Regulated industries spend weeks assembling compliance packages from scattered PLM data. Sentinel renders them automatically from the digital thread — because every decision, approval, and verification already exists in the product knowledge graph.
The documentation burden is not the cost of doing business — it is the cost of doing compliance wrong.
In regulated industries, an engineering change is not just a design decision — it is a compliance event. FDA requires traceable design history files. AS9100D demands controlled configuration management. IATF 16949 mandates production part approval documentation. ITAR restricts which personnel can even view certain changes. In traditional PLM, assembling the evidence takes weeks — someone extracts documents, compiles evidence, and builds a submission package from scattered data. Sentinel makes compliance a property of the architecture, not a burden on the team.
Because every requirement, design decision, engineering change, verification result, and approval signature already exists in the Axiom digital thread, compliance packages are not assembled — they are rendered from data that is already governed. The Design History File is not a document you build; it is a view of the product knowledge graph. The First Article Inspection package is not a binder you compile; it is a query against the verification matrix. Compliance is not something you do after engineering. It is something that happens because of how engineering is done.
From electronic signatures through export control to substance compliance — Sentinel embeds regulatory governance into every action in the product lifecycle.
"The FDA auditor asked me to show her the design history for our newest implantable device. In our old system, that request would have started a six-week documentation exercise. In Sentinel, I pressed a button and the complete DHF rendered in front of her — design inputs traced to design outputs, verification methods linked to evidence, every change documented with electronic signatures. She paused, looked at me, and said 'this is how it should work everywhere.' Zero findings for the first time in three inspections."
"We discovered twenty-three non-US-person employees had access to ITAR-controlled technical data without TAA coverage. Twenty-three potential violations at up to five hundred thousand dollars each. Sentinel blocked every unauthorized access path within the first hour of deployment. The system evaluates citizenship, clearance, and TAA scope on every single data access request. Not annually. Not quarterly. Every request. That is the difference between perimeter security and data-layer enforcement."
Assign your regulatory frameworks. Watch Sentinel configure governance rules, activate audit trails, and compute your readiness score — in minutes, not months.