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实例探究 > From ‘pain’ to ‘fun’

From ‘pain’ to ‘fun’

技术
  • 功能应用 - 计算机化维护管理系统 (CMMS)
  • 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
  • 药品
适用功能
  • 商业运营
  • 质量保证
用例
  • 监管合规监控
服务
  • 系统集成
  • 培训
挑战
Founder and President Graham Taylor began his career in quality as an associate quality engineer in 2007. Having spent over 15 years in the medical device and pharmaceutical worlds, he recognized the importance of an optimized QMS as he set up Helix. At a previous role, Graham battled the time and effort demands of a paper-based quality system, which included constant circulation, completion, and filing of paper documents. A single FTE, a full 10% of labor costs, was swallowed up by quality admin demands. With Helix as a blank slate, Graham wanted to sidestep the effort of paper and build an efficient, easy-to-run quality system from the company's first days.
关于客户
Tennessee-based Helix Biotech, founded in May 2022, develops and manufactures lipid nanoparticles, liposomes, and hybrid nanoparticles for customers, as well as producing manufacturing tools like extrusion and injection systems. Robust quality and GMP processes are vital to support the company's work from R&D to manufacturing.
解决方案
Graham compared multiple eQMS vendors like MasterControl and Greenlight Guru, and found it 'easy' to home in on Qualio as the most valuable and sensibly priced option on the market. Graham was also swayed by Qualio's 'straightforward’, ‘refreshing’ and 'easy-to-use' interface, particularly in relation to other, less intuitive systems he'd used in the past like TrackWise. Graham trusted Qualio with the future of his infant company’s quality system and went live with the software in October 2022.
运营影响
  • Qualio empowered Helix Biotech with a quality cornerstone to begin their journey. Rapid set-up of a quality foundation. The infancy of Helix Biotech meant Graham faced a double task of scaling the company and building a quality management system from scratch. Starting with Qualio, and leveraging extra guidance and support from the Qualio+ team, made that task rapid and simple.
  • Helix’s shiny new eQMS was populated with industry-ready document templates and augmented by expert Qualio+ QA/RA guidance. Helix established the structure of their biotech quality management system within a matter of weeks of becoming Qualio customers.
  • An eQMS to connect the business from day 1. Graham wanted an easy-to-use, collaborative eQMS to build his company around. All Helix employees now use Qualio day-to-day, accessing a continuously expanding single source of truth quality, manufacturing and more. And as new employees are onboarded, they can be integrated into Helix’s quality approach quickly and easily. 90% of company activity is already housed in Qualio.
数量效益
  • 1x FTE of quality admin mitigated.
  • 3 days sliced from each quality event close-out time.
  • 95% of scheduled training is completed on time, with an average of 2 days' completion time.

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