Case Study: The FDA Group achieves faster, 100% QMS audit reviews with EPAM's Audit Intelligence Compliance Assistant

The FDA Group reviews 100% of QMS documentation in hours with EPAM Systems

The FDA Group, a leading provider of regulatory compliance consulting, partnered with EPAM Systems to address the challenge of time-consuming and subjective safety audits for life sciences companies. Preparing for high-stakes FDA audits traditionally required weeks to review only a small sample of documentation, a process that was expensive and left firms vulnerable to compliance risks.

EPAM built the Audit Intelligence Compliance Assistant (AICA) on its DIAL platform. This agentic AI solution enables a comprehensive review of 100% of a company's quality management system documentation in hours instead of weeks. The results for EPAM's customer include same-day analysis, instant report generation, and unbiased findings, fundamentally transforming safety auditing and allowing quality professionals to focus on strategic issues.

The FDA Group

Nicholas Capman

President and CEO, The FDA Group