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About us

We build the systems QA teams sign their name to.

OneXPro makes quality and compliance software for regulated industries — pharma and life sciences, engineering and manufacturing. Our products replace paper registers and uncontrolled spreadsheets with records that are complete, attributable and ready for inspection — without asking people to change how good quality work is done.

Our mission

Make compliance the natural result of doing the work.

In a GMP plant, a change control or a calculation sheet is more than a document — it is evidence. Every signature says someone reviewed, approved or verified something, and an inspector may ask about it years later.

We start from the forms and SOPs our customers already use, transcribe them faithfully, and then build the controls regulators expect directly into each step: who may act, in what order, what their signature means, and a trail of everything that happened.

The result is software that QA can validate, users can learn in a session, and inspectors can follow without a guide.

Built for regulated industries

Designed for the records regulated plants and engineering teams sign — pharma-grade controls, not adapted from generic workflow tools.

Compliance in the code

Part 11, Annex 11 and ALCOA+ are enforced on the server, documented in our validation package, and re-documented whenever a control changes.

How we work

Principles we hold ourselves to.

Honest about limits

We say what the software does and what remains your responsibility — on our website and in our validation documents.

People decide

Automation and AI may propose. Only a person reviews, decides and signs — always.

Your data is yours

Each customer's data is isolated, used only to provide the service, and returned to you on request.

Simple on purpose

Most users work to SOPs, not software manuals. We design screens they can follow on the first day.

What we offer

A growing quality suite, and the services around it.

Products for regulated quality records — starting with QMS Change Control and Controlled Spreadsheet Review — delivered with implementation, validation support and training.

Let's talk about your quality records.

Tell us what you're working with today — we'll show you what it could look like.