Compliance and hosting

Ready for the audit before the auditor is.

Artifice is built for ISO 13485 §4.2.4, MDSAP and 21 CFR Part 11 from the data model up — not bolted on afterwards.

Built for medical device quality systems

Hosting

Your data in its own place.

Your own instance: Every customer runs an isolated deployment with its own database, file storage and hostname.
Hosted by us: We run and update the infrastructure. You run your quality system.
Never shared: No shared tenant, no shared database. Your records stay with your instance.

Built for 21 CFR Part 11.

Bound to content: Each signature stores a fingerprint of exactly what was signed. Change the content and the signature no longer matches.
Meaning, name and time: A signature records what it means, the printed name of the signer and the server time.
Sign-off rules: Rules decide who signs, seat by seat, with stand-ins — nobody picks approvers by hand.
Frozen for review: Reviewers are fixed once the content is frozen for review, and signing order is kept.

Everything an auditor asks for, already recorded.

A complete history: Every record keeps who changed what, and when.
AI is accountable: The Assistant and AI Connections save nothing without a person's approval, and their edits are marked.
Standards coverage: See which documents cite each clause of ISO 13485 and MDSAP, and where the gaps are.

Change on your schedule, not ours.

Versioned releases: Packages ship as numbered releases. You decide when your instance adopts one.
Validate before you adopt: Validate each release for your intended use, as ISO 13485 §4.1.6 and 21 CFR 820.70(i) ask, before your team relies on it.

Tell us what you build and where it hurts today. We will walk you through the platform with your records, not a generic script.