Pharmigon 实施 DocuWare 以实现符合 GMP 的质量管理
地区
- Europe
国家
- Germany
产品
- DocuWare
技术栈
- Digital Document Management
- Barcode Scanning
实施规模
- Enterprise-wide Deployment
影响指标
- Productivity Improvements
- Digital Expertise
技术
- 功能应用 - 企业资源规划系统 (ERP)
适用行业
- 医疗保健和医院
适用功能
- 离散制造
- 质量保证
用例
- 库存管理
服务
- 系统集成
关于客户
Pharmigon 是一家总部位于德国的医疗保健公司，专门生产针对特定患者且高度专业化的制剂，主要用于肿瘤的靶向治疗。该公司的生产在最先进的洁净室实验室中进行，这些实验室配备了符合良好生产规范 (GMP) 的精确计算机辅助监控。这需要严格的文档处理和归档，这是符合 GMP 的质量管理的关键要素。该公司多年来一直依赖数字文档管理，并将其集成到其现有的药房管理系统中。
挑战
Pharmigon 是一家专门生产针对特定患者且高度专业化的肿瘤靶向治疗制剂的制造商，其运营场所是最先进的洁净室实验室。该公司必须遵守良好生产规范 (GMP)，因此必须对文档进行细致的处理和归档。所有文档（包括工作说明、表格和计划）都必须进行版本控制并遵循定义的生命周期。此外，还必须创建记录并在指定期限内存档，并防止篡改或操纵。该公司多年来一直依赖数字文档管理，但需要一种能够与其现有药房管理系统无缝集成的解决方案。
解决方案
Pharmigon 选择 DocuWare 是因为其功能强大、使用直观，并且能够无缝集成到其现有的药房管理系统中。这种集成允许将生产文档、患者数据或商业记录从行业解决方案自动传输到中央文档池。Pharmigon 员工还拥有三台功能强大的文档扫描仪，用于将纸质文档数字化。索引和归档通过应用于每个订单的条形码进行。DocuWare 将这些详细信息作为索引术语，并将其用作后续工作流程的中心参数，以验证制造是否正确。生产经理进行初步检查，质量控制部门进行第二次检查。如果质量控制部门还使用电子印章确认制造物质的正确性，则由负责的员工进行最终放行。
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