FDA and EMA Inspection Readiness Consulting: Top services for GVP Audit and Compliance Checklist
Inspection readiness means being audit-ready every day, not reacting when inspection letters arrive.
– What Inspectors Actually Review
ICSR quality and timeliness
Signal management documentation
SOP effectiveness
QPPV oversight
Vendor governance
– Common FDA & EMA Findings
Late or inaccurate ICSRs
Poor signal documentation
SOPs not followed in practice
– GPLACO’s Inspection Readiness Model
Pre-inspection mock audits
ICSR quality benchmarking (>98%)
System and process gap remediation
CAPA strategy support