Our Services
Better Results through Integration
Validation
Genesis offers qualification and validation services for building systems and clean utilities. Our project management focus allows us to deliver effective validation programs sensitive to cost and schedule.
A Common Sense Approach to Validation
Leveraging our commissioning capabilities, internal Subject Matter Experts and external relationships, we offer a common sense approach for validation of facilities, systems, utilities, and equipment, minimizing redundant activities and inefficiencies.
We integrate with our clients' engineering, quality assurance and operational personnel to meet cGMP requirements.
VALIDATION SERVICES
- Validation Master Plan Development
- Risk Management
- Enhanced Design Review
- System Impact Assessments
- Critical Component Risk Assessments
- Development of System Boundaries
- Equipment Qualification Protocols
- Environmental Monitoring
- Performance Qualifications
RETRO-COMMISSIONING SERVICES
- Analytical Instrument Qualification
- Computer System Life Cycle Documentation
- Factory Acceptance Testing (FAT)
- Site Acceptance Testing (SAT)
- Cleaning Validation
- Standard Operating Procedures (SOPs)
- Preventive Maintenance Procedures (PMs)
- Change Control
- GMP Training
Genesis Engineers provides comprehensive validation services from planning and risk management through plan implementation and monitoring.