Restech's Transition to Qualio's eQMS for Enhanced Quality Management
公司规模
11-200
地区
- America
国家
- United States
产品
- Qualio
技术栈
- Electronic Quality Management System (eQMS)
- Salesforce Integration
实施规模
- Enterprise-wide Deployment
影响指标
- Customer Satisfaction
- Digital Expertise
- Productivity Improvements
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)
适用行业
- 医疗保健和医院
适用功能
- 商业运营
- 质量保证
服务
- 系统集成
- 培训
关于客户
Restech is a medical device company specializing in the production of devices for minimally invasive diagnosis and treatment of reflux disorders. The company has experienced impressive growth and operates in multiple international territories. To support its operations and ensure compliance with various regulations such as FDA 21 CFR 820, ISO 13485, CGMP, EU MDR, and UK Medical Device Regulations, Restech required a carefully constructed Quality Management System (QMS). The company's commitment to quality and regulatory compliance is evident in its adoption of advanced quality management solutions.
挑战
Restech and its Director of Quality Assurance, Lowell Hoffman, faced significant challenges with their manual, paper-based quality management system (QMS). The old system was labor-intensive, time-consuming, and prone to human errors. Document control was particularly problematic, with local saving of document copies preventing access to centralized, up-to-date information. The process of creating paper folders and collecting wet signatures was also time-demanding. These inefficiencies hindered Restech's ability to maintain strong document control, which is crucial for a robust QMS, especially in the medical device industry where regulatory compliance is stringent.
解决方案
To address these challenges, Restech decided to adopt an electronic quality management system (eQMS). After evaluating various options, Lowell Hoffman and the senior management team chose Qualio as the optimal platform. The decision was based on several criteria, including cost, ease of use, look and feel, ease of setup and transfer from the old QMS, and long-term customer support. Qualio's eQMS provided a comprehensive solution that eliminated the administrative burden of the paper-based system. It streamlined document control processes, reduced the time required for document updates, and minimized human errors. Additionally, Qualio's digital workflows for managing quality events like CAPAs and deviations significantly improved efficiency.
运营影响
数量效益
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