43 controls across both frameworks, scored on evidence rather than intent — because "we do this" and "we can show an inspector we do this" are different answers, and the gap between them is where findings come from.
Used only to label the report generated in your browser. Nothing is transmitted or stored — which matters, because an honest self-assessment is a candid record of your own gaps.
Across inspections the same few patterns recur. Most are self-detectable before anyone else finds them — which is the entire point of assessing yourself first.
No, and nothing here has any standing with a regulator. This is a structured way to find your own gaps before someone else does. Compliance depends on your predicate rules, your jurisdiction, and how the system is actually used — none of which a self-assessment can determine for you.
Because that distinction is where findings live. A control performed correctly but with no retrievable evidence is indistinguishable from an absent control during an inspection. Separating them tells you whether your problem is practice or proof — and those need completely different remediation.
Every §-reference follows the 2011 Annex 11 and the page says so explicitly. A revised Annex 11 went to public consultation in 2025; that draft substantially restructures the annex and its numbering does not map one-to-one onto the 2011 clauses. Check whether a revised text has been adopted and re-verify before citing any reference in a regulated record.
Different job, same buyer. ValidoQA drafts validation protocols — IQ/OQ/PQ, traceability, GAMP categorisation. Part11Pass audits electronic-record and electronic-signature controls on a system that already exists. Teams typically need both, at different points.
No. There's no backend. The assessment, scoring and report generation all run in your browser. That matters more here than in most tools: an honest self-assessment is a candid written record of your own weaknesses.
Enter it here — it unlocks the inspector's notes and casebook on this device.
Enter your licence code (from your receipt). It unlocks the inspector's-eye notes, the failure-pattern casebook, the remediation phrasing rules and the auditor-review prompt on this device.
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