Case Study: Northeastern Pharmaceutical Contract Manufacturer achieves faster audits and business growth with DocXellent ENSUR

ENSUR Helps Pharmaceutical Contract Manufacturer Work Smarter and Build Their Business

Northeastern Pharmaceutical Contract Manufacturer, a rapidly growing CMO, was hampered by an elaborate paper-based document management process that consumed hours of non–value-added time, created SOP discrepancies, complicated training, and increased FDA audit and data security risk. With limited budget and free DMS options lacking necessary security, the company selected DocXellent’s ENSUR as a right-sized, secure document management solution.

DocXellent implemented ENSUR to organize, code and securely store documents, reliably route approvals (including external client approvers), link related materials, and provide auditors access to any report or version on demand. ENSUR centralized electronic signatures, freed several employees from manual document tasks, returned months of lab manager time, enabled the CMO to take on more projects, and—per the principal scientist—paid for itself within the first month while markedly improving audit readiness and allowing expansion of ENSUR use across departments.