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GxP Medtech Station

Record and audit medical device manufacturing with regulatory compliance

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Record and audit medical device manufacturing with regulatory compliance. FDA 21 CFR Part 11 compliant workstation with tamper-proof audit trails and electronic signatures. Built on ubuntu-24.04 with 6 pre-configured features including ssh, desktop, gxp.

Use Case

GxP-compliant workstation for medical device manufacturing, quality control, and production environments

Description

FDA 21 CFR Part 11 compliant workstation for medical device manufacturing with full audit trails and electronic signatures

Features

  • ssh
  • desktop
  • gxp
  • hipaa
  • audit-logging
  • security-hardening

OS Details

Base Imageubuntu-24.04
Packages21
Servicesssh
Security Levelstrict

Hardware Requirements

Architecturex86_64
Memory8 GB
Storage128 GB

Compliance

FDA-21CFR11GxPGMPISO-13485