One conversational AI interface connecting specialized agents for SOP drafting, audit readiness, CSV, and 21 CFR Part 11 compliance.
Saram ConsultingThoughts and strategies on the intersection of Biotech, Artificial Intelligence, and Regulatory Compliance.
Most IT helpdesk bots are static FAQ search engines with a chat interface. Here is the architecture for one that actually gets smarter — a closed-loop system where every resolved ticket becomes institutional knowledge.
Read Article →How GxPChat uses the Model Context Protocol to connect a single conversational interface to specialized AI agents for SOP drafting, audit readiness, CSV documentation, IT support, and regulatory asset management — all under 21 CFR Part 11.
Read Article →A practical framework for deploying AI agents across GxP-regulated IT operations — from CSV documentation to audit readiness — with realistic effort estimates, savings projections, and a phased rollout that won't get you a 483.
Read Article →FDA's finalized CSA guidance replaces exhaustive scripted testing with risk-proportionate assurance. Here is the concrete, phased roadmap for Quality teams to make the transition — from SOP rewrites to AI governance to cultural retraining.
Read Article →From Kaplan's parameter obsession to Chinchilla's correction to GLM-5.3's post-training proof — the real history of how AI scaling went multi-dimensional, and what it means for anyone building agents today.
Read Article →