CSV
Ficus Realtime: Precision-Driven Computer System Validation(CSV)
Solutions
for Pharma Compliance
Ensure seamless adherence to FDA 21 CFR Part 11, EU Annex 11, and global
regulations with Ficus Realtime’s targeted Computer System Validation (CSV)
services.
We deliver:
Risk-Based Validation Frameworks: Prioritize critical systems with
risk
assessments, minimizing redundant testing while ensuring compliance.
End-to-End Validation: From GxP systems (LIMS, ERP, MES) to IoT/cloud
platforms, we validate with precision—requirements traceability, protocol
design, UAT, and audit-ready documentation.
Continuous Compliance: Proactive monitoring, change control, and
automated
validation lifecycle management (ALM) tools to maintain system integrity
post-deployment.
