FDA 21 CFR Part 11
US FDA regulation for trustworthy electronic records and signatures
FedRAMP
U.S. government framework standardizing federal cloud security authorization
Quick Verdict
FDA 21 CFR Part 11 ensures trustworthy electronic records for life sciences, while FedRAMP authorizes secure cloud services for federal agencies. Pharma firms adopt Part 11 for compliance; CSPs pursue FedRAMP to win government contracts.
FDA 21 CFR Part 11
21 CFR Part 11: Electronic Records; Electronic Signatures
Key Features
- Equivalency criteria for electronic records to paper records
- Secure, time-stamped audit trails for data integrity
- Controls for closed and open system environments
- Multi-component electronic signature requirements
- Risk-based validation and enforcement discretion
FedRAMP
Federal Risk and Authorization Management Program
Key Features
- "Assess once, use many times" reusability model
- NIST 800-53 Rev 5 controls at three impact levels
- Independent third-party assessments by accredited 3PAOs
- Ongoing continuous monitoring with monthly deliverables
- FedRAMP Marketplace for authorized CSP visibility
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
FDA 21 CFR Part 11 Details
What It Is
FDA 21 CFR Part 11 is a U.S. regulation establishing criteria for electronic records and electronic signatures to be trustworthy, reliable, and equivalent to paper records and handwritten signatures. It applies to FDA-regulated industries using electronic systems for predicate-rule records. The approach is risk-based, with narrow scope per 2003 FDA guidance, focusing on reliance on electronic records.
Key Components
- Subparts: General provisions, electronic records controls (§11.10 closed, §11.30 open systems), electronic signatures (§§11.50-11.300).
- Core controls: validation, audit trails, access limits, operational/authority/device checks, training, accountability policies, signature linking/uniqueness.
- Built on ALCOA+ principles for data integrity; no fixed control count, but enforced elements despite some discretion.
Why Organizations Use It
Mandatory for life sciences using electronic records to meet predicate rules; mitigates enforcement risks like warning letters. Enhances data integrity, inspection readiness, operational efficiency; builds stakeholder trust via non-repudiation.
Implementation Overview
Risk-based CSV lifecycle: scope records, GAMP categorization, IQ/OQ/PQ validation, SOPs/training. Applies to pharma/biotech/devices; no certification, but FDA inspection-enforced. Phased: gap analysis, vendor governance, change control.
FedRAMP Details
What It Is
FedRAMP (Federal Risk and Authorization Management Program) is a U.S. government-wide framework standardizing security assessment, authorization, and continuous monitoring for cloud service offerings (CSOs) used by federal agencies. Its core purpose is "assess once, use many times," enabling reusable authorizations based on NIST SP 800-53 Rev 5 controls mapped to FIPS 199 impact levels (Low, Moderate, High).
Key Components
- **Baselines~150-410 controls by level (Low ~156, Moderate ~323, High ~410); LI-SaaS variant for low-risk SaaS.
- Key artifacts: SSP, SAR, POA&M, continuous monitoring plans.
- Relies on 3PAO independent assessments.
- Paths: Agency or Program Authorization.
Why Organizations Use It
- Unlocks federal/state contracts ($20M+ potential).
- Required for CMMC compliance in DoD work.
- Mitigates risks, builds stakeholder trust.
- Serves as security differentiator for commercial clients.
Implementation Overview
- 12-18 months typical: FIPS categorization, documentation, 3PAO assessment, ongoing monitoring.
- Targets CSPs of all sizes pursuing government business.
- No certification; requires sustained ATO via audits.
Key Differences
| Aspect | FDA 21 CFR Part 11 | FedRAMP |
|---|---|---|
| Scope | Electronic records/signatures trustworthiness | Cloud service security assessment/monitoring |
| Industry | Life sciences, pharma, medical devices | Federal government cloud providers |
| Nature | Mandatory FDA regulation with discretion | Mandatory government-wide authorization program |
| Testing | Risk-based system validation, audit trails | 3PAO assessments, continuous monitoring |
| Penalties | Warning letters, enforcement actions | Revocation of authorization, contract loss |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about FDA 21 CFR Part 11 and FedRAMP
FDA 21 CFR Part 11 FAQ
FedRAMP FAQ
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