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1<header class="fixed inset-x-0 top-0 z-[60] border-b border-brand-line bg-[var(--brand-header-bg)] backdrop-blur-[18px] [transform:translateZ(0)] [will-change:transform]"><nav class="mx-auto flex min-h-[46px] max-w-[1240px] items-center gap-x-6 px-5 py-3 xl:px-8"><a class="mr-auto flex flex-shrink-0 items-center" href="/en"><img alt="T2 Software" width="30" height="28" decoding="async" data-nimg="1" class="block h-[28px] w-auto xl:hidden [filter:var(--brand-logo-filter)]" style="color:transparent" srcSet="/_next/image?url=%2Ft2-icon.png&amp;w=32&amp;q=75 1x, /_next/image?url=%2Ft2-icon.png&amp;w=64&amp;q=75 2x" src="/_next/image?url=%2Ft2-icon.png&amp;w=64&amp;q=75"/><img alt="T2 Software" width="162" height="26" decoding="async" data-nimg="1" class="hidden h-[26px] w-auto xl:block [filter:var(--brand-logo-filter)]" style="color:transparent" srcSet="/_next/image?url=%2Ft2-logo.png&amp;w=256&amp;q=75 1x, /_next/image?url=%2Ft2-logo.png&amp;w=384&amp;q=75 2x" src="/_next/image?url=%2Ft2-logo.png&amp;w=384&amp;q=75"/></a><ul class="hidden items-center gap-x-6 xl:flex"><li class="relative"><button type="button" aria-expanded="false" class="flex items-center gap-1 whitespace-nowrap text-sm font-medium text-brand-muted transition-colors hover:text-brand-ink">Company<svg xmlns="http://www.w3.org/2000/svg" width="24" height="24" viewBox="0 0 24 24" fill="none" stroke="currentColor" stroke-width="2" stroke-linecap="round" stroke-linejoin="round" class="lucide lucide-chevron-down h-3.5 w-3.5 transition-transform" aria-hidden="true"><path d="m6 9 6 6 6-6"></path></svg></button><div class="absolute left-0 top-[calc(100%+14px)] w-[240px] max-w-[calc(100vw-48px)] origin-top rounded-2xl border border-brand-line bg-brand-surface p-3 shadow-[0_24px_60px_rgba(24,12,36,0.18)] backdrop-blur-[18px] transition-all duration-150 invisible -translate-y-1 opacity-0"><div class="grid gap-1"><a class="rounded-xl px-3 py-2.5 font-display text-sm font-semibold text-brand-ink transition-colors hover:bg-brand-fill1 hover:text-brand-purple" href="/en#company">Overview</a><a class="rounded-xl px-3 py-2.5 font-display text-sm font-semibold text-brand-ink transition-colors hover:bg-brand-fill1 hover:text-brand-purple" href="/en/customers">Customers</a><a class="rounded-xl px-3 py-2.5 font-display text-sm font-semibold text-brand-ink transition-colors hover:bg-brand-fill1 hover:text-brand-purple" href="/en/about">About</a></div></div></li><li class="relative"><button type="button" aria-expanded="false" class="flex items-center gap-1 whitespace-nowrap text-sm font-medium text-brand-muted transition-colors hover:text-brand-ink">Products<svg xmlns="http://www.w3.org/2000/svg" width="24" height="24" viewBox="0 0 24 24" fill="none" stroke="currentColor" stroke-width="2" stroke-linecap="round" stroke-linejoin="round" class="lucide lucide-chevron-down h-3.5 w-3.5 transition-transform" aria-hidden="true"><path d="m6 9 6 6 6-6"></path></svg></button><div class="absolute left-0 top-[calc(100%+14px)] w-[560px] max-w-[calc(100vw-48px)] origin-top rounded-2xl border border-brand-line bg-brand-surface p-3 shadow-[0_24px_60px_rgba(24,12,36,0.18)] backdrop-blur-[18px] transition-all duration-150 invisible -translate-y-1 opacity-0"><a class="mb-1 block rounded-xl border border-brand-line bg-brand-fill1 p-4 transition-colors hover:border-brand-purple/40" href="/en#neo"><div class="font-display text-[15px] font-semibold text-brand-ink">NEO Platform</div><div class="mt-1 text-[13px] leading-snug text-brand-dim">One platform, from shop floor to release.</div></a><div class="mt-2 grid grid-cols-2 gap-1"><a class="group flex flex-col rounded-xl px-3 py-2.5 transition-colors hover:bg-brand-fill1" href="/en/products/ebr"><span class="font-display text-sm font-semibold text-brand-ink group-hover:text-brand-purple">NEO EBR</span><span class="mt-0.5 text-xs leading-snug text-brand-dim">Paperless batch records with enforced GxP workflows and review by exception.</span></a><a class="group flex flex-col rounded-xl px-3 py-2.5 transition-colors hover:bg-brand-fill1" href="/en/products/wd"><span class="font-display text-sm font-semibold text-brand-ink group-hover:text-brand-purple">NEO W&amp;D</span><span class="mt-0.5 text-xs leading-snug text-brand-dim">Guided weighing and dispensing with lot and tolerance verification, scale integration and full material genealogy.</span></a><a class="group flex flex-col rounded-xl px-3 py-2.5 transition-colors hover:bg-brand-fill1" href="/en/products/oee"><span class="font-display text-sm font-semibold text-brand-ink group-hover:text-brand-purple">NEO OEE</span><span class="mt-0.5 text-xs leading-snug text-brand-dim">Real-time equipment performance, availability and OEE.</span></a><a class="group flex flex-col rounded-xl px-3 py-2.5 transition-colors hover:bg-brand-fill1" href="/en/products/aps"><span class="font-display text-sm font-semibold text-brand-ink group-hover:text-brand-purple">NEO APS</span><span class="mt-0.5 text-xs leading-snug text-brand-dim">Finite-capacity sequencing with workshift-aware time, linked cleaning and setup, what-if scenarios and two-way sync to the floor.</span></a><a class="group flex flex-col rounded-xl px-3 py-2.5 transition-colors hover:bg-brand-fill1" href="/en/products/flow"><span class="font-display text-sm font-semibold text-brand-ink group-hover:text-brand-purple">
1NEO FLOW</span><span class="mt-0.5 text-xs leading-snug text-brand-dim">Real-time visibility of production orders, stage times and the resources on each one.</span></a><a class="group flex flex-col rounded-xl px-3 py-2.5 transition-colors hover:bg-brand-fill1" href="/en/products/sensor"><span class="font-display text-sm font-semibold text-brand-ink group-hover:text-brand-purple">NEO SENSOR</span><span class="mt-0.5 text-xs leading-snug text-brand-dim">IoT data collection from equipment, sensors and legacy systems.</span></a><a class="group flex flex-col rounded-xl px-3 py-2.5 transition-colors hover:bg-brand-fill1" href="/en/products/task"><span class="font-display text-sm font-semibold text-brand-ink group-hover:text-brand-purple">NEO TASK</span><span class="mt-0.5 text-xs leading-snug text-brand-dim">Resource readiness controlled by the system: validity, state and a block on anything not compliant.</span></a><a class="group flex flex-col rounded-xl px-3 py-2.5 transition-colors hover:bg-brand-fill1" href="/en/products/track"><span class="font-display text-sm font-semibold text-brand-ink group-hover:text-brand-purple">NEO TRACK</span><span class="mt-0.5 text-xs leading-snug text-brand-dim">End-to-end product traceability and genealogy.</span></a><a class="group flex flex-col rounded-xl px-3 py-2.5 transition-colors hover:bg-brand-fill1" href="/en/products/pi"><span class="font-display text-sm font-semibold text-brand-ink group-hover:text-brand-purple">NEO PI</span><span class="mt-0.5 text-xs leading-snug text-brand-dim">Industrial data historian and Unified Namespace — every plant reading captured, contextualized and auditable.</span></a><a class="group flex flex-col rounded-xl px-3 py-2.5 transition-colors hover:bg-brand-fill1" href="/en/products/vlms"><span class="font-display text-sm font-semibold text-brand-ink group-hover:text-brand-purple">NEO VLMS</span><span class="mt-0.5 text-xs leading-snug text-brand-dim">Paperless computerized system validation: URS, risk, IQ/OQ/PQ protocols, electronic signatures and end-to-end traceability.</span></a><a class="group flex flex-col rounded-xl px-3 py-2.5 transition-colors hover:bg-brand-fill1" href="/en/products/middleware"><span class="font-display text-sm font-semibold text-brand-ink group-hover:text-brand-purple">NEO MIDDLEWARE</span><span class="mt-0.5 text-xs leading-snug text-brand-dim">Register integrations without code: map public routes to backend APIs, with schema validation, payload transforms, scheduling, API keys and a full audit trail.</span></a><a class="group flex flex-col rounded-xl px-3 py-2.5 transition-colors hover:bg-brand-fill1" href="/en/products/lms"><span class="font-display text-sm font-semibold text-brand-ink group-hover:text-brand-purple">NEO LMS</span><span class="mt-0.5 text-xs leading-snug text-brand-dim">Train, qualify and prove it: versioned courses, video that survives a factory network, skills that expire before they surprise you, and reports drawn from an event log that is only ever appended to.</span></a></div></div></li><li class="relative"><button type="button" aria-expanded="false" class="flex items-center gap-1 whitespace-nowrap text-sm font-medium text-brand-muted transition-colors hover:text-brand-ink">Solutions<svg xmlns="http://www.w3.org/2000/svg" width="24" height="24" viewBox="0 0 24 24" fill="none" stroke="currentColor" stroke-width="2" stroke-linecap="round" stroke-linejoin="round" class="lucide lucide-chevron-down h-3.5 w-3.5 transition-transform" aria-hidden="true"><path d="m6 9 6 6 6-6"></path></svg></button><div class="absolute left-0 top-[calc(100%+14px)] w-[320px] max-w-[calc(100vw-48px)] origin-top rounded-2xl border border-brand-line bg-brand-surface p-3 shadow-[0_24px_60px_rgba(24,12,36,0.18)] backdrop-blur-[18px] transition-all duration-150 invisible -translate-y-1 opacity-0"><div class="grid gap-1"><a class="group flex flex-col rounded-xl px-3 py-2.5 transition-colors hover:bg-brand-fill1" href="/en/solutions/digital-compliance"><span class="font-display text-sm font-semibold text-brand-ink group-hover:text-brand-purple">Digital Compliance</span><span class="mt-0.5 text-xs leading-snug text-brand-dim">Manage every layer of production in real time — resources, workflow, tasks, process and performance — so the Electronic Batch Record assembles itself.</sp
1an></a><a class="group flex flex-col rounded-xl px-3 py-2.5 transition-colors hover:bg-brand-fill1" href="/en/solutions/electronic-logbook"><span class="font-display text-sm font-semibold text-brand-ink group-hover:text-brand-purple">Electronic Logbook</span><span class="mt-0.5 text-xs leading-snug text-brand-dim">Paperless equipment logbooks with a complete history.</span></a><a class="group flex flex-col rounded-xl px-3 py-2.5 transition-colors hover:bg-brand-fill1" href="/en/solutions/weighing-dispensing"><span class="font-display text-sm font-semibold text-brand-ink group-hover:text-brand-purple">Weighing &amp; Dispensing</span><span class="mt-0.5 text-xs leading-snug text-brand-dim">Guided, traceable dispensing that prevents errors.</span></a><a class="group flex flex-col rounded-xl px-3 py-2.5 transition-colors hover:bg-brand-fill1" href="/en/solutions/manufacturing-execution"><span class="font-display text-sm font-semibold text-brand-ink group-hover:text-brand-purple">Manufacturing Execution</span><span class="mt-0.5 text-xs leading-snug text-brand-dim">Orchestrate orders, materials and equipment in real time.</span></a><a class="group flex flex-col rounded-xl px-3 py-2.5 transition-colors hover:bg-brand-fill1" href="/en/solutions/iot"><span class="font-display text-sm font-semibold text-brand-ink group-hover:text-brand-purple">Internet of Things (IoT)</span><span class="mt-0.5 text-xs leading-snug text-brand-dim">Connect equipment and sensors into a single digital thread.</span></a><a class="group flex flex-col rounded-xl px-3 py-2.5 transition-colors hover:bg-brand-fill1" href="/en/solutions/analytics"><span class="font-display text-sm font-semibold text-brand-ink group-hover:text-brand-purple">Analytics</span><span class="mt-0.5 text-xs leading-snug text-brand-dim">Real-time manufacturing metrics and decision support.</span></a><a class="group flex flex-col rounded-xl px-3 py-2.5 transition-colors hover:bg-brand-fill1" href="/en/solutions/product-traceability"><span class="font-display text-sm font-semibold text-brand-ink group-hover:text-brand-purple">Product Traceability</span><span class="mt-0.5 text-xs leading-snug text-brand-dim">End-to-end batch genealogy across the operation.</span></a></div></div></li><li class="relative"><button type="button" aria-expanded="false" class="flex items-center gap-1 whitespace-nowrap text-sm font-medium text-brand-muted transition-colors hover:text-brand-ink">Services<svg xmlns="http://www.w3.org/2000/svg" width="24" height="24" viewBox="0 0 24 24" fill="none" stroke="currentColor" stroke-width="2" stroke-linecap="round" stroke-linejoin="round" class="lucide lucide-chevron-down h-3.5 w-3.5 transition-transform" aria-hidden="true"><path d="m6 9 6 6 6-6"></path></svg></button><div class="absolute left-0 top-[calc(100%+14px)] w-[320px] max-w-[calc(100vw-48px)] origin-top rounded-2xl border border-brand-line bg-brand-surface p-3 shadow-[0_24px_60px_rgba(24,12,36,0.18)] backdrop-blur-[18px] transition-all duration-150 invisible -translate-y-1 opacity-0"><div class="grid gap-1"><a class="group flex flex-col rounded-xl px-3 py-2.5 transition-colors hover:bg-brand-fill1" href="/en/services/consulting"><span class="font-display text-sm font-semibold text-brand-ink group-hover:text-brand-purple">Consulting</span><span class="mt-0.5 text-xs leading-snug text-brand-dim">Digitalization &amp; traceability consulting.</span></a><a class="group flex flex-col rounded-xl px-3 py-2.5 transition-colors hover:bg-brand-fill1" href="/en/services/gxp-development"><span class="font-display text-sm font-semibold text-brand-ink group-hover:text-brand-purple">GxP Development</span><span class="mt-0.5 text-xs leading-snug text-brand-dim">Custom software engineered for GxP.</span></a><a class="group flex flex-col rounded-xl px-3 py-2.5 transition-colors hover:bg-brand-fill1" href="/en/services/professional-services"><span class="font-display text-sm font-semibold text-brand-ink group-hover:text-brand-purple">Professional Services</span><span class="mt-0.5 text-xs leading-snug text-brand-dim">Support and SLAs for mission-critical operations.</span></a></div></div></li><li><a class="whitespace-nowrap text-sm font-medium text-brand-muted transition-colors hover:text-brand-ink" href="/en/contact">Contact</a></li></ul><div class="hidden flex-shrink-0 items-center gap-3 xl:flex"><button type="button" aria-label="Toggle theme" class="flex h-9 w-9 flex-shrink-0 items-center justify-center rounded-full border border-brand-line2 text-brand-dim transition-colors hover:text-brand-ink"><span class="h-[18px] w-[18px]"></span></button><div class="flex flex-shrink-0 items-center gap-1 rounded-full border border-brand-line2 p-[3px]"><a aria-current="true" class="cursor-pointer rounded-full border-none bg-[linear-gradient(135deg,#A855F7,#7C1BD8)] px-[13px] py-[6px] text-[12.5px] font-bold text-white" href="/en">EN</a><a class="cursor-pointer rounded-full border-none bg-transparent px-[13px] py-[6px] text-[12.5px] font-semibold text-brand-dim transition-colors hover:text-brand-ink" href="/pt-br">PT</a><a class="cursor-pointer rounded-full border-none bg-transparent px-[13px] py-[6px] text-[12.5px] font-semibold text-brand-dim transition-colors hover:text-brand-ink" href="/es">ES</a></div><a class="inline-flex items-center justify-center whitespace-nowrap rounded-full bg-[linear-gradient(135deg,#A855F7,#7C1BD8)] font-semibold text-white transition-[transform,box-shadow] duration-150 hover:-translate-y-
1px hover:shadow-[0_8px_28px_rgba(138,31,211,0.45)] px-[22px] py-[10px] text-sm" data-umami-event="cta-talk-to-expert" data-umami-event-placement="header" href="/en/contact">Talk to an expert</a></div><div class="flex flex-shrink-0 items-center gap-2 xl:hidden"><button type="button" aria-label="Toggle theme" class="flex h-9 w-9 flex-shrink-0 items-center justify-center rounded-full border border-brand-line2 text-brand-dim transition-colors hover:text-brand-ink"><span class="h-[18px] w-[18px]"></span></button><button type="button" aria-label="Menu" aria-expanded="false" class="flex h-9 w-9 items-center justify-center rounded-full border border-brand-line2 text-brand-ink"><svg width="18" height="18" viewBox="0 0 24 24" fill="none" stroke="currentColor" stroke-width="2" stroke-linecap="round"><path d="M3 6h18M3 12h18M3 18h18"></path></svg></button></div></nav></header><main><section id="top" class="relative flex min-h-[54vh] items-center px-5 pb-10 pt-[78px] md:px-8"><canvas aria-hidden="true" style="position:absolute;inset:0;width:100%;height:100%;display:block"></canvas><div class="pointer-events-none absolute inset-0 [background:radial-gradient(ellipse_90%_70%_at_50%_110%,var(--brand-vignette),transparent_60%)]"></div><div class="relative mx-auto w-full max-w-[1240px]"><div class="t2-fade-up max-w-[780px]"><div class="font-brand-mono text-[13px] tracking-[0.22em] text-brand-purple mb-6">ENTERPRISE SOFTWARE FOR DIGITAL MANUFACTURING</div><h1 class="font-display m-0 mb-6 text-[clamp(44px,5.6vw,82px)] font-semibold leading-[1.04] tracking-[-0.03em] text-brand-ink">The digital backbone of<!-- --> <span class="bg-[linear-gradient(100deg,var(--brand-violet),var(--brand-deep))] bg-clip-text text-transparent">regulated manufacturing.</span></h1><p class="m-0 mb-9 max-w-[600px] text-[19px] leading-[1.65] text-brand-muted">T2 Software helps Life Sciences manufacturers digitize operations — from batch record to release — with NEO, an enterprise platform built for GxP environments.</p><div class="flex flex-wrap items-center gap-4"><a href="#contact" class="inline-flex items-center rounded-full bg-[linear-gradient(135deg,#A855F7,#7C1BD8)] font-semibold text-white transition-[transform,box-shadow] duration-150 hover:-translate-y-0.5 hover:shadow-[0_12px_36px_rgba(138,31,211,0.5)] px-8 py-[15px] text-base">Talk to an expert</a><a href="#neo" class="inline-flex items-center gap-2 rounded-full border border-brand-purple/40 font-semibold text-brand-ghost transition-colors duration-150 hover:border-brand-purple/70 hover:text-brand-ink px-[30px] py-[14px] text-base">Explore NEO<!-- --> <span class="text-brand-purple">→</span></a></div></div></div></section><section class="border-y border-brand-line bg-brand-surface py-10"><div class="mx-auto max-w-[1240px] px-5 md:px-8"><div class="mb-7 text-center font-brand-mono text-xs leading-[1.7] tracking-[0.18em] text-brand-faint">TRUSTED BY REGULATED MANUFACTURERS</div><ul class="flex flex-wrap items-center justify-center gap-4 md:gap-5"><li class="t2-logo-slot"><img class="t2-logo-tile" src="/customers/biolab.png" alt="Biolab" width="480" height="176" loading="lazy" decoding="async"/></li><li class="t2-logo-slot"><img class="t2-logo-tile" src="/customers/sanofi.png" alt="Sanofi" width="480" height="176" loading="lazy" decoding="async"/></li><li class="t2-logo-slot"><img class="t2-logo-tile" src="/customers/lundbeck.png" alt="Lundbeck" width="480" height="176" loading="lazy" decoding="async"/></li><li class="t2-logo-slot"><img class="t2-logo-tile" src="/customers/boehringer-ingelheim.png" alt="Boehringer Ingelheim" width="480" height="176" loading="lazy" decoding="async"/></li><li class="t2-logo-slot"><img class="t2-logo-tile" src="/customers/eurofarma.png" alt="Eurofarma" width="480" height="176" loading="lazy" decoding="async"/></li><li class="t2-logo-slot"><img class="t2-logo-tile" src="/customers/marjan.png" alt="Marjan" width="480" height="176" loading="lazy" decoding="async"/></li></ul><div class="mt-8 text-center"><a class="inline-flex items-center gap-1.5 text-sm font-medium text-brand-purple transition-colors hover:text-brand-ink" href="/en/customers">See all customers<span aria-hidden="true">→</span></a></div></div></section><section id="company" class="mx-auto max-w-[1240px] scroll-mt-24 px-5 py-20 md:px-8 md:pb-[120px] md:pt-[120px]"><div class="grid grid-cols-1 items-start gap-10 md:grid-cols-2 md:gap-16"><div><div class="font-brand-mono text-[13px] tracking-[0.22em] text-brand-purple mb-[22px]">WHAT WE DO</div><h2 class="font-display m-0 text-[clamp(32px,3.4vw,48px)] font-semibold leading-[1.12] tracking-[-0.02em] text-brand-ink">Complete digital transformation. Not just software.</h2></div><div><p class="m-0 mb-9 text-lg leading-[1.75] text-brand-muted">We design, implement, validate and operate the systems that run regulated production — so quality, engineering and operations work from a single digital thread.</p><div class="flex flex-wrap gap-2.5"><div class="rounded-full border border-brand-purple/25 bg-brand-fill2 px-[18px] py-[9px] text-sm font-semibold text-brand-ghost">Pharmaceutical</div><div class="rounded-full border border-brand-purple/25 bg-brand-fill2 px-[18px] py-[9px] text-sm font-semibold text-brand-ghost">Biotechnology</div><div class="rounded-full border border-brand-purple/25 bg-brand-fill2 px-[18px] py-[9px] text-sm font-semibold text-brand-ghost">Medical Devices</div><div class="rounded-full border border-brand-purple/25 bg-brand-fill2 px-[18px] py-[9px] text-sm font-semibold text-brand-ghost">Cosmetics</div><div class="rounded-full border border-brand-purple/25 bg-brand-fill2 px-[18px] py-[9px] text-sm font-semibold text-brand-ghost">Regulated Food</div></div></div></div></section><section id="neo" class="scroll-mt-24 border-y border-brand-line [background:linear-gradient(180deg,var(--brand-surface),var(--brand-surface2)_40%,var(--brand-surface))]"><div class="mx-auto max-w-[1240px] px-5 py-20 md:px-8 md:py-[110px]"><div class="mb-16 flex flex-wrap items-end justify-between gap-10"><div class="max-w-[640px]"><div class="font-brand-mono text-[13px] tracking-[0.22em] text-brand-purple mb-[22px]">THE NEO PLATFORM</div><h2 class="font-display m-0 mb-5 text-[clamp(32px,3.4vw,48px)] font-semibold leading-[1.12] tracking-[-0.02em] text-brand-ink">One platform, from shop floor to release.</h2><p class="m-0 text-lg leading-[1.7] text-brand-muted">NEO connects execution, quality and equipment in a single system of record for manufacturing.</p></div><a href="#contact" class="inline-flex items-center gap-2 rounded-full border border-brand-purple/40 font-semibold text-brand-ghost transition-colors duration-150 hover:border-brand-purple/70 hover:text-brand-ink flex-shrink-0 px-[30px] py-[14px] text-base">Explore NEO<!-- --> <span class="text-brand-purple">→</span></a></div><div class="grid grid-cols-[repeat(auto-fill,minmax(260px,1fr))] gap-[18px]"><a class="group rounded-2xl border border-brand-line bg-brand-fill1 p-7 transition-[border-color,background,transform] duration-200 hover:-translate-y-[3px] hover:border-brand-purple/40 hover:bg-brand-fill2" href="/en/products/ebr"><div class="mb-5 h-2.5 w-2.5 rounded-full" style="background:#F59E0B;box-shadow:0 0 14px #F59E0Bcc"></div><div class="font-display mb-2.5 flex items-center gap-1.5 text-[17px] font-semibold text-brand-ink transition-colors group-hover:text-brand-purple">NEO EBR<span class="translate-x-0 text-brand-purple opacity-0 transition-all group-hover:translate-x-0.5 group-hover:opacity-100">→</span></div><div class="text-sm leading-[1.65] text-brand-dim">Paperless batch records with enforced GxP workflows and review by exception.</div></a><a class="group rounded-2xl border border-brand-line bg-brand-fill1 p-7 transition-[border-color,background,transform] duration-200 hover:-translate-y-[3px] hover:border-brand-purple/40 hover:bg-brand-fill2" href="/en/products/wd"><div class="mb-5 h-2.5 w-2.5 rounded-full" style="background:#14B8A6;box-shadow:0 0 14px #14B8A6cc"></div><div class="font-display mb-2.5 flex items-center gap-1.5 text-[17px] font-semibold text-brand-ink transition-colors group-hover:text-brand-purple">NEO W&amp;D<span class="translate-x-0 text-brand-purple opacity-0 transition-all group-hover:translate-x-0.5 group-hover:opacity-100">→</span></div><div class="text-sm leading-[1.65] text-brand-dim">Guided weighing and dispensing with lot and tolerance verification, scale integration and full material genealogy.</div></a><a class="group rounded-2xl border border-brand-line bg-brand-fill1 p-7 transition-[border-color,background,transform] duration-200 hover:-translate-y-[3px] hover:border-brand-purple/40 hover:bg-brand-fill2" href="/en/products/oee"><div class="mb-5 h-2.5 w-2.5 rounded-full" style="background:#06B6D4;box-shadow:0 0 14px #06B6D4cc"></div><div class="font-display mb-2.5 flex items-center gap-1.5 text-[17px] font-semibold text-brand-ink transition-colors group-hover:text-brand-purple">NEO OEE<span class="translate-x-0 text-brand-purple opacity-0 transition-all group-hover:translate-x-0.5 group-hover:opacity-100">→</span></div><div class="text-sm leading-[1.65] text-brand-dim">Real-time equipment performance, availability and OEE.</div></a><a class="group rounded-2xl border border-brand-line bg-brand-fill1 p-7 transition-[border-color,background,transform] duration-200 hover:-translate-y-[3px] hover:border-brand-purple/40 hover:bg-brand-fill2" href="/en/products/aps"><div class="mb-5 h-2.5 w-2.5 rounded-full" style="background:#22C55E;box-shadow:0 0 14px #22C55Ecc"></div><div class="font-display mb-2.5 flex items-center gap-1.5 text-[17px] font-semibold text-brand-ink transition-colors group-hover:text-brand-purple">NEO APS<span class="translate-x-0 text-brand-purple opacity-0 transition-all group-hover:translate-x-0.5 group-hover:opacity-100">→</span></div><div class="text-sm leading-[1.65] text-brand-dim">Finite-capacity sequencing with workshift-aware time, linked cleaning and setup, what-if scenarios and two-way sync to the floor.</div></a><a class="group rounded-2xl border border-brand-line bg-brand-fill1 p-7 transition-[border-color,background,transform] duration-200 hover:-translate-y-[3px] hover:border-brand-purple/40 hover:bg-brand-fill2" href="/en/products/flow"><div class="mb-5 h-2.5 w-2.5 rounded-full" style="background:#84CC16;box-shadow:0 0 14px #84CC16cc"></div><div class="font-display mb-2.5 flex items-center gap-1.5 text-[17px] font-semibold text-brand-ink transition-colors group-hover:text-brand-purple">NEO FLOW<span class="translate-x-0 text-brand-purple opacity-0 transition-all group-hover:translate-x-0.5 group-hover:opacity-100">→</span></div><div class="text-sm leading-[1.65] text-brand-dim">Real-time visibility of production orders, stage times and the resources on each one.</div></a><a class="group rounded-2xl border border-brand-line bg-brand-fill1 p-7 transition-[border-color,background,transform] duration-200 hover:-translate-y-[3px] hover:border-brand-purple/40 hover:bg-brand-fill2" href="/en/products/sensor"><div class="mb-5 h-2.5 w-2.5 rounded-full" style="background:#3B82F6;box-shadow:0 0 14px #3B82F6cc"></div><div class="font-display mb-2.5 flex items-center gap-1.5 text-[17px] font-semibold text-brand-ink transition-colors group-hover:text-brand-purple">NEO SENSOR<span class="translate-x-0 text-brand-purple opacity-0 transition-all group-hover:translate-x-0.5 group-hover:opacity-100">→</span></div><div class="text-sm leading-[1.65] text-brand-dim">IoT data collection from equipment, sensors and legacy systems.</div></a><a class="group rounded-2xl border border-brand-line bg-brand-fill1 p-7 transition-[border-color,background,transform] duration-200 hover:-translate-y-[3px] hover:border-brand-purple/40 hover:bg-brand-fill2" href="/en/products/task"><div class="mb-5 h-2.5 w-2.5 rounded-full" style="background:#6366F1;box-shadow:0 0 14px #6366F1cc"></div><div class="font-display mb-2.5 flex items-center gap-1.5 text-[17px] font-semibold text-brand-ink transition-colors group-hover:text-brand-purple">NEO TASK<span class="translate-x-0 text-brand-purple opacity-0 transition-all group-hover:translate-x-0.5 group-hover:opacity-100">→</span></div><div class="text-sm leading-[1.65] text-brand-dim">Resource readiness controlled by the system: validity, state and a block on anything not compliant.</div></a><a class="group rounded-2xl border border-brand-line bg-brand-fill1 p-7 transition-[border-color,background,transform] duration-200 hover:-translate-y-[3px] hover:border-brand-purple/40 hover:bg-brand-fill2" href="/en/products/track"><div class="mb-5 h-2.5 w-2.5 rounded-full" style="background:#4F46E5;box-shadow:0 0 14px #4F46E5cc"></div><div class="font-display mb-2.5 flex items-center gap-1.5 text-[17px] font-semibold text-brand-ink transition-colors group-hover:text-brand-purple">NEO TRACK<span class="translate-x-0 text-brand-purple opacity-0 transition-all group-hover:translate-x-0.5 group-hover:opacity-100">→</span></div><div class="text-sm leading-[1.65] text-brand-dim">End-to-end product traceability and genealogy.</div></a><a class="group rounded-2xl border border-brand-line bg-brand-fill1 p-7 transition-[border-color,background,transform] duration-200 hover:-translate-y-[3px] hover:border-brand-purple/40 hover:bg-brand-fill2" href="/en/products/pi"><div class="mb-5 h-2.5 w-2.5 rounded-full" style="background:#38BDF8;box-shadow:0 0 14px #38BDF8cc"></div><div class="font-display mb-2.5 flex items-center gap-1.5 text-[17px] font-semibold text-brand-ink transition-colors group-hover:text-brand-purple">NEO PI<span class="translate-x-0 text-brand-purple opacity-0 transition-all group-hover:translate-x-0.5 group-hover:opacity-100">→</span></div><div class="text-sm leading-[1.65] text-brand-dim">Industrial data historian and Unified Namespace — every plant reading captured, contextualized and auditable.</div></a><a class="group rounded-2xl border border-brand-line bg-brand-fill1 p-7 transition-[border-color,background,transform] duration-200 hover:-translate-y-[3px] hover:border-brand-purple/40 hover:bg-brand-fill2" href="/en/products/vlms"><div class="mb-5 h-2.5 w-2.5 rounded-full" style="background:#10B981;box-shadow:0 0 14px #10B981cc"></div><div class="font-display mb-2.5 flex items-center gap-1.5 text-[17px] font-semibold text-brand-ink transition-colors group-hover:text-brand-purple">NEO VLMS<span class="translate-x-0 text-brand-purple opacity-0 transition-all group-hover:translate-x-0.5 group-hover:opacity-100">→</span></div><div class="text-sm leading-[1.65] text-brand-dim">Paperless computerized system validation: URS, risk, IQ/OQ/PQ protocols, electronic signatures and end-to-e
1nd traceability.</div></a><a class="group rounded-2xl border border-brand-line bg-brand-fill1 p-7 transition-[border-color,background,transform] duration-200 hover:-translate-y-[3px] hover:border-brand-purple/40 hover:bg-brand-fill2" href="/en/products/middleware"><div class="mb-5 h-2.5 w-2.5 rounded-full" style="background:#7C3AED;box-shadow:0 0 14px #7C3AEDcc"></div><div class="font-display mb-2.5 flex items-center gap-1.5 text-[17px] font-semibold text-brand-ink transition-colors group-hover:text-brand-purple">NEO MIDDLEWARE<span class="translate-x-0 text-brand-purple opacity-0 transition-all group-hover:translate-x-0.5 group-hover:opacity-100">→</span></div><div class="text-sm leading-[1.65] text-brand-dim">Register integrations without code: map public routes to backend APIs, with schema validation, payload transforms, scheduling, API keys and a full audit trail.</div></a><a class="group rounded-2xl border border-brand-line bg-brand-fill1 p-7 transition-[border-color,background,transform] duration-200 hover:-translate-y-[3px] hover:border-brand-purple/40 hover:bg-brand-fill2" href="/en/products/lms"><div class="mb-5 h-2.5 w-2.5 rounded-full" style="background:#EC4899;box-shadow:0 0 14px #EC4899cc"></div><div class="font-display mb-2.5 flex items-center gap-1.5 text-[17px] font-semibold text-brand-ink transition-colors group-hover:text-brand-purple">NEO LMS<span class="translate-x-0 text-brand-purple opacity-0 transition-all group-hover:translate-x-0.5 group-hover:opacity-100">→</span></div><div class="text-sm leading-[1.65] text-brand-dim">Train, qualify and prove it: versioned courses, video that survives a factory network, skills that expire before they surprise you, and reports drawn from an event log that is only ever appended to.</div></a></div>
1<div class="mt-11 flex items-center gap-4 rounded-2xl border border-brand-purple/20 bg-brand-fill1 px-7 py-[22px]"><div class="t2-pulse h-2 w-2 flex-shrink-0 rounded-full bg-brand-purple"></div><div class="text-[15px] leading-[1.6] text-brand-muted">Open by design — ERP and LIMS integration, equipment connectivity and open APIs on cloud infrastructure.</div></div></div></section><section id="services" class="mx-auto max-w-[1240px] scroll-mt-24 px-5 py-16 md:px-8 md:py-[120px]"><div class="mb-[70px] max-w-[680px]"><div class="font-brand-mono text-[13px] tracking-[0.22em] text-brand-purple mb-[22px]">HOW WE DELIVER</div><h2 class="font-display m-0 mb-5 text-[clamp(32px,3.4vw,48px)] font-semibold leading-[1.12] tracking-[-0.02em] text-brand-ink">We deliver projects, not licenses.</h2><p class="m-0 text-lg leading-[1.7] text-brand-muted">Every deployment includes the engineering, validation and infrastructure needed to run in production — end to end.</p></div><div class="border-t border-brand-line pt-12"><div class="relative"><div class="hidden lg:block"><div class="relative h-4"><div class="absolute top-1/2 h-px -translate-y-1/2 bg-brand-line" style="left:10%;right:10%"></div><span class="absolute top-1/2 h-[13px] w-[13px] -translate-x-1/2 -translate-y-1/2 rounded-full border border-brand-line2 bg-brand-surface" style="left:10%"></span><span class="absolute top-1/2 h-[13px] w-[13px] -translate-x-1/2 -translate-y-1/2 rounded-full border border-brand-line2 bg-brand-surface" style="left:30%"></span><span class="absolute top-1/2 h-[13px] w-[13px] -translate-x-1/2 -translate-y-1/2 rounded-full border border-brand-line2 bg-brand-surface" style="left:50%"></span><span class="absolute top-1/2 h-[13px] w-[13px] -translate-x-1/2 -translate-y-1/2 rounded-full border border-brand-line2 bg-brand-surface" style="left:70%"></span><span class="absolute top-1/2 h-[13px] w-[13px] -translate-x-1/2 -translate-y-1/2 rounded-full border border-brand-line2 bg-brand-surface" style="left:90%"></span><div class="absolute inset-y-0" style="left:10%;right:10%"><div class="t2-fill absolute inset-0"><div class="absolute left-0 right-0 top-1/2 h-px -translate-y-1/2 bg-[linear-gradient(90deg,var(--brand-violet),var(--brand-purple))]"></div><span class="absolute top-1/2 h-[13px] w-[13px] -translate-x-1/2 -translate-y-1/2 rounded-full bg-brand-violet shadow-[0_0_14px_rgba(168,85,247,0.9)]" style="left:0%"></span><span class="absolute top-1/2 h-[13px] w-[13px] -translate-x-1/2 -translate-y-1/2 rounded-full bg-brand-violet shadow-[0_0_14px_rgba(168,85,247,0.9)]" style="left:25%"></span><span class="absolute top-1/2 h-[13px] w-[13px] -translate-x-1/2 -translate-y-1/2 rounded-full bg-brand-violet shadow-[0_0_14px_rgba(168,85,247,0.9)]" style="left:50%"></span><span class="absolute top-1/2 h-[13px] w-[13px] -translate-x-1/2 -translate-y-1/2 rounded-full bg-brand-violet shadow-[0_0_14px_rgba(168,85,247,0.9)]" style="left:75%"></span><span class="absolute top-1/2 h-[13px] w-[13px] -translate-x-1/2 -translate-y-1/2 rounded-full bg-brand-violet shadow-[0_0_14px_rgba(168,85,247,0.9)]" style="left:100%"></span></div><span class="t2-comet absolute top-1/2 h-[10px] w-[10px] -translate-x-1/2 -translate-y-1/2 rounded-full bg-brand-purple shadow-[0_0_14px_rgba(168,85,247,0.9)]"></span></div></div><div class="mt-8 grid grid-cols-5"><div class="px-3 text-center"><div class="font-brand-mono text-[13px] text-brand-violet">01</div><div class="font-display mb-2 mt-3 text-[19px] font-semibold text-brand-ink">Implementation</div><div class="text-[14.5px] leading-[1.65] text-brand-dim">From process mapping to deployment, led by engineers who know GxP manufacturing.</div></div><div class="px-3 text-center"><div class="font-brand-mono text-[13px] text-brand-violet">02</div><div class="font-display mb-2 mt-3 text-[19px] font-semibold text-brand-ink">Validation</div><div class="text-[14.5px] leading-[1.65] text-brand-dim">CSV documentation and execution aligned with GAMP 5.</div></div><div class="px-3 text-center"><div class="font-brand-mono text-[13px] text-brand-violet">03</div><div class="font-display mb-2 mt-3 text-[19px] font-semibold text-brand-ink">
1Training</div><div class="text-[14.5px] leading-[1.65] text-brand-dim">Operators, reviewers and administrators ready from day one.</div></div><div class="px-3 text-center"><div class="font-brand-mono text-[13px] text-brand-violet">04</div><div class="font-display mb-2 mt-3 text-[19px] font-semibold text-brand-ink">Go Live</div><div class="text-[14.5px] leading-[1.65] text-brand-dim">Cutover to production with our engineers beside your team at every step.</div></div><div class="px-3 text-center"><div class="font-brand-mono text-[13px] text-brand-violet">05</div><div class="font-display mb-2 mt-3 text-[19px] font-semibold text-brand-ink">Hypercare</div><div class="text-[14.5px] leading-[1.65] text-brand-dim">Intensive post-go-live support until the operation runs stable on its own.</div></div></div></div><ol class="grid grid-cols-1 gap-y-9 lg:hidden"><li class="relative pl-9"><span class="absolute -bottom-9 left-[7px] top-[18px] w-px bg-brand-line"></span><span class="absolute left-0 top-[2px] flex h-[15px] w-[15px] items-center justify-center"><span class="t2-ping absolute inline-flex h-full w-full rounded-full bg-brand-violet" style="animation-delay:0s"></span><span class="relative h-[9px] w-[9px] rounded-full bg-brand-violet shadow-[0_0_14px_rgba(168,85,247,0.9)]"></span></span><div><div class="font-brand-mono text-[13px] text-brand-violet">01</div><div class="font-display mb-2 mt-3 text-[19px] font-semibold text-brand-ink">Implementation</div><div class="text-[14.5px] leading-[1.65] text-brand-dim">From process mapping to deployment, led by engineers who know GxP manufacturing.</div></div></li><li class="relative pl-9"><span class="absolute -bottom-9 left-[7px] top-[18px] w-px bg-brand-line"></span><span class="absolute left-0 top-[2px] flex h-[15px] w-[15px] items-center justify-center"><span class="t2-ping absolute inline-flex h-full w-full rounded-full bg-brand-violet" style="animation-delay:1s"></span><span class="relative h-[9px] w-[9px] rounded-full bg-brand-violet shadow-[0_0_14px_rgba(168,85,247,0.9)]"></span></span><div><div class="font-brand-mono text-[13px] text-brand-violet">02</div><div class="font-display mb-2 mt-3 text-[19px] font-semibold text-brand-ink">Validation</div><div class="text-[14.5px] leading-[1.65] text-brand-dim">CSV documentation and execution aligned with GAMP 5.</div></div></li><li class="relative pl-9"><span class="absolute -bottom-9 left-[7px] top-[18px] w-px bg-brand-line"></span><span class="absolute left-0 top-[2px] flex h-[15px] w-[15px] items-center justify-center"><span class="t2-ping absolute inline-flex h-full w-full rounded-full bg-brand-violet" style="animation-delay:2s"></span><span class="relative h-[9px] w-[9px] rounded-full bg-brand-violet shadow-[0_0_14px_rgba(168,85,247,0.9)]"></span></span><div><div class="font-brand-mono text-[13px] text-brand-violet">03</div><div class="font-display mb-2 mt-3 text-[19px] font-semibold text-brand-ink">Training</div><div class="text-[14.5px] leading-[1.65] text-brand-dim">Operators, reviewers and administrators ready from day one.</div></div></li><li class="relative pl-9"><span class="absolute -bottom-9 left-[7px] top-[18px] w-px bg-brand-line"></span><span class="absolute left-0 top-[2px] flex h-[15px] w-[15px] items-center justify-center"><span class="t2-ping absolute inline-flex h-full w-full rounded-full bg-brand-violet" style="animation-delay:3s"></span><span class="relative h-[9px] w-[9px] rounded-full bg-brand-violet shadow-[0_0_14px_rgba(168,85,247,0.9)]"></span></span><div><div class="font-brand-mono text-[13px] text-brand-violet">04</div><div class="font-display mb-2 mt-3 text-[19px] font-semibold text-brand-ink">Go Live</div><div class="text-[14.5px] leading-[1.65] text-brand-dim">Cutover to production with our engineers beside your team at every step.</div></div></li><li class="relative pl-9"><span class="absolute left-0 top-[2px] flex h-[15px] w-[15px] items-center justify-center"><span class="t2-ping absolute inline-flex h-full w-full rounded-full bg-brand-violet" style="animation-delay:4s"></span><span class="relative h-[9px] w-[9px] rounded-full bg-brand-violet shadow-[0_0_14px_rgba(168,85,247,0.9)]"></span></span><div><div class="font-brand-mono text-[13px] text-brand-violet">05</div><div class="font-display mb-2 mt-3 text-[19px] font-semibold text-brand-ink">Hypercare</div><div class="text-[14.5px] leading-[1.65] text-brand-dim">Intensive post-go-live support until the operation runs stable on its own.</div></div></li></ol></div></div></section><section class="border-t border-brand-line bg-brand-surface"><div class="mx-auto flex max-w-[1240px] flex-wrap items-center justify-between gap-8 px-5 py-16 md:gap-10 md:px-8 md:py-20"><div class="max-w-[460px]"><div class="font-display mb-3 text-2xl font-semibold text-brand-ink">Built for regulated environments</div><div class="text-[15px] leading-[1.7] text-brand-dim">
1Compliance is not a feature — it is the foundation of everything we build and deliver.</div></div><div class="flex flex-wrap gap-3.5"><div class="rounded-[10px] border border-brand-purple/30 bg-brand-fill1 px-[22px] py-3 font-brand-mono text-[13px] tracking-[0.08em] text-brand-lav">GxP</div><div class="rounded-[10px] border border-brand-purple/30 bg-brand-fill1 px-[22px] py-3 font-brand-mono text-[13px] tracking-[0.08em] text-brand-lav">21 CFR Part 11</div><div class="rounded-[10px] border border-brand-purple/30 bg-brand-fill1 px-[22px] py-3 font-brand-mono text-[13px] tracking-[0.08em] text-brand-lav">GAMP 5</div><div class="rounded-[10px] border border-brand-purple/30 bg-brand-fill1 px-[22px] py-3 font-brand-mono text-[13px] tracking-[0.08em] text-brand-lav">EU Annex 11</div></div></div></section><section class="border-t border-brand-line bg-brand-surface"><div class="mx-auto max-w-[1240px] px-5 py-16 md:px-8 md:py-[100px]"><div class="mb-12 flex flex-wrap items-end justify-between gap-6"><div class="max-w-[560px]"><div class="font-brand-mono text-[13px] tracking-[0.22em] text-brand-purple mb-[22px]">FROM THE BLOG</div><h2 class="font-display m-0 text-[clamp(32px,3.4vw,48px)] font-semibold leading-[1.12] tracking-[-0.02em] text-brand-ink">Latest insights</h2></div><a class="inline-flex items-center gap-2 rounded-full border border-brand-purple/40 font-semibold text-brand-ghost transition-colors duration-150 hover:border-brand-purple/70 hover:text-brand-ink px-[30px] py-[14px] text-base" href="/en/blog">View all articles<!-- --> <span class="text-brand-purple">→</span></a></div><div class="grid grid-cols-1 gap-6 sm:grid-cols-2 lg:grid-cols-3"><a class="group flex flex-col overflow-hidden rounded-2xl border border-brand-line bg-brand-fill1 transition-[border-color,transform] duration-200 hover:-translate-y-[3px] hover:border-brand-purple/40" href="/en/blog/annex-22-draft-ai-gmp-what-you-can-do-now"><div class="relative aspect-[16/10] w-full"><div class="relative h-full w-full overflow-hidden bg-brand-surface2"><img alt="Annex 22 is still a draft. Here&#x27;s what you can already do with AI in GMP" loading="lazy" decoding="async" data-nimg="fill" class="object-cover" style="position:absolute;height:100%;width:100%;left:0;top:0;right:0;bottom:0;color:transparent" sizes="(max-width: 768px) 100vw, 400px" srcSet="/_next/image?url=https%3A%2F%2Ft2-software-media-208034490417.s3.us-east-1.amazonaws.com%2Fannex-22-draft-ai-gmp-what-you-can-do-now-hero-light.png&amp;w=640&amp;q=75 640w, /_next/image?url=https%3A%2F%2Ft2-software-media-208034490417.s3.us-east-1.amazonaws.com%2Fannex-22-draft-ai-gmp-what-you-can-do-now-hero-light.png&amp;w=750&amp;q=75 750w, /_next/image?url=https%3A%2F%2Ft2-software-media-208034490417.s3.us-east-1.amazonaws.com%2Fannex-22-draft-ai-gmp-what-you-can-do-now-hero-light.png&amp;w=828&amp;q=75 828w, /_next/image?url=https%3A%2F%2Ft2-software-media-208034490417.s3.us-east-1.amazonaws.com%2Fannex-22-draft-ai-gmp-what-you-can-do-now-hero-light.png&amp;w=1080&amp;q=75 1080w, /_next/image?url=https%3A%2F%2Ft2-software-media-208034490417.s3.us-east-1.amazonaws.com%2Fannex-22-draft-ai-gmp-what-you-can-do-now-hero-light.png&amp;w=1200&amp;q=75 1200w, /_next/image?url=https%3A%2F%2Ft2-software-media-208034490417.s3.us-east-1.amazonaws.com%2Fannex-22-draft-ai-gmp-what-you-can-do-now-hero-light.png&amp;w=1920&amp;q=75 1920w, /_next/image?url=https%3A%2F%2Ft2-software-media-208034490417.s3.us-east-1.amazonaws.com%2Fannex-22-draft-ai-gmp-what-you-can-do-now-hero-light.png&amp;w=2048&amp;q=75 2048w, /_next/image?url=https%3A%2F%2Ft2-software-media-208034490417.s3.us-east-1.amazonaws.com%2Fannex-22-draft-ai-gmp-what-you-can-do-now-hero-light.png&amp;w=3840&amp;q=75 3840w" src="/_next/image?url=https%3A%2F%2Ft2-software-media-208034490417.s3.us-east-1.amazonaws.com%2Fannex-22-draft-ai-gmp-what-you-can-do-now-hero-light.png&amp;w=3840&amp;q=75"/></div></div><div class="flex flex-1 flex-col p-6"><span class="mb-3 w-fit rounded-full border border-brand-purple/25 bg-brand-fill2 px-3 py-1 font-brand-mono text-[11px] uppercase tracking-[0.08em] text-brand-lav">GxP Compliance</span>
1<h3 class="font-display text-[20px] font-semibold leading-[1.25] text-brand-ink group-hover:text-brand-purple">Annex 22 is still a draft. Here&#x27;s what you can already do with AI in GMP</h3><p class="mt-3 flex-1 text-[15px] leading-[1.6] text-brand-dim">The draft EU GMP Annex 22 (public consultation July–October 2025) does not ban AI on the shop floor. It separates where a model may decide from where it may only assist. Here is what you can put in place now, without rework when the final text lands.</p><div class="mt-5 flex items-center gap-3 font-brand-mono text-[12px] text-brand-faint"><span>Oct 06, 2026</span><span aria-hidden="true">·</span><span>8<!-- --> <!-- -->min read</span></div></div></a><a class="group flex flex-col overflow-hidden rounded-2xl border border-brand-line bg-brand-fill1 transition-[border-color,transform] duration-200 hover:-translate-y-[3px] hover:border-brand-purple/40" href="/en/blog/ich-q12-lifecycle-sem-revalidar-o-mundo"><div class="relative aspect-[16/10] w-full"><div class="relative h-full w-full overflow-hidden bg-brand-surface2"><img alt="ICH Q12: CMC lifecycle with a change map" loading="lazy" decoding="async" data-nimg="fill" class="object-cover" style="position:absolute;height:100%;width:100%;left:0;top:0;right:0;bottom:0;color:transparent" sizes="(max-width: 768px) 100vw, 400px" srcSet="/_next/image?url=https%3A%2F%2Ft2-software-media-208034490417.s3.us-east-1.amazonaws.com%2Fich-q12-lifecycle-sem-revalidar-o-mundo-hero-light.png&amp;w=640&amp;q=75 640w, /_next/image?url=https%3A%2F%2Ft2-software-media-208034490417.s3.us-east-1.amazonaws.com%2Fich-q12-lifecycle-sem-revalidar-o-mundo-hero-light.png&amp;w=750&amp;q=75 750w, /_next/image?url=https%3A%2F%2Ft2-software-media-208034490417.s3.us-east-1.amazonaws.com%2Fich-q12-lifecycle-sem-revalidar-o-mundo-hero-light.png&amp;w=828&amp;q=75 828w, /_next/image?url=https%3A%2F%2Ft2-software-media-208034490417.s3.us-east-1.amazonaws.com%2Fich-q12-lifecycle-sem-revalidar-o-mundo-hero-light.png&amp;w=1080&amp;q=75 1080w, /_next/image?url=https%3A%2F%2Ft2-software-media-208034490417.s3.us-east-1.amazonaws.com%2Fich-q12-lifecycle-sem-revalidar-o-mundo-hero-light.png&amp;w=1200&amp;q=75 1200w, /_next/image?url=https%3A%2F%2Ft2-software-media-208034490417.s3.us-east-1.amazonaws.com%2Fich-q12-lifecycle-sem-revalidar-o-mundo-hero-light.png&amp;w=1920&amp;q=75 1920w, /_next/image?url=https%3A%2F%2Ft2-software-media-208034490417.s3.us-east-1.amazonaws.com%2Fich-q12-lifecycle-sem-revalidar-o-mundo-hero-light.png&amp;w=2048&amp;q=75 2048w, /_next/image?url=https%3A%2F%2Ft2-software-media-208034490417.s3.us-east-1.amazonaws.com%2Fich-q12-lifecycle-sem-revalidar-o-mundo-hero-light.png&amp;w=3840&amp;q=75 3840w" src="/_next/image?url=https%3A%2F%2Ft2-software-media-208034490417.s3.us-east-1.amazonaws.com%2Fich-q12-lifecycle-sem-revalidar-o-mundo-hero-light.png&amp;w=3840&amp;q=75"/></div></div><div class="flex flex-1 flex-col p-6"><span class="mb-3 w-fit rounded-full border border-brand-purple/25 bg-brand-fill2 px-3 py-1 font-brand-mono text-[11px] uppercase tracking-[0.08em] text-brand-lav">GxP Compliance</span><h3 class="font-display text-[20px] font-semibold leading-[1.25] text-brand-ink group-hover:text-brand-purple">ICH Q12: CMC lifecycle with a change map</h3><p class="mt-3 flex-1 text-[15px] leading-[1.6] text-brand-dim">Every plant knows the situation: a small process improvement—a slightly narrower range, an alternate site, an analytical adjustment—and the regulatory schedule starts setting the pace of operations. Variation, regulatory submission, review queue, and validation that seems to reopen more than necessary. Some of that burden is real and necessary. Some of it comes from not…</p><div class="mt-5 flex items-center gap-3 font-brand-mono text-[12px] text-brand-faint"><span>Oct 01, 2026</span><span aria-hidden="true">·</span><span>7<!-- --> <!-- -->min read</span></div></div></a><a class="group flex flex-col overflow-hidden rounded-2xl border border-brand-line bg-brand-fill1 transition-[border-color,transform] duration-200 hover:-translate-y-[3px] hover:border-brand-purple/40" href="/en/blog/ich-q8-q11-design-space-ebr-mes"><div class="relative aspect-[16/10] w-full"><div class="relative h-full w-full overflow-hidden bg-brand-surface2"><img alt="ICH Q8/Q11 → floor: design space in EBR/MES" loading="lazy" decoding="async" data-nimg="fill" class="object-cover" style="position:absolute;height:100%;width:100%;left:0;top:0;right:0;bottom:0;color:transparent" sizes="(max-width: 768px) 100vw, 400px" srcSet="/_next/image?url=https%3A%2F%2Ft2-software-media-208034490417.s3.us-east-1.amazonaws.com%2Fich-q8-q11-design-space-ebr-mes-hero-light.png&amp;w=640&amp;q=75 640w, /_next/image?url=https%3A%2F%2Ft2-software-media-208034490417.s3.us-east-1.amazonaws.com%2Fich-q8-q11-design-space-ebr-mes-hero-light.png&amp;w=750&amp;q=75 750w, /_next/image?url=https%3A%2F%2Ft2-software-media-208034490417.s3.us-east-1.amazonaws.com%2Fich-q8-q11-design-space-ebr-mes-hero-light.png&amp;w=828&amp;q=75 828w, /_next/image?url=https%3A%2F%2Ft2-software-media-208034490417.s3.us-east-1.amazonaws.com%2Fich-q8-q11-design-space-ebr-mes-hero-light.png&amp;w=1080&amp;q=75 1080w, /_next/image?url=https%3A%2F%2Ft2-software-media-208034490417.s3.us-east-1.amazonaws.com%2Fich-q8-q11-design-space-ebr-mes-hero-light.png&amp;w=1200&amp;q=75 1200w, /_next/image?url=https%3A%2F%2Ft2-software-media-208034490417.s3.us-east-1.amazonaws.com%2Fich-q8-q11-design-space-ebr-mes-hero-light.png&amp;w=1920&amp;q=75 1920w, /_next/image?url=https%3A%2F%2Ft2-software-media-208034490417.s3.us-east-1.amazonaws.com%2Fich-q8-q11-design-space-ebr-mes-hero-light.png&amp;w=2048&amp;q=75 2048w, /_next/image?url=https%3A%2F%2Ft2-software-media-208034490417.s3.us-east-1.amazonaws.com%2Fich-q8-q11-design-space-ebr-mes-hero-light.png&amp;w=3840&amp;q=75 3840w" src="/_next/image?url=https%3A%2F%2Ft2-software-media-208034490417.s3.us-east-1.amazonaws.com%2Fich-q8-q11-design-space-ebr-mes-hero-light.png&amp;w=3840&amp;q=75"/></div></div><div class="flex flex-1 flex-col p-6">
1<span class="mb-3 w-fit rounded-full border border-brand-purple/25 bg-brand-fill2 px-3 py-1 font-brand-mono text-[11px] uppercase tracking-[0.08em] text-brand-lav">GxP Compliance</span><h3 class="font-display text-[20px] font-semibold leading-[1.25] text-brand-ink group-hover:text-brand-purple">ICH Q8/Q11 → floor: design space in EBR/MES</h3><p class="mt-3 flex-1 text-[15px] leading-[1.6] text-brand-dim">Design space and control strategy only hold on the floor if EBR/MES enforces what development registered — the registered range is not a shift suggestion.</p><div class="mt-5 flex items-center gap-3 font-brand-mono text-[12px] text-brand-faint"><span>Oct 01, 2026</span><span aria-hidden="true">·</span><span>8<!-- --> <!-- -->min read</span></div></div></a></div></div></section><section id="contact" class="relative scroll-mt-24 overflow-hidden border-t border-brand-line"><div class="pointer-events-none absolute inset-0 [background:radial-gradient(ellipse_60%_90%_at_50%_120%,rgba(138,31,211,0.28),transparent_65%)]"></div><div class="relative mx-auto max-w-[1240px] px-5 py-20 md:px-8 md:py-[120px] text-center"><h2 class="font-display m-0 mb-6 text-[clamp(36px,4.4vw,62px)] font-semibold leading-[1.08] tracking-[-0.025em] text-brand-ink">Let’s digitize your operation.</h2><p class="mx-auto m-0 mb-11 max-w-[560px] text-lg leading-[1.7] text-brand-muted">Talk to our engineers about your digital manufacturing roadmap — from a single line to a global rollout.</p><a class="inline-flex items-center rounded-full bg-[linear-gradient(135deg,#A855F7,#7C1BD8)] font-semibold text-white transition-[transform,box-shadow] duration-150 hover:-translate-y-0.5 hover:shadow-[0_12px_36px_rgba(138,31,211,0.5)] px-10 py-[17px] text-[17px]" data-umami-event="cta-talk-to-expert" data-umami-event-placement="home-cta" href="/en/contact">Talk to an expert</a></div></section></main><footer class="border-t border-brand-line bg-brand-footer"><div class="mx-auto grid max-w-[1240px] gap-10 px-5 py-12 md:grid-cols-[1.2fr_repeat(3,0.8fr)_1.5fr] md:gap-8 md:px-8 md:py-14"><div class="flex flex-col gap-3.5"><a aria-label="T2 Software" href="/en"><img alt="T2 Software" loading="lazy" width="137" height="22" decoding="async" data-nimg="1" class="h-[22px] w-auto self-start [filter:var(--brand-logo-filter)]" style="color:transparent" srcSet="/_next/image?url=%2Ft2-logo.png&amp;w=256&amp;q=75 1x, /_next/image?url=%2Ft2-logo.png&amp;w=384&amp;q=75 2x" src="/_next/image?url=%2Ft2-logo.png&amp;w=384&amp;q=75"/></a><div class="text-[13.5px] text-brand-faint">Enterprise software for digital manufacturing in Life Sciences.</div><div class="mt-1 flex flex-wrap gap-4"><a href="https://www.linkedin.com/company/t2-software/" target="_blank" rel="noopener noreferrer" class="font-brand-mono text-[12.5px] text-brand-dim transition-colors hover:text-brand-purple">LinkedIn</a></div></div><nav aria-label="Company" class="flex flex-col gap-2.5"><div class="font-brand-mono text-[12px] tracking-[0.18em] text-brand-faint">COMPANY</div><a class="text-[13.5px] text-brand-dim transition-colors hover:text-brand-ink" href="/en/about">About</a><a class="text-[13.5px] text-brand-dim transition-colors hover:text-brand-ink" href="/en/customers">Customers</a><a class="text-[13.5px] text-brand-dim transition-colors hover:text-brand-ink" href="/en/contact">Contact</a></nav><nav aria-label="What we do" class="flex flex-col gap-2.5"><div class="font-brand-mono text-[12px] tracking-[0.18em] text-brand-faint">WHAT WE DO</div><a class="text-[13.5px] text-brand-dim transition-colors hover:text-brand-ink" href="/en/products">Products</a><a class="text-[13.5px] text-brand-dim transition-colors hover:text-brand-ink" href="/en/solutions">Solutions</a><a class="text-[13.5px] text-brand-dim transition-colors hover:text-brand-ink" href="/en/services">Services</a></nav><nav aria-label="Resources" class="flex flex-col gap-2.5"><div class="font-brand-mono text-[12px] tracking-[0.18em] text-brand-faint">RESOURCES</div><a class="text-[13.5px] text-brand-dim transition-colors hover:text-brand-ink" href="/en/blog">Blog</a><a class="text-[13.5px] text-brand-dim transition-colors hover:text-brand-ink" href="/en/resources">Resources</a><a class="text-[13.5px] text-brand-dim transition-colors hover:text-brand-ink" href="/en/events">Events</a></nav><div><div class="font-brand-mono text-[12px] tracking-[0.18em] text-brand-faint">NEWSLETTER</div><p class="mt-2.5 text-[13.5px] leading-[1.55] text-brand-dim">Practical writing on GxP, MES, data integrity and shop-floor systems. 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