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FDA Validation

FDA Validation has been called a necessary evil. However, it is still the number one reason that agencies find fault with Life Sciences companies. It is simple – validation MUST be executed in order to be compliant with Gxp processes. FDA Validation comes in all flavors – computer systems, equipment, process, procedure, methodology. USDM has experts in ALL of these areas. We separate ourselves from the all the rest by not only performing FDA validation, but we also help firms with uncovering areas that need help! We not only tell you what to do RIGHT, but also tell you what NOT to do based on our years of relevant and direct experience!!

Some typical areas of validation audits/assessments services include:

  • Risk Based Validation Programs
  • Cleaning Validation Development and Pre-Audit Readiness Assessment
  • Laboratory Method Validation
  • Computer Systems Validation
  • Software Development Lifecycle Validation
  • Process Validation
  • Suppliers of Infusion Pumps, Peristaltic Pumps, Needles, Syringes, Catheters & Auto Injection Devices


  • 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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