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.
Every QMS vendor now claims to be 'AI-powered.' A vendor-by-vendor teardown of what Veeva, MasterControl, ComplianceQuest, Dot Compliance, and nine others have actually shipped — and what it means for regulated life-sciences buyers in 2026.
Read Article →On April 2, 2026, the FDA cited a drug manufacturer for over-reliance on AI. 'The AI said so' is now a cGMP violation. A deep dive into the validation problem that every QMS vendor is avoiding: how do you validate a system that gives different answers to the same question?
Read Article →ValGenesis claims 80% faster document creation. Kneat built a four-pillar AI framework. Sware converts video into test scripts. Ketryx raised $55M to be AI-native from day one. A vendor-by-vendor teardown of who's actually automating validation — and who's just talking about it.
Read Article →Veeva shipped Falcon. Benchling shipped three products in seven days. Revvity Signals pushed its AI layer deeper. A 10-day news sweep across MES, QMS, LIMS, ELN, lab automation, and CSV/validation, and what it means for regulated software buyers.
Read Article →AI agents that generate and execute code need stronger isolation than containers. A deep dive into MicroVMs, gVisor, WebAssembly, and the sandbox platforms racing to become the runtime layer for the agent economy.
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