Proscia Uses Qualio to Bring High-Quality Medical Device Software to Pathologists around the World
公司规模
11-200
国家
- Australia
- Brazil
- Canada
- European Union
- Japan
- United States
产品
- Qualio
- Concentriq Dx
技术栈
- eQMS
实施规模
- Enterprise-wide Deployment
影响指标
- Customer Satisfaction
- Digital Expertise
- Productivity Improvements
技术
- 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)
- 功能应用 - 远程监控系统
适用行业
- 医疗保健和医院
- Software
适用功能
- 产品研发
- 质量保证
用例
- 监管合规监控
- 远程协作
- 远程控制
服务
- 软件设计与工程服务
- 系统集成
- 培训
关于客户
Since 2014, Proscia has been building software solutions for pathology and cancer research. The company recently decided to apply their software to a clinical setting to enable pathologists to work more effectively by moving from microscope-based workflows to a slide image management system that imports and reads digitized slides from multiple scanning sources, making it easier for doctors to store, retrieve, manipulate, and annotate them from any location where there is internet access. To ensure the transition to the new market was a smooth one, Proscia needed a complete and compliant electronic quality management system (eQMS) that was cost-effective and could be implemented rapidly. After researching their options, they chose Qualio and were able to achieve Medical Device Single Audit Program (MDSAP) compliance shortly thereafter, allowing them to bring powerful software as a medical device to pathologists around the world.
挑战
To sell their medical device software to healthcare customers, Proscia needed a quality management system that would enable them to enforce high quality standards to ensure compliance with all relevant regulations. Since they wanted to sell their product internationally, the company needed a solution that would help them achieve MDSAP certification thereby ensuring compliance with FDA and ISO regulations and allowing them to sell to organizations in Australia, Brazil, Canada, Japan, the European Union, and the United States.
解决方案
As they searched for a new solution, the team at Proscia demoed three products, including Qualio. Ultimately, they chose Qualio as their eQMS because of its simplicity and intuitive user interface. Proscia has many young designers on staff who aren’t used to working in regulated environments; Qualio has made these employees’ transition to this kind of work setting much easier. In particular, Proscia enjoys Qualio’s search function, which enables them to quickly find documents by keyword and reference IDs that appear either within the documents themselves or in document properties. They also enjoy Qualio’s tag function which enables multiple documents to be grouped into sets that are created as needed and allows documents to belong to more than one group.
运营影响
数量效益
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