Auditing Services
We audit your facility or systems and identify gaps against current guidance and regulation and present solutions quickly and systematically. Our approach is to understand the risks and focus on critical areas and systems. Our auditors have significant experience in the pharmaceutical and medical device industries. We can provide auditors that have ASQ certifications.
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.
