FDA Audit Preparation with Intelligent IFU Search

import { Mixpeek } from 'mixpeek';

const client = new Mixpeek({ apiKey: process.env.MIXPEEK_API_KEY });

// Index regulatory document library
await client.buckets.connect({
  collection_id: 'regulatory-docs',
  bucket_uri: 's3://regulatory/docs/',
  extractors: [
    'document-parser',     // PDFs, Word docs
    'table-extraction',    // Specifications tables
    'image-analysis',      // Device diagrams, labels
    'form-recognition'     // FDA forms, templates
  ],
  settings: {
    preserve_structure: true,
    extract_metadata: ['doc_type', 'product_family', 'version', 'effective_date'],
    languages: ['en', 'de', 'fr', 'es', 'ja'] // Multi-language IFUs
  }
});

// Process MAUDE reports for post-market surveillance
await client.buckets.connect({
  collection_id: 'maude-reports',
  bucket_uri: 's3://regulatory/maude/',
  extractors: [
    'document-parser',
    'entity-extraction'   // Extract device names, problem codes
  ],
  settings: {
    update_frequency: 'daily',  // Sync with FDA updates
    filters: {
      product_codes: ['DTM', 'DXN', 'LYZ'],  // Your device codes
      date_range: 'last_5_years'
    }
  }
});

// Monitor for new similar-device events
await client.webhooks.create({
  collection_id: 'maude-reports',
  event: 'new_document',
  url: 'https://your-app.com/api/maude-alert',
  filters: {
    severity: { $in: ['death', 'serious_injury'] }
  }
});

// Respond to auditor requests instantly
async function searchRegulatoryDocs(request: string) {
  const results = await client.retrieve({
    collection_id: 'regulatory-docs',
    query: {
      type: 'text',
      text: request // e.g., "all complaints related to battery overheating"
    },
    filters: {
      doc_type: { $in: ['complaint', 'capa', 'ncr', 'ifu'] }
    },
    return_fields: [
      'content', 'doc_type', 'product_family',
      'version', 'effective_date', 'file_path'
    ],
    limit: 100
  });

  // Group by document type for auditor
  return {
    complaints: results.filter(r => r.doc_type === 'complaint'),
    capas: results.filter(r => r.doc_type === 'capa'),
    ifus: results.filter(r => r.doc_type === 'ifu'),
    total_documents: results.length
  };
}

// Create audit response package
async function prepareAuditPackage(auditRequest: {
  topic: string;
  products: string[];
  dateRange: { start: string; end: string };
}) {
  const docs = await searchRegulatoryDocs(auditRequest.topic);

  // Filter by products and dates
  const filtered = docs.filter(d =>
    auditRequest.products.includes(d.product_family) &&
    d.effective_date >= auditRequest.dateRange.start
  );

  // Generate package with cover sheet
  return {
    cover_sheet: {
      request_summary: auditRequest.topic,
      documents_included: filtered.length,
      date_prepared: new Date().toISOString(),
      prepared_by: 'Regulatory Affairs'
    },
    documents: filtered,
    index: generateDocumentIndex(filtered)
  };
}