{
  "pif_version": "0.2",
  "pif_corpus_version": "preclari-eu-gmp-2026-w20",
  "assertion_id": "pa_v02_example_001",
  "workflow_ref": "wf_v02_pharma_example",
  "produced_by": {
    "tool": "preclari",
    "version": "0.5.0",
    "methodology": "preclari-method-v1.0",
    "provider": "anthropic",
    "model_used": "claude-sonnet-4.6"
  },
  "produced_at": "2026-05-19T10:00:00Z",
  "corpus_snapshot": {
    "snapshot_id": "corpus_2026_w20",
    "snapshot_hash": "sha256:9e8b7a6c5d4f3e2d1c0b9a8f7e6d5c4b3a2918072615140312fefdfcfbfaf9f8",
    "snapshot_date": "2026-05-15T00:00:00Z",
    "source_count": 247
  },
  "risk_classification": {
    "level": "medium",
    "rationale": "Workflow influences GxP decisions but human approval gate is required before any downstream action; pilot stage narrows the operational scope."
  },
  "regulatory_domains_identified": [
    "gxp:GMP",
    "gxp:data_integrity",
    "gxp:quality_systems"
  ],
  "applicable_requirements": [
    {
      "requirement_id": "req_001",
      "requirement_text": "Computerised systems used in GxP activities require risk-based validation proportionate to their intended use.",
      "source": {
        "url": "https://example-regulator.eu/annex-11",
        "canonical_document_id": "EU-GMP-Annex-11",
        "issuing_authority": "European Commission",
        "jurisdiction": "EU",
        "document_type": "annex"
      },
      "applicability_basis": "The workflow uses an AI system to produce structured recommendations that feed into GxP decisions; Annex 11 applies.",
      "confidence": "high",
      "conditional_applicability": false
    },
    {
      "requirement_id": "req_002",
      "requirement_text": "ALCOA+ attribution requires distinguishing AI-generated content from human-authored content in the final record.",
      "source": {
        "url": "https://example-mhra.gov.uk/data-integrity-guidance",
        "canonical_document_id": "MHRA-DI-2018",
        "issuing_authority": "MHRA",
        "jurisdiction": "UK",
        "document_type": "guidance"
      },
      "applicability_basis": "Applies IF the AI's suggestion is persisted as part of the GxP record; demonstrated by the human approval workflow.",
      "confidence": "high",
      "conditional_applicability": true
    }
  ],
  "missing_controls": [
    {
      "control": "iso27001:A.8.1.1",
      "rationale": "Asset inventory of the AI model and its training corpus is not documented.",
      "criticality": "required",
      "related_requirements": ["req_001"]
    },
    {
      "control": "gamp5:appendix_m4",
      "rationale": "GAMP 5 categorisation of the AI system not formally assigned.",
      "criticality": "recommended",
      "related_requirements": ["req_001"]
    }
  ],
  "assumptions_made": [
    {
      "assumption": "The AI suggestion is persisted into the QMS deviation record as a distinguishable element (not merged into narrative text).",
      "impact_if_wrong": "If AI suggestion is merged into the narrative without attribution, ALCOA+ attribution control is materially weaker and req_002 becomes unconditional.",
      "basis": "Inferred from the human_gate=approve_each design; the assumption resolves req_002's conditional_applicability."
    }
  ],
  "clarifying_questions": [
    {
      "question": "How is the AI suggestion captured in the QMS deviation record?",
      "would_change": "Resolves the conditional_applicability flag on req_002."
    }
  ],
  "out_of_scope": [
    {
      "topic": "US FDA 21 CFR Part 11 expectations",
      "reason": "Workflow jurisdictions are EU/CH only."
    }
  ],
  "verification_steps": [
    {
      "step": "Confirm the Annex 11 citation in req_001 matches the current published version.",
      "type": "source_check",
      "applies_to": "applicable_requirements[0]"
    }
  ],
  "status": "draft",
  "notice": "This is an illustrative v0.2 PIF document. Demonstrates: regulatory_domains_identified with CURIE values, missing_controls.control in CURIE form (iso27001:, gamp5:), conditional_applicability on req_002 with the corresponding assumption in assumptions_made, pif_corpus_version envelope field, and the v0.2 required-array tightening (out_of_scope + clarifying_questions present)."
}