Expression Therapeutics 使用 Qualio 简化文档管理
适用行业
- 建筑物
- 药品
适用功能
- 设施管理
- 质量保证
用例
- 库存管理
- 视觉质量检测
服务
- 测试与认证
- 培训
关于客户
Expression Therapeutics, Inc. 是一家完全整合的临床阶段基因和细胞治疗公司，致力于开发针对致命的儿童和成人遗传性疾病的新型、具有潜在治愈性的疗法。该公司最近在俄亥俄州韦斯特切斯特建造了一座占地 43,000 平方英尺的最先进工厂，以增强其产品组合的内部制造能力。在该设施中，Expression Therapeutics 能够生产慢病毒 (LV) 和腺相关病毒 (AAV) 载体、细胞治疗产品和重组蛋白，以加快其临床项目的开发。
挑战
Expression Therapeutics 是一家临床阶段的基因和细胞治疗公司，在规划在俄亥俄州韦斯特切斯特新建 43,000 平方英尺的设施时面临着重大挑战。该公司正在进入新的增长阶段，需要实施不依赖纸张的现代质量管理体系。该公司对俄亥俄州业务的重大投资代表了新的增长阶段，质量保证总监 Eric Day 认为文档控制效率是他们最大的挑战。该公司之前通过电子表格和硬文档来跟踪偏差、CAPA 和培训，效率低下且耗时。
解决方案
Expression Therapeutics 评估了多家 eQMS 供应商，考虑了他们的能力、定价和客户支持。他们最终选择了 Qualio，因为它具有强大的功能和可用性。该公司相信 Qualio 是加快行动速度、提高效率的最佳方式。作为数据驱动型组织，KPI 和指标的可见性是一项关键要求。借助 Qualio，团队可以将数据整合到一个地方，并主动找出需要改进的领域。从纸质文档到电子文档的过渡得到了 Qualio+ 团队的帮助，他们帮助构建了系统文档模板，以推动一致、受控的质量方法。
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