技术
- 基础设施即服务 (IaaS) - 云数据库
- 平台即服务 (PaaS) - 设备管理平台
适用行业
- 教育
- 电子产品
适用功能
- 质量保证
用例
- 实验自动化
- 视觉质量检测
服务
- 测试与认证
- 培训
关于客户
Ender Diagnostics 是一家瑞士公司,开发和生产用于检测 SARS-CoV-2 的快速分子诊断试剂盒。该公司处于全球抗击新冠肺炎 (COVID-19) 斗争的最前沿,提供快速、高精度的现场和实验室测试。作为 COVID-19 PCR 检测的生产商,Ender 的质量管理体系符合体外诊断医疗器械标准和法规,包括欧盟 IVDD(过渡到 IVDR)和 ISO 13485。该公司成立于 2020 年,由于对 COVID-19 检测的高需求。安德的大部分员工由科学家和毕业生组成。
挑战
Ender Diagnostics 是一家瑞士 SARS-CoV-2 快速分子诊断试剂盒开发商和制造商,其质量管理体系 (QMS) 面临着重大挑战。该公司成立于 2020 年,由于对 COVID-19 检测的高需求而迅速扩张。然而,Ender 的手动纸质 QMS 无法跟上这种增长。它缺乏审计就绪的可追溯性和控制,并且不支持远程和家庭工作。安德的大部分员工由科学家和毕业生组成,只有一小部分具有特定的质量管理经验。该公司需要一个不会因耗时的管理任务而分散科学工作注意力的系统。面临的挑战是实施一个能够满足公司快速扩张和远程工作需求的文档和培训管理系统。
解决方案
Ender Diagnostics 的质量经理 Mohamad El Zein 开始寻找一种易于使用、设置时间短并为国际远程分布团队提供基于云的访问的电子质量管理系统 (eQMS)。实施和验证的速度和简便性给他留下了深刻的印象,他决定实施 Qualio。以符合 ISO 13485 为主要目标,Mohamad 在 Qualio 团队的帮助下开始围绕标准要求构建 eQMS。作为 Qualio+ 客户,他可以请求专门的 QA 支持和预构建的合规文档模板,以加速 ISO 13485 准备工作。 Qualio 的实施使 Ender Diagnostics 能够拥有完整的基于云的 eQMS,包括文档控制、培训管理和质量事件管理。
运营影响
数量效益
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