Quality to Match Your Standards
Our processes are designed to ensure the highest quality data, documents, and services for our partners.
Our Quality unit remains independent from operations and reports directly to the President. Their main responsibilities under the GXP-compliant quality system include:
• Maintaining an audit ready document control system
• Performing internal audits to promote continuous improvement
• Conducting vendor qualification audits to ensure supplier quality is consistent with Cambridge Biomedical’s internal standards
• Auditing critical phase and data/report to ensure data accuracy and integrity
• Hosting and managing client and regulatory inspections (FDA, CAP, CLIA, NYSDOH, etc.)
• Providing recommendation and consultation to operations management for continuous improvement and process improvement initiatives
• Overseeing training management
• Secure management of the regulated archives
In a continuing effort to exceed client quality standards and improve efficiency and service, the Cambridge Biomedical Quality unit stays up to date on new regulatory trends and evaluates new technologies and systems.