50+ validated modules. One platform.
Six interconnected domains covering the full medical-device manufacturing lifecycle — from incoming inspection to executive intelligence.
Quality, end to end. ISO 13485 by design.
A complete quality management suite covering incoming goods, in-process inspection, FAI, SPC, NCR/CAPA workflows, and OEM-facing customer portals. Every record is electronically signed and version-locked under 21 CFR Part 11.
- ✓First Article Inspection (FAI)
- ✓First Pass Yield (FPY) tracking
- ✓Statistical Process Control (SPC)
- ✓Device History Record (DHR)
- ✓Incoming Inspection workflow
- ✓Non-Conformance Reports (NCR)
- ✓Corrective Action (CAPA)
- ✓Customer Quality Portal
- ✓Hold & quarantine management
- ✓Quality KPI dashboards
- ✓Out-of-tolerance alerting
- ✓Root-cause analysis tooling
Quality Operations
Live · Sample data · 7 day rolling
| # | Type | Part | Operation | Inspector | Status |
|---|---|---|---|---|---|
| INS-4892 | FAI | PT-2103-A | OP-030 | Patel R. | ● In progress |
| INS-4891 | In-process | PT-2049-B | OP-020 | Doyle M. | ● Pass |
| INS-4890 | Final | PT-2210-C | OP-070 | Walsh F. | ● Pass |
| INS-4889 | Incoming | RM-7732 | — | Doyle M. | ● Pending |
Real-time floor intelligence. No manual entry.
Live OEE direct from machine telemetry. Closed-loop scheduling that absorbs unplanned downtime in real time. In-process documentation that operators actually use because it's on the work order, not on the shared drive.
- ✓OEE — live per machine and fleet
- ✓Production scheduling (closed-loop)
- ✓In-Process Documentation (IPD)
- ✓Standard Times & variance analysis
- ✓Operator graduation & release
- ✓Work order execution tracking
- ✓Setup time tracking
- ✓Downtime root-cause coding
- ✓Shift handover briefings
- ✓Throughput vs. takt time
- ✓Cell load balancing
- ✓Live escalation routing
Production schedule · Today
Updated 14:06 · 4 cells · 3 shifts
CMM data, parsed automatically.
AI-powered ingestion for Renishaw, Hexagon, and Zeiss output. The platform reads the report, extracts every feature, links it back to the part drawing tolerance, flags out-of-tolerance, and writes the result to the DHR — without an inspector touching a keyboard.
- ✓CMM result ingestion (auto)
- ✓Renishaw / Hexagon / Zeiss support
- ✓AI feature-to-tolerance mapping
- ✓Calibration management
- ✓Out-of-tolerance alerting
- ✓GD&T attribute parsing
- ✓Instrument type classification
- ✓Operator-readable PDF reports
- ✓Drift detection over lots
- ✓Auto-link to part revision
HX-2026-1184 · Hexagon Global S
Part PT-2049-B rev D · Op 020 · 18 features · auto-parsed in 1.2s
| Feature | Type | Nominal | Actual | Dev | Tol | Status |
|---|---|---|---|---|---|---|
| D1 | Diameter | 12.700 | 12.703 | +0.003 | ±0.050 | |
| D2 | Diameter | 8.500 | 8.498 | −0.002 | ±0.030 | |
| L1 | Length | 45.000 | 45.012 | +0.012 | ±0.100 | |
| L2 | Length | 22.500 | 22.498 | −0.002 | ±0.050 | |
| P1 | Position | 0.000 | 0.018 | +0.018 | ⌀0.050 MMC | |
| P2 | Position | 0.000 | 0.012 | +0.012 | ⌀0.050 MMC | |
| F1 | Flatness | 0.000 | 0.008 | +0.008 | 0.020 | |
| CY1 | Cylindricity | 0.000 | 0.012 | +0.012 | 0.030 | |
Training enforced at the point of work.
Operators only see operations they're trained for. Trainer/trainee workflows are built into the work order, not bolted on as a checklist. Cert expiry triggers automatic graduation review.
- ✓Training enforcement at WO start
- ✓Trainer/trainee context tracking
- ✓Operator scope by part / op
- ✓Qualio QMS bidirectional sync
- ✓Cert expiry alerts
- ✓Graduation workflow
- ✓Training gap analytics
- ✓Skills matrix by cell
- ✓Re-training trigger rules
- ✓Audit-ready training history
Skills Matrix · Cell 01–04
9 operators · 8 part programs · live from Qualio
| Operator | PT-2049-B | PT-2103-A | PT-2210-C | PT-2188-D | PT-2099-E | PT-2317-F | PT-2401-G | CMM Ops |
|---|---|---|---|---|---|---|---|---|
| Smith K. | ● | ● | ● | ▲ | ● | ✕ | ● | ● |
| Jones K. | ● | ● | ● | ● | ▲ | ▲ | ● | ● |
| Patel R. | ● | ● | ▲ | ● | ● | ● | ● | ● |
| Doyle M. | ● | ▲ | ● | ● | · | ● | ▲ | ● |
| Walsh F. | ● | ● | ● | ● | ● | ● | ● | ● |
| O'Brien S. | ▲ | ● | ● | ● | ● | · | ● | ▲ |
| Lynch J. | ● | ● | ✕ | ● | ● | ● | ● | ● |
| Ryan P. | ● | · | ● | ● | ▲ | ● | ▲ | · |
| Murphy A. | ▲ | · | ● | ● | ● | ● | ● | ● |
From shop floor to CEO. One pane of glass.
Live executive intelligence aggregated across operations, finance, supply chain, and quality. Powered by a purpose-built LLM that reads your ERP, your QMS, and your floor in real time.
- ✓CEO Intelligence Dashboard
- ✓AI Executive Agent (LLM)
- ✓Energy & sustainability intel
- ✓Machine intelligence (predictive)
- ✓Customer-facing portals
- ✓Power BI bidirectional
- ✓Ops intelligence stream
- ✓Continuous improvement tracker
- ✓BD & pipeline intel
- ✓Competitive intel feed
- ✓Energy ECM live data
- ✓Anomaly detection (auto)
Operations Pulse · May 2026
Compliance-grade foundations.
Every record signed, hashed, and audit-trailed. Every action role-gated. Every customer in their own isolated environment. The platform is the validation evidence — not a layer on top of one.
- ✓Mobile PWA (install-ready)
- ✓Digital factory floor signage
- ✓Full audit trail (21 CFR Part 11)
- ✓Electronic signatures (Annex 11)
- ✓Role-based access control
- ✓Microsoft Entra SSO
- ✓Siloed SaaS deployment
- ✓Validated backups (verified daily)
- ✓ERP integration (M1/SAP/Plex)
- ✓Power BI bidirectional
- ✓OneDrive document linking
- ✓Self-service environment provisioning
Audit Trail · 21 CFR Part 11
Immutable · Hash-chained · Exportable to FDA-ready PDF
Ready to see the full platform?
A 30-minute demo walks through every domain, with live data mapped to your stack.
Book a Demo