Case Study: Navidea Biopharmaceuticals achieves ISO 13485 compliance and zero QMS non-conformances with Ideagen's Q-Pulse

Ideagen’s global partner – ProcessPower Solutions Inc – help Navidea Biopharmaceuticals reap the benefits of Q-Pulse

Navidea Biopharmaceuticals, based in Dublin, Ohio, develops gamma detection devices and diagnostic radiopharmaceuticals for cancer surgery. The company was hampered by a decentralized, paper-based Quality Management System that caused inefficiencies, inaccuracies and regulatory compliance risks, so they worked with ProcessPower Solutions to select Q‑Pulse as a replacement.

Q‑Pulse centralized and integrated Navidea’s document and quality management, adding e-signatures, audit trails and 21 CFR Part 11 capability while supporting ISO 13485 requirements. The solution eliminated document-related non-conformances, produced zero QMS non-conformances from external audits over three years, reduced document review times from weeks to hours, and improved traceability, reporting and overall efficiency at a cost effective price.

Navidea Biopharmaceuticals

Rodger A. Brown

Vice-President