The Challenge: Nearly 2,000 GxP Systems, One 12-Month FDA Clock
In the wake of unsavory FDA audit findings, a global medical device company was charged with reassessing nearly 2,000 GxP software applications for remediation to current computer system validation (CSV) standards and procedures. With $7.5B in annual revenue and more than 100,000 products commercially available, the company could not afford a misstep, and the FDA had set a completion timeline of just 12 months.
- Approximately 2,000 GxP software applications flagged for assessment and remediation following FDA audit findings
- A fixed FDA completion timeline of 12 months
- Systems spanned enterprise and business-unit-specific platforms across the organization, including cloud, in-house developed, LMS, ERP, lab, manufacturing, and clinical systems
- Systems ranged widely in both risk and complexity
The Approach: Risk-Based Scoping Before Remediation
Rather than remediate everything in sight, USDM performed a detailed assessment of all systems the customer determined to be GxP compliant and reduced the number of systems in the original scope by over 80%. Every deselection was defensible: USDM ensured proper justification was in alignment with both customer SOPs and global regulatory guidelines, applying a modern, risk-based mindset consistent with computer software assurance (CSA) and 21 CFR Part 11 expectations.
USDM leveraged existing documents wherever possible and developed a streamlined risk program, then managed the remediation end to end with controls that protected data integrity throughout.
- USDM managed the program and remediated 287 systems — including 86 that the customer identified during the project and were initially out of scope
- A 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 so the organization could sustain compliance after the engagement
The Results: Faster, Cheaper, and Audit-Ready
By scoping intelligently before remediating, USDM delivered the program inside the FDA's window while spending less and finishing sooner than planned.
- Project delivered $600k under planned budget through domain expertise and highly efficient delivery
- 25% less time to complete the project than anticipated
- 287 systems remediated, including 86 surfaced mid-project, with quality and IT teams trained and audit-ready
The result was a remediation program that satisfied the FDA's mandate on time, controlled cost, and left the customer's teams equipped to keep their systems compliant. To make audit readiness a continuous state rather than a one-time scramble, explore USDM's continuous compliance approach.