0 to 13485 in 6 months
公司规模
11-200
地区
- Europe
国家
- United Kingdom
产品
- Qualio
技术栈
- eQMS
实施规模
- Enterprise-wide Deployment
影响指标
- Cost Savings
- Customer Satisfaction
- Productivity Improvements
技术
- 功能应用 - 企业资源规划系统 (ERP)
适用行业
- 药品
适用功能
- 商业运营
- 质量保证
服务
- 软件设计与工程服务
- 系统集成
- 培训
关于客户
30 Technology is a UK-based developer of therapeutic nitric oxide products. With a medical device in development and laboratory-driven pharmaceutical products as well, 30 Technology has a complex double regulatory landscape to navigate. The company is committed to a quality culture of continuous improvement and is constantly looking to challenge existing processes, embed a right-first-time go-to-market approach, and unlock faster, smarter ways of doing things. The team is largely remote, requiring digital access to the latest operating procedures with strict version control.
挑战
30 Technology has two products in development for the market. A quality culture of continuous improvement means the business is constantly looking to challenge existing processes, embed a right-first-time go-to-market approach, and unlock faster, smarter ways of doing things. Above all, a largely remote team required digital access to, and training on, the latest and greatest operating procedures with strict version control. However, a heavily paper-based QMS meant a slew of time-heavy manual processes which cluttered and complicated compliance, as Head of Quality & GxP Compliance Karen Hue discovered when she joined the business. Karen wanted to implement a simpler electronic way of managing the 30 Technology QMS, that matched the company's size. Speed, agility, cost-effectiveness, and ease of use were the primary requirements.
解决方案
Two weeks after joining 30 Technology in November 2020, Karen led the search for an electronic quality management system (eQMS) and approached three vendors after a Google search. Karen was impressed by Qualio and had a detailed discussion about how Qualio's software would fit into 30 Technology's operation, including cost, users, and scalability potential. After a rapid implementation and validation process, Karen and 30 Technology's Qualio system went live in mid-December and was christened Fort NOx: a nod to Qualio's security credentials and 30 Technology's nitrous oxide product base. By January, all users were fully trained and accessing Qualio on a daily basis – less than two months after Karen's search began.
运营影响
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