Skip to content
Synapse Soft
tren
Request a demo

Axon Product Documents

Data-processing roles, AI and regulatory-statement notes for Axon demo and deployment models.

Version: 3.0 (Taslak)Last updated: 29 September 2026

This document is a draft. Fields in square brackets (address, registry/MERSIS and VERBIS details, retention periods, transfer mechanisms) must be completed and counsel must approve before it goes live.

1. Demo environment

The demo environment runs on illustrative data. Real production, patient or trade-secret data must not be uploaded to it.

2. Data-processing roles

[Role and contract structure to be set by counsel]

DeploymentRoles
On-premise / air-gappedThe customer is the data controller; data stays on the customer's infrastructure. Synapse Soft may act as processor for support and maintenance (under a DPA).
GCP demo environmentRoles for the demo user are defined separately. Not for real data.

3. AI features

Which service provider AI requests go to is set per deployment model and clarified in the contract. Every request is written to the audit trail with the model, input summary and engine version.

4. Regulatory statement

Axon is designed to support regulations such as 21 CFR Part 11 and EU GMP Annex 11. This is not an FDA approval, a certificate or a statement of absolute compliance; compliance is achieved on the customer side through validation and procedures.

5. Simulators

The audit-trail, e-signature and Golden Thread simulators on the site are illustrative; see Terms of Use Art. 4.

Contact channels