Ender Diagnostics' Transition to a Cloud-Based Quality Management System with Qualio
Technology Category
- Infrastructure as a Service (IaaS) - Cloud Databases
- Platform as a Service (PaaS) - Device Management Platforms
Applicable Industries
- Education
- Electronics
Applicable Functions
- Quality Assurance
Use Cases
- Experimentation Automation
- Visual Quality Detection
Services
- Testing & Certification
- Training
About The Customer
Ender Diagnostics is a Swiss company that develops and manufactures rapid molecular diagnostic kits for the detection of SARS-CoV-2. The company is at the forefront of the global fight against COVID-19, offering rapid, high-accuracy on-site and laboratory testing. As a producer of COVID-19 PCR tests, Ender's quality management system falls under in vitro diagnostic medical device standards and regulations, including the EU IVDD (transitioning to the IVDR) and ISO 13485. Founded in 2020, the company has grown rapidly due to the high demand for COVID-19 testing. The majority of Ender's workforce is made up of scientists and graduates.
The Challenge
Ender Diagnostics, a Swiss developer and manufacturer of rapid molecular diagnostic kits for the detection of SARS-CoV-2, faced a significant challenge with its quality management system (QMS). Founded in 2020, the company expanded rapidly due to the high demand for COVID-19 testing. However, Ender's manual, paper-based QMS was unable to keep up with this growth. It lacked audit-ready traceability and control and did not support remote and home working. The majority of Ender's workforce consisted of scientists and graduates, with only small pockets of specific quality management experience. The company needed a system that would not distract from scientific work with time-consuming administrative tasks. The challenge was to implement a document and training management system that could handle the company's rapid expansion and remote working needs.
The Solution
Mohamad El Zein, Ender Diagnostics' quality manager, began searching for an electronic Quality Management System (eQMS) that was easy to use, had a rapid set-up time, and offered cloud-based access for an international, remotely distributed team. He decided to implement Qualio, impressed by the speed and ease of the implementation and validation. With ISO 13485 compliance as the primary objective, Mohamad began to construct his eQMS around the requirements of the standard with help from the Qualio team. As a Qualio+ customer, he could request dedicated QA support and pre-built compliant document templates to accelerate his ISO 13485 preparations. The implementation of Qualio allowed Ender Diagnostics to have a complete cloud-based eQMS comprising document control, training management, and quality event management.
Operational Impact
Quantitative Benefit
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