United States (global supply chains selling into US)

FSMA records that FDA inspectors find organized and complete

Food Safety Modernization Act (FSMA)

Preventive controls, monitoring records, and corrective action documentation — captured as a byproduct of food production, not assembled before FDA inspections.

FDA (US Food and Drug Administration)United States (global supply chains selling into US)
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Private deployment · Sovereign infrastructure · Architecture session included

About FSMA

FSMA is the most significant food safety legislation since 1938, shifting FDA's focus from responding to foodborne illness to preventing it. It requires documented preventive controls, monitoring records, and supply chain programs.

Top audit finding

"Corrective actions documented without verification that the problem was resolved"

Most common FSMA non-conformance finding

Requirement mapping

FSMA requirements — and how Certexi addresses them

Framework requirements

  • 1Hazard analysis with documented scientific basis
  • 2Preventive controls with monitoring procedures and records
  • 3Corrective action records when preventive controls fail
  • 4Verification activities including records review and environmental monitoring
  • 5Supply chain program with approved supplier verification
  • 6Recall plan with records to support rapid traceability

Certexi approach

  • Preventive control monitoring records captured at the process point, not reconstructed later
  • Corrective action workflow: deviation detected → documented → action taken → verification → seal
  • Environmental monitoring program: sample, result, trend, and corrective action linked
  • Supplier program records: approved supplier list, verification activities, and outcome documentation
  • Recall traceability: one-step-forward and one-step-back records available within hours

Industry relevance

Sectors where FSMA compliance applies

Logistics
Manufacturing & Operations
Retail & Distribution
Agriculture & Food

Core capabilities

Use cases central to FSMA compliance

audit preparationincident reportingtraining recordschain of custodydocument control

PRICING

Aligned to Operational Value, Not User Count

Pricing scales with deployment scope, not headcount. Your data. Your infrastructure. Your rules.

All plans include private deployment. Your data never leaves your infrastructure.

ISO 27001 Aligned
Private Deployment
Unlimited Users
Currency

Pilot

Validate before you commit

Custom

5 spots per quarter

  • Full platform deployment
  • Configuration support
  • Onboarding and training
  • Direct product team access
  • Feedback-driven iteration
  • 8-week evaluation period

Standard

Single-location operations

From $4,800 / month

per month, billed annually

  • All core platform capabilities
  • Standard template library
  • Private deployment included
  • Email support (24h response)
  • Quarterly platform updates
  • Unlimited users

Enterprise

Multi-location, high-compliance

Custom

Based on deployment scope

  • Everything in Standard
  • Custom template development
  • Dedicated support engineer
  • SLA guarantees
  • Advanced integrations
  • Air-gapped deployment option

Private Deployment Included in All Plans

Every plan includes full deployment on your infrastructure — Nextcloud, Linux servers, Docker, Kubernetes, or air-gapped environments. Your data never leaves your control.

FSMA evidence generated by production, not created for inspections.

Private deployment on your infrastructure. Architecture session included.

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