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.
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.