{ "_gtmos": 1, "exportedAt": "2026-07-21T00:00:00.000Z", "note": "ProofX launch worked example — Launch OS, Capability Explorer, firm profile, campaign.", "data": { "firm": { "firmName": "NovintiX", "tagline": "MedTech & life-sciences engineering — maker of ProofX, our AI-native test-proof product", "senderName": "[NovintiX Founder]", "senderTitle": "Founder", "city": "Coimbatore", "capabilities": [ "AI test-case generation from requirements", "Live requirements-to-test traceability", "Notified-body-ready V&V evidence assembly", "Standard packs (62304 / 14971 / MDR / GAMP5)" ], "keyMessages": [ "ProofX turns your requirements and tests into audit-ready V&V evidence — automatically, with a human in the loop" ], "products": [ { "name": "ProofX", "capability": "test-proof management", "benefit": "audit-ready V&V evidence, 50–70% less assembly time" } ], "proofPoints": [ "Evidence-assembly time cut 50–70% on SaMD programs with zero new audit findings" ], "approach": "Founder-led (builder voice)" }, "launch.products": [ { "id": "px_1", "name": "ProofX", "oneLiner": "AI-native test-proof management for SaMD & medical devices — audit-ready V&V evidence, automatically, with a human in the loop.", "stage": "Building", "createdAt": "2026-07-05", "positioning": { "alternatives": "manual assembly across ALM + spreadsheets + docs; validation consultants", "attributes": "AI generation + live traceability + notified-body-ready evidence, layered on your ALM", "value": "evidence off the critical path; submissions on time; audits passed", "segment": "SaMD & medical-device V&V / regulatory teams and their GCCs", "category": "AI-native test-proof management for regulated products", "trends": "EU MDR/IVDR & EUDAMED pressure; AI in regulated engineering", "stIcp": "SaMD/MedTech teams with active V&V & submission load", "stStruggle": "V&V evidence is assembled by hand and breaks on every change", "stValue": "always-current, audit-ready evidence in a fraction of the time", "stAlt": "ALM + spreadsheets + overloaded engineers", "stDiff": "regulated-domain AI with a human-in-the-loop trust model auditors accept" }, "icp": { "firmo": "SaMD/MedTech, 20–500 engineers, active regulatory load", "role": "VP R&D / Head of Quality or Regulatory; V&V lead", "trigger": "MDR/IVDR submission, audit finding, SaMD/AI feature in review", "holes": "no scalable way to keep V&V evidence audit-ready", "wtp": "$15k pilot → $120k+ platform" }, "jtbd": [ { "id": "px_j1", "situation": "a device feature is built and a submission deadline is closing", "motivation": "its V&V evidence complete, traceable and audit-ready without pulling senior engineers off the roadmap", "outcome": "pass review and submit on time", "imp": 9, "sat": 2 } ], "pillars": [ { "pillar": "Generate", "features": "requirement→test generation, gap-mining, protocol/report drafting", "benefit": "weeks of assembly become minutes", "proof": "beta: 50–70% time saved" }, { "pillar": "Trace", "features": "live requirements-to-test-to-risk traceability + change impact", "benefit": "traceability survives change; no audit gaps", "proof": "" }, { "pillar": "Trust", "features": "human-in-the-loop sign-off, audit trail, explainable output", "benefit": "evidence a notified body accepts", "proof": "" } ], "objections": [ { "id": "px_o1", "objection": "We can't put AI near regulatory evidence", "response": "ProofX keeps a qualified human approver on every regulator-facing artefact, with a full audit trail and explainable, sourced generation — AI assembles, humans sign." }, { "id": "px_o2", "objection": "We already have Jama/Polarion", "response": "ProofX layers on top — it reads your ALM and adds the AI evidence generation and audit-ready assembly those tools don't do. Integrate, don't replace." } ], "landing": { "heroPick": "0", "customHeadline": "", "subhead": "", "socialProof": "Built with SaMD & MedTech design partners on real submissions", "how1": "Connect your ALM / requirements", "how2": "AI generates tests & traceability, you approve", "how3": "Export a notified-body-ready evidence file", "plan1": "Pilot — one program", "plan2": "Team — per seat", "plan3": "Platform — org-wide", "ctaLabel": "Start a pilot", "ctaSub": "One program, 6–8 weeks" }, "checklist": { "pre1": true, "pre2": true, "pre3": true, "pre4": true, "pre5": false, "pre6": false, "pre7": false } } ], "launch.activeId": "px_1", "explorer.taxonomy": [ { "id": "px_d_evi", "name": "AI Evidence Engine", "desc": "The core: generate, trace and assemble regulated V&V evidence with a human-in-the-loop trust model — the part that never forks across industries.", "capabilities": [ { "id": "px_c_gen", "name": "AI Test & Protocol Generation", "maturity": "Differentiating", "desc": "Generate test cases, V&V protocols and reports from requirements and user stories, with coverage-gap mining — every output human-reviewed.", "features": [ { "id": "px_f_req2test", "name": "Requirement → test generation" }, { "id": "px_f_gap", "name": "Coverage-gap mining" }, { "id": "px_f_draft", "name": "Protocol & report drafting" } ], "boundaries": { "core": [ "Generation of test cases/protocols/reports from requirements", "Coverage-gap analysis", "Human-in-the-loop review of every artefact" ], "adjacent": [ "ALM/requirements management (integrate, not replace)", "eQMS process management (feed, not own)" ], "out": [ "Being the regulatory decision-maker or sign-off authority", "Guaranteeing approval without human review" ], "risks": "Generated artefacts are a reviewed starting corpus, never auto-certified. A qualified human approver signs everything regulator-facing." } }, { "id": "px_c_trace", "name": "Live Traceability & Change Impact", "maturity": "Established", "desc": "Always-current requirements-to-test-to-risk traceability with automated change-impact analysis so evidence never silently goes stale.", "features": [ { "id": "px_f_matrix", "name": "Auto traceability matrix" }, { "id": "px_f_impact", "name": "Change-impact analysis" }, { "id": "px_f_export", "name": "Notified-body-ready export" } ] } ] }, { "id": "px_d_packs", "name": "Standard Packs", "desc": "The expansion layer: per-standard compliance mappings, artefact templates and rule sets that let the same engine speak each industry's evidence language.", "capabilities": [ { "id": "px_c_med", "name": "MedTech Pack (62304 / 14971 / MDR)", "maturity": "Differentiating", "desc": "The launch pack: IEC 62304 lifecycle, ISO 14971 risk linkage, FDA design controls and EU MDR evidence structures built in.", "features": [ { "id": "px_f_62304", "name": "IEC 62304 lifecycle mapping" }, { "id": "px_f_14971", "name": "ISO 14971 risk linkage" }, { "id": "px_f_mdr", "name": "EU MDR / UDI evidence structures" } ] }, { "id": "px_c_gxp", "name": "GxP Pack (GAMP5 / Part 11)", "maturity": "Emerging", "desc": "First adjacency: computer-system validation for pharma — GAMP5 categories, 21 CFR Part 11 and data-integrity (ALCOA+) evidence.", "features": [ { "id": "px_f_gamp", "name": "GAMP5 category mapping" }, { "id": "px_f_part11", "name": "21 CFR Part 11 evidence" }, { "id": "px_f_alcoa", "name": "ALCOA+ data-integrity checks" } ] } ] } ], "db.explorer.valuemaps": [ { "capabilityId": "px_c_gen", "capabilityName": "AI Test & Protocol Generation", "tech": "LLM generation of test cases, protocols and reports grounded in the client's requirements, with coverage-gap detection and mandatory human review, logged in an audit trail.", "plain": "ProofX drafts the test cases and V&V paperwork straight from your requirements — your engineers review and approve instead of writing it all from scratch.", "outcome": "Cuts V&V evidence-assembly time 50–70% and removes the submission delays caused by hand-built paperwork.", "cxo": "Your submissions stop waiting on paperwork — evidence is drafted in minutes and signed off by your team, not rebuilt for every audit.", "kpi": "Evidence-assembly time; submission delays avoided; audit findings on traceability", "proof": "Design-partner beta: 50–70% assembly time saved on real SaMD submissions with zero new audit findings." }, { "capabilityId": "px_c_trace", "capabilityName": "Live Traceability & Change Impact", "tech": "Automated requirements-to-test-to-risk graph with change-impact propagation and one-click notified-body-ready export.", "plain": "When something changes, ProofX shows exactly which tests and evidence are affected — so the traceability never quietly breaks.", "outcome": "Eliminates the traceability gaps auditors find and the rework of rebuilding the matrix by hand each cycle.", "cxo": "Audit readiness becomes a property of the system, not a fire drill before every review.", "kpi": "Traceability gaps at audit; matrix rebuild effort; review cycle time", "proof": "" } ], "db.explorer.usecases": [ { "title": "MDR submission evidence for a SaMD feature", "industry": "MedTech", "function": "Regulatory", "problem": "A SaMD feature needs MDR-ready V&V evidence and traceability, and the team is assembling it by hand under a deadline.", "capabilityIds": [ "px_c_gen", "px_c_trace", "px_c_med" ], "impact": 5, "feasibility": 4, "status": "in-market" }, { "title": "Traceability remediation after an audit finding", "industry": "MedTech", "function": "Quality", "problem": "An audit flagged broken requirements-to-test traceability across a device family; rebuilding it manually would take weeks.", "capabilityIds": [ "px_c_trace" ], "impact": 5, "feasibility": 5, "status": "validated" }, { "title": "GxP computer-system validation for a pharma app", "industry": "Pharma & Life Sciences", "function": "Quality", "problem": "A GxP system needs GAMP5/Part 11 validation evidence and the validation team has no bandwidth.", "capabilityIds": [ "px_c_gen", "px_c_gxp" ], "impact": 4, "feasibility": 3, "status": "idea" } ], "db.explorer.comparisons": [ { "name": "Keeping V&V evidence audit-ready — ProofX vs ALM vs manual", "context": "A SaMD team deciding how to keep V&V evidence audit-ready through a submission cycle.", "options": [ "ProofX", "ALM alone (Jama/Polarion)", "Validation consultants", "Manual (spreadsheets/docs)" ], "criteria": [ { "name": "Evidence generation", "weight": 5, "scores": [ 5, 2, 4, 1 ], "notes": [ "AI-generated + reviewed", "Stores, doesn't generate", "Human-built, slow", "All by hand" ] }, { "name": "Live traceability", "weight": 5, "scores": [ 5, 3, 2, 1 ], "notes": [ "Auto + change impact", "Manual links", "Point-in-time", "Breaks constantly" ] }, { "name": "Time to audit-ready", "weight": 5, "scores": [ 5, 3, 3, 1 ], "notes": [ "Minutes to assemble", "Manual assembly", "Weeks of consulting", "Weeks of rework" ] }, { "name": "Auditor trust", "weight": 4, "scores": [ 4, 4, 5, 3 ], "notes": [ "Human-in-loop + audit trail", "Established tools", "Human expertise", "Error-prone" ] }, { "name": "Cost at scale", "weight": 4, "scores": [ 4, 3, 2, 3 ], "notes": [ "Seats + platform", "Per-seat licenses", "Recurring consulting", "Hidden rework cost" ] }, { "name": "Fits existing stack", "weight": 3, "scores": [ 5, 5, 3, 4 ], "notes": [ "Layers on ALM", "Is the ALM", "Tool-agnostic advice", "Spreadsheets" ] } ] } ], "db.content.campaigns": [ { "id": "px_cmp1", "name": "ProofX — recruit SaMD design partners", "goal": "gcc", "accountId": "", "accountName": "SaMD / MedTech design-partner prospects", "contactId": "", "contactName": "", "startDate": "2026-08-04", "createdAt": "2026-07-16", "steps": [ { "templateId": "gcc-linkedin-connect", "dayOffset": 0, "done": false }, { "templateId": "gcc-peer-operator-open", "dayOffset": 3, "done": false }, { "templateId": "gcc-roundtable-invite", "dayOffset": 10, "done": false }, { "templateId": "gcc-referral-broker", "dayOffset": 18, "done": false } ] } ] } }