• Manufacturing Systems

 
 
 

Facilities and Utilities

 

USDM provides our partners in the Life Science Industry with industry proven engineering consultants that are experienced in multi-discipline start-up and operations activities. USDM engineering consultants routinely perform start-up and commissioning of a variety of systems in accordance with Regulatory and ISPE Guidelines for numerous facility systems.

The design phase is very important in the development of quality products and an efficient validation. Proper reviews during the engineering phase and good coordination between the validation department and contractors during the construction phase can eliminate headaches and project delays. Our engineering consultants can assist you with the coordination and support in the following 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

USDM engineering consultants routinely develop and execute, Engineering Checkouts, Installation Qualifications (IQ), Operation Qualifications (OQ), Performance Qualifications (PQ), Re-Qualifications, and Final Reports on HVAC, Compressed Air, Instrument Air, Process Air, Hot Water, Chilled Water, Plant Steam, Purified (RO) Water, Caustic and Acid Dilution, Water for Injection (WFI), Clean Steam and Process systems.

 

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…
See all Testimonials