技术
- 网络安全和隐私 - 安全合规
- 基础设施即服务 (IaaS) - 云数据库
适用行业
- 教育
- 电子产品
适用功能
- 采购
- 质量保证
用例
- 租赁金融自动化
- 视觉质量检测
服务
- 测试与认证
- 培训
关于客户
EvoEndo 是一家位于科罗拉多州 Centennial 的医疗器械公司,拥有 1-10 名员工。该公司开发了一种一次性胃镜系统,无需镇静或麻醉即可进行经鼻上消化道内窥镜检查。作为 II 类 510(k) 医疗器械,EvoEndo 的产品意味着该企业及其外包合同制造组织必须满足 ISO 13485 和 FDA 21 CFR 820 的要求。该公司正在过渡到新的合同制造组织并正在寻找更高效、更有效的电子质量管理系统。
挑战
EvoEndo 是一家医疗器械公司,其现有的电子质量管理系统 (eQMS) 面临着挑战。该系统由另一个合同制造组织 (CMO) 构建,是在本地部署的,并且严重依赖纸张,使其笨重且不适合用途。该公司的首席执行官 Heather Underwood 发现效率和文件控制正在下滑,对公司的 FDA 510(k) 准备工作产生了负面影响。审查和批准文件的过程非常耗时,涉及打印、签名和扫描。获取重要的质量管理体系信息也很困难。随着 EvoEndo 过渡到新的 CMO,他们开始寻找现有的、基于云的 eQMS,以更好地满足他们的需求。 Heather 希望增强 EvoEndo 的内部质量管理系统,包括文档控制和培训管理,而不仅仅是依赖 CMO 质量管理体系中基于产品的数据。
解决方案
Heather 寻求一个直观、易于使用的 eQMS 平台,该平台可以将 EvoEndo 的运营与她位于佛罗里达州的 CMO 以及该公司在密歇根州的分销合作伙伴整合起来。在审查了几家潜在供应商后,Heather 选择了 Qualio,因为它支持 Qualio+ 产品。 EvoEndo 于 2020 年中期成为 Qualio 客户。尽管以前从未进行过 eQMS 验证练习,但 Heather 发现这个过程直接、简单且令人愉快。通过 Qualio 客户成功团队的有针对性的培训和 Qualio+ 支持,EvoEndo 的新系统很快就填充了合规的文档模板,使 Heather 能够在几周内开始使用她的新 eQMS。
运营影响
数量效益
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