Other GxP Audits

PVCON extends its audit expertise beyond pharmacovigilance and clinical practice to deliver specialized GxP audits across CSV, GLP, GMP, and GDP disciplines. Our auditors evaluate compliance with EU Annex 11, 21 CFR Part 11, OECD GLP principles, and global GDP guidelines, providing organizations with a complete compliance assessment across all regulated operations.

Our audit portfolio includes Computer Systems Validation audits for electronic systems and data integrity, Good Laboratory Practice audits for non-clinical study sites, Good Manufacturing Practice audits for production facilities, and Good Distribution Practice audits ensuring supply chain integrity. We also conduct due diligence and for cause audits as required.

Additionally, PVCON performs archive facility audits, vendor and supplier qualification assessments, and regulatory submission readiness reviews. Whether your organization requires targeted compliance verification or a comprehensive multi-disciplinary audit program, our experienced team delivers actionable findings and practical recommendations for remediation.