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.”
Trained by Regulatory Experts, Not Just Data Scientists
Unlike general-purpose AI tools applied to compliance use cases, AICA was trained by more than 15 experienced FDA and ISO auditors using real-world pharmaceutical QMS documentation. The training process focused on how regulations are actually interpreted and applied during inspections, not simply the text of the regulations themselves.
AICA currently supports auditing against 21 CFR Parts 11, 211, and 600, each mapped at the section and subsection levels. Additional regulations, including 21 CFR Parts 50, 54, 56, 58, 312, 314, and 320, along with ICH guidance documents, are in active development.
Human-in-the-Loop Design
AICA is designed to maximize the productivity of quality professionals with a human-in-the-loop approach as a fundamental principle. Every AI-generated observation must be reviewed by a qualified quality professional before the final report is generated. Users can include, exclude, or edit findings to reflect their institutional knowledge and specific organizational context.
The platform generates detailed compliance reports that include regulatory citations, prioritized observations, suggested corrective actions, and executive-level dashboards with heat maps for visibility across the entire quality management system.
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.”
Availability
AICA is available now. Life sciences companies interested in learning more or scheduling a demo can visit aica.thefdagroup.com or contact Alan Greathouse at agreathouse@thefdagroup.com.
Media Contact:
Alan Greathouse, Sr. Director of Quality and Service Assurance, The FDA Group
agreathouse@thefdagroup.com
1-833-FDA-GROUP
About The FDA Group
The FDA Group helps life science organizations rapidly access the industry’s best RA/QA subject matter experts—experienced practitioners who plan and execute critical quality, regulatory, and clinical work with full accountability. Our professionals support every stage of the product lifecycle, from clinical development through commercialization. Headquartered in Boston, MA, The FDA Group serves life sciences companies from startups to global enterprises. Learn more at www.thefdagroup.com.
Alan Greathouse
The FDA Group
+1 833-332-4768
email us here
See AICA in Action
Legal Disclaimer:
EIN Presswire provides this news content “as is” without warranty of any kind. We do not accept any responsibility or liability
for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this
article. If you have any complaints or copyright issues related to this article, kindly contact the author above.
