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.