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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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

PRECIOS

Alineado al Valor Operativo, No al Número de Usuarios

El precio depende del alcance del despliegue, no del número de usuarios. Tus datos. Tu infraestructura. Tus reglas.

Todos los planes incluyen despliegue privado. Tu información permanece en tu infraestructura.

ISO 27001 Aligned
Private Deployment
Unlimited Users

Piloto

Valida antes de comprometerte

Personalizado

5 lugares por trimestre

  • Despliegue completo de plataforma
  • Soporte de configuración
  • Capacitación e incorporación
  • Acceso directo al equipo de producto
  • Iteración basada en retroalimentación
  • Período de evaluación de 8 semanas

Estándar

Operaciones de una ubicación

Desde $2,500

por mes, facturado anualmente

  • Todas las capacidades centrales
  • Biblioteca de plantillas estándar
  • Despliegue privado incluido
  • Soporte por email (respuesta 24h)
  • Actualizaciones trimestrales
  • Usuarios ilimitados

Enterprise

Multi-ubicación, alto cumplimiento

Personalizado

Basado en alcance del despliegue

  • Todo lo de Estándar
  • Desarrollo de plantillas personalizadas
  • Ingeniero de soporte dedicado
  • Garantías SLA
  • Integraciones avanzadas
  • Opción de despliegue air-gapped

Despliegue Privado Incluido en Todos los Planes

Cada plan incluye despliegue completo en tu infraestructura — Nextcloud, servidores Linux, Docker, Kubernetes o entornos air-gapped. Tu información nunca sale de tu control.

FSMA evidence generated by production, not created for inspections.

30-day free trial. Private deployment on your infrastructure.

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