Logistics

Cold chain compliance that survives an FDA audit

Continuous temperature monitoring, automatic excursion alerts, and cryptographically sealed records for every link in the cold chain. No more reconstructed logs.

fsmafda 21 cfr part 11iso 22000gdp
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Private deployment · Sovereign infrastructure · Architecture session included

The problem

Why existing approaches fail

  • ×Temperature excursions discovered after product reaches destination
  • ×Monitoring data lives in disconnected data loggers, not the compliance system
  • ×FDA audits require weeks of manual log reconstruction from paper and CSV exports

The Certexi approach

Evidence generated at the point of work

  • Real-time sensor integration with automatic excursion detection and sealed records
  • Chain-of-custody documentation with photo evidence at every transfer point
  • One-click FDA/FSMA audit bundle: temperature logs, excursions, corrective actions

Compliance coverage

Regulatory frameworks supported

Evidence generated by Certexi is designed to satisfy the requirements of these frameworks.

FSMAFDA 21 CFR PART 11ISO 22000GDP

Related capabilities

Use cases that power this solution

chain of custodyaudit preparationincident reporting

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.

On-Premise Deployment
Offline-First
ISO 27001 Ready
Sovereign Deployment

Ready to generate cold chain compliance software evidence automatically?

Provable cold chain compliance from pickup to delivery.

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