Quality Solutions
 

 

Client Services
  1. freezerValidation
    • Preparation and Execution of Validation Master Plans
    • Validation Project Management
    • Preparation and Execution of Validation Protocols
    • Facility Qualification
    • Utility Qualification
    • Equipment Qualification
    • Software Qualification
    • Sterilization Cycle Development and Validation
    • Process Validation
    • FAT/SAT Testing
  2. CGMP Compliance and Optimization
    • Assessment/Audits
    • Process Scale-Up, Optimization and Production Plans
  3. Clean Room/HEPA/Laminar Flow Certification
    • NSF Certified Services
    • Program Management
  4. Design Services
    • Clean Room
    • Facility
    • Laboratory
  5. Quality Assurance Services
    • Evaluation of 21 CFR Part 11 (Electronic Records and Signatures) compliance
    • Vendor and Quality System Auditing
    • SOP development
  6. USP 797
  7. Calibration
    • On-site Calibration
    • Facility Calibration Program Management
  8. Lab Environmental Health and Safety
    • OSHA Compliance Program
    • Maintenance of Safety Equipment
    • Hazardous Waste Management Program
    • MSDS Management Program
  9. Support Services
    • Project Management
    • Troubleshooting, Repair, Maintenance
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