https://trutechnologies.ai/assets/cfr-part-11-CSJ4K95R.js

1import{j as e,N as n,m as a,o as l,S as r,B as o,E as d,p as c,M as m,L as x,n as p}from"./index-D3rhyPz2.js";const u=[{icon:r,title:"Validated systems",body:"Computer System Validation aligned with GAMP 5. IQ/OQ/PQ documentation, traceability matrices, and release records available under NDA."},{icon:o,title:"Secure user authentication",body:"Access requires unique credentials. The system encrypts passwords, enforces strong selection criteria, and automates credential expiration."},{icon:d,title:"Secure, time-stamped audit trails",body:"Every create, read, update, and delete action is recorded with attributable user, UTC timestamp, and before/after values — independent of operator control."},{icon:c,title:"Access & authority checks",body:"Role-based access, MFA, and authority checks ensure only authorized individuals can use the system or alter operations."}],g=[{ref:"§ 11.10(a)",title:"Validation",body:"Systems are validated to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records."},{ref:"§ 11.10(b)",title:"Accurate copies",body:"Records are generated in electronic and human-readable forms suitable for agency inspection, review, and copying."},{ref:"§ 11.10(c)",title:"Records protection",body:"Records are protected to enable accurate and ready retrieval throughout the retention period."},{ref:"§ 11.10(d)",title:"System access",body:"Access is limited to authorized individuals via unique credentials, role-based permissions, and automated password expiration."},{ref:"§ 11.10(e)",title:"Audit trails",body:"Secure, computer-generated, time-stamped audit trails capture operator actions that create, modify, or delete electronic records."},{ref:"§ 11.10(f)",title:"Operational checks",body:"Workflow sequencing and operational checks enforce protocol-defined steps and prevent out-of-order events."},{ref:"§ 11.10(g)",title:"Authority checks",body:"Authority checks ensure only individuals with administrator-managed permissions can execute system tasks and access information."},{ref:"§ 11.10(h)",title:"Device checks",body:"Data input and operational sources are validated and secured using strict HTTPS protocols."},{ref:"§ 11.10(i)",title:"Personnel qualifications",body:"Personnel managing client-facing systems are verified to be fully trained on all relevant security policies and SOPs."},{ref:"§ 11.10(k)",title:"Documentation controls",body:"System documentation is protected via strict access controls and a formal, time-sequenced Quality Management System."}];function b(){return e.jsxs("main",{className:"min-h-screen bg-background",children:[e.jsx(n,{}),e.jsxs("section",{className:"relative overflow-hidden bg-hero text-white pt-32 lg:pt-40 pb-20 lg:pb-28",children:[e.jsx("div",{className:"absolute -top-32 left-1/2 -translate-x-1/2 w-[900px] h-[900px] rounded-full bg-teal/15 blur-3xl pointer-events-none"}),e.jsxs("div",{className:"relative mx-auto max-w-7xl px-6 lg:px-10",children:[e.jsxs(a.div,{initial:{opacity:0,y:12},animate:{opacity:1,y:0},transition:{duration:.5},className:"inline-flex items-center gap-2 rounded-full border border-white/15 bg-white/5 backdrop-blur px-3.5 py-1.5 text-xs font-medium text-teal-glow",children:[e.jsx(l,{size:14}),"FDA 21 CFR Part 11"]}),e.jsxs(a.h1,{initial:{opacity:0,y:16},animate:{opacity:1,y:0},transition:{duration:.6,delay:.1},className:"mt-6 text-4xl sm:text-5xl lg:text-6xl font-semibold leading-[1.05] tracking-tight max-w-3xl",children:["Electronic records, controlled and ",e.jsx("span",{className:"text-gradient",children:"trusted"}),"."]}),e.jsx(a.p,{initial:{opacity:0,y:16},animate:{opacity:1,y:0},transition:{duration:.6,delay:.2},className:"mt-5 text-lg lg:text-xl text-white/75 max-w-2xl leading-relaxed",children:"TruTechnologies is designed to support 21 CFR Part 11.10 — the FDA’s closed-system controls for electronic records in clinical research."})]})]}),e.jsx("section",{className:"py-20 lg:py-28 bg-surface",children:e.jsxs("div",{className:"mx-auto max-w-5xl px-6 lg:px-10",children:[e.jsx("span",{className:"font-mono text-xs uppercase tracking-[0.18em] text-teal",children:"Overview"}),e.jsx("h2",{className:"mt-3 text-3xl sm:text-4xl font-semibold tracking-tight text-anchor",children:"What 21 CFR Part 11.10 requires."}),e.jsx("p",{className:"mt-5 text-base text-muted-foreground leading-relaxed",children:"Part 11 

1sets the criteria under which the FDA considers electronic records to be trustworthy, reliable, and equivalent to paper records. It applies to records created, modified, maintained, archived, retrieved, or transmitted under any FDA predicate rule — including GCP-regulated clinical trials."}),e.jsx("p",{className:"mt-4 text-base text-muted-foreground leading-relaxed",children:"Meeting § 11.10 is not a single feature — it is a combination of data integrity, strict access controls, independent tracking, and rigorous system validation. TruTechnologies delivers all four."})]})}),e.jsx("section",{className:"py-20 lg:py-28 bg-background",children:e.jsxs("div",{className:"mx-auto max-w-7xl px-6 lg:px-10",children:[e.jsxs("div",{className:"max-w-2xl",children:[e.jsx("span",{className:"font-mono text-xs uppercase tracking-[0.18em] text-teal",children:"How we comply"}),e.jsx("h2",{className:"mt-3 text-3xl sm:text-4xl font-semibold tracking-tight text-foreground",children:"Four pillars of § 11.10 compliance."})]}),e.jsx("div",{className:"mt-12 grid grid-cols-1 md:grid-cols-2 gap-5",children:u.map((t,s)=>{const i=t.icon;return e.jsxs(a.div,{initial:{opacity:0,y:16},whileInView:{opacity:1,y:0},viewport:{once:!0,amount:.2},transition:{duration:.5,delay:s*.05},className:"shape-tru border border-border bg-card p-7",children:[e.jsx("div",{className:"h-11 w-11 rounded-lg bg-teal/10 text-teal grid place-items-center",children:e.jsx(i,{size:20})}),e.jsx("h3",{className:"mt-5 text-base font-semibold text-foreground",children:t.title}),e.jsx("p",{className:"mt-2 text-sm text-muted-foreground leading-relaxed",children:t.body})]},t.title)})})]})}),e.jsx("section",{className:"py-20 lg:py-28 bg-surface",children:e.jsxs("div",{className:"mx-auto max-w-7xl px-6 lg:px-10 grid lg:grid-cols-12 gap-12",children:[e.jsxs("div",{className:"lg:col-span-4",children:[e.jsx("span",{className:"font-mono text-xs uppercase tracking-[0.18em] text-teal",children:"Subpart B"}),e.jsx("h2",{className:"mt-3 text-3xl sm:text-4xl font-semibold tracking-tight",children:"Electronic records controls."}),e.jsx("p",{className:"mt-5 text-base text-muted-foreground leading-relaxed",children:"Here’s how key § 11.10 requirements map to supporting TruTechnologies capabilities for electronic records."})]}),e.jsx("div",{className:"lg:col-span-8 grid sm:grid-cols-2 gap-4",children:g.map(t=>e.jsxs("div",{className:"shape-tru border border-border bg-card p-6",children:[e.jsxs("div",{className:"inline-flex items-center gap-2 rounded-full border border-border bg-background px-3 py-1 font-mono text-[11px] uppercase tracking-[0.12em] text-foreground",children:[e.jsx(r,{size:12}),t.ref]}),e.jsx("div",{className:"mt-3 text-sm font-semibold text-foreground",children:t.title}),e.jsx("p",{className:"mt-1.5 text-sm text-muted-foreground leading-relaxed",children:t.body})]},t.ref))})]})}),e.jsxs("section",{className:"py-20 lg:py-28 bg-hero relative overflow-hidden",children:[e.jsx("div",{className:"absolute inset-0 grid-bg pointer-events-none opacity-50"}),e.jsxs("div",{className:"relative mx-auto max-w-5xl px-6 lg:px-10",children:[e.jsx("span",{className:"font-mono text-xs uppercase tracking-[0.18em] text-teal",children:"Validation package"}),e.jsx("h2",{className:"mt-3 text-3xl sm:text-4xl font-semibold tracking-tight text-foreground",children:"Audit-ready documentation."}),e.jsx("p",{className:"mt-5 text-base text-muted-foreground leading-relaxed max-w-3xl",children:"Sponsors and CROs can request our full Part 11 validation package under NDA, including:"}),e.jsx("div",{className:"mt-10 grid sm:grid-cols-2 gap-4 text-sm",children:[["Validation Master Plan","GAMP 5–aligned plan governing scope, risk, and approach."],["IQ / OQ / PQ protocols","Installation, operational, and performance qualification with executed evidence."],["Requirements & traceability","User and functional requirements traced to test cases and code."],["Risk assessment","Documented analysis of system functionality, data integrity, and product quality risk."],["Change & release control","SOPs for change management, release approval, and emergency fixes."],["Audit trail samples","Representative exports demonstrating completeness and immutability."]].map(([t,s])=>e.jsxs("div",{className:"shape-tru border border-border bg-card p-5",children:[e.jsx("div",{className:"text-sm font-semibold text-foreground",children:t}),e.jsx("p",{className:"mt-1.5 text-sm text-muted-foreground leading-relaxed",children:s})]},t))})]})]}),e.jsxs("section",{className:"relative isolate overflow-hidden py-20 lg:py-28",children:[e.jsx("div",{"aria-hidden":!0,

1className:"absolute inset-0 -z-20",style:{background:"linear-gradient(135deg, #FF302D 0%, #FF5A03 50%, #FF9A2E 100%)"}}),e.jsx("div",{"aria-hidden":!0,className:"absolute inset-0 -z-10 opacity-[0.18] mix-blend-overlay",style:{backgroundImage:"linear-gradient(rgba(255,255,255,0.6) 1px, transparent 1px), linear-gradient(90deg, rgba(255,255,255,0.6) 1px, transparent 1px)",backgroundSize:"44px 44px"}}),e.jsx("div",{"aria-hidden":!0,className:"absolute -top-32 -right-32 -z-10 h-[28rem] w-[28rem] rounded-full blur-3xl opacity-40",style:{background:"radial-gradient(circle, #FDF8F2 0%, transparent 70%)"}}),e.jsx("div",{"aria-hidden":!0,className:"absolute -bottom-40 -left-24 -z-10 h-[24rem] w-[24rem] rounded-full blur-3xl opacity-30",style:{background:"radial-gradient(circle, #FF302D 0%, transparent 70%)"}}),e.jsx("div",{className:"relative mx-auto max-w-7xl px-6 lg:px-10",children:e.jsxs("div",{className:"shape-tru border border-white/15 bg-white/5 backdrop-blur-xl p-8 lg:p-12 grid lg:grid-cols-2 gap-10 items-center",children:[e.jsxs("div",{children:[e.jsx("span",{className:"font-mono text-xs uppercase tracking-[0.18em] text-milk/70",children:"Request documentation"}),e.jsx("h2",{className:"mt-3 text-2xl sm:text-3xl font-semibold tracking-tight text-milk",children:"Need our Part 11 package for an audit?"}),e.jsx("p",{className:"mt-4 text-base text-milk/80 leading-relaxed",children:"We'll share validation evidence, SOPs, and a clause-by-clause compliance matrix under NDA — typically within two business days."})]}),e.jsxs("div",{className:"flex flex-col gap-3",children:[e.jsxs("a",{href:"mailto:[email protected]",className:"inline-flex items-center gap-2 rounded-full border-0 bg-ash text-white font-mono font-bold uppercase text-[12px] tracking-[0.08em] h-11 px-6 hover:bg-ash-7 transition self-start",children:[e.jsx(m,{size:14}),"[email protected]"]}),e.jsx(x,{to:"/contact",className:"inline-flex items-center justify-center rounded-full border-[1.5px] border-white/30 text-milk font-mono font-bold uppercase text-[12px] tracking-[0.08em] h-11 px-6 hover:bg-white/10 transition self-start",children:"Contact our team"})]})]})})]}),e.jsx(p,{})]})}export{b as component};