ZenQMS
55 Case Studies
A ZenQMS Case Study
SeLux Diagnostics, a medical device company developing its NGP antimicrobial susceptibility testing platform, outgrew its manual, paper-based quality processes as it moved into clinical trials. The team needed an electronic quality management system that would be easy to implement, validate, and use, so they evaluated ZenQMS after struggling with home-grown tools, shared files, and document control risks.
ZenQMS provided a configurable eQMS that improved document management, training, and design history file handling, while making validation and implementation painless. With ZenQMS, SeLux was able to pull 99.9% of auditor requests directly from the system and reduce audit time by almost a full day, while also improving compliance visibility and gaining an immediate ROI from quality audits.
Ellin Drouin
Consultant