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