AICA is trained on the depth, rigor, and repeatable patterns behind The FDA Group’s most thorough FDA audits, not surface-level checklists, or generic compliance rules.
Reviews large volumes of documentation with the same discipline, judgment, and consistency applied by The FDA Group’s audit teams, delivered at AI scale.
Enables teams to initiate and complete audit-grade analyses without waiting for traditional audit timelines or external scheduling constraints.
Produces structured, decision-ready outputs aligned to The FDA Group’s audit methodology, minimizing interpretation gaps and follow-up cycles.
Reduces manual review burden while raising the overall depth and consistency of audit outcomes, allowing teams to do more with fewer internal resources.
AICA was born from a simple frustration: the AI tools entering our industry weren’t built by people who actually do this work. They’re built by tech companies trying to sell to life sciences, not by regulatory professionals solving real compliance problems.
We took a different approach. Our AI was trained by regulatory experts who’ve conducted thousands of audits. They know what regulators actually look for, not just what the regulations say. That expertise is AICA’s foundation, and it’s why we’re confident this platform will transform how companies approach compliance auditing.”
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.
Upload policies, procedures, work instructions, and forms.
Choose which requirements to audit against.
AICA compares your docs against regulatory requirements.
Quality expert reviews AI-generated observations.
Download audit-ready compliance reports.
For the first time, life sciences companies can run AI-driven compliance audits without pulling their teams off higher-value work.
AICA handles the heavy lifting — cross-referencing regulations, flagging gaps, and generating audit-ready reports — so your team can focus on the decisions that actually move your programs forward. If you're spending more time preparing for audits than acting on what they find, we should talk.”
