From the FAT at the supplier's factory to operational qualification on your own line: checklist with objective acceptance criteria, photo evidence attached to each item, numbered deviations, signatures from both parties and a full audit trail, in a final PDF ready for inspection.
No subscription: you pay per approved protocol.Most acceptance tests and qualifications still happen on improvised paper. The document exists — until the day it actually needs to hold up.
A six-figure filling machine arrives and the doser doesn't hit the precision promised in the quote. The final installment was paid on shipment. The manufacturer, thousands of kilometers away, says the problem is the installation. When it's time to back the claim, the buyer opens the FAT they ran and finds out what they actually have on hand:
An acceptance document without traceability doesn't hold up a contractual claim and doesn't pass an audit. It's just paper.
Qualifica Cartesiano digitizes the full protocol cycle (FAT, SAT, IQ or OQ) with the traceability that spreadsheets and paper can't fake.
The template is the foundation of your protocol. You build it in the system, item by item, from your purchase specification (URS), and reuse and edit it for the next machines. Prefer to receive it ready-made? We build yours from the machine's documentation, on quote.
External participants (the manufacturer's technician, the validation consultant) join via QR code and answer their own sections, each with their own trail.
Each item logs OK, NOK or N/A against a criterion defined before execution. "Works fine" is not a result.
Photos and measurements stay attached to the item they prove, not on someone's phone.
Anything that fails becomes a numbered record, with an owner, a deadline, and a resolution tracked through to closure.
Who answered what, when, and what changed. In the end, a signed PDF that holds up in an audit and backs a contractual claim.
FAT, SAT, IQ and OQ aren't a consultant's invention. They're stages described in the main qualification standards, and all of them require the same documented evidence.
If your operation includes Brazil, two additional references apply:
Engineering, quality, validation and industry stakeholders:
Manufacturers who want to deliver a professional acceptance process:
You buy credits and one is consumed per approved protocol. Building templates, running executions and collaborating don't consume credit. You're only charged when the protocol is approved.
FAT (Factory Acceptance Test) is the acceptance test carried out at the manufacturer's facility, before shipment, where manufacturer and buyer jointly verify, item by item, whether the machine meets what was specified in the purchase, with objective criteria, evidence, formalized deviations and both parties' signatures.
Yes. The protocol format follows what qualification standards require: pre-approved protocol, traceable criteria, attached evidence, resolved deviations, dated signatures and a full audit trail, from FAT through operational qualification.
External participants join the execution via QR code, straight from the browser, with nothing to install. Each one answers their own sections with an individual trail of who answered what, and when.
No, and that's on purpose. You build your protocol template in the system, item by item, from your own specification, and reuse and edit it for the next machines. There's no library of ready-made templates by machine type, because a generic protocol is exactly what fails an audit. If you'd rather receive it ready-made, we build yours from the machine's documentation, as a separate quoted service.
By credit: you buy credits and one credit is consumed per approved protocol. Creating templates, running executions and collaborating don't consume credit. No subscription, no lock-in.
Create your account, build your protocol template and run it from the browser, with everyone in and everything tracked.