VELARU GALACTIC EXHIBIT PACK — PHARMA / CLINICAL TRIALS
Jurisdiction: China (cn)
Modality: Text / Chat
Program: Velaru Pharma / Clinical Trials · China (galactic_pharma_cn)
Product ID: pharma:cn:bundle:text
Vertical: pharma
Generated: 2026-08-15T10:21:04.782662Z
Authority: China CAC Algorithm Filing Pack — 21 CFR Part 11 Clinical AI Audit Pack
Deadline: CAC algorithm filing + PIPL
Velaru verify: https://velaru.onrender.com/verify

EXHIBIT A — AI INVENTORY
[
  {
    "named_entity": "Velari",
    "slug": "velari",
    "ai_use_case": "AI-assisted Pharma / Clinical Trials decisions",
    "vertical": "pharma",
    "risk_tier": "elevated",
    "external_validation": "Velaru independent receipt verification",
    "handler_receipt_lock": "https://velaru.onrender.com/r/4c58eac890bfd031ce2189de5a1ca9ea292a0c837f5f535daf164aef34f31e53",
    "compliance_state": "grace_period",
    "asymmetry_grade": "A",
    "found_scripture_export": "https://velaru.onrender.com/bundle/pre-dispute/d8fb129c0c0c78d05256/export.txt",
    "diligence_url": "https://velaru.onrender.com/diligence/velari"
  },
  {
    "named_entity": "LinkAudit Test",
    "slug": "linkaudit-test",
    "ai_use_case": "AI-assisted Pharma / Clinical Trials decisions",
    "vertical": "pharma",
    "risk_tier": "elevated",
    "external_validation": "Velaru independent receipt verification",
    "handler_receipt_lock": "https://velaru.onrender.com/r/58ddedd1974156453bc55daef6a9857d8570d56388becbb2a80bf5bac76b771b",
    "compliance_state": "grace_period",
    "asymmetry_grade": "A",
    "found_scripture_export": "https://velaru.onrender.com/bundle/pre-dispute/78aa6e3f3a84cf1a88c0/export.txt",
    "diligence_url": "https://velaru.onrender.com/diligence/linkaudit-test"
  },
  {
    "named_entity": "Link Audit Co",
    "slug": "link-audit-co",
    "ai_use_case": "AI-assisted Pharma / Clinical Trials decisions",
    "vertical": "pharma",
    "risk_tier": "elevated",
    "external_validation": "Velaru independent receipt verification",
    "handler_receipt_lock": "https://velaru.onrender.com/r/d00533b7b6c0495802b4250abd5c29f60bd9f2ad3fb141bba2d9a5afee5f5542",
    "compliance_state": "grace_period",
    "asymmetry_grade": "A",
    "found_scripture_export": "https://velaru.onrender.com/bundle/pre-dispute/fea572f3996c4b963779/export.txt",
    "diligence_url": "https://velaru.onrender.com/diligence/link-audit-co"
  }
]

EXHIBIT B — GOVERNANCE FRAMEWORK
{
  "framework": "Velaru Mandate Registry \u2014 Pharma / Clinical Trials",
  "exhibit_authority": "China CAC Algorithm Filing Pack \u2014 21 CFR Part 11 Clinical AI Audit Pack",
  "regulatory_frameworks": [
    "FDA 21 CFR Part 11",
    "GCP ICH E6",
    "EU AI Act Annex III",
    "CAC Generative AI Measures",
    "PIPL",
    "DSL",
    "Algorithm Recommendation Rules"
  ],
  "standards_alignment": [
    "POSS-2",
    "DRP-1",
    "TCB",
    "FRE 707 pre-compliance",
    "ISO 42001"
  ],
  "human_oversight": "release clinical batch / report adverse event",
  "third_party_verification": "https://velaru.onrender.com/verify (operator-independent)",
  "data_lineage": "Hash-chained Ed25519 receipts; optional RFC3161 + external anchor",
  "mirror_trap": "Sponsors using vendor AI for protocol deviation detection \u2014 sponsor owns FDA finding, vendor owns nothing. \u00b7 Algorithm filing requires decision logic documentation \u2014 independent verify acceptable to CAC review.",
  "chain_integrity": {
    "depth": 340,
    "invariant_holds": true
  }
}

EXHIBIT D — DATA INPUTS & VALIDATION
{
  "data_validation_method": "Cryptographic receipt per AI decision; public verify without trusting deployer, vendor, or Velaru operator",
  "bias_testing_proxy": "Asymmetry score from live chain signals",
  "model_change_control": "Policy lock registry \u2014 criteria hash frozen pre-dispute",
  "logging_retention": "90-day pre-dispute window minimum; permanent verify permalinks",
  "external_validator": "Nisaba LLC / Velaru",
  "validator_independence": "Client-side Ed25519 verify; BYOK tri-receipt optional",
  "headline_stat": "21 CFR Part 11 already requires what Velaru does \u2014 not AI safety, compliance",
  "global_leaders_addressed": [
    "FDA",
    "Pfizer",
    "IQVIA",
    "Veeva",
    "EMA",
    "CAC",
    "Tencent",
    "Alibaba"
  ]
}

MIRROR TRAP (regulatory insight)
Sponsors using vendor AI for protocol deviation detection — sponsor owns FDA finding, vendor owns nothing. · Algorithm filing requires decision logic documentation — independent verify acceptable to CAC review.

NERVE CARDS — WHY GLOBAL LEADERS CARE
[
  {
    "title": "483 observations",
    "body": "FDA inspection: show audit trail for AI-flagged deviation \u2014 altered records = criminal referral pattern.",
    "source": "vertical"
  },
  {
    "title": "ICH E6 GCP",
    "body": "AI-assisted monitoring must be in validation documentation \u2014 post-hoc PowerPoint fails.",
    "source": "vertical"
  },
  {
    "title": "Trial insurance",
    "body": "Clinical trial insurers now ask AI governance questionnaire \u2014 receipts beat questionnaires.",
    "source": "vertical"
  },
  {
    "title": "[China] Dual compliance",
    "body": "Multinationals operating CN + US/EU \u2014 one architecture, jurisdiction-tagged receipts.",
    "source": "jurisdiction"
  },
  {
    "title": "[China] DeepSeek moment",
    "body": "Chinese model deployment globally \u2014 provenance receipt links model to decision.",
    "source": "jurisdiction"
  },
  {
    "title": "[Text / Chat] Modality hook",
    "body": "Baseline \u2014 all frameworks apply to text decisions.",
    "source": "modality"
  }
]

BOOK SUMMARY: {
  "total_insureds": 3,
  "compliant": 0,
  "grace_period": 3,
  "non_compliant": 0,
  "expired": 0,
  "not_enrolled": 0,
  "compliant_pct": 0.0
}

TAM / EXPOSURE: $200B+ pharma R&D · AI in trial design exploding
INSURANCE LINES: Product liability, Clinical trial E&O

DISCLAIMER: External validation evidence pack — not legal advice, not filed rate approval.