Our Quality Assurance Department supports sponsors and sites in the development and maintenance of Quality Management Systems (QMS). Our services range from training your QA staff on general QMS principles up to developing a complete program.
An effective QMS supports the production of reliable and compliant end-results by minimizing errors relative to clinical procedures, data recording, and findings’ analysis, which improves your ability to accurately assess your product’s risks, benefits, and efficacy, and make better decisions.
Our Quality Assurance experts draft Quality Manuals that define your Quality Management System by establishing policies, comprehensive process maps, and roles and responsibilities. We develop efficient communication flows and lead educational initiatives to ensure that every staff member and all stakeholders have a clear understanding of their responsibilities and the underlying procedures, and are actively involved in quality management. At the earliest stage of development, our QA team develops performance indicators and quality goals that are used to assess - through thorough monitoring and auditing - all elements of your quality systems (e.g. Corrective Action and Preventive Action system, Change Management System) for improvement purposes and consistent performance.
- Quality Systems Development
- GCP, GMP, GLP, ISO
- Clinical Quality Management Programs