GxP Computer System Risk Assessment Generator

This agent transforms days of risk analysis into minutes by generating complete, ICH Q9(R1)-compliant GxP Risk Assessments using a structured FMEA methodology. Built by a 25-year pharmaceutical validation expert using current FDA CSA Guidance (February 2026), GAMP5 2nd Edition, and ICH Q9(R1), it delivers audit-ready risk documentation for LIMS, QMS, MES, CDS, ELN, LMS, and custom GxP systems. Every risk item is traced to parent URS requirements, scored using a calibrated Likelihood × Severity matrix, and assigned a specific control measure and verification phase — directing exactly what gets tested in IQ, OQ, and PQ. Includes full FMEA risk register, risk control measures summary, testing recommendations, and residual risk assessment. Part of the QualGen AI validation lifecycle suite — reads directly from your URS output to inherit all system parameters, GAMP5 classification, and requirement counts with no re-entry required. Perfect for validation leads, QA engineers, pharmaceutical quality managers, biotech compliance teams, and medical device quality professionals who need a traceable, inspection-ready risk assessment that bridges requirements and qualification protocols.