Case Study: ZS/Medullan achieves a future-proof, configurable eQMS and streamlined postmarket surveillance with AssurX

ZS/Medullan, a Pioneer in Digital Health Technology, Turns to AssurX for a Future-Proof eQMS

ZS/Medullan, a pioneer in digital health (Medullan founded 2005; acquired by ZS in 2021) that serves 49 of the top 50 life sciences companies, needed a more robust electronic quality management system. Their previous eQMS was ineffective for postmarket surveillance—users couldn’t submit electronically to regulators, required fields and metric calculations were missing, and overall functionality fell short of the RQC team’s identified needs.

Medullan chose AssurX for its high configurability and partnered with AssurX Professional Services to implement Complaints Management (with tailored views), plus CAPA, Audit, Document Management, and Training. The platform went live in December 2022 and immediately met PMS, EUMDR and FDA reporting requirements, reduced errors and staffing costs, and delivered fast, responsive support—results that led the team to recommend AssurX and continue expanding its use.

ZS/Medullan

Umer Rathore

Senior Quality Analyst