Qualio Case Studies Koneksa's Digital Transformation: Saving Time and Enhancing Quality Management

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	Koneksa's Digital Transformation: Saving Time and Enhancing Quality Management Qualio

Koneksa's Digital Transformation: Saving Time and Enhancing Quality Management

Qualio

Technology Category	Analytics & Modeling - Real Time Analytics Cybersecurity & Privacy - Security Compliance
Applicable Industries	Education
Applicable Functions	Quality Assurance
Use Cases	Virtual Training Visual Quality Detection
Services	Testing & Certification Training
Challenge	Koneksa, a provider of digital biomarker technology for clinical trials, was facing a significant challenge in 2020. As the company began to realize its ambitious growth plans, it found that its legacy quality management system was becoming a hindrance. The system, a combination of multiple learning management systems (LMS), Google folders, spreadsheets, and manual document and training management activities, was manageable during Koneksa's early stages. However, as the company grew, this system was unable to keep pace with the increasing demands and objectives. Read More
About Customer	Koneksa is a New York-based company that operates in the Software as a Medical Device (SaMD) industry. With a workforce of 51-200 employees, Koneksa provides digital biomarker technology to sponsors of clinical trials, enabling the remote capture of clinical data from patients. This is achieved through wearable actigraphic technology and a connected SaaS platform, which provides real-time data on various aspects such as vital signs, spirometry, gait, and balance. Koneksa operates under the quality and compliance requirements of Good Clinical Practice (GCP) and ICH E6, as well as the information security benchmarks of ISO 27001 and the GDPR. Read More
Solution	In response to this challenge, Koneksa evaluated five different electronic Quality Management System (eQMS) vendors. They ultimately chose Qualio for its readiness, simplicity of implementation, and the vendor's similar growth trajectory. Qualio was implemented across the quality team in late 2020 and was rolled out across the entire business by mid-2021. The new system transformed Koneksa's approach to quality and compliance, turning it from an admin-heavy task to a natural and supported component of the company culture. Read More Log in to view content
Contents

Technology Category

Analytics & Modeling - Real Time Analytics

Cybersecurity & Privacy - Security Compliance

Applicable Industries

Education

Applicable Functions

Quality Assurance

Use Cases

Virtual Training

Visual Quality Detection

Services

Testing & Certification

Training

Challenge

Koneksa, a provider of digital biomarker technology for clinical trials, was facing a significant challenge in 2020. As the company began to realize its ambitious growth plans, it found that its legacy quality management system was becoming a hindrance. The system, a combination of multiple learning management systems (LMS), Google folders, spreadsheets, and manual document and training management activities, was manageable during Koneksa's early stages. However, as the company grew, this system was unable to keep pace with the increasing demands and objectives.

About Customer

Koneksa is a New York-based company that operates in the Software as a Medical Device (SaMD) industry. With a workforce of 51-200 employees, Koneksa provides digital biomarker technology to sponsors of clinical trials, enabling the remote capture of clinical data from patients. This is achieved through wearable actigraphic technology and a connected SaaS platform, which provides real-time data on various aspects such as vital signs, spirometry, gait, and balance. Koneksa operates under the quality and compliance requirements of Good Clinical Practice (GCP) and ICH E6, as well as the information security benchmarks of ISO 27001 and the GDPR.

Solution

In response to this challenge, Koneksa evaluated five different electronic Quality Management System (eQMS) vendors. They ultimately chose Qualio for its readiness, simplicity of implementation, and the vendor's similar growth trajectory. Qualio was implemented across the quality team in late 2020 and was rolled out across the entire business by mid-2021. The new system transformed Koneksa's approach to quality and compliance, turning it from an admin-heavy task to a natural and supported component of the company culture.

Impact #1	The implementation of Qualio had a significant impact on Koneksa's operations. The time saved from the reduction in training management time was repurposed to strengthen and refine the company's approach to quality events like CAPAs, NCRs, and audit findings. The use of Qualio's Events functionality, including tags, provided Koneksa with granular control and visibility of their quality landscape across a complex raft of client and clinical study data. Furthermore, the user-friendliness of Qualio led to an immediate increase in engagement with quality activities like training, thereby strengthening the Koneksa workforce and embedding demonstrable competence and compliance. Lastly, the new system allowed for deeper metrics and faster reporting, enabling Koneksa management to make stronger, smarter decisions based on accurate and real-time quality metrics.

Impact #1

The implementation of Qualio had a significant impact on Koneksa's operations. The time saved from the reduction in training management time was repurposed to strengthen and refine the company's approach to quality events like CAPAs, NCRs, and audit findings. The use of Qualio's Events functionality, including tags, provided Koneksa with granular control and visibility of their quality landscape across a complex raft of client and clinical study data. Furthermore, the user-friendliness of Qualio led to an immediate increase in engagement with quality activities like training, thereby strengthening the Koneksa workforce and embedding demonstrable competence and compliance. Lastly, the new system allowed for deeper metrics and faster reporting, enabling Koneksa management to make stronger, smarter decisions based on accurate and real-time quality metrics.

Benefit #1	25% reduction in training management time, saving a week every month.
Benefit #2	Increased engagement with quality activities like training due to the user-friendliness of Qualio.
Benefit #3	Faster reporting with touch-of-a-button access to up-to-date data.

Benefit #1

25% reduction in training management time, saving a week every month.

Benefit #2

Increased engagement with quality activities like training due to the user-friendliness of Qualio.

Benefit #3

Faster reporting with touch-of-a-button access to up-to-date data.

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Overview

Koneksa's Digital Transformation: Saving Time and Enhancing Quality Management

Operational Impact

Quantitative Benefit