We base our approach to compliance on the current industry guidance and methods and we strive to understand the fundamentals of everything that we do, applying our approach in the appropriate method to provide a solution. Our services are tailored for the specific needs of our clients and each project.
We understand the standards, regulations, directives, and guidance applicable to your biomedical and pharmaceutical systems and we will apply various techniques to examine, question, evaluate, and report on the areas of adequacy or deficiency of a system and/or associated documentation and operational processes. In addition, we can also evaluate using such tools as root cause analysis, the six sigma model (DMAIC), lean tools, and corrective and preventive action (CAPA) methods to pinpoint the source of problems. Based on our evaluation, we provide a plan to correct deficiencies and provide recommendations for process improvement.