Harness QMS
Nothing in your QMS changes.
The box sits in your building. It drafts from the procedures you already have. A person signs before anything can be exported.
Your eQMS stays
MasterControl, Greenlight Guru, QT9, Veeva, or SharePoint remains the official record.
Data stays in the building
The appliance is the system. It is not a cloud tenancy for your design history file.
A person signs
21 CFR Part 11 sign-off. The model can draft. It cannot approve the record.
How it works
1
Read
The box reads the procedures and design files you already keep.
2
Draft
It proposes language and traces. Every draft is marked as a draft.
3
Sign, then export
A person signs. You export a package. The official record stays in your eQMS.
Pricing sketch
The appliance is $10,000. The license is $48,000 a year for the first site. This is a sketch, not a quote.
See the sketch