Case Study: CytoVale accelerates change impact assessment with Ketryx AI

CytoVale cuts change assessment time by 70% with Ketryx

CytoVale, a developer of an AI-enabled diagnostic system for sepsis, faced significant challenges in managing the rigorous documentation and traceability required by the FDA. Their engineering team spent weeks manually performing change impact assessments, which created bottlenecks by requiring multiple subject matter experts and delayed critical product improvements. They turned to Ketryx to address these inefficiencies.

Ketryx provided an AI-powered platform that unified traceability data from systems like Polarion and generated comprehensive change impact assessments. The solution delivered a 70% reduction in the time spent on documentation and achieved 90% accuracy in its analysis. By using Ketryx, CytoVale eliminated SME bottlenecks, allowing engineers to focus on high-value decision-making instead of administrative overhead.

CytoVale