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 Tester
To learn more about USDM and how we can assist with your compliance and business objectives, please contact:
Rebecca Meledy
888.231.0816 x161
775.213.5943 (fax)
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"Simplify, Unify and Optimize your business & compliance needs with USDM"
