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Facility Validation

Chicago Controls validation team has a broad-based experience in designing GMP

facilities so they will be easy to keep clean, have logical product and personnel flow, and pass regulatory scrutiny.

We offer to review your current design plans, help you figure out a scientific-based remodel, investigate problem areas, determine the best room classifications. Also, we would integrate your design so it meets both FDA and EU regulations and inform you of the latest industry practices. Our ultimate goal is to get your facility operating smoothly, with fewer investigations and corrective actions that might otherwise slow down your day to day operations.

Chicago Controls adheres to the industry standards below for its 100% quality deliverables.

  • Facility Description
    • Description of Process/Rooms

  • Installation Qualification
    • Major Facility Components and Design Features
    • Room Classifications/ Floors/ Walls/ Ceiling/ Doors
    • Pass-throughs/ Windows/ Barriers and Entryways
    • Atmosphere
    • Process Equipment Design
    • Furniture
    • Illumination
    • HVAC System
    • Auxiliary Services

  • Performance Qualification
    • Sample Plan
    • Sample Types & Locations

  • Environmental Impact

  • Suitability of Operating Environment