Illumina 使用 Veeva Vault CDMS 简化研究构建并消除回归测试
适用功能
- 质量保证
用例
- 实验自动化
- 快速原型制作
服务
- 系统集成
- 测试与认证
关于客户
Illumina 是一家全球生物技术公司，专注于 DNA 测序和基于阵列的技术。该公司提供一系列产品和服务，服务于测序、基因分型和基因表达以及蛋白质组学市场。其产品被世界各地的学术、政府、制药、生物技术和其他领先机构广泛使用。 Illumina 的使命是通过释放基因组的力量来改善人类健康。该公司在管理研究构建方面面临挑战，正在寻求一种可以简化流程并改善团队内部协作的解决方案。
挑战
Illumina 是一家领先的生物技术公司，在管理其研究构建方面面临着重大挑战。传统流程需要花费三个多月的时间来编写和审查规范，之后合同研究组织 (CRO) 将建立数据库。这个过程不仅耗时，而且缺乏效率和敏捷性。然后，研究团队将审查规范，这是一个手动、纸质的过程。此外，Illumina 在用户验收测试 (UAT) 期间进行了 100% 回归测试，这是一个很大的负担。该公司还在大流行期间进行了 COVID-19 诊断试验，这需要极大的灵活性和快速的变化。
解决方案
Illumina 采用 Veeva Vault CDMS 来简化研究构建并改善研究团队内部的协作。借助 Veeva Vault EDC，该公司消除了对手动纸质规范的需求。相反，快速原型设计是直接在系统内完成的，并且 Vault EDC 自动生成规范。这使得数据管理员能够配置病例报告表 (CRF)、访问结构和基本规则，从而减少大量编程的需要。研究团队能够在线审查该系统，这有助于更好的参与和反馈。此外，Illumina 能够使用 Veeva Vault EDC 消除 UAT 期间的回归测试。系统生成了一份“差异报告”，记录了每个更改，允许团队仅测试更改。这显着减轻了 UAT 负担，并且没有增加额外的风险。
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