CMIC's Quality Commitment
The Quality Assurance Unit (QAU) at CMIC, Inc. was established to provide data quality and study integrity in accordance with Good Laboratory Practice (GLP) regulations.
CMIC QAU staff members are Registered Quality Assurance Professionals in Good Laboratory Practice (RQAP-GLP) and have over 20 years of combined experience inspecting and auditing studies designed to comply with the US FDA and EPA as well as international regulations such as OECD and JMHW GLPs. Each QAU staff member receives ongoing training and education in Quality Assurance.
- Perform inspections and audits throughout the facility to ensure practices are in conformance with GLP standards.
- The QAU inspects all studies during critical phases for adherence to study plan requirements and company standard operating procedures (SOPs).
- The QAU audits study data, notebooks and related files and documents to ensure adherence to the plan, SOP's, and GLP regulations. The QAU audits final study reports to ensure they accurately reflect raw data and provide a description of the experimental methods, observations and results. The QAU prepares and signs a quality assurance statement that is included in the final report.
- Upon study completion, the QAU assures that study raw data, study plan, final report, and all study-related material are retained in CMIC’s environmentally monitored archives. Access to the archives is limited to authorized personnel and the area is protected by fire suppression system as per local building codes.
- Management of Quality Document System