| 单词 | qumas | ||||||||||||
| 释义 |
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三星生物将引入QUMAS合规 平台，该平台是监管合规领域的领导者，将首先用于保证生产质量，以便从创建伊始即确保质量与监管合规。 tipschina.gov.cn | Initially, QUMAS ComplianceSP will be deployed in the Research and Development group and will provide users with [...] a secure, structured, [...]and controlled environment for creation, approval, and management of documents from all areas of the organization that have an impact on regulatory submissions, including electronic common technical documents (eCTDs). tipschina.gov.cn |
QUMAS解决方案可以帮助组织机构智慧地解决合规难题，从而获得更好的综合治理和更好的经营业绩预测性。 tipschina.gov.cn | QUMAS Quality Management [...] solutions provide Electronic Document Management (SOPs, QA documents), Electronic Process Management [...](CAPA, Deviation, Change Control, Audit), and GMP Compliance Management. tipschina.gov.cn |
QUMAS合规 平台是一套完整的合规解决方案，它将一整套监管合规方案的所有要素整合于同一平台上。 tipschina.gov.cn | QUMASComplianceSP is an [...] innovative compliance management solution that combines the power of Microsoft SharePoint 2010 [...]with the proven regulatory domain expertise that QUMAS has gained since 1994 in providing solutions to regulated industries. tipschina.gov.cn |
QUMAS是企业合规解决方案的全球领先供应商，全球超过250家客户部署了QUMAS的解决方案，QUMAS在高监管行业积累了20年的从业经验。 tipschina.gov.cn | QUMAS is the leader in Compliance and Quality Management Solutions for the Life Sciences industry, with more than 260 global customer [...] deployments and domain [...]expertise in regulatory compliance since 1994. tipschina.gov.cn |
三星生物副总裁、质量保证部负责人Greg [...] Tewalt表示：“我们非常高兴能受益于QUMAS团 队以及QUMAS合规 平台的精湛知识与专业水平，我们期待着双方的合作能够取得丰硕的成果。 tipschina.gov.cn | It was clear that our product has [...] the built-in regulatory compliance [...] features they Samsung Bioepis required, such as support [...]for electronic signatures, full [...]lifecycle state management and an extended audit trail. tipschina.gov.cn |
在与三星生物合作的第一阶段，QUMAS合规平台将依照21 CFR Part 11的规定，提供质量保证包，用于控制所有生产文件，包括所有相关内容和报告的生成、生命周期管理和可靠的审计控制等。 tipschina.gov.cn | Samsung Bioepis chose QUMAS for a number of reasons," said Steve Dawson, Head of the QUMAS Asia office. tipschina.gov.cn |
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