United States

FDA 21 CFR Part 11 compliant records deployed on your infrastructure

FDA 21 CFR Part 11 — Electronic Records and Electronic Signatures

Complete audit trails, access controls, and record integrity evidence — all meeting FDA 21 CFR Part 11 requirements and deployed on your own infrastructure for full data control.

FDA (US Food and Drug Administration)United States
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About FDA 21 CFR Part 11

FDA 21 CFR Part 11 establishes the criteria under which the FDA considers electronic records and electronic signatures to be trustworthy and equivalent to paper records.

Top audit finding

"Audit trail captures changes but does not record the reason for change as required"

Most common FDA 21 CFR Part 11 non-conformance finding

Requirement mapping

FDA 21 CFR Part 11 requirements — and how Certexi addresses them

Framework requirements

  • 1Audit trail for electronic records capturing who changed what and when
  • 2Access controls limiting system use to authorized individuals
  • 3Electronic signatures with identity verification and meaning indication
  • 4Computer system validation documentation
  • 5Record retention and retrieval capabilities

Certexi approach

  • Immutable audit trail: every record creation, modification, and access captured with user identity and timestamp
  • Role-based access control with authorization review and deprovisioning workflows
  • Electronic signatures with configurable meaning, identity confirmation, and re-authentication
  • Record integrity verification: cryptographic hashing detects any post-creation modification
  • 21 CFR Part 11 validation package: IQ/OQ/PQ documentation framework available

Industry relevance

Sectors where FDA 21 CFR Part 11 compliance applies

Manufacturing & Operations
Agriculture & Food
Healthcare & Pharma

Core capabilities

Use cases central to FDA 21 CFR Part 11 compliance

document controlaudit preparationaccess control recordstraining 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.

21 CFR Part 11 compliant records with complete audit trails.

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

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