European Union (with international equivalents)

GDP compliance records that regulatory authorities accept without questions

Good Distribution Practice (GDP) — Pharmaceutical

Temperature monitoring, storage records, and distribution documentation — 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)
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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 — deviation documented but product impact assessment and disposition decision not recorded"

Most common GDP non-conformance finding

Requirement mapping

GDP requirements — 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

Logistics
Healthcare & Pharma

Core capabilities

Use cases central to GDP compliance

chain of custodyaudit preparationequipment calibrationtraining records

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.

GDP compliance evidence that protects pharmaceutical supply chain integrity.

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