How IVD Manufacturer Streamlined Production and Improved Quality Processes with Industry Specific QMS
Customer Company Size
SME
Region
- America
- Asia
- Europe
Country
- China
- European Union
- New Zealand
- United States
Product
- Greenlight Guru
Tech Stack
- Electronic Quality Management System (eQMS)
Implementation Scale
- Enterprise-wide Deployment
Impact Metrics
- Customer Satisfaction
- Productivity Improvements
- Digital Expertise
Technology Category
- Functional Applications - Enterprise Resource Planning Systems (ERP)
- Functional Applications - Enterprise Asset Management Systems (EAM)
Applicable Industries
- Healthcare & Hospitals
- Life Sciences
Applicable Functions
- Quality Assurance
- Business Operation
Use Cases
- Regulatory Compliance Monitoring
Services
- System Integration
- Training
About The Customer
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.
The Challenge
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 The system, while functional, was outdated and inefficient, leading to issues with document progression, timeline management for nonconformances, and change controls.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.
The Solution
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.
Operational Impact
Quantitative Benefit
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