code5x
eQMS · In development

Coming soon · Pre-release
OmniQMS is being built for clinical laboratories first — CAP/CLIA and ISO 15189 environments — on a data layer that also extends to manufacturing, medical device design and workplace safety, so teams stop reconciling separate systems by hand.
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See How It Works

Product

OmniQMS

Status

In development

Early access

Open to selected teams

Built for

Quality, regulatory and IT leads

The problem

Quality systems are usually designed for a single regulated domain. Organizations that run a plant, a design team and a lab often end up with a separate system for each, and reconcile them by hand. OmniQMS is being designed to give them one adaptable record instead.

Donut chart of eQMS market focus by regulated domain, showing the unaddressed functional gap OmniQMS is designed to cover

Market research used to shape OmniQMS's architecture, not a published study.

Overview

01

One data layer, several standards

Documents, training, events and corrective actions live in one record. We are designing for ISO 9001, ISO 13485, FDA QMSR, CAP/CLIA, ISO 15189 and ISO 45001 environments.

02

AI that assists, people who decide

OmniQMS is being designed to suggest likely causes and route corrective actions. Your team reviews and approves each one, and every step is logged.

03

Connects to the systems you run

Planned connections to ERP, LIMS, MES and PLM tools, so quality records sit next to the work that creates them.

OmniQMS planned high-level system architecture: compliance engine, core modules, AI validation layer, and integration mesh

Planned architecture. Layers, standards coverage and integrations shown here may change before release.

How it works

The same four steps apply whether the event comes from a production line, a design review, a lab result or a safety report.
1

Capture

Log an event from an audit, complaint, test result or incident.

2

Investigate

Review suggested causes and agree on the real one.

3

Fix

Update documents, assign actions and retrain the people affected.

4

Verify

Check that the fix worked and keep the record for audit.

If the fix did not work, the event goes back to Investigate.
OmniQMS planned end-to-end quality pipeline: incident capture, AI root-cause, CAPA and risk, document control and training, automated validation

Planned pipeline, shown in more detail than the four-step loop above.

Status

OmniQMS is in development. We are working with a small group of early adopters to shape the first release. Features, standards coverage and timing described on this page are planned and may change.

Early access

Help shape the first release.

Tell us what your quality team needs most. We are taking early access requests from selected teams.

Request Early Access

OmniQMS is in development. Descriptions of features, standards coverage and availability on this page are planned and may change. This page is not regulatory advice. OmniQMS is built by Code5X. See our other products on Procure and OmniERP.