Comprehensive Services

End-to-end solutions for drug safety and compliance

Computer System Validation

Comprehensive CSV services for life sciences organizations ensuring systems are compliant, audit-ready, and functionally robust

Our Approach

  • Regulatory Alignment: FDA 21 CFR Part 11, EU Annex 11, GAMP 5, ALCOA+
  • Full Lifecycle: URS → FS → Risk Assessment → IQ/OQ/PQ → Reporting
  • Platform Expertise: Argus Safety, Veeva Vault, LifeSphere, ArisGlobal
  • Flexible Models: Traditional, Agile, AI-Assisted approaches
  • Quality Assurance: 100% traceability, audit-ready documentation
CSV

Safety System Services

NovaVire provides end-to-end pharmacovigilance safety system services to ensure your systems are efficient, compliant, and inspection-ready. We combine regulatory expertise with practical system know-how to support patient safety, data integrity, and operational efficiency

Our Capabilities

  • System Configuration & Setup: Workflow design, role-based access, and PV database configuration
  • Custom Reports & Analytics: Regulatory, management, and operational reporting
  • Data Migration & Integration: Legacy data mapping, migration, and validation
  • System Maintenance & Support: Monitoring, troubleshooting, and performance optimization
  • Workflow Optimization: Automating tasks and enhancing case processing efficiency
  • Compliance & Audit Support: GxP, 21 CFR Part 11, EU Annex 11–aligned inspection readiness
Safety Systems

Managed Services

Comprehensive managed services providing sustained compliance, operational continuity, and system stability for your safety environments

What's Included

  • 24/7 Monitoring: Proactive system monitoring and issue prevention
  • Incident Management: Rapid response and resolution protocols
  • Change Management: Controlled updates, patches, releases
  • Compliance: Continuous validation and compliance documentation
  • CRO Support: Dedicated resources for clinical research organizations
Managed