• Manufacturing Systems

 
 
 

Manufacturing System Validation

System/Instrument/Equipment Validation

 

USDM Life Sciences has extensive skills and experience in providing rapid, low-cost and effective validation services for computerized manufacturing systems and equipment. USDM validation services include support for engineering change control, factory acceptance testing, site acceptance testing, and the standard validation deliverables (e.g., FRS, SRS, URS, IQ/OQ/PQ, validation plans, risk assessments and validation summary documents).

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, and Performance Qualifications on a wide variety of equipment used by the Life Science Industry. Here is an example of some of these systems:

  • IT systems
  • Process control systems
  • Data historians
  • Manufacturing equipment
  • Manufacturing Execution systems
  • Electronic Batch Records systems
  • Computerized Maintenance Management systems
  • Facility historians
  • Calibration/metrology systems
  • SCADA
  • DCS
  • Delta V
  • HVAC
  • PLCs
  • Automated packaging equipment
  • Labeling equipment
  • Building management 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…
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