ZenQMS
44 Case Studies
A ZenQMS Case Study
Vizuri Health Sciences, a biopharmaceutical company that moved from R&D into manufacturing to launch PainBloc24®, needed a paperless, Part 11/Annex 11–compliant quality management system that could scale with the business and support distributed employees and contractors. Facing potential annual archiving costs and the chance of adding headcount to manage paper records, Vizuri selected ZenQMS’s cloud-based eQMS to meet those requirements.
ZenQMS delivered a fully supported, cloud-based QMS that automated document control, training, and complaint handling while meeting regulatory electronic-signature requirements. The solution enabled Vizuri to support regulatory filings and clinical trials for PainBloc24, avoid roughly $30K/year in storage and archiving fees, eliminate the need for an additional quality FTE, and scale to separate OTC and pharmaceutical divisions.
Tracy Fuller
Senior Quality Assurance Director