Commitment to Quality

Quality is in our DNA

BioBridge Global focuses on excellence in our mission to save and enhance lives through the healing power of cells and tissue.

 

Through design and control of processes and systems using operational excellence and risk-based methodologies, our unified Quality Management System (QMS) brings simplicity to complex capabilities.

 

Our QMS meets globally recognized standards and best practices, while being both scalable and adaptable.

A Unified Quality Management System

Our electronic Quality Management System allows us to automate control, authorization and access to relevant documentation and procedures. The system ensures that Change Controls, Risk Assessments, Validations, Audits, Documentation and Standard Operating Procedures, Supplier Records, as well as Training Records, are readily and electronically retrievable. All records and documents can be electronically cross-referenced for traceability and accessibility to Relevant Documents and Tools.

Our quality management tools help our organization access crucial metrics and key performance indicators to enable effective management review, and performance and benchmarking trends. Short cycle times for quality events are a point of pride for the organization and a key indicator of our focus on addressing and mitigating quality risks by ensuring corrective and preventive actions occur when and where needed.

By leveraging knowledge and resource transferability across the enterprise, our centralized quality unit can scale and adapt to meet needs across all operational areas. Simplified process designs ensure systems can be readily adapted and modified to meet process variables.

Automation and robust process designs are hallmarks of our quality philosophy: control risk and simplify the user experience. They assure that we focus on the critical steps to achieve product and service requirements.

We foster open dialogue and industry collaboration. We look to act as change agents for industries we serve by working closely with regulatory and standards bodies. We help establish new standards and pave the way for transfusible products, regenerative medicines, advanced therapies, and relevant test methods.

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Certifications
Our organization complies with multiple U.S. and international standards. A full list of accreditations, certifications and registrations can be found here.