下载PDF
实例探究 > Expert support for a growing company’s first quality steps

Expert support for a growing company’s first quality steps

技术
  • 分析与建模 - 机器学习
  • 功能应用 - 企业资源规划系统 (ERP)
  • 功能应用 - 产品生命周期管理系统 (PLM)
适用行业
  • 医疗保健和医院
  • 生命科学
适用功能
  • 产品研发
  • 质量保证
用例
  • 监管合规监控
服务
  • 系统集成
  • 培训
挑战
The company's continued evolution into the life science sector, and their software's use as a medical device data system (MDDS) for preclinical work, prompted the ViQi team to begin planning a quality and regulatory pathway for the future. Co-founder and CTO Dmitry Fedorov wanted to set a solid, proactive quality baseline for the organization in line with their digital, cloud-based 'mindset'. It was important for the business to embrace modern eQMS technology early, before 'progressively more difficult' regulatory demands started to slow company growth. Critically, the organization had no internal quality expertise. Any quality software vendor they found would need to offer a highly supportive and collaborative relationship.
关于客户
Californian start-up ViQi emerged from UC Santa Barbara and develops cloud-based image analysis software powered by AI and machine learning. Their technology is used by life science organizations to accelerate drug discovery by modeling treatment and cell behavior, and has even been applied by the Bureau of Ocean Energy Management to perform oil spill risk modeling.
解决方案
Dmitry and Project Manager Hallie Greene began to search for the perfect eQMS platform and the close QA/ RA support they needed. A call with Sumatha Kondabolu on the Qualio+ team 'sealed the deal’. Going into September 2022, the ViQi team had the ambitious goal of getting the fundamentals of a quality management system in place and getting registered with the FDA by December. They became Qualio customers at the end of the month and let themselves be guided by Qualio's expert onboarding team. Qualio provided both software and support to help ViQi quickly build their quality fundamentals from scratch. The ViQi team received both a brand new, fully digital quality management system and expert quality and regulatory guidance from Sumatha to help them build and populate it, from document and SOP creation to managing workflows and development lifecycles. Sumatha even prepared a special presentation on MDDS regulatory strategy. Her targeted support allowed ViQi to forego an additional $20,000 in planned consultancy spend.
运营影响
  • Qualio provided both software and support to help ViQi quickly build their quality fundamentals from scratch.
  • The ViQi team received both a brand new, fully digital quality management system and expert quality and regulatory guidance from Sumatha to help them build and populate it, from document and SOP creation to managing workflows and development lifecycles.
  • Sumatha even prepared a special presentation on MDDS regulatory strategy. Her targeted support allowed ViQi to forego an additional $20,000 in planned consultancy spend.
数量效益
  • $20,000 of consultancy spend mitigated
  • 12 weeks to construct an eQMS from scratch
  • 35 key quality documents built with Qualio+ support

相关案例.

联系我们

欢迎与我们交流!

* Required
* Required
* Required
* Invalid email address
提交此表单,即表示您同意 IoT ONE 可以与您联系并分享洞察和营销信息。
不,谢谢,我不想收到来自 IoT ONE 的任何营销电子邮件。
提交

Thank you for your message!
We will contact you soon.