Regulatory position

The apps are off-the-shelf software for research and education. They have not been validated for use in a regulated (GxP) environment, and we make no claim of compliance with FDA 21 CFR Part 11, EU Annex 11 or any GxP requirement; no software can be certified as "Part 11 compliant" on its own. Responsibility for compliance, including any validation of the software in your environment, lies with the organisation that uses it. Their prices, when set, will not include validation services.

What we provide to help you qualify them yourself: a dated changelog and release notes for every version; a methods page naming each algorithm, parameter default, data source and version; a verification dataset with expected outputs for each release so you can run your own checks; exports and reports that carry the data versions, parameters, limits and a timestamp needed to reproduce a result; and a security overview.

What the apps do not do: they do not keep a server-side record of who changed what, they have no electronic signatures, they provide no IQ/OQ package, and Bench account permissions do not establish regulated access controls. Scientific computation is local; optional account backups store selected Studies. If you need those controls, an app can sit inside a validated system that provides them; it cannot provide them itself.

Supplier questionnaires: we answer with a short security and architecture summary (see Trust), and we will say plainly which questions apply to the individual apps and configured Bench services.