A Medical Device Daily

Camstar (Charlotte, North Carolina) reported that Gambro BCT (Lakewood, Colorado) has selected Camstar’s Medical Device Suite software to manage device history records, ensure process enforcement, and facilitate regulatory compliance.

Medical Device Suite will be deployed at Gambro facilities in the U.S. and U.K. The software will provide a production and quality management system that includes self-auditing electronic Device History Records (eDHR), process enforcement, material traceability and genealogy, and reporting, the companies ssaid.

“Gambro BCT is fully committed to continually improving operational performance,” said Gary Heath, vice president of operations for Gambro. “We are experiencing tremendous growth both in new products and within our existing product lines. By streamlining key manufacturing processes and enforcing process controls, Camstar’s Medical Device Suite will be an important tool for helping us ensure regulatory compliance, increase time-to-volume, and improve operational efficiency.”

The system will act as a repository for Gambro BCT’s production data in order to ensure that information is consistent and accurate, and will facilitate real-time visibility to improvedecision-making, avoid potential problems, and benchmark performance, according to Camstar.

Jason Adams, vice president of sales, life sciences, for Camstar. “Gambro BCT is a great example of the tremendous acceptance that our solutions have achieved in the Life Sciences industry.”

Camstar’s Medical Device Suite manages, monitors and synchronizes manufacturing activities across globally distributed plants, and integrates them in real-time with core business processes. Camstar says the system provides the manufacturing control needed to help eliminate scrap, rework, paperwork errors, and redundant checks. As a result, manufacturers improve yields and product quality, shorten lead times and reach volumes quickly, respond to changing demand, and reduce the cost of compliance.

According to Camstar, more than 100 leading companies use Camstar software.

Gambro BCT is focused on automated blood collections, therapeutic apheresis and cell therapy, as well as blood component separation and purification.