One price change. It happens when the FDA says so, not when you hire someone.

The difference, drawn

Theirs climbs. Ours steps.

Seat-metered pricing turns every hire into a line item. Buyers of the leading platforms report their total cost roughly doubling as the team grows — one published teardown of a major vendor’s increase is titled simply “Crazy increase.” The bill tracks headcount, which has nothing to do with what the regulator asks of you.

Our line is flat until a regulatory event moves it. Hire five people, hire fifty — the price is the same, because none of that changed what you owe the FDA. Register your establishment and it steps once, because that genuinely did.

Three stages

You move between them when your obligations do.

Unlimited users on every tier. Your quality manager, your contract manufacturer, your consultant and your auditor all need to see the record. Charging you per person to show the auditor your own data is not a pricing model, it is a toll.

Straight answers

The questions you were going to ask.

What exactly triggers the change?

FDA establishment registration. We capture the registration number and hold it in the record, so the tier is a documented fact rather than a checkbox someone can toggle. No sales call required to move — it moves because the regulation moved.

What if we register and then decide we’re not ready?

You keep every record you created, at the tier you’re actually operating at. Your quality data is yours, in export formats an auditor accepts, whether or not you stay a customer.

We already have an eQMS. How bad is the migration?

Honest answer: migrations are work, and anyone who tells you otherwise has not done one. What we can promise is that we import your documents with their identifiers intact — your DWG-INS-004 stays DWG-INS-004, because your auditors and your own cross-references depend on it.

Do we have to validate it ourselves?

You are always responsible for validating software for your intended use — that is the regulation, and no vendor can take it from you. What we can do is make it a review rather than a project: IQ, OQ and PQ artifacts with executed evidence, change impact assessment and a traceability matrix, generated with every release rather than written by hand when you ask.

How did you arrive at these numbers?

We took the published pricing of the leading platforms and charged 40% of it. That is the whole method, and we’re publishing it because the opacity is half of what people dislike about buying quality software. If a competitor changes their price, you can check our arithmetic.

How can you be that much cheaper?

Because we are not carrying a decade of acquired products, a services organisation that bills for configuration, or a sales motion built around annual seat expansion. The software does the work; the price reflects that rather than the cost of selling it to you.