Heading to the Bio-IT World Conference & Expo in Boston this month? Meet up with us to learn more about AICA, the Audit Intelligence Compliance Assistant, which has been nominated for the Bio-IT World Innovative Practices Award!
Nicholas Capman and Eric Boyd will be there throughout the conference in partnership with EPAM Systems. Come find us at Booth 204 (within the EPAM booth) to chat and get a hands-on demo of AICA.
We'll also be EPAM's Continuum Evening Event on Wednesday, May 20, from 6–8 pm, at the EPAM Continuum Office (21 Drydock Ave, Boston, MA), where you can tour and explore the lab of the future.
This event is a chance to see what’s how deep life sciences expertise is meeting world-class engineering and experience design. Enjoy an evening filled with inspiring demonstrations, engaging conversations, refreshing drinks and delicious appetizers. Learn more and RSVP here »
The Audit Intelligence Compliance Assistant is AI purpose-built for pharma and biologic compliance auditing. Unlike generic AI tools, AICA was trained by 15+ regulatory professionals on real quality documentation.
Upload your policies and procedures, select which regulations to audit against, and AICA identifies gaps between what your documents say and what regulations require in minutes or hours instead of days or weeks.
Customize each audit by selecting specific regulatory requirements. Focus on the regulations that matter most for your products and markets.
Planning to expand into a new market? Run a gap analysis against the specific requirements before you submit. Preparing for an FDA inspection focused on Part 11? Audit just those requirements. AICA adapts to your compliance priorities.
AICA processes thousands of pages of documentation. What used to require pulling employees off projects for week-long internal audits now happens at machine speed.
Upload documents individually or in batches. AICA immediately flags non-conformances, suggests remediation strategies, and generates prioritized action lists.
Finally you can take a step toward proactive compliance monitoring across your entire QMS.
Every AICA analysis generates a series of detailed compliance reports with a gap analysis, specific CFR references, prioritized observations, and executive dashboards with heat maps.
These reports support internal audits, supplier audits, and preparation for regulatory inspections. Each finding includes the specific clause, the non-conforming document, a clear explanation of the gap, and detailed corrective action recommendations.
Quickly identify exactly where your team or an external auditor should direct time and attention.
| Connect with Nicholas or Eric if you want to meet up, or drop us a line at info@thefdagroup.com. We'd love to connect! |