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Free Tools 21 CFR Part 11 Result

Results

21 CFR Part 11 Readiness Checker

You can access your 21 CFR Part 11 Readiness Checker results below. If you wish, you can download the report and contact us for more features.

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Overall Readiness

Calculated across 140 regulatory checkpoints

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0% —

Section Scores

Based on your responses across 9 regulatory control areas

0 25 50 75 100

Compliance Profile

Performance across the 5 core regulatory pillars.

Identified High-Risk Gaps

Priority areas identified from your assessment results

CRITICAL

Insufficient Audit Trail Granularity

The system fails to capture “Reason for Change” metadata for records modified during clinical validation phases.

Recommendation: Enable mandatory 'Reason Code' prompts for all field-level updates.

CRITICAL

Insufficient Audit Trail Granularity

The system fails to capture “Reason for Change” metadata for records modified during clinical validation phases.

Recommendation: Enable mandatory 'Reason Code' prompts for all field-level updates.

Complaince Strengths

Highest-performing sections from your assessment

Excellent

Advanced Password Complexity

System enforces 12+ characters mixed-case requirements and 90-day rotation cycles, exceeding FDA baseline.

Good

Time-Stamping Integrity

All record entries use a centralized NIST-synchronized server clock, preventing local manual oveerrides.

Good

Limited System Access

RBAC is strictly defined with zero ‘Default All’ permissions founds.

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/** * Validfor access form → Lambda /api/register * Paste into Elementor → Custom Code → Body End (NOT HTML widget). * Requires #vf-form-wrap on the page (Brevo form markup). */ (function () { var SERVICE_URL = 'https://pbdvrqzxthnrm7v63bqlifyky40ylbhp.lambda-url.eu-central-1.on.aws'; var registering = false; function qs(sel, root) { return (root || document).querySelector(sel); } function getWrap(form) { return (form && form.querySelector('#vf-form-wrap')) || document.getElementById('vf-form-wrap'); } function getEmail(root) { var el = qs('#vf-email', root) || qs('input[type=email]', root) || qs('input[name=email]', root); return el ? (el.value || '').trim() : ''; } function showError(root, msg) { var err = qs('#vf-error', root); if (!err) { console.warn('[vf-register]', msg); return; } err.textContent = msg; err.style.display = 'block'; } function hideError(root) { var err = qs('#vf-error', root); if (err) err.style.display = 'none'; } function setLoading(root, on) { var btn = qs('#vf-submit', root) || qs('input[type=submit],button[type=submit]', root); if (!btn) return; btn.disabled = !!on; if ('value' in btn) btn.value = on ? 'Sending…' : 'Submit'; } function showSuccess(root, email) { var fields = qs('#vf-fields', root); var success = qs('#vf-success', root); var sent = qs('#vf-sent-email', root); if (fields) fields.style.display = 'none'; if (success) success.style.display = 'block'; if (sent) sent.textContent = email; } function runRegister(form) { var wrap = getWrap(form); if (!wrap) return null; if (!form || (!form.contains(wrap) && form.id !== 'vf-form')) return null; var tool = wrap.getAttribute('data-vf-tool') || 'annex11'; var email = getEmail(wrap); hideError(wrap); if (!email || !/^[^\s@]+@[^\s@]+\.[^\s@]+$/.test(email)) { showError(wrap, 'Please enter a valid email address.'); return false; } if (registering) return true; registering = true; setLoading(wrap, true); fetch(SERVICE_URL + '/api/register', { method: 'POST', headers: { 'Content-Type': 'application/json' }, body: JSON.stringify({ tool: tool, email: email }) }) .then(function (res) { return res.json(); }) .then(function (data) { if (data && data.success) { showSuccess(wrap, email); } else { registering = false; setLoading(wrap, false); showError(wrap, (data && data.error) || 'Something went wrong. Please try again.'); } }) .catch(function (err) { console.error('[vf-register]', err); registering = false; setLoading(wrap, false); showError(wrap, 'Network error. Please try again.'); }); return true; } document.addEventListener('submit', function (e) { var form = e.target; if (!form || form.tagName !== 'FORM') return; var result = runRegister(form); if (result === null) return; if (result === false) { e.preventDefault(); e.stopPropagation(); } }, true); document.addEventListener('click', function (e) { var t = e.target; if (!t || !t.closest) return; var btn = t.closest('#vf-submit, .sib-default-btn, input[type=submit]'); if (!btn) return; var wrap = document.getElementById('vf-form-wrap'); if (!wrap) return; var form = wrap.closest('form') || btn.form; if (!form || !form.contains(wrap)) return; setTimeout(function () { runRegister(form); }, 0); }, true); console.log('[vf-register] ready'); })();