About QUALITY SYSTEM SERVICES LLC
Quality System Services (QSYS) is a GMP remediation and quality systems consulting firm supporting regulated manufacturers in the pharmaceutical, biotechnology, medical device, compounding, and contract manufacturing sectors. The company specializes in restoring control to quality systems under regulatory pressure and delivering sustainable compliance solutions.
GMP remediationCompliance recovery for FDA Form 483 observations and Warning LettersCAPA system reconstruction and effectiveness verificationEnvironmental monitoring program optimizationData integrity remediation and governance reinforcementMock FDA inspections and inspection readiness preparationQuality Management System (QMS) design and rebuild
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