Medical device contract manufacturers face some of the strictest traceability and documentation requirements in discrete manufacturing. Axis is built to handle them without adding overhead.
FDA 21 CFR Part 820 requires a Device History Record for every lot or batch. When your data lives across spreadsheets, paper forms, and email, assembling a DHR is a multi-day effort. Axis generates a complete production record automatically because every transaction is already linked.
If you cannot trace a component back to its incoming lot and supplier cert, an FDA auditor will write it up. Axis tracks every material from receiving through consumption, linking lots to incoming inspection results, work orders, and outgoing shipments.
ISO 13485 requires documented change control. If a build plan revision happens via email ("hey, updated the BOM, see attached"), there is no approval chain and no effective date. Axis build plans have built-in revision control with owner, approver, and release workflow.
Inspection results in one system, production data in another, complaints in a third. Axis links quality records — FAIs, in-process checks, final inspections — directly to the part, lot, and work order they verified.
Assign lot numbers at receiving. Track consumption per work order. Link each lot to its supplier cert, inspection result, and outgoing shipment. Every handoff is timestamped.
First article inspections, in-process checks, and final inspections are recorded digitally and linked to the part, lot, and work order. No paper forms to lose or misfile.
Each build plan carries a full revision history with owner, approver, and effective date. Revisions flow through an approval workflow before they can be used in production.
Every action is logged: who created, edited, approved, or closed a record — and when. The log is append-only. No deletions, no overwrites, no gaps.
Attach SOPs, material specs, customer drawings, and certs of conformity directly to the records they support. Documents are versioned and searchable.
Engineers, operators, inspectors, and quality managers each have appropriate access. Row-level security in the database prevents cross-tenant data leakage even at the infrastructure level.
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