Governing Equations

eCTD Structure (ICH M4):
  m1: Administrative & prescribing info
  m2: Common Technical Document summaries
  m3: Quality (CMC)
  m4: Nonclinical study reports
  m5: Clinical study reports

Validation Rules:
  Critical: Missing required documents, broken hyperlinks to safety data
  Warning: PDF version < 1.4, bookmarks missing, font embedding
  Pass: All structural and technical requirements met

Hyperlink Integrity:
  Integrity = (valid_links / total_links) × 100%
  Target: > 99.5%

PDF Technical Compliance:
  PDF/A-1b or PDF/A-2b for archival
  Embedded fonts, searchable text, bookmarks

Scoring:
  Score = 100 - (critical × 10 + warning × 2 + pdf_err × 1)
  Pass: Score ≥ 95