Case Study: Duke University Medical Center achieves scalable compliant research quality management with AssurX

Duke University Quality Assurance Team scales research portfolio while staying compliant with AssurX

Duke University Medical Center’s Quality Assurance for Duke Vaccine Immunogenicity Programs (QADVIP) needed a better way to manage document approvals, employee training, and compliance as its research portfolio expanded during COVID-19 vaccine trials. Its legacy QMS relied heavily on paper signatures, manual approvals, and difficult reporting across more than 150 users in multiple internal and external labs, creating significant workflow and compliance challenges. AssurX was selected as the cloud-based quality management system to address these needs.

AssurX implemented configurable modules for Document Management, Employee Training, Asset Management, and Deviation Management, automating workflows and centralizing training data with real-time visibility into tasks and compliance status. The result was greater efficiency, fewer manual steps, faster access to records, and clearer accountability across QA and lab teams. Duke University Medical Center also reduced the need for manual document activation and improved oversight through dashboards, alerts, and direct links in notification emails, helping the team maintain growing revision cycles while staying compliant with AssurX.

Duke University Medical Center

Rebecca Beerman

QA Manager