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.
Why we built an MIT-licensed replacement for the OSIsoft / AVEVA PI System using ClickHouse 24.8 LTS, PostgreSQL 16 WORM audit trails, Telegraf disk WAL buffering, Pydantic AI, and an 8-document GAMP 5 / FDA CSA validation binder.
Read Article →Liquid handlers converged on specs years ago, so the control plane moved to the orchestrator — and the driver layer is still the weakest link in the chain. A verified map of the lab automation stack across hardware, transport, orchestration, standards and regulation, with the statistics that circulate in the industry corrected against primary sources.
Read Article →A 2025 review scoped 86 AI models for Alzheimer's digital biomarkers. Two had external validation. Three or four checked calibration. One acknowledged TRIPOD reporting. Separately, a 2021 review found 78% of omics-based stratification studies validated internally only. This is a provenance audit of AI precision medicine — including the regulatory path, which is narrower than most business plans assume.
Read Article →The best randomized evidence for AI in clinical trials is a chart-accuracy gain of 76.1% over 71.5% — on retrospectively collected records. Around that sits a market narrative built on vendor self-reports, including four widely repeated statistics with no traceable source at all and two that are simply false. An evidence audit, with the regulatory dates corrected.
Read Article →Five single-cell foundation models and two deep learning models were benchmarked on the standard CRISPRa doubles task. All of them had higher prediction error than a deliberately trivial additive baseline, and none beat predicting no change. The rebuttal says the metrics are miscalibrated. Either way, evaluation design — not architecture — is the contested variable, and the field's own 2026 challenge goes zero-shot in November.
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