European Union (with international equivalents)

GDP compliance records that regulatory authorities accept without questions

Good Distribution Practice (GDP) β€” Pharmaceutical

Temperature monitoring, storage records, and distribution documentation β€” all sealed at the point of activity and organized for GDP regulatory inspections worldwide.

EMA, national competent authorities (EU), WHO (international)European Union (with international equivalents)

Private deployment Β· Sovereign infrastructure Β· Architecture session included

About GDP

GDP guidelines establish requirements for the proper distribution of medicinal products, ensuring maintained quality and integrity throughout the supply chain from manufacturer to patient.

Top audit finding

"Temperature excursion records incomplete β€” deviation documented but product impact assessment and disposition decision not recorded"

Most common GDP non-conformance finding

Requirement mapping

GDP requirements β€” and how Certexi addresses them

Framework requirements

  • 1Quality management system with documented procedures and records
  • 2Personnel qualification and training records
  • 3Temperature-controlled storage with continuous monitoring records
  • 4Transportation records with temperature excursion documentation
  • 5Supplier and customer qualification records
  • 6Complaint handling and recall management documentation

Certexi approach

  • Temperature monitoring: continuous data with excursion alerts and sealed corrective action records
  • Distribution records: chain of custody from manufacturer to customer with temperature history
  • Supplier qualification: approved supplier list, audit records, and certificate management
  • GDP inspection bundle: organized by EU GDP chapter with evidence for any inspection period

Industry relevance

Sectors where GDP compliance applies

Core capabilities

Use cases central to GDP compliance

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 β€” Nextcloud, Linux servers, Docker, Kubernetes, or air-gapped environments. Your data never leaves your control.

GDP compliance evidence that protects pharmaceutical supply chain integrity.

Private deployment on your infrastructure. Architecture session included.

Request Architecture Session