FDA Mandated Global CSV Remediation

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