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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Private deployment · Sovereign infrastructure · Architecture session included

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

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.

21 CFR Part 11 compliant records with complete audit trails.

Private deployment on your infrastructure. Architecture session included.

Request Architecture Session