Case Study: OPK Biotech achieves successful implementation and faster SOP access with MasterControl

Teamwork Key to OPK Biotech’s Successful Implementation

OPK Biotech, a developer and manufacturer of oxygen‑carrying products operating two cGMP facilities in Cambridge, MA and Souderton, PA, faced the challenge of implementing a new quality system while preparing for a European Medicines Agency (EMA) inspection in 2012. The company postponed implementation, then had to rapidly refresh training, revise legacy document practices before importing records, and rely on a small, committed team — including a lone training coordinator — to get back on track.

OPK purchased MasterControl All Access and implemented MasterControl Documents and Training, later adding MasterControl Mobile and the Organizer for mobile access to procedures. With strong management support and close collaboration with MasterControl consultants, the project was completed successfully: document control and training were streamlined, access to updated SOPs sped up, and the company improved operational efficiency while maintaining regulatory readiness.

OPK Biotech

David J. Restivo

IT Director and Implementation Project Manager