One-time
The appliance
$10,000
Per site · industrial enclosure
- Local inference hardware and on-box model weights
- Physical air-gap key
- IQ / OQ protocols in the crate
- Designed as an instrument, not a PC
Target BOM well under $2,000. The price is the sovereignty handshake and CAC recovery, not a hardware margin story.
Annual
Harness QMS license
$48,000
First manufacturing site / year
- Living requirements graph and Part 11 signatures
- One eQMS connector and one ERP connector
- On-box audit log and draft generation
- PQ-lite support against mapped SOPs
Each additional site $18,000 / year. Each additional connector $6,000 / year. Implementation of SOP mapping is quoted, not bundled as a surprise.
Included, and not
In the first-year crate
- Appliance, weights, and validation pack
- Read-first connector for one eQMS and one ERP
- Signature workflow and export queue
Not claimed here
- No customer logos — there is no fake installed base
- No FDA clearance for Harness QMS as a medical device
- No unsupervised official-record writing, at any price