Improving Safety in Life Sciences with Agentic AI

100%

of uploaded documentation reviewed

Same Day

full QMS analysis completed

Instant

reports generated after analysis

We created a way to transform safety audits: Instead of spending a week or more to spot check 10-20% of documentation, AI enables 100% review in hours. 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. 

Across the pharma, biotech and medical device landscape, companies prepare for regular FDA safety audits, in addition to their own internal reviews. They often employ the services of firms like TFDA to conduct “mock” audits. Such audits encompass a review of a company’s standard operating procedures (SOPs) to verify that the devices or pharmaceuticals in question are manufactured in compliance with applicable government regulations.

For example, under good manufacturing practice (GMP), companies are legally required to maintain a quality management system (QMS) that’s compliant with complex government regulations. An auditor (whether a “mock” auditor or an official FDA auditor) reviews the company’s QMS to create a list of observations, which could include non-conformances and potential corrective and preventative actions.

Since even a small biotech firm may be responsible for thousands of SOPS, including those of external vendors, an auditor only has time to “spot check” a subset of the SOPs for compliance. (Companies are responsible for ensuring their suppliers are compliant as well, which prompts more required audits in addition to their internal QMS.) Even “spot checking” is expensive, time consuming and inherently subjective due to varying interpretations of the rules by different human auditors.

The consequences for failing a quality audit are existential, ranging from public disclosure and substantial fines to product recalls or even facility shutdowns.

Built on EPAM’s DIAL platform, AICA analyzes uploaded QMS documentation against 10 parts of the FDA's Title 21 Code of Federal Regulations:

• Title 21 CFR Part 11 (Electronic Records)
• Title 21 CFR Part 50 (Protection of Human Subjects)
• Title 21 CFR Part 54 (Financial Disclosure by Clinical Investigators)
• Title 21 CFR Part 56 (Institutional Review Boards)
• Title 21 CFR Part 58 (Good Laboratory Practice for Nonclinical Laboratory Studies)
• Title 21 CFR Part 211 (Current Good Manufacturing Practice)  
• Title 21 CFR Part 312 (Investigational New Drug Application)
• Title 21 CFR Part 314 (Applications for FDA Approval to Market a New Drug)
• Title 21 CFR Part 320 (Bioavailability and Bioequivalence Requirements)
• Title 21 CFR Part 600 (Biological Products)

The review can be completed in hours rather than weeks, simultaneously maximizing the efficiency of human quality professionals while also enhancing the accuracy, objectivity and thoroughness of audits. The regulations covered continue to expand, with comprehensive medical device regulations such as ISO 13485 in development.

DIAL is EPAM’s open source, service-native platform for enterprise AI. As part of AI/Run™.Tools, it provides the reusable blueprints, governance and integration foundation for AICA, enabling AI capabilities to be applied consistently, improved over time and evolved without locking the client into a single vendor or technology path.

EPAM is also supporting the go-to-market strategy for AICA, including managing the beta testing and customer success programs; supporting new customer acquisition with marketing materials, demos and technical support; and leveraging EPAM’s existing customers and marketing channels to amplify the launch and build market awareness for the tool.

Traditional Audits

Often 1+ week of dedicated auditor time

Usually only 10–20% document coverage

Annual or semi-annual frequency

Days to weeks to generate reports

Sampling methodology

Subjective, auditor-dependent results

AICA Audits

Just hours to process the entire QMS

100% document coverage

Instant report generation on demand

Comprehensive analysis in minutes

Consistent methodology everywhere

Unbiased, repeatable findings