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Home > Full Service Laboratory > Quality Assurance
Quality Assurance
Experimental Surgical Services (ESS), in accordance with the FDA 21CFR58:Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies, has established a Quality Assurance Unit (QAU). This QAU is independent of all ESS personnel engaged in the direction and conduct of GLP compliant studies. It is the responsibility of the QAU professional staff to monitor every GLP study conducted at ESS to assure that all aspects are in compliance with GLP regulations.
The ESS Quality Assurance unit:
- Maintains a master schedule of GLP studie
- Inspects in-life phases of the studies
- Inspects testing facility operations
- Ensures that no deviations are made from the protocols or standard operating procedures without proper documentation
- Supplies written inspection reports
- Audits final reports for accuracy
- Provides quality assurance statements for final reports
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