Über diesen Experten

Senior CSV / GxP Validation Consultant with 8 years of experience supporting computerized system validation in GMP-regulated pharmaceutical environments. I support the full validation lifecycle, from validation planning and risk assessments to requirements review, IQ/OQ/PQ, traceability, validation reporting, periodic reviews and change control. My services include: CSV documentation development and review Risk-based validation and requirements traceability Validation lifecycle and periodic review support GMP documentation, CAPA and audit readiness Validation gap assessments and remediation recommendations Experienced with enterprise, laboratory and manufacturing systems, I help regulated organizations maintain compliant, well-documented and inspection-ready computerized systems. Available for remote freelance consulting and project-based documentation support.