Manufacturing & Operations

Production traceability that makes recalls survivable

Every component, every batch, every operator action — recorded at the point of production. Trace forward to finished goods or backward to raw materials in minutes.

iso 9001fda 21 cfr part 11eu gmpiatf 16949
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Private deployment · Sovereign infrastructure · Architecture session included

The problem

Why existing approaches fail

  • ×Batch records completed manually at end of shift, losing real-time production events
  • ×Component genealogy requires linking records across multiple disconnected systems during recalls
  • ×Production deviations documented in quality system but not linked to the affected product records

The Certexi approach

Evidence generated at the point of work

  • Real-time production event capture: component scans, operator sign-offs, equipment readings
  • Batch genealogy: trace any finished product to every raw material, supplier, and production step
  • Recall scope identification in minutes: which batches used the affected component

Compliance coverage

Regulatory frameworks supported

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

ISO 9001FDA 21 CFR PART 11EU GMPIATF 16949

Related capabilities

Use cases that power this solution

chain of custodyincident reportingaudit preparation

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 production line traceability evidence automatically?

Complete production genealogy for every unit you make.

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