Koneksa's Digital Transformation: Saving Time and Enhancing Quality Management
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
About The 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.
The 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.
The 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.
Operational Impact
Quantitative Benefit
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