Greenlight Guru
Case Studies
Tenacore's Successful ISO 13485:2016 Recertification Audit with Greenlight Guru's eQMS
Overview
Tenacore's Successful ISO 13485:2016 Recertification Audit with Greenlight Guru's eQMSGreenlight Guru |
Platform as a Service (PaaS) - Application Development Platforms Platform as a Service (PaaS) - Device Management Platforms | |
Equipment & Machinery Healthcare & Hospitals | |
Maintenance Quality Assurance | |
Virtual Training Visual Quality Detection | |
Testing & Certification Training | |
Operational Impact
The adoption of Greenlight Guru's eQMS has brought significant operational benefits to Tenacore. The company has become more efficient, passed audits, and reduced risk. The eQMS has enabled Tenacore to manage its processes more effectively on a daily basis, quickly identify gaps, and migrate their existing processes from a paper-based system. The platform has also facilitated better collaboration among teams and streamlined their work processes. Looking ahead, Tenacore is committed to putting its patients, customers, and quality at the core of everything, even at an executive level. Their senior leadership team will be taking Greenlight Guru Academy certification courses on Intro to ISO 13485 and Intro to 21 CFR Part 820 in 2023 to uphold this commitment. The company will continue to use Greenlight Guru as they scale operations across the United States. | |
Quantitative Benefit
Tenacore doubled in efficiency by replacing disconnected processes and tools with Greenlight Guru as the source of truth for their Documents, Change Management, Audits, CAPA, Nonconformance, Customer Feedback, Training, and more. | |
Within 10 months of purchasing Greenlight Guru, Tenacore passed its ISO 13485:2016 audit with no major nonconformities. | |
The company reduced compliance risk by taking a risk-based approach to all of its quality operations. | |