AI-Driven GxP Compliance Solutions
At GxP Central (QualRS), we combine our 15 years of global GxP expertise with modern AI tools to help sponsors, CROs, CMOs, and investigator sites operate with greater accuracy, speed, and compliance confidence. Our AI-assisted solutions strengthen traditional QA systems, streamline audit readiness, and reduce operational burden.
AI-Enhanced GxP Audits
Our auditors use AI to perform rapid pre-audit reviews of SOPs, TMF/eTMF documentation, batch records, and Quality Manuals. This technology helps identify data-integrity risks, missing documentation, and trend signals—allowing our team to focus onsite time where it matters most.
Automated SOP Drafting & Redlining
We leverage AI to produce clear, inspection-ready SOPs aligned with FDA, ICH E6(R3), Annex 11, and 21 CFR Part 11. AI also redlines SOPs against updated regulations and industry expectations, helping clients stay ahead of compliance shifts.
QA Dashboards & Predictive Risk Analytics
Using AI-powered analytics, we build dashboards that visualize GxP risk, CAPA performance, vendor reliability, temperature-excursion trends, and clinical-site quality signals. This enables faster decision-making and a more proactive quality culture.
AI-Accelerated Vendor & Site Qualification
Through advanced automation, we evaluate vendor performance, review historic data, and screen global compliance databases for red flags—including FDA 483s, warning letters, and regulatory trends—delivering faster and more reliable qualification assessments.
Intelligent TMF/eTMF & ISF Review
AI reviews essential-document completeness, detects inconsistencies, and maps TMF artifacts to ICH Section 8. This dramatically reduces QC timelines and increases TMF accuracy.
GxP On-Demand™ (Custom AI Chatbot)
Clients gain a secure, private AI assistant trained on their SOPs, policies, and industry regulations. It supports staff with instant answers to GCP, GMP, GLP, GDP, and CSV questions—reducing dependency on QA for routine guidance.
Regulatory Intelligence, Powered by AI
We provide curated updates from the FDA, EMA, MHRA, Health Canada, PMDA, and WHO. AI monitors global guidance,