Life Sciences
Looking for meaningful work in a company that values expertise, collaboration, and professional growth? Join SOKOL GxP and help deliver solutions in some of the world’s most demanding industries.
CQV Services Designed for Your Operational Success
SOKOL delivers integrated CQV solutions that ensure facilities, utilities, equipment, and systems are compliant, reliable, and ready for GMP operations.
End-to-End CQV Lifecycle
IQ / OQ / PQ Protocol Development & Execution
Validation Plans & Strategies
Requirements Traceability Matrix (RTM)
Validation Summary Reports (VSRs)
Equipment qualification
Temperature mapping
Monitoring probe placement strategy and integration
Periodic re-qualification
Autoclave validation
Sterilization cycle development and validation using Biological Indicators (BI)
VHP cycle development
SIP systems validation with BIs
Equipment
Full lifecycle qualification
Integration with automation systems
Facilities
Cleanroom qualification
Clean up & recovery studies
Utilities
HVAC systems
Process gases (CO₂, Nitrogen, Process Air)
Clean utilities (WFI, Clean Steam)
Analytical Equipment
Qualification aligned with data integrity expectations
Computerized Systems Validation (CSV)
Lifecycle validation
21 CFR Part 11 compliance
From Concept to GMP Operation-Delivered with Precision
SOKOL provides end-to-end project delivery support, ensuring seamless execution from concept through GMP readiness. We act as a bridge between engineering, quality, and operations to keep projects on track, compliant, and efficient.
CQV Integration
Alignment of CQV strategy with project milestones
Early-stage risk-based qualification planning
Commissioning and validation readiness
Project Management
Capital project execution
Schedule, cost, and risk management
Stakeholder coordination
Technical Oversight
Design review (URS, DQ support)
Vendor and contractor management
FAT/SAT coordination
Strategic GxP Consulting for Complex Environments
SOKOL provides strategic and technical consulting services to help organizations navigate complex GxP environments, optimize processes, and maintain compliance.
GxP Advisory
Regulatory strategy
Risk-based decision frameworks
Quality system development and optimization
Process & System Optimization
Lean and risk-based validation strategies
Lifecycle management approach
Efficiency improvements for CQV and operations
Facility & Process Design Support
Cleanroom layout optimization
Material and personnel flow analysis
Airflow and contamination control strategy
Digital & Data Integrity
CSV strategy and remediation
Data governance and compliance
Contamination Control Strategy (CCS)
Development aligned with Annex 1 requirements
Risk assessments and implementation support
HVAC systems