AssurX
16 Case Studies
A AssurX Case Study
EyePoint Pharmaceuticals, a developer of retinal disease therapeutics, faced fragmented quality processes in 2021: separate document and learning-management tools, paper-based workflows, slow change control requiring multiple signatures, and gaps in records management. Adding vendor modules looked costly given the number of processes that needed modernization.
The company implemented AssurX as an integrated QMS—validated for document and change control within three months, with training, CAPA, supplier quality, and audits added—importing LMS content and automating document-to-training links and approvals. The change eliminated several systems, cut at least $100K in annual licensing costs, delivered real-time visibility and faster reporting, reduced delays, and enabled about 20% more CDMO work without adding staff, while providing a scalable platform for future CMMS and facility expansion.
David Vario
Vice President of Quality