The FDA Group Launches AICA, an AI-Powered Compliance Auditing Platform Purpose-Built for Life Sciences
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The FDA Group Launches AICA, an AI-Powered Compliance Auditing Platform Purpose-Built for Life Sciences
The Audit Intelligence Compliance Assistant enables pharmaceutical and biologic companies to audit their QMS documentation in hours instead of weeks.
BOSTON, MA, UNITED STATES, March 2, 2026 /EINPresswire.com/ -- The FDA Group, a leading provider of regulatory compliance consulting to the life science industries, has announced the commercial launch of AICA (Audit Intelligence Compliance Assistant), an AI-powered platform purpose-built for pharmaceutical and biologic compliance auditing. AICA was developed in collaboration with EPAM Systems, Inc. (EPAM) is a global leader in AI transformation engineering and integrated consulting.
AICA enables quality and regulatory professionals to upload their QMS documentation — including policies, procedures and work instructions — select which FDA regulations to audit against, and receive a comprehensive gap analysis identifying areas of non-conformance. The platform analyzes 100% of uploaded documentation rather than relying on traditional sampling methods, and delivers results in hours rather than the days or weeks typically required for manual audits.
"Quality leaders have faced the same frustrating choice for decades: conduct thorough compliance audits that take their teams off critical work for weeks, or use sampling methods that leave most of their QMS unexamined," said Nicholas Capman, President and CEO of The FDA Group. "AICA gives them a third option — an AI trained by actual auditors that analyzes all of their documentation at machine speed, so they can identify every compliance gap before regulators do, without disrupting daily operations."
Built on a Secure Enterprise Platform
AICA is built on EPAM DIAL Open-Source GenAI Enterprise Platform and hosted on Microsoft Azure servers in the United States. The platform features enterprise-grade encryption, RBAC access controls, and isolated document storage. Customer data is never used to train the AI model unless they opt in. For organizations with additional security requirements, AICA can be deployed on private cloud infrastructure.
“Our partnership with The FDA Group on AICA represents the kind of applied AI solution that delivers measurable impact in regulated industries," said Preston Keller, Principal, Life Sciences Business Consulting of EPAM. "By combining EPAM's advanced data science and engineering capabilities with The FDA Group's deep regulatory expertise, we've built a platform that addresses a real operational challenge for life sciences companies of all sizes.”
Read the full press release to discover how AICA leverages applied AI to transform compliance auditing and accelerate regulatory gap analysis for life sciences organizations, here.
Explore additional expert resources and discover how EPAM’s proven digital engineering solutions drive measurable compliance and operational excellence across the industry. https://www.epam.com/industries/life-sciences-and-healthcare
