Where databecomes decision.

Yes. The system was built with an immutable audit trail, role-based access control and data integrity following ALCOA+ principles — the requirements for a computerised system in a regulated environment. It falls under GAMP 5 Category 3 (non-configured off-the-shelf software), which reduces the validation effort on your side.

Yes — in a GxP environment the regulated user is always accountable for validation, never the vendor, regardless of the tool. What reduces the effort is the categorisation: as GAMP 5 Category 3, the required test scope is narrower than for configured or bespoke systems. We provide the technical and functional specifications of the system, which your team uses as input to build its own qualification protocols.

It depends on the process, but the recurring core is: control charts to demonstrate statistical control, capability indices (Cp, Cpk, Pp, Ppk) for annual product review, normality testing before applying parametric methods, measurement system analysis (MSA / Gauge R&R) for equipment qualification, and stability studies under ICH Q1E for shelf-life. All of them are in RBN Stat.

The functions are deterministic and anchored in public industry references — AIAG for MSA, Montgomery for SPC and capability, ICH for stability. We maintain an equivalence report comparing results against the established statistical tools on the market, which you can request and use as evidence in your validation dossier.

The established tools were born as desktop software and still carry that legacy: per-machine installation, collaboration by passing files around and compliance treated as an add-on. RBN Stat starts from the same rigour — the same references, the same formulas — but on a current architecture: it runs in the browser, is collaborative by default, ships with an audit trail and access control out of the box, and opens every result with a readable verdict instead of raw tables. For a regulated operation, it is the whole set in one place, without the cost of maintaining workstations and licences.

It serves any operation with a statistical requirement. Medical device manufacturers lean on MSA, capability and DOE; cosmetics and personal care on control charts and stability studies; distributors on statistical control of incoming goods and storage conditions. The analysis set is the same — what changes is the priority.

In cloud infrastructure with per-organisation isolation: each company sees only its own data, enforced at the database level and not merely in the interface. Access is role-based, two-factor authentication is available, and every relevant action is recorded in the audit trail.

No. It runs entirely in the browser — no installation, no licence tied to a single machine and no dependency on IT to roll out a new version. The whole team works on the same dataset instead of passing spreadsheets between workstations.

You leave your contact, our team unlocks an evaluation account and you bring your own dataset. The point is to see how the tool behaves on your real process, not on a demo database.