安全处方：Profusio Leipzig 的 DocuWare 实施
公司规模
SME
地区
- Europe
国家
- Germany
产品
- DocuWare
- Steribase
技术栈
- Windows 2008 Server
- VPN
实施规模
- Enterprise-wide Deployment
影响指标
- Productivity Improvements
- Cost Savings
技术
- 应用基础设施与中间件 - 数据交换与集成
适用行业
- 药品
- 医疗保健和医院
适用功能
- 质量保证
用例
- 监管合规监控
服务
- 系统集成
关于客户
Profusio Leipzig Gesundheits GmbH 是一家位于德国莱比锡的制药厂。该公司是药房的承包商，专门生产患者专用的静脉滴注器。一流的产品质量和准时交货是该公司成功的主要因素，该公司于 2006 年以 Oncosachs Pharma 的名义成立，是德国市场领导者之一。德国的药品生产受到非常严格的法律约束。生产过程的安全性和控制需要得到保证和记录。因此，制药公司必须创建有关生产过程的全面文件和协议，并且必须在药品有效期结束后至少保留 5 年。
挑战
制药商 Profusio Leipzig 需要创建有关生产过程的全面文档和协议，并且必须在药品有效期结束后至少保留 5 年。这导致每年必须归档超过 450,000 页的生产、质量控制和发布文档，每天增加 1,500 页。该公司需要一个解决方案来更好地处理此文档量并能够根据需要快速查找文档。该公司还希望通过完全无纸化来节省自然资源。文档安全是药品制造的关键方面。
解决方案
DocuWare 文档管理系统于 2010 年 2 月实施。该系统安装在现有的 Windows 2008 Server 和所有参与生产流程的客户端工作站上。与 Profusio 使用的药品生产软件 Steribase 的集成由授权的 DocuWare 合作伙伴执行，然后由位于德累斯顿的国家测试机构批准。这确保了 DocuWare 的生产、测试和发布流程的文档符合 GMP 标准的规定。集成的文档工作流程还以完全自动化的方式控制所有步骤 - 从生产到药品发布。作为附加硬件，购买了 Kodak I1220 用于捕获纸质文档。
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