Case Study: Paragon Biomedical achieves a streamlined, compliant QMS with MasterControl

MasterControl as the Foundation for Quality Management Systems Success

Paragon Biomedical, led by Gary Urban in Global Quality Management Systems, faced a fragmented QMS built on spreadsheets, email-based document collaboration, manual approval pages, a SharePoint library of uncontrolled copies, and labor-intensive tracking of required reading and exams. These manual processes created inefficiency, risk of outdated documents in circulation, and heavy administrative burden for global teams.

Paragon implemented MasterControl as a single EDMS, consolidating collaboration on redline documents, enforcing version control, routing and audit trails, and using “time‑bombed” documents to ensure users access current copies. Automated training job codes and exam scoring, plus MasterControl’s validation services and support, cut manual work, reduced compliance risk, improved document and training visibility, and enabled ongoing quality improvement (including a planned CAPA rollout).

Paragon Biomedical

Gary Urban

Global Quality Management Systems