🇺🇸 Live Medical Devices & Diagnostics

FDA 21 CFR 11

Establishes criteria for the FDA's acceptance of electronic records and electronic signatures as equivalent to paper records and handwritten signatures. Applies to organizations that maintain records or submit documents to the FDA electronically.

View official source document

Rules extracted

Obligations decomposed

7.0x

Avg obligations per rule

🇺🇸 United States

Jurisdiction

About this regulation

21 CFR Part 11 sets forth the criteria under which the FDA considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. The regulation applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in FDA regulations. It covers general provisions, controls for electronic records (both closed and open systems), and requirements for electronic signatures.

What AuditDSS covers

Source

Regulation

Extracted

Rules

Decomposed

Obligations

7.0x

Decomposition ratio

Each rule is decomposed into an average of 7.0 atomic obligations — the smallest testable units that can be independently violated.

Fully extracted & scored

All 70 obligations have been decomposed, titled, risk-scored, and embedded for semantic matching.

Risk scoring

Every obligation in 21 CFR Part 11 is scored across independent risk dimensions:

Obligation Weight

How critical within the regulatory framework

Violation Likelihood

How often breached in practice

Enforcement Evidence

Regulator enforcement history and penalties

Cascade Dependency

How many obligations depend on this one

Regulatory details

Full title: FDA 21 CFR 11
Regulatory body: Food and Drug Administration
Jurisdiction: 🇺🇸 United States
Document type: regulation
Effective date: August 20, 1997
Issuing authority: U.S. Food and Drug Administration (FDA)
Industry: Medical Devices & Diagnostics
Official source: View source document ↗

Who this applies to

pharmaceutical manufacturersmedical device companiesbiotech firmsCROslaboratories

Key requirements

electronic signature controls
audit trail requirements
system validation
access controls
authority checks
device checks
open and closed system controls

Frequently asked questions about 21 CFR Part 11

What is 21 CFR Part 11?

Who does 21 CFR Part 11 apply to?

21 CFR Part 11 applies to pharmaceutical manufacturers, medical device companies, biotech firms, CROs, laboratories.

How many obligations does 21 CFR Part 11 contain?

AuditDSS has decomposed 21 CFR Part 11 into 70 atomic obligations from 10 rules. Each obligation is independently testable and risk-scored.

What are the key requirements of 21 CFR Part 11?

The key requirements include: electronic signature controls, audit trail requirements, system validation, access controls, authority checks, device checks, open and closed system controls.

How can I assess my 21 CFR Part 11 compliance?

Upload your compliance policy to AuditDSS. The platform maps your document against all 70 21 CFR Part 11 obligations using deterministic AI scoring — not checklists or LLM summaries. You get a risk-scored gap analysis showing exactly which obligations are covered, partially covered, or missing.

Which jurisdiction enforces 21 CFR Part 11?

21 CFR Part 11 is enforced in United States by Food and Drug Administration.

When did 21 CFR Part 11 come into effect?

21 CFR Part 11 became effective on August 20, 1997.

What industry does 21 CFR Part 11 apply to?

21 CFR Part 11 is primarily relevant to the Medical Devices & Diagnostics industry. AuditDSS covers 64 regulations in this industry sector.

Build a 21 CFR Part 11 compliance pack

Don't have a compliance policy yet? AuditDSS generates a complete compliance pack for 21 CFR Part 11 — alone or combined with other regulations your business needs. Every clause is mapped to specific obligations.

Policy

High-level commitments and governance framework covering 21 CFR Part 11 requirements.

Procedures

Step-by-step operational procedures to implement each policy commitment.

Forms & checklists

Ready-to-use forms, registers, and checklists for day-to-day compliance operations.

Multi-regulation

Combine 21 CFR Part 11 with other regulations into a single unified compliance pack for your business.

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Upload your document

Upload your compliance policy, program manual, or operational document. AuditDSS accepts any text-based document.

AI maps against 70 obligations

Your document is scored against every obligation in 21 CFR Part 11. Each claim is mapped to the obligation tree and evaluated for coverage.

Risk-scored gap report

Receive every gap ranked by risk priority with remediation guidance, enforcement evidence, and cascade impact analysis.