Where databecomes decision.
Cut audit risk with precise analyses and reports ready for regulatory use. Control charts, capability, hypothesis testing, DOE and MSA — in the browser, in your team's language.
- GxPRegulated manufacturing
- 21 CFR Part 11FDA · electronic records
- EU GMP Annex 11Computerised systems
- GAMP 5 / CSVSystems validation
- ALCOA+Data integrity
Regulated statistics
turned into budget risk.
Regulated manufacturers still run statistics on tools designed for another era. And with no native audit trail, access control or data integrity, every FDA, Health Canada or EU GMP inspection becomes direct exposure to risk.
Per-seat licences tied to specific machines
100% in the browser, with no installation and no licence bound to a workstation.
Analyses locked to a single desktop
Collaborative by default: shared workspaces per team and per legal entity, with data kept in one place.
Results that travel as file attachments
One platform from raw data to the signed report, with an immutable trail behind every analysis.
35+ analyses quality engineering demands.
From control chart to product shelf-life — the complete arsenal, without needing more than one tool.
Statistical process control
- I-MR
- Xbar-R
- Xbar-S
- CUSUM
- EWMA
- C chart
- U chart
- Laney U'
Capability
- Cp · Cpk
- Pp · Ppk
- Capability Panel
- Box-Cox
- Johnson
- Distribution ID
Hypothesis tests
- Anderson-Darling
- Shapiro-Wilk
- KS
- ANOVA
- Kruskal-Wallis
- Levene
- Grubbs
- Bonferroni
Regression and time series
- Simple regression
- Multiple regression
- Polynomial
- Time series
- Exponential smoothing
DOE and MSA
- Factorial DOE
- MSA · Gauge R&R
Stability
- Shelf-life
- ICH Q1E validity
Regulatory governance
treated as part of the product.
Aligned to your regulatory requirements and prepared for 21 CFR Part 11 (FDA) and EU GMP Annex 11. Security, traceability and data integrity are the foundation — governance from the ground up, not a plugin.
- Immutable audit trail
- Role-based access control
- Signatures and versioning
- End-to-end traceability
Auditable by design
Deterministic functions anchored in AIAG, Montgomery and ICH references, with an equivalence report for your dossier.
Validation-friendly
GAMP 5 Category 3, with technical and functional specifications available as input to your CSV effort.
Your data, isolated
Each organization only sees its own data — enforced in the database, not just in the interface.
Take a testcompletely free.
Leave your contact and our team will unlock your evaluation access. Bring your own dataset and see RBN Stat's rigor applied to your real process.
- ✓No installation — runs in the browser
- ✓Guidance from our team of specialists
- ✓Your analyses, with your own data
Plans on request
We put together a proposal for your team's size after the trial — no workstation licences to count.
What quality teams ask
before they decide.
Questions from teams that use statistics because the regulation demands it — pharmaceutical manufacturing and distribution, medical devices, cosmetics and personal care.
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.