FSMA §117 · 21 CFR Part 117

Your FDA HARPC plan,
drafted with AI.

FoodReport AI guides FDA-registered facilities through every FSMA §117 requirement — hazard analysis, process controls, sanitation, allergens, supply-chain program, records and PCQI approvals — and drafts justifications and SOPs with AI.

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PCQI-friendly
Stainless steel commercial food prep area with packaged foods and an FDA inspection clipboard

Every preventive control FSMA §117 requires

Hazard analysis with severity × likelihood scoring drives your preventive controls — exactly the way 21 CFR Part 117 expects.

Process preventive controls

CCP-style critical limits, monitoring, corrective actions and verification at each process step.

Sanitation preventive controls

Zone cleaning, environmental monitoring, allergen-aware sanitation procedures.

Food allergen preventive controls

Ingredient analysis, line-by-line allergen mapping and label verification.

Supply-chain program

Approved supplier verification, hazard-based receiving and audit-ready records.

AI hazard justifications & SOP rewrites
  • • Draft hazard justifications grounded in FSMA §117 language
  • • Rewrite procedures in clear SOP style
  • • Compare original vs suggested text — accept or reject
  • • Every suggestion logged for your audit trail

A PCQI-friendly co-author, not a black box

Your Preventive Control Qualified Individual stays in control. AI proposes; you decide. Every accepted suggestion shows up in revision history with a clear before / after.

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FDA-ready binder export

One click compiles your full HARPC plan — facility profile, hazard analysis, preventive controls, records review and PCQI approvals — into a fully editable DOCX or print-ready PDF.

  • 12 HARPC sections compiled in order
  • Hazard analysis with risk scores
  • Allergen ingredient + line + label verification
  • Approval page with PCQI signature
Export formats
DOCX binder
Fully editable Word document
PDF binder
Print-ready master copy

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