Qualio Case Studies Ender Diagnostics' Transition to a Cloud-Based Quality Management System with Qualio

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	Ender Diagnostics' Transition to a Cloud-Based Quality Management System with Qualio Qualio

Ender Diagnostics' Transition to a Cloud-Based Quality Management System with Qualio

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
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. Read More
About 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. Read More
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. Read More Log in to view content
Contents

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

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.

About 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.

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.

Impact #1	The implementation of Qualio has brought about significant operational benefits for Ender Diagnostics. The company now has a cloud-based single source of truth that is vital for continued compliance and quality improvement. With digitally enforced compliance, the organization can now focus on further market expansion and has begun work on territory-specific requirements. The control, consistency, and traceability that were lacking in the paper-based quality framework have been embedded into the new system. This has made the quality manager's job easier in a hybrid working world. There has also been a noticeable uptick in engagement with the quality system, with more Ender employees comfortably accessing and completing quality tasks within Qualio than the previous system.

Impact #1

The implementation of Qualio has brought about significant operational benefits for Ender Diagnostics. The company now has a cloud-based single source of truth that is vital for continued compliance and quality improvement. With digitally enforced compliance, the organization can now focus on further market expansion and has begun work on territory-specific requirements. The control, consistency, and traceability that were lacking in the paper-based quality framework have been embedded into the new system. This has made the quality manager's job easier in a hybrid working world. There has also been a noticeable uptick in engagement with the quality system, with more Ender employees comfortably accessing and completing quality tasks within Qualio than the previous system.

Benefit #1	Ender Diagnostics' manufacturing sites and testing laboratories now access Qualio as the company's dedicated eQMS.
Benefit #2	Ender passed its ISO 13485 audits in February and April 2022, unlocking new regulated markets.
Benefit #3	The headcount of Ender Diagnostics has tripled to over 180 employees since the implementation of Qualio.

Benefit #1

Ender Diagnostics' manufacturing sites and testing laboratories now access Qualio as the company's dedicated eQMS.

Benefit #2

Ender passed its ISO 13485 audits in February and April 2022, unlocking new regulated markets.

Benefit #3

The headcount of Ender Diagnostics has tripled to over 180 employees since the implementation of Qualio.

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Overview

Ender Diagnostics' Transition to a Cloud-Based Quality Management System with Qualio

Operational Impact

Quantitative Benefit