• Manufacturing Systems

 
 
 

Equipment Qualification

 

USDM provides our customers in the Life Science Industry with industry proven engineering consultants that are experienced in equipment qualification. US Data Management engineering consultants routinely perform start-up and commissioning of a variety of equipment and systems in accordance with Regulatory, USP, IEEE, and ISPE Guidelines.

Our validation engineers can assist you with the coordination and support in many areas:

  • Design Qualification
  • Conducting Vendors Audits, FAT (factory acceptance testing), and SAT (site acceptance testing)
  • Software Developer Assessment
  • Specifications—User Requirements, Functional Requirements, and Detailed Design
  • Commissioning

Our Validation Engineering Consultants have developed and executed, Installation Qualifications, Operational Qualifications, Performance Qualifications on a wide variety of equipment used by the Life Science Industry. Here is an example of some of these systems:

  • Depyrogenation Tunnels
  • Liquid and Parenteral Filling Equipment
  • Cappers
  • Packaging Equipment
  • Tray Loaders
  • Sanitization and Sterilization Equipment
  • Lyophilizers
  • Incubators
  • Tanks and Process Piping
  • Cell Mates and Puma Robotic Systems
  • Resin Dryers
  • Chromatography & Ultra-filtration Skids
  • Freezers
  • Refrigerators
  • Warm and Cold Rooms
  • Fluid Bed Dryers
  • Labeling Equipment
  • Capsulation Machines & Tablet Presses
  • Vial Washers
  • Blistering Machines
  • CIP, SIP, and COP Equipment
  • Glass Washers
  • Axial Fatigue Teste

 

Testimonials

  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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