How IVD Manufacturer Streamlined Production and Improved Quality Processes with Industry Specific QMS
公司规模
SME
地区
- America
- Asia
- Europe
国家
- China
- European Union
- New Zealand
- United States
产品
- Greenlight Guru
技术栈
- Electronic Quality Management System (eQMS)
实施规模
- Enterprise-wide Deployment
影响指标
- Customer Satisfaction
- Productivity Improvements
- Digital Expertise
技术
- 功能应用 - 企业资源规划系统 (ERP)
- 功能应用 - 企业资产管理系统 (EAM)
适用行业
- 医疗保健和医院
- 生命科学
适用功能
- 质量保证
- 商业运营
用例
- 监管合规监控
服务
- 系统集成
- 培训
关于客户
Canterbury Scientific is a leading global OEM supplier of high-quality, stable In Vitro Diagnostic (IVD) Controls and Calibrators for diabetes and hemoglobinopathy assays. The company operates in multiple regulatory jurisdictions, including the USA, EU, and China, and has obtained 510(k) clearances, CE Marks, and ISO 13485:2016 certification. Under the leadership of CEO Clive Seymour, who has a global background in life sciences, the company has focused on improving its quality and regulatory systems. Canterbury Scientific's global footprint necessitates adherence to various regulatory standards, making a robust Quality Management System (QMS) essential for their operations.
挑战
Canterbury Scientific faced significant challenges with their paper-based Quality Management System (QMS). The system, while functional, was outdated and inefficient, leading to issues with document progression, timeline management for nonconformances, and change controls. The paper-based system required constant involvement from the quality team, particularly impacting the manufacturing and Science, Design, and Development teams. The need to update design history files and design manufacturing files further complicated the process. The realization that their existing QMS was not suitable for the 21st century and the updates to ISO 13485:2016 standards acted as catalysts for seeking a more modern, scalable solution.
解决方案
Canterbury Scientific decided to transition from their paper-based QMS to an electronic Quality Management System (eQMS) and chose Greenlight Guru as their solution. The implementation was carried out in two phases: first, moving Standard Operating Procedures (SOPs), work instructions, and relevant documents to the Greenlight Guru platform; second, focusing on an enhanced internal audit approach to systematically improve documentation and embed the system throughout all company functions. The transition was smoother than anticipated, with seamless document uploading and immediate version control. Automated processes for quality events and change orders were quickly established. Training the team on the new system was initially seen as a challenge, but the ease of use won them over, making logging into Greenlight Guru a part of their daily routine.
运营影响
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