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.

Find out how we assuaged the company’s plight by engaging with them at key stages and utilizing the systems expertise of our Senior Consultants to ultimately reduce the scope of the issue, remediate systems and conserve time and money.

The Situation

FDA audit findings required that approximately 2,000 GxP software applications be assessed for remediation to current CSV standards and procedures
FDA completion commitment timeline was 12 months
Systems included enterprise, spreadsheet 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

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%

We 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 Sr. Consultants, onsite and remote testers and technical writers produced further cost savings.
Performed Audit Readiness Training to prepare Client teams in Quality, IT and the business.

$600k Under Budget Based on Efficient Delivery

Key Takeaways

Executive Sponsorship from Client and USDM Critical to Success

Engagement of the Business at Key Program Stages

Tight Communication, Management and Reporting by USDM Project Managers