钟表匠基因组学：使用 Qualio 实施质量控制
技术
- 功能应用 - 制造执行系统 (MES)
适用行业
- 建筑物
- 教育
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
Watchmaker Genomics 是一家位于科罗拉多州博尔德的公司，拥有 50-99 名员工。该公司专注于蛋白质工程和酶制造领域。 Watchmaker 成立于 2019 年，为基因组、分子诊断和合成生物学应用提供精密工具，包括下一代测序 (NGS) 扩增试剂盒和 DNA/RNA 制备试剂盒。作为这些产品的制造商，Watchmaker 已将 ISO 13485 认证作为核心质量和合规目标。该公司的产品用于 CAP/CLIA 实验室进行样品分析，因此密封的产品质量至关重要。
挑战
Watchmaker Genomics 是一家专门从事蛋白质工程和酶制造的公司，在建立强大的质量控制体系方面面临着重大挑战。该公司的产品用于 CAP/CLIA 实验室进行样品分析，因此密封的产品质量至关重要。首席执行官 Trey Foskett 过去曾创办过其他几家公司，他很早就意识到实施数字质量方法（而不是将其添加到现有流程中）对业务的影响。该公司渴望建立一个单一的中央机制来管理质量，从访问日常信息和记录工作到访问丰富的质量数据，并能够通过受控的 CAPA 计划快速灵活地响应缺陷。质量控制经理 Skyler Mishkin 的任务是寻找最佳的电子质量管理系统 (eQMS)，搜索工作在公司成立的最初几个月内就开始了。
解决方案
Skyler 和他的团队选择 Qualio 作为他们的 eQMS 供应商，这一决定后来由质量保证总监 Peter Bruesehoff 进行了审查。 Peter 不仅发现了企业可以轻松使用的完善的 eQMS，而且与 Qualio 建立了牢固的合作伙伴关系，并在满足复杂的质量需求和避免过于繁琐的定制和验证之间采取了平衡的方法。另一位团队成员 Maran 负责对同事进行 Qualio 培训，内容涵盖从用户权限到系统功能和“操作方法”。 Maran 发现向团队成员介绍该系统并在几个小时内对他们进行培训“很容易”。整个企业的 88 名员工现在登录并使用 Qualio 来支持组织质量体系。
运营影响
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