Case Studies How IVD Manufacturer Streamlined Production and Improved Quality Processes with Industry Specific QMS

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	How IVD Manufacturer Streamlined Production and Improved Quality Processes with Industry Specific QMS

How IVD Manufacturer Streamlined Production and Improved Quality Processes with Industry Specific QMS

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
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 The system, while functional, was outdated and inefficient, leading to issues with document progression, timeline management for nonconformances, and change controls.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. Read More
About 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. Read More
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. Read More Log in to view content
Contents

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

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.

About 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.

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.

Impact #1	The transition to Greenlight Guru has significantly simplified internal audits, allowing auditors to quickly access necessary documents and complete audits on time.
Impact #2	The automated tracking and task management features of Greenlight Guru have improved quality processes, enabling quicker decision-making and saving time.
Impact #3	The system provides online access in the lab, allowing team members to access information in real-time and make informed decisions promptly.

Impact #1

The transition to Greenlight Guru has significantly simplified internal audits, allowing auditors to quickly access necessary documents and complete audits on time.

Impact #2

The automated tracking and task management features of Greenlight Guru have improved quality processes, enabling quicker decision-making and saving time.

Impact #3

The system provides online access in the lab, allowing team members to access information in real-time and make informed decisions promptly.

Benefit #1	Canterbury Scientific has maintained ISO 13485:2016 certification.
Benefit #2	The company has obtained 510(k) clearances and CE Marks for their products.

Benefit #1

Canterbury Scientific has maintained ISO 13485:2016 certification.

Benefit #2

The company has obtained 510(k) clearances and CE Marks for their products.

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Overview

How IVD Manufacturer Streamlined Production and Improved Quality Processes with Industry Specific QMS

Operational Impact

Quantitative Benefit