Partnering with The FDA Group to Build the Audit Intelligence Compliance Assistant, Enabling Comprehensive Reviews in Hours Rather Than Weeks
Improving Safety in Life Sciences with Agentic AI
EXECUTIVE SUMMARY
CLIENT
The FDA Group
SERVICES
Strategy
Engineering
Data & Analytics
Artificial Intelligence
INDUSTRY
Life Sciences & Healthcare
In the highly regulated world of life sciences, pharmaceuticals and medical devices can only help people if their safety record is proven. The U.S. Food and Drug Administration (FDA) monitors ongoing safety primarily through audits, which are as critical as they are time-consuming.
The consequences for failing a quality audit are existential, ranging from public disclosure and substantial fines to product recalls or even facility shutdowns.
In partnership with The FDA Group, EPAM built the Audit Intelligence Compliance Assistant (AICA), powering comprehensive, unbiased reviews of safety documentation for pharmaceuticals and medical devices.
AICA enables comprehensive coverage of 100% of standard operating procedures (SOPs), not the typical 10–20% sampled in a human audit. The immediate benefit is improved safety and quality as life sciences professionals can quickly and easily see where the greatest risks are and focus their attention where most needed.
Results
100%
of uploaded documentation reviewed
Same Day
full QMS analysis completed
Instant
reports generated after analysis
Preparing for High-Stakes Audits
Across the Pharma, biotech and medical device landscape, companies prepare for regular FDA safety audits, in addition to their own internal reviews. They employ the services of firms like The FDA Group (TFDA) to conduct “mock” audits. Such audits encompass a review of a company’s and external vendors’ standard operating procedures (SOPs) to verify that the devices or pharmaceuticals in question are manufactured in compliance with applicable government regulations.
An auditor only has time to “spot check” a subset of the SOPs for compliance. Even “spot checking” is expensive, time consuming and inherently subjective due to varying interpretations of the rules by different human auditors.
What if artificial intelligence (AI) could help companies — spanning the biotech, pharma, medical device and diagnostic sectors — prepare for audits by automating and standardizing the process, while saving time and money?
That’s the question The FDA Group (TFDA), a leading provider of regulatory compliance consulting to the life science industry, posed to EPAM.
Leveraging our DIAL platform, we partnered with TFDA to build a best-in-class product, the Audit Intelligence Compliance Assistant (AICA), which uses the power of agentic AI to cut audit time from days or weeks to hours.