Ideagen’s global partner – ProcessPower Solutions Inc – help Navidea Biopharmaceuticals reap the benefits of Q-Pulse
Based in Dublin, Ohio, Navidea Biopharmaceuticals is concurrently developing both gamma detection systems and radio labelled tracers for cancer surgery. Navidea’s primary focus is to improve the diagnostic tools for cancer surgery by using their market-leading gamma detection devices in combination with the new diagnostic radiopharmaceuticals they are developing.
Navidea had experienced frequent document process inefficiency and accuracy issues with their paper-based Quality Management System (QMS), which was neither centralised nor controlled. The company realised they needed to replace their previous paper-based QMS and, through working with ProcessPower Solutions Inc – part of Ideagen’s Global Partner Network, they chose Q-Pulse as the product which best met their needs.
Benefits
- Q-Pulse helps Navidea adhere to multiple regulations and industry standards for healthcare products including international ISO 13485 standard
- Addition of 21 CFR Part 11 enhances compliance with electronic records and signatures requirement
- Non-conformances relating to maintenance of documents and records “completely eliminated”
- Zero QMS non-conformances raised by external auditors during the last three years
- Document review and approval process reduced from weeks to hours
- Simple reporting of business performance to senior management
We have utilised the Q-Pulse application for four years and are pleased with its ability to fully integrate the QMS and DMS processes in support of our life science business plans.