For manufacturing & operations
Design, BOM, suppliers, process risk, line qualification, and work instructions hang off one system of record, so a change reveals the affected parts, suppliers, process steps, and qualifications before you scrap or re-validate anything.
A design change shows which assemblies, parts, suppliers, and in-flight orders are hit, so you don't scrap long-lead inventory bought before V&V.
Process risk derives from the design risk it mitigates and links forward to the process steps that implement the controls: one chain, dFMEA to the line, that siloed tools structurally can't hold.
Compiled from specs, BOM, work-instruction documents, QC, and labeling; never a stale binder.
Multi-level BOMs, compare, where-used; variants and configurations as branches of one system of record, so there's no second BOM to drift. Assemblies and BOMs extracted from native CAD land here, proposed for review. Avera Drive →
DQ/IQ/OQ/PQ and process validation, sterilization and cleanliness included: the transfer story as records, not binders.
Supplier qualification, purchasing, and receiving; supplier audits as checklists on the record engine.
Controlled documents built from the process steps your pFMEA already analyzes: change a risk control and the flow reaches the instruction that implements it. Versioned, approved, and compiled into the DMR.
Units and lots are items: genealogy per serial, device history records, and retrofits recorded against each unit, traced to the exact design version it was built from.
The ERP boundary
Avera owns the device record: designs, BOMs, processes, quality, history. Financials, inventory, and orders stay in your ERP, connected over the REST API. The boundary is deliberate, and it keeps both systems honest.
A design input changes. Instantly see the affected BOM lines, suppliers, and in-flight purchase orders, including long-lead parts ordered before V&V, and the process steps and qualifications that move with them. Decide before you commit capital, not after.
No: Avera is light MES (supplier qualification, procurement, receiving, lots and device history). Full shop-floor execution isn't our territory.
ERP flows over the REST API; you build the connector to your system.
Units are items: the trace enumerates affected serials, and each retrofit is recorded against that unit's device history.
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