Protostar ERP
The Manufacturing ERP Built for Medical Device Companies
Protostar ERP combines multi-level BOM control, inventory and quality operations with FDA-ready compliance — operated as a validated system, so you stay production-ready and audit-ready in one platform.
One platform from purchase order to finished device
A modern, fast web application for daily work, backed by a full ERP core — manufacturing, stock, buying, selling, accounting, projects and quality in one validated system, one login, one audit trail.
Features
Multi-level BOM control
Arena-style indented explosion, flat rollups, per-assembly costing checks and where-used — with revision and lifecycle tracking on every item.
Electronic signatures & audit trail
Part 11 subpart C signatures with password re-authentication, meaning, and tamper-evident content fingerprints; append-only signature records.
Per-company isolation
Each company runs in its own database with its own users, files and audit trail — restore, upgrade or revalidate one tenant without touching another.
One central login
One identity for every workspace you belong to; short-lived, single-use, tenant-bound handoff tokens and host-bound sessions.
SequenceQMS integration
Supplier qualification status from your QMS gates purchasing automatically — fail-closed, synced hourly, mirrored to native supplier holds.
Validated lifecycle
Operated under ISO/IEC/IEEE 12207 with IQ/OQ evidence, a maintained design history file, and every defect that reaches a build logged.