AI-Driven Quality Assurance and Regulatory Compliance
Human assurance. AI precision.
QA²I AG develops AI agents that produce pharmaceutical quality management and regulatory compliance documents. Starting with Product Quality Reviews (PQR) and supplier audits, QA²I delivers inspection-ready documents from raw source data, with full traceability, human oversight, and reproducibility
About QA²I
Pharmaceutical quality teams spend hundreds of hours compiling regulatory documents, pulling data from batch records, deviation reports, stability studies, and corrective action logs across disconnected systems.
QA²I replaces this manual process with purpose-built AI agents that read raw source data, map it against applicable regulatory requirements, and produce structured, inspection-ready documents with every claim traced back to its source. Our agents are designed for GMP-regulated environments: outputs are reproducible, human-reviewed, and audit-defensible.
Compliance Confidence
With transparent, traceable processes and rigorous quality checks, QA²I provides assurance you can trust, whether you’re an investor, partner, or regulator.
Smart Automation
Our proprietary system streamlines quality management creation using custom-developed AI trained to understand pharmaceutical compliance requirements. This reduces manual workload, minimizes human error, and enables faster supplier qualification.
Human-in-the-Loop
Every AI-generated document is reviewed and finalized by certified QA professionals, ensuring results meet regulatory expectations and industry standards.
Tailored Intelligence
Our technology is designed to extract relevant information from diverse sources, such as SOPs, batch records, and regulatory documents, using retrieval-augmented generation (RAG) and automated extraction agents. This ensures quality management documents are both thorough and inspection-ready.