一个供应商—— 医药产品信息领域的市场领导者。可提供唯一的新一代解决方案:Integral by Design、Modular by Implementation。唯一权威性真实信息来源。

利用 AMPLEXOR Life Sciences Suite 来管理企业受管制的内容和流程以及出版。实现和维持全球监管合规。

  • Best Total Cost of Ownership (TCO)
  • Extremely configurable and agile in adapting to new business processes
  • Ready to be validated and deployed without expensive customization
  • Supports efficient enterprise-wide collaboration
  • Bolsters data standardization – no data redundancy
  • Ensures simple upgrades and backwards compatibility configuration
  • Guarantees easy and flexible migrations, interfaces, and process automation
  • Incorporates best-practice modules as a quick start
  • Best design for on- or off-premises – no need for interfaces between subsystems
  • Completely self-reliant as it is independent of application, tenancy, infrastructure, and location

This second-generation, compliance-centric solution suite enables life sciences companies to replace siloed tools with a single authoritative software product to proactively manage information, business processes, regulated documents, and electronic records, and to use advanced reporting tools across the entire product lifecycle: from product nomination to post-submission and post-approval maintenance. Enter or import the data into the system only once. Don’t leave your metadata redundant – leverage it over the entire product value chain!

AMPLEXOR Life Sciences Suite is built on unique and innovative Integral by Design, Modular by ImplementationTM architecture, which allows for seamless integration of all of its modules. Depending on your organization’s needs, it can support either singular compliance-relevant processes or complete enterprise compliance management. This unprecedented level of integration increases the level of efficiency, promotes enterprise-wide standardization and enables the transformation of your business. This results in lower complexity, higher overall quality of products, and sustainable compliance.

Take advantage of the best TCO on market.

  • 最佳总体拥有成本 (TCO)
  • 可配置性极强并且能灵活适应全新业务流程
  • 可随时验证和部署,无需昂贵的定制化服务
  • 支持高效的企业范围内协作
  • 支持数据标准化——无数据冗余
  • 确保简易的升级和向后兼容性配置
  • 保证简易且灵活的迁移功能、界面和流程自动化
  • 包含作为快速启动项的最佳实践模块
  • 用于本地或异地的最佳设计——无需子系统间的接口
  • 完全自适应,因为它独立于应用程序、租赁制度、基础设施和场地

这个以合规为中心的第二代套件使得生命科学公司能够使用单个可靠的软件产品来取代孤立的工具,以便在从产品命名到提交后和批准后维护的整个产品生命周期中积极地管理信息、业务流程、受监管文件和电子记录以及利用先进的报告工具。只需将数据输入或导入系统一次。不要让您的元数据成为累赘——在整个产品价值链中好好地利用它们吧!

AMPLEXOR Life Sciences Suite 建立在独特而创新的Integral by Design、Modular by ImplementationTM 架构之上,实现了其所有模块的无缝集成。它可根据您企业的需求,支持单独的合规相关流程完整的企业合规管理。这种史无前例的集成水平提升了效率、促进了企业范围内的标准化并使您的业务转型成为可行。这降低了复杂性、提升了产品整体质量并实现了可持续合规。

充分利用市场上的最佳 TCO。

AMPLEXOR Life Sciences Suite 建基于强大且著名的产业平台——EMC DocumentumTM之上。

Amplexor Life Sciences Suite Circle s

AMPLEXOR Life Sciences Suite is a compliance foundation composed by: ProductExpert, R&DExpert, QualityExpert, RIMExpert, SubmissionExpert, ClinicalExpert, ManufacturingExpert and VigilanceExpert.


质量和制造流程以及
文件管理


研发项目和文件管理(包括试验管理)


监管信息管理和提交管理(包括发布)

 

药物警戒管理

 

监管档案管理

 

可操作的业务智能

AMPLEXOR Life Sciences Suite 能帮助用户有效地处理在研发、临床试验、RA、PhV、QA/QC、制造等过程中面临的行业特定挑战。

AMPLEXOR Life Sciences Suite 可通过许可证或订阅两种方式提供,您可以选择最合适的一种。

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