Quality Assurance/Quality Control Unit (QAU)

• Maintains listings of all studies conducted at NEA under EPA, FDA, or other Good Laboratory Practice regulations.
• Assure that all aspects of a project necessary to maintain the integrity of that project are detailed by properly authorized standard operating procedures (SOPs) or in the project protocol.
• Review, distribute, and maintain all SOPs written for regulatory compliance.
• Perform audits of computer validation, protocols, raw data and reports.
• Inspect each project at intervals adequate to ensure the integrity of the project, and maintain written and properly reviewed records of these inspections.
• Periodically perform general inspections of NEA GLP facility, and maintain written and properly reviewed records of these inspections.
• Review the raw data generated during regulated study/project to assure that study/project procedures and experimental data were properly recorded and verified.
• Review final reports to assure that each report accurately describes the methods and standard operating procedures utilized during the project, and that the reported results reflect the raw data of the project.
• Prepare and sign a statement to be included with each final study report specifying the dates study inspections were made and findings reported to management and to the study director (GLP only).
• Review analysis records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated.
• Participate, as requested, in inspections of NEA facility conducted by clients of regulated projects and supervise inspections conducted by authorized regulatory agency representatives.