CQV

Qualification & Validation

We Offer a Common Sense Approach to Meeting GMP Requirements

Genesis offers a common sense approach for qualification and validation of facilities, systems, utilities, and equipment. Our CQV capabilities, coupled with our internal Subject Matter Experts and external relationships, help minimize redundant activities and inefficiencies. Furthermore, we integrate with our clients’ engineering, quality assurance, and operational personnel to meet all cGMP requirements.

QUALIFICATION AND VALIDATION SERVICES

  • Validation Master Plan Development
  • Risk Management
  • FMEA/FMECA, HACCP, FTA, PHA
  • System Level Impact Assessments
  • Component Criticality Assessments
  • Development of System Boundaries
  • Enhanced Design Review
  • Equipment Qualification Protocols
  • Environmental Monitoring
  • Performance Qualifications
  • 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

 

Our Commissioning team is proficient in building automation, MEP, and process system design. Read More.