医疗器械
当今的医疗设备公司在控制成本和扩大运营规模的同时，还要面临着不断变化的法规，如 FDA 的 UDI 和欧盟的 MDR 系统。标签和效果图管理在应对这些挑战方面发挥着关键作用。
Achieving sustainability in the life sciences supply chain
Want to find out how your life sciences organization can become more sustainable without compromising on quality or cost?
Download white paper today保持您的标签系统处于良好的健康状态。
实现监管合规
简化合规流程。您需要一个内置基于角色的访问权限控制并具有文档版本控制、可配置的审批工作流程以及电子记录和电子签名（ERES）的可满足合规要求的解决方案，所有这些都旨在简化合规流程。
整合数据来源
确保 UDI DI 和 PI 数据安全。当您从经批准的、能生成法规要求的序列号和其他数据的内容管理系统、可信的 ERP 和其他应用程序获取数据时，避免不必要的风险。
集中您的数据
完全可见性。您的企业在多个地点有布局，但这并不意味着“每个实体都自成体系”。集中式标签带来可见性和控制力 – 以及合规能力和满足企业标准的证明。
给标签变更赋能
减轻 IT 负担。业务用户应该能够创建和管理医疗条形码标签并配置业务规则，而无需 IT 部门支持。这使他们能够对任何法规变化做出快速反应。
确保安全性/可审计性
安全可靠的数据。借助商业智能、完整的审计和报告功能，您可以监控和跟踪所有标签活动和电子签名功能，从而安全地满足法规要求。
对旧系统予以重新思考
轻松实现自动化。电子表格和其他手动流程并不安全。自动化、经过验证的标签解决方案可以轻松适应新要求、应对未来法规并可快速扩展规模。
相关资源
电子书
6 critical questions and answers on medical device labeling
This Q&A addresses key challenges that medical device companies face and how leveraging innovation in cloud labeling helps organizations succeed in a highly regulated, highly competitive global marketplace.
博客
Why medical device manufacturers are embracing cloud-first labeling strategies
With cloud labeling, medical device companies improve regulatory compliance and avoid costly labeling errors, while maintaining a crucial level of safety customers and supply chains require. Additionally, organizations can be up and running quickly, benefit from automatic software updates, pay on a subscription basis, easily scale their printing operations when needed, reduce infrastructure costs, obtain advanced IT security, and improve their sustainability credentials.
Case Study
W.L. Gore enables compliance and accelerates go-to-market with cloud-based labeling
Learn how W.L. Gore has modernized and future-proofed labeling by migrating to Loftware Spectrum, and benefited from improved speed-to-market, automated label design and management to easily meet complex regulatory requirements and simplified auditing processes to enable compliance.
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