Quality Solutions, LLC Validation Experience in Detail

Master Plan Development
  • Facility Design and Development
  • Facility Validation Master Plan
  • Computer/Software/Automation Validation Master Plan
  • Cleaning Validation Master Plan
  • Calibration Master Plan
  • Preventive Maintenance Master Plan
Computer/Software Validation
  • Electronic Signature Requirements, 21 CFR Part 11
  • Building Monitoring System Design and Validation
  • Building Control System Design and Validation (inclusive of HVAC and Cleanroom)
  • SCADA Systems
  • Programmable Logic Controllers
  • Chromatography Software
  • Custom Software Packages
Process Equipment
  • Bioreactors
  • Autoclaves
  • Custom Equipment Design
  • Glassware Washers
  • Chromatography Systems
  • Clean in Place Systems
  • Ultra and Micro Filtration Equipment
  • Cleaning Validation Approaches for Process Equipment
  • Various Controlled Temperature Units
Utility Validation
  • Cleanroom Design
  • Cleanroom Validation to Harmonized ISO Regulations
  • Clean/Plant Steam Systems
  • RO/WFI Water Systems
  • Compressed Air Systems
  • Facility Waste Neutralization/Decon Systems
Process Validation
  • Steam in Place (SIP) Development
  • Cleaning Validation Methodologies and Implementation
  • Cell Culture
  • Fermentation

 
  Copyright 2006 - 2014 by Quality Solutions, LLC Privacy    |    Legal    |    Sitemap