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Saram ConsultingThoughts and strategies on the intersection of Biotech, Artificial Intelligence, and Regulatory Compliance.
AI agents won't automate computer system validation — they'll invert it. The 80% of CSV that's manual paperwork becomes the AI's job. The 20% that requires human judgment stays human. Here's what changes, what doesn't, and where the guardrails are non-negotiable.
Read Article →Greenlight Guru just became one of two life sciences QMS vendors with ISO 42001 certification. MasterControl is the other. Everyone else is either building toward it or hoping nobody asks. Here's what the certification actually requires, what it costs, and why using a shared LLM doesn't disqualify you — but does make the audit harder.
Read Article →Microsoft open-sourced an OS-inspired governance toolkit. Google bet on identity-first Zero Trust. AWS built a deterministic policy wall outside the LLM. A deep comparison of the three platforms racing to make autonomous AI agents safe enough for production — mapped against the OWASP Agentic Top 10.
Read Article →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?
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