Charged with reassessing nearly 2,000 GxP software applications in the wake of unsavory FDA audit findings, a $7.5B annual revenue, global medical device company teamed up with USDM to meet CSV standards.

The Situation
  • Global medical device company
  • $7.5B annual revenue with over 100k products commercially available
  • FDA audit findings required that approximately 2,000 GxP software applications be assessed for remediation to current CSV standards and procedures
  • FDA completion timeline of 12 months
  • Systems included enterprise and business unit specific systems cross organization (including cloud, in-house developed, LMS, ERP, Lab, manufacturing, clinical, etc.)
  • Systems ranged in both risk and complexity
The Solution
USDM performed a detailed assessment of all systems determined by client to be GxP compliant and reduced the number of systems in the client’s original scope by over 80%.

USDM ensured that proper justification was in alignment with both customer SOPs and global regulatory guidelines, leveraged existing documents wherever possible and developed a streamlined risk program.
  • USDM managed the program and remediated 287 systems – including 86 that were identified by client during the project and initially out of scope
  • Team of highly skilled senior consultants, onsite and remote testers, and technical writers created critical efficiencies while reducing costs
  • Conducted Audit Readiness Training for quality and IT teams

Project delivered $600k under planned budget through domain expertise and highly efficient delivery

25% less time to complete project than anticipated

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