—关键参数：</span></strong></span> </p> <p style="line-height: 1.75em;"> <span style="background-color: transparent; caret-color: red; font-family: "Helvetica Neue", Helvetica, "Hiragino Sans GB", "Apple Color Emoji", "Emoji Symbols Font", "Segoe UI Symbol", Arial, sans-serif; letter-spacing: 1px;">综合图表和报告（包括(C)PP和基本原理的用户自定义输入）使确定患者风险变得容易。我们详尽的风险评估文档报告可帮助您比以往更快地准备FDA提交。</span> </p> </section> </section> </section> </section> </section> </section> </section> </section> </section>
