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。
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
Secure UDI DI and PI data. Avoid unnecessary risk when your source data from approved content management systems, trusted ERPs, and other applications that generate serial numbers and other data needed to meet regulatory requirements.
集中您的数据
Complete visibility. Your business may have many locations, but that doesn’t mean it should be “every entity for itself.” Centralized labeling brings visibility, control, and the ability to demonstrate compliance and meet corporate standards.
给标签变更赋能
Unburden IT. Business users should be able to create and manage medical barcode labels and configure business rules without calling on IT. This allows them to respond to any pressing regulations quickly.
确保安全性/可审计性
Data that’s safe and sound. With business intelligence, full auditing and reporting capabilities allows you to monitor and track all labeling activity and eSignature capabilities so you can safely meet regulations.
对旧系统予以重新思考
Automate for Ease. Spreadsheets and other manual processes are not secure. Automated, validated labeling solutions can easily accommodate new requirements, safeguard against future regulations, and scale quickly.
相关资源
Case Study
Quest Medical 将标签周转时间缩短了 70%
了解 Loftware Spectrum 如何帮助 Quest Medical 创造新的效率并驱动获得投资回报，包括将标签模板数减少 80%，将标签变更处理时间缩短 70%。
网络讲座
标签系统验证的 4 大好处
这似乎是一个近乎不可能的任务 – 验证标签解决方案的同时，还能实现简化运营、降低成本和提高效率。好消息是，这是可以做到的。
Case Study
Going Beyond UDI Compliance: How LiNA Medical drove process improvement as part of its UDI compliance initiative
LiNA Medical 需要满足 II 类设备 UDI 合规期限。该公司充分利用合规行动，来降低生产成本并建立更精简的标签流程。
