技术
- 网络安全和隐私 - 安全合规
- 平台即服务 (PaaS) - 应用开发平台
适用行业
- 建筑物
- 医疗保健和医院
适用功能
- 质量保证
用例
- 质量预测分析
- 视觉质量检测
服务
- 测试与认证
- 培训
关于客户
Bond Digital Health 是一家位于威尔士卡迪夫的初创公司,团队规模为 10-49 名员工。该公司从事医疗器械软件 (SaMD) 行业,提供可将来自体外诊断设备(例如 COVID-19 侧流测试)的原始数据数字化的医疗软件。 Bond 的 Transform SaaS 平台被护理点诊断提供商用来实时捕获和存储患者数据。这使得 ISO 13485 和 IEC 62304 合规性成为 Bond 运营的重要组成部分。该公司每天还处理数千份患者记录,使 GDPR 和 HIPAA 合规成为至关重要的质量和监管目标。
挑战
Bond Digital Health 是一家医疗软件提供商,面临着从头开始建立质量管理体系 (QMS) 的挑战。作为一家初创企业,该公司的雄心是成为一个以质量为中心、以质量文化为导向、以既定流程为指导的组织。质量经理 Phil Cooley 的任务是建立公司的质量管理体系并帮助将 Bond 的软件系统推向市场。他希望为核心质量管理活动(例如文档控制)建立合规的、记录在案的流程,而无需费时费力地手动构建流程并鼓励同事遵循这些流程。该公司每天还处理数千份患者记录,使 GDPR 和 HIPAA 合规成为至关重要的质量和监管目标。 Phil 认识到电子质量管理系统 (eQMS) 将成为一条重要的捷径,为他的同事提供现成的质量管理结构和集中的单一事实来源。
解决方案
由于没有预先存在的 QMS,Phil 可以自由地寻找最佳的 eQMS 供应商,无需考虑任何限制或遗留系统。他开始寻找一个易于使用、直观的 eQMS 平台,为 Bond 的启动阶段提供并启用流程。 Phil 被 Qualio 的易用性、快速设置、直观的用户体验和庞大的初创客户群等优势所吸引。 Qualio 被认为最符合 Bond 的要求,Bond Digital Health 于 2020 年中期成为 Qualio 的客户。即使在 COVID-19 大流行期间,Qualio 的远程实施方法也使 Phil 和 Bond 团队能够在几个月内接受有关 Qualio 的培训并开始使用。作为一个基于云的整体质量软件系统,Qualio 为 Phil 提供了他所需的基本质量管理要素,同时简单直观,足以鼓励整个企业的参与。
运营影响
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