<!-- ============================================================
Mareana — FDA Regulations Every AI-Enabled Pharma Manufacturer Must Know
Paste this whole thing into a single WordPress "Custom HTML" block.
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/* ============ HERO ============ */
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/* ============ REGULATION CARDS ============ */
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/* ============ GUIDANCE CARDS ============ */
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/* ============ CLOSING BANNER ============ */
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font-size: .875rem; font-weight: 500; color: var(--color-neutral-100);
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.mrn-chip svg { width: 18px; height: 18px; color: var(--color-accent); }
/* ============ ENTRANCE ANIMATION ============ */
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/* ============ CTAs ============ */
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/* whitepaper band */
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/* --- text alignment: beats any theme rule targeting bare tags --- */
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.mrn-ig .mrn-hero-title, .mrn-ig .mrn-hero-sub, .mrn-ig .mrn-eyebrow,
.mrn-ig .mrn-sec-head, .mrn-ig .mrn-sec-head p, .mrn-ig .mrn-sec-head h2,
.mrn-ig .mrn-closing, .mrn-ig .mrn-closing p, .mrn-ig .mrn-closing h2,
.mrn-ig .mrn-chips, .mrn-ig .mrn-cta-hero, .mrn-ig .mrn-cta-close,
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/* cards and the whitepaper band must stay left-aligned */
.mrn-ig .mrn-hub, .mrn-ig .mrn-hub p, .mrn-ig .mrn-hub h2,
.mrn-ig .mrn-reg-card, .mrn-ig .mrn-reg-card p, .mrn-ig .mrn-reg-card h3,
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.mrn-ig .mrn-wp, .mrn-ig .mrn-wp p, .mrn-ig .mrn-wp h3,
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/* --- shell background must always paint --- */
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/* --- no-JS guarantee: every element visible regardless of scripts --- */
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/* --- defensive: stop theme CSS leaking in --- */
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/* --- full-bleed: lets the dark sections span the window inside a boxed
theme column. Delete this block if you want it to stay in-column. --- */
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.mrn-ig .mrn-section {
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.mrn-reg-card, .mrn-guide-card { box-shadow: none; border: 1px solid #ccc; break-inside: avoid; }
}
</style>
<!-- ===================== DARK HERO SHELL ===================== -->
<div class="mrn-dark-shell">
<div class="mrn-container">
<!-- Hero -->
<section class="mrn-hero">
<span class="mrn-eyebrow mrn-reveal">Infographic</span>
<h1 class="mrn-hero-title mrn-reveal">FDA Regulations Every<br><span class="mrn-gradient-text">AI-Enabled Pharma Manufacturer</span><br>Must Know</h1>
<p class="mrn-hero-sub mrn-reveal">AI can transform pharmaceutical manufacturing, but it does not replace FDA requirements. These cGMP regulations apply whenever AI influences GMP activities or generates regulated records.</p>
<div class="mrn-hub mrn-reveal">
<div class="mrn-hub-icon" aria-hidden="true">
<!-- brain-circuit -->
<svg viewBox="0 0 24 24" fill="none" stroke="currentColor" stroke-width="1.6" stroke-linecap="round" stroke-linejoin="round">
<path d="M12 5a3 3 0 1 0-5.997.125 4 4 0 0 0-2.526 5.77 4 4 0 0 0 .556 6.588A4 4 0 1 0 12 18Z"></path>
<path d="M12 5a3 3 0 1 1 5.997.125 4 4 0 0 1 2.526 5.77 4 4 0 0 1-.556 6.588A4 4 0 1 1 12 18Z"></path>
<path d="M15 13a4.5 4.5 0 0 1-3-4 4.5 4.5 0 0 1-3 4"></path><path d="M17.599 6.5a3 3 0 0 0 .399-1.375"></path>
<path d="M6.003 5.125A3 3 0 0 0 6.401 6.5"></path><path d="M3.477 10.896a4 4 0 0 1 .585-.396"></path>
<path d="M19.938 10.5a4 4 0 0 1 .585.396"></path><path d="M6 18a4 4 0 0 1-1.967-.516"></path><path d="M19.967 17.484A4 4 0 0 1 18 18"></path>
</svg>
</div>
<div>
<h2>AI in Pharmaceutical Manufacturing</h2>
<p>Powerful. Predictive. Efficient.</p>
<span class="mrn-pill">Still accountable to cGMP</span>
</div>
</div>
<div class="mrn-cta-hero mrn-reveal">
<a class="mrn-btn mrn-btn-primary" href="https://mareana.com/request-a-demo/">Book a demo<svg viewBox="0 0 24 24" fill="none" stroke="currentColor" stroke-width="2.2" stroke-linecap="round" stroke-linejoin="round" aria-hidden="true"><path d="M5 12h14"></path><path d="m12 5 7 7-7 7"></path></svg></a>
<span class="mrn-cta-note">See how Mareana keeps AI-assisted batch review audit-ready.</span>
</div>
</section>
</div>
</div>
<!-- ===================== REGULATIONS ===================== -->
<section class="mrn-section mrn-section-light">
<div class="mrn-container">
<div class="mrn-sec-head mrn-reveal">
<p class="mrn-eyebrow">Core cGMP Regulations</p>
<h2>Six rules that still govern AI on the manufacturing floor</h2>
<p>Each regulation still applies the moment AI touches a GMP activity. Here is what the rule says, why AI changes the stakes, and what manufacturers should do.</p>
</div>
<div class="mrn-grid">
<!-- 1 -->
<article class="mrn-reg-card mrn-reveal" data-delay="0">
<div class="mrn-reg-top">
<span class="mrn-reg-icon" aria-hidden="true"><svg viewBox="0 0 24 24" fill="none" stroke="currentColor" stroke-width="2" stroke-linecap="round" stroke-linejoin="round"><path d="M20 13c0 5-3.5 7.5-7.66 8.95a1 1 0 0 1-.67-.01C7.5 20.5 4 18 4 13V6a1 1 0 0 1 1-1c2 0 4.5-1.2 6.24-2.72a1.17 1.17 0 0 1 1.52 0C14.51 3.81 17 5 19 5a1 1 0 0 1 1 1z"></path><path d="m9 12 2 2 4-4"></path></svg></span>
<span class="mrn-reg-num">01</span>
</div>
<span class="mrn-reg-cite">21 CFR 211.22</span>
<h3 class="mrn-reg-title">Quality Control Unit Responsibilities</h3>
<div class="mrn-block">
<div class="mrn-block-label mrn-label-rule"><svg viewBox="0 0 24 24" fill="none" stroke="currentColor" stroke-width="2" stroke-linecap="round" stroke-linejoin="round"><path d="M15 2H6a2 2 0 0 0-2 2v16a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V7z"></path><path d="M14 2v4a2 2 0 0 0 2 2h4"></path><path d="M16 13H8"></path><path d="M16 17H8"></path></svg>What the rule says</div>
<p>Requires the Quality Unit (QU) to approve or reject procedures, records, and specifications that affect product quality. The QU remains accountable for GMP compliance.</p>
</div>
<div class="mrn-block">
<div class="mrn-block-label mrn-label-impact"><svg viewBox="0 0 24 24" fill="none" stroke="currentColor" stroke-width="2" stroke-linecap="round" stroke-linejoin="round"><path d="m21.73 18-8-14a2 2 0 0 0-3.48 0l-8 14A2 2 0 0 0 4 21h16a2 2 0 0 0 1.73-3"></path><path d="M12 9v4"></path><path d="M12 17h.01"></path></svg>Why it impacts AI</div>
<p>AI can draft SOPs, batch records, investigations, and specifications, but FDA does not consider AI an approver. Human oversight is mandatory.</p>
</div>
<div class="mrn-block">
<div class="mrn-block-label mrn-label-do"><svg viewBox="0 0 24 24" fill="none" stroke="currentColor" stroke-width="2" stroke-linecap="round" stroke-linejoin="round"><circle cx="12" cy="12" r="10"></circle><path d="m9 12 2 2 4-4"></path></svg>What manufacturers should do</div>
<p>Ensure every AI-generated GMP document is independently reviewed and approved by qualified Quality personnel. Train reviewers to identify AI errors or hallucinations before approval.</p>
</div>
</article>
<!-- 2 -->
<article class="mrn-reg-card mrn-reveal" data-delay="90">
<div class="mrn-reg-top">
<span class="mrn-reg-icon" aria-hidden="true"><svg viewBox="0 0 24 24" fill="none" stroke="currentColor" stroke-width="2" stroke-linecap="round" stroke-linejoin="round"><path d="M12.22 2h-.44a2 2 0 0 0-2 2v.18a2 2 0 0 1-1 1.73l-.43.25a2 2 0 0 1-2 0l-.15-.08a2 2 0 0 0-2.73.73l-.22.38a2 2 0 0 0 .73 2.73l.15.1a2 2 0 0 1 1 1.72v.51a2 2 0 0 1-1 1.74l-.15.09a2 2 0 0 0-.73 2.73l.22.38a2 2 0 0 0 2.73.73l.15-.08a2 2 0 0 1 2 0l.43.25a2 2 0 0 1 1 1.73V20a2 2 0 0 0 2 2h.44a2 2 0 0 0 2-2v-.18a2 2 0 0 1 1-1.73l.43-.25a2 2 0 0 1 2 0l.15.08a2 2 0 0 0 2.73-.73l.22-.39a2 2 0 0 0-.73-2.73l-.15-.08a2 2 0 0 1-1-1.74v-.5a2 2 0 0 1 1-1.74l.15-.09a2 2 0 0 0 .73-2.73l-.22-.38a2 2 0 0 0-2.73-.73l-.15.08a2 2 0 0 1-2 0l-.43-.25a2 2 0 0 1-1-1.73V4a2 2 0 0 0-2-2z"></path><circle cx="12" cy="12" r="3"></circle></svg></span>
<span class="mrn-reg-num">02</span>
</div>
<span class="mrn-reg-cite">21 CFR 211.100</span>
<h3 class="mrn-reg-title">Production and Process Controls</h3>
<div class="mrn-block">
<div class="mrn-block-label mrn-label-rule"><svg viewBox="0 0 24 24" fill="none" stroke="currentColor" stroke-width="2" stroke-linecap="round" stroke-linejoin="round"><path d="M15 2H6a2 2 0 0 0-2 2v16a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V7z"></path><path d="M14 2v4a2 2 0 0 0 2 2h4"></path><path d="M16 13H8"></path><path d="M16 17H8"></path></svg>What the rule says</div>
<p>Requires scientifically justified and validated production processes that consistently produce quality products. Process validation is mandatory.</p>
</div>
<div class="mrn-block">
<div class="mrn-block-label mrn-label-impact"><svg viewBox="0 0 24 24" fill="none" stroke="currentColor" stroke-width="2" stroke-linecap="round" stroke-linejoin="round"><path d="m21.73 18-8-14a2 2 0 0 0-3.48 0l-8 14A2 2 0 0 0 4 21h16a2 2 0 0 0 1.73-3"></path><path d="M12 9v4"></path><path d="M12 17h.01"></path></svg>Why it impacts AI</div>
<p>AI cannot determine or replace process validation requirements. Manufacturers remain responsible for validating every manufacturing process.</p>
</div>
<div class="mrn-block">
<div class="mrn-block-label mrn-label-do"><svg viewBox="0 0 24 24" fill="none" stroke="currentColor" stroke-width="2" stroke-linecap="round" stroke-linejoin="round"><circle cx="12" cy="12" r="10"></circle><path d="m9 12 2 2 4-4"></path></svg>What manufacturers should do</div>
<p>Use AI only to support process analysis or optimization. Validate every critical process using documented scientific evidence and human approval.</p>
</div>
</article>
<!-- 3 -->
<article class="mrn-reg-card mrn-reveal" data-delay="180">
<div class="mrn-reg-top">
<span class="mrn-reg-icon" aria-hidden="true"><svg viewBox="0 0 24 24" fill="none" stroke="currentColor" stroke-width="2" stroke-linecap="round" stroke-linejoin="round"><rect x="4" y="4" width="16" height="16" rx="2"></rect><rect x="9" y="9" width="6" height="6"></rect><path d="M15 2v2"></path><path d="M15 20v2"></path><path d="M2 15h2"></path><path d="M2 9h2"></path><path d="M20 15h2"></path><path d="M20 9h2"></path><path d="M9 2v2"></path><path d="M9 20v2"></path></svg></span>
<span class="mrn-reg-num">03</span>
</div>
<span class="mrn-reg-cite">21 CFR 211.68</span>
<h3 class="mrn-reg-title">Automatic, Mechanical, and Electronic Equipment</h3>
<div class="mrn-block">
<div class="mrn-block-label mrn-label-rule"><svg viewBox="0 0 24 24" fill="none" stroke="currentColor" stroke-width="2" stroke-linecap="round" stroke-linejoin="round"><path d="M15 2H6a2 2 0 0 0-2 2v16a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V7z"></path><path d="M14 2v4a2 2 0 0 0 2 2h4"></path><path d="M16 13H8"></path><path d="M16 17H8"></path></svg>What the rule says</div>
<p>Requires computerized systems to be validated and their inputs, outputs, and changes to be controlled for accuracy.</p>
</div>
<div class="mrn-block">
<div class="mrn-block-label mrn-label-impact"><svg viewBox="0 0 24 24" fill="none" stroke="currentColor" stroke-width="2" stroke-linecap="round" stroke-linejoin="round"><path d="m21.73 18-8-14a2 2 0 0 0-3.48 0l-8 14A2 2 0 0 0 4 21h16a2 2 0 0 0 1.73-3"></path><path d="M12 9v4"></path><path d="M12 17h.01"></path></svg>Why it impacts AI</div>
<p>AI systems used for inspections, monitoring, or predictions become regulated computerized systems. Their performance must remain reliable throughout their lifecycle.</p>
</div>
<div class="mrn-block">
<div class="mrn-block-label mrn-label-do"><svg viewBox="0 0 24 24" fill="none" stroke="currentColor" stroke-width="2" stroke-linecap="round" stroke-linejoin="round"><circle cx="12" cy="12" r="10"></circle><path d="m9 12 2 2 4-4"></path></svg>What manufacturers should do</div>
<p>Validate AI models before deployment, continuously monitor for performance drift, and manage all model updates through formal change control.</p>
</div>
</article>
<!-- 4 -->
<article class="mrn-reg-card mrn-reveal" data-delay="0">
<div class="mrn-reg-top">
<span class="mrn-reg-icon" aria-hidden="true"><svg viewBox="0 0 24 24" fill="none" stroke="currentColor" stroke-width="2" stroke-linecap="round" stroke-linejoin="round"><rect width="8" height="4" x="8" y="2" rx="1" ry="1"></rect><path d="M16 4h2a2 2 0 0 1 2 2v14a2 2 0 0 1-2 2H6a2 2 0 0 1-2-2V6a2 2 0 0 1 2-2h2"></path><path d="M12 11h4"></path><path d="M12 16h4"></path><path d="M8 11h.01"></path><path d="M8 16h.01"></path></svg></span>
<span class="mrn-reg-num">04</span>
</div>
<span class="mrn-reg-cite">21 CFR 211.188 & 211.192</span>
<h3 class="mrn-reg-title">Batch Records and Batch Review</h3>
<div class="mrn-block">
<div class="mrn-block-label mrn-label-rule"><svg viewBox="0 0 24 24" fill="none" stroke="currentColor" stroke-width="2" stroke-linecap="round" stroke-linejoin="round"><path d="M15 2H6a2 2 0 0 0-2 2v16a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V7z"></path><path d="M14 2v4a2 2 0 0 0 2 2h4"></path><path d="M16 13H8"></path><path d="M16 17H8"></path></svg>What the rule says</div>
<p>Requires complete batch records and Quality Unit review of every batch before release. Any discrepancy must be investigated.</p>
</div>
<div class="mrn-block">
<div class="mrn-block-label mrn-label-impact"><svg viewBox="0 0 24 24" fill="none" stroke="currentColor" stroke-width="2" stroke-linecap="round" stroke-linejoin="round"><path d="m21.73 18-8-14a2 2 0 0 0-3.48 0l-8 14A2 2 0 0 0 4 21h16a2 2 0 0 0 1.73-3"></path><path d="M12 9v4"></path><path d="M12 17h.01"></path></svg>Why it impacts AI</div>
<p>AI can automate review-by-exception, but it cannot replace the Quality Unit's release decision. The manufacturer remains responsible for missed deviations.</p>
</div>
<div class="mrn-block">
<div class="mrn-block-label mrn-label-do"><svg viewBox="0 0 24 24" fill="none" stroke="currentColor" stroke-width="2" stroke-linecap="round" stroke-linejoin="round"><circle cx="12" cy="12" r="10"></circle><path d="m9 12 2 2 4-4"></path></svg>What manufacturers should do</div>
<p>Validate AI-assisted batch review systems, maintain complete audit trails, and require human approval before batch release.</p>
</div>
</article>
<!-- 5 -->
<article class="mrn-reg-card mrn-reveal" data-delay="90">
<div class="mrn-reg-top">
<span class="mrn-reg-icon" aria-hidden="true"><svg viewBox="0 0 24 24" fill="none" stroke="currentColor" stroke-width="2" stroke-linecap="round" stroke-linejoin="round"><path d="M14 2v6a2 2 0 0 0 .245.96l5.51 10.08A2 2 0 0 1 18 22H6a2 2 0 0 1-1.755-2.96l5.51-10.08A2 2 0 0 0 10 8V2"></path><path d="M6.453 15h11.094"></path><path d="M8.5 2h7"></path></svg></span>
<span class="mrn-reg-num">05</span>
</div>
<span class="mrn-reg-cite">21 CFR 211.198</span>
<h3 class="mrn-reg-title">Complaint Files</h3>
<div class="mrn-block">
<div class="mrn-block-label mrn-label-rule"><svg viewBox="0 0 24 24" fill="none" stroke="currentColor" stroke-width="2" stroke-linecap="round" stroke-linejoin="round"><path d="M15 2H6a2 2 0 0 0-2 2v16a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V7z"></path><path d="M14 2v4a2 2 0 0 0 2 2h4"></path><path d="M16 13H8"></path><path d="M16 17H8"></path></svg>What the rule says</div>
<p>Written procedures must ensure every quality-related complaint is reviewed, evaluated, and—where warranted—thoroughly investigated with documented findings.</p>
</div>
<div class="mrn-block">
<div class="mrn-block-label mrn-label-impact"><svg viewBox="0 0 24 24" fill="none" stroke="currentColor" stroke-width="2" stroke-linecap="round" stroke-linejoin="round"><path d="m21.73 18-8-14a2 2 0 0 0-3.48 0l-8 14A2 2 0 0 0 4 21h16a2 2 0 0 0 1.73-3"></path><path d="M12 9v4"></path><path d="M12 17h.01"></path></svg>Why it impacts AI</div>
<p>AI can cluster, categorize, or triage complaints at scale, but it cannot close the loop—evaluations, root-cause investigations, and final dispositions require documented human oversight.</p>
</div>
<div class="mrn-block">
<div class="mrn-block-label mrn-label-do"><svg viewBox="0 0 24 24" fill="none" stroke="currentColor" stroke-width="2" stroke-linecap="round" stroke-linejoin="round"><circle cx="12" cy="12" r="10"></circle><path d="m9 12 2 2 4-4"></path></svg>What manufacturers should do</div>
<p>Leverage AI for automated complaint triage and early signal detection, but keep investigation sign-off, root cause analysis, and CAPA decisions strictly with qualified personnel.</p>
</div>
</article>
<!-- 6 -->
<article class="mrn-reg-card mrn-reveal" data-delay="180">
<div class="mrn-reg-top">
<span class="mrn-reg-icon" aria-hidden="true"><svg viewBox="0 0 24 24" fill="none" stroke="currentColor" stroke-width="2" stroke-linecap="round" stroke-linejoin="round"><path d="M12.5 22H18a2 2 0 0 0 2-2V7l-5-5H6a2 2 0 0 0-2 2v9.5"></path><path d="M14 2v4a2 2 0 0 0 2 2h4"></path><path d="M10.42 12.61a2.1 2.1 0 1 1 2.97 2.97L7.95 21 4 22l.99-3.95z"></path></svg></span>
<span class="mrn-reg-num">06</span>
</div>
<span class="mrn-reg-cite">21 CFR Part 11</span>
<h3 class="mrn-reg-title">Electronic Records and Electronic Signatures</h3>
<div class="mrn-block">
<div class="mrn-block-label mrn-label-rule"><svg viewBox="0 0 24 24" fill="none" stroke="currentColor" stroke-width="2" stroke-linecap="round" stroke-linejoin="round"><path d="M15 2H6a2 2 0 0 0-2 2v16a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V7z"></path><path d="M14 2v4a2 2 0 0 0 2 2h4"></path><path d="M16 13H8"></path><path d="M16 17H8"></path></svg>What the rule says</div>
<p>Defines requirements for trustworthy electronic records, electronic signatures, audit trails, and data integrity.</p>
</div>
<div class="mrn-block">
<div class="mrn-block-label mrn-label-impact"><svg viewBox="0 0 24 24" fill="none" stroke="currentColor" stroke-width="2" stroke-linecap="round" stroke-linejoin="round"><path d="m21.73 18-8-14a2 2 0 0 0-3.48 0l-8 14A2 2 0 0 0 4 21h16a2 2 0 0 0 1.73-3"></path><path d="M12 9v4"></path><path d="M12 17h.01"></path></svg>Why it impacts AI</div>
<p>AI generates regulated electronic records. FDA expects complete traceability of prompts, outputs, model versions, approvals, and changes.</p>
</div>
<div class="mrn-block">
<div class="mrn-block-label mrn-label-do"><svg viewBox="0 0 24 24" fill="none" stroke="currentColor" stroke-width="2" stroke-linecap="round" stroke-linejoin="round"><circle cx="12" cy="12" r="10"></circle><path d="m9 12 2 2 4-4"></path></svg>What manufacturers should do</div>
<p>Maintain secure audit trails, preserve AI prompts and outputs, implement version control, and archive the exact AI model used for regulated decisions.</p>
</div>
</article>
</div>
<div class="mrn-wp mrn-reveal">
<div class="mrn-wp-icon" aria-hidden="true"><svg viewBox="0 0 24 24" fill="none" stroke="currentColor" stroke-width="1.8" stroke-linecap="round" stroke-linejoin="round" aria-hidden="true"><path d="M15 2H6a2 2 0 0 0-2 2v16a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V7z"></path><path d="M14 2v4a2 2 0 0 0 2 2h4"></path><path d="M10 9H8"></path><path d="M16 13H8"></path><path d="M16 17H8"></path></svg></div>
<div class="mrn-wp-copy">
<span class="mrn-wp-eyebrow">Free whitepaper</span>
<h3>The AI Never Told Us: Inside the First FDA Warning Letter for AI Misuse</h3>
<p>These six rules are the standard. This whitepaper shows what happened when a manufacturer fell short of it — and the compliance architecture that would have caught it.</p>
</div>
<div class="mrn-wp-action">
<a class="mrn-btn mrn-btn-accent" href="https://mareana.com/whitepaper/fda-warning-letter-ai-misuse/">Read the whitepaper<svg viewBox="0 0 24 24" fill="none" stroke="currentColor" stroke-width="2.2" stroke-linecap="round" stroke-linejoin="round" aria-hidden="true"><path d="M5 12h14"></path><path d="m12 5 7 7-7 7"></path></svg></a>
</div>
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</div>
</section>
<!-- ===================== FDA GUIDANCE ===================== -->
<section class="mrn-section mrn-section-sunken">
<div class="mrn-container">
<div class="mrn-sec-head mrn-reveal">
<p class="mrn-eyebrow">Supporting Direction</p>
<h2>FDA Guidance Supporting AI Compliance</h2>
<p>These are not regulations, but FDA expectations that help manufacturers implement AI safely and compliantly.</p>
</div>
<div class="mrn-guide-grid">
<article class="mrn-guide-card mrn-reveal" data-delay="0">
<div class="mrn-guide-top">
<span class="mrn-guide-icon" aria-hidden="true"><svg viewBox="0 0 24 24" fill="none" stroke="currentColor" stroke-width="2" stroke-linecap="round" stroke-linejoin="round"><rect width="20" height="14" x="2" y="3" rx="2"></rect><path d="M8 21h8"></path><path d="M12 17v4"></path><path d="m9 10 2 2 4-4"></path></svg></span>
<h3>Computer Software Assurance (CSA) Guidance (2026)</h3>
</div>
<p>Introduces a risk-based approach for validating software—including AI—used in production and quality systems.</p>
<div class="mrn-takeaway">
<span class="mrn-k">Key takeaway</span>
<p>Validation effort should match the software's intended use and risk level.</p>
</div>
</article>
<article class="mrn-guide-card mrn-reveal" data-delay="90">
<div class="mrn-guide-top">
<span class="mrn-guide-icon" aria-hidden="true"><svg viewBox="0 0 24 24" fill="none" stroke="currentColor" stroke-width="2" stroke-linecap="round" stroke-linejoin="round"><path d="m3 17 2 2 4-4"></path><path d="m3 7 2 2 4-4"></path><path d="M13 6h8"></path><path d="M13 12h8"></path><path d="M13 18h8"></path></svg></span>
<h3>Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products (Draft Guidance, 2025)</h3>
</div>
<p>Introduces the FDA's seven-step framework for establishing AI model credibility before using AI to support regulatory or manufacturing decisions.</p>
<div class="mrn-takeaway">
<span class="mrn-k">Key takeaway</span>
<p>Build model credibility through a structured process covering data, performance, transparency, and human oversight.</p>
</div>
</article>
</div>
</div>
</section>
<!-- ===================== CLOSING ===================== -->
<div class="mrn-dark-shell">
<div class="mrn-container">
<section class="mrn-closing">
<div class="mrn-badge mrn-reveal" aria-hidden="true">
<svg viewBox="0 0 24 24" fill="none" stroke="currentColor" stroke-width="2" stroke-linecap="round" stroke-linejoin="round"><path d="M20 13c0 5-3.5 7.5-7.66 8.95a1 1 0 0 1-.67-.01C7.5 20.5 4 18 4 13V6a1 1 0 0 1 1-1c2 0 4.5-1.2 6.24-2.72a1.17 1.17 0 0 1 1.52 0C14.51 3.81 17 5 19 5a1 1 0 0 1 1 1z"></path><path d="m9 12 2 2 4-4"></path></svg>
</div>
<h2 class="mrn-reveal">AI is a tool,<br><span class="mrn-gradient-text">not the approver</span></h2>
<p class="mrn-reveal">Existing cGMP regulations still apply. Strong validation, human oversight, and documentation keep patients safe and your business compliant.</p>
<div class="mrn-chips mrn-reveal">
<span class="mrn-chip"><svg viewBox="0 0 24 24" fill="none" stroke="currentColor" stroke-width="2" stroke-linecap="round" stroke-linejoin="round"><circle cx="12" cy="12" r="10"></circle><path d="m9 12 2 2 4-4"></path></svg>Strong validation</span>
<span class="mrn-chip"><svg viewBox="0 0 24 24" fill="none" stroke="currentColor" stroke-width="2" stroke-linecap="round" stroke-linejoin="round"><path d="M16 21v-2a4 4 0 0 0-4-4H6a4 4 0 0 0-4 4v2"></path><circle cx="9" cy="7" r="4"></circle><path d="M22 21v-2a4 4 0 0 0-3-3.87"></path><path d="M16 3.13a4 4 0 0 1 0 7.75"></path></svg>Human oversight</span>
<span class="mrn-chip"><svg viewBox="0 0 24 24" fill="none" stroke="currentColor" stroke-width="2" stroke-linecap="round" stroke-linejoin="round"><path d="M15 2H6a2 2 0 0 0-2 2v16a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V7z"></path><path d="M14 2v4a2 2 0 0 0 2 2h4"></path><path d="M16 13H8"></path><path d="M16 17H8"></path></svg>Documentation</span>
</div>
<div class="mrn-cta-close mrn-reveal">
<a class="mrn-btn mrn-btn-primary" href="https://mareana.com/request-a-demo/">Book a demo<svg viewBox="0 0 24 24" fill="none" stroke="currentColor" stroke-width="2.2" stroke-linecap="round" stroke-linejoin="round" aria-hidden="true"><path d="M5 12h14"></path><path d="m12 5 7 7-7 7"></path></svg></a>
</div>
</section>
</div>
</div>
</div>
