What is the primary objective of **FDA 21 CFR Part 11**?

**The primary objective of FDA 21 CFR Part 11 is to establish criteria under which the FDA considers electronic records and electronic signatures trustworthy, reliable, and equivalent to paper records and handwritten signatures (§11.1(a)).** This equivalency enables electronic methods while ensuring authenticity, integrity, availability, and non-repudiation through controls like validation (§11.10(a)), audit trails (§11.10(e)), access limitations (§11.10(d)), and electronic signature requirements (§§11.50–11.300).

Who is legally or professionally required to comply with **FDA 21 CFR Part 11**?

**FDA 21 CFR Part 11 applies to organizations using electronic records created, modified, maintained, archived, retrieved, or transmitted under predicate rules, or submitted electronically to FDA (§11.1(b)).** This includes pharmaceutical, biotech, medical device, and CRO/CMO firms relying on electronic records in lieu of paper for regulated activities, or using legally binding electronic signatures (§11.100(c)).

Does **FDA 21 CFR Part 11** require an external audit or third-party certification?

**No, FDA 21 CFR Part 11 does not require external audits or third-party certification.** Compliance is demonstrated through internal controls, validation (§11.10(a)), SOPs, training (§11.10(i)), and inspection readiness (§11.1(e)), with systems and documentation available for FDA review. FDA’s 2003 guidance emphasizes predicate rule enforcement over formal certification.

How often should an assessment for **FDA 21 CFR Part 11** be performed?

**FDA 21 CFR Part 11 does not specify a fixed frequency for assessments; they must occur via change control, periodic reviews, and risk-based revalidation to maintain system fitness (§11.10(k)).** Organizations implement ongoing monitoring, such as quarterly audit trail reviews and annual management reviews, tied to predicate rules and operational changes.

What are the consequences of non-compliance with **FDA 21 CFR Part 11**?

**Non-compliance with FDA 21 CFR Part 11 can result in FDA Form 483 observations, warning letters, product holds, import alerts, or injunctions, as predicate rules remain fully enforceable.** The 2003 guidance notes continued enforcement of access controls, checks, training, signatures, and documentation failures, often leading to data integrity violations and CAPA deficiencies.

Can **FDA 21 CFR Part 11** be mapped to other international frameworks?

**FDA 21 CFR Part 11 is not explicitly mapped to other frameworks in its text or 2003 guidance; compliance stands alone based on its criteria.** Organizations may align controls risk-based but must satisfy Part 11’s specific requirements for electronic records/signatures independently of external standards.

What is the first step to begin implementing **FDA 21 CFR Part 11**?

**The first step to implement FDA 21 CFR Part 11 is to establish a formal applicability framework mapping predicate rules to records and documenting reliance decisions (electronic vs. paper) in SOPs.** FDA’s 2003 guidance recommends this narrow scope assessment to identify Part 11 records before applying controls like §11.10 closed/open system safeguards.

What is the primary objective of **EU AI Act**?

**The primary objective of the EU AI Act is to establish a risk-based regulatory framework ensuring AI systems are safe, transparent, and respect fundamental rights across the EU.** Regulation (EU) 2024/1689, effective 1 August 2024, prohibits unacceptable-risk practices (Article 5), imposes lifecycle controls on high-risk systems (Articles 9–15), mandates transparency for limited-risk systems (Article 50), and regulates general-purpose AI models (Chapter V), fostering trust while enabling innovation.

Who is legally or professionally required to comply with **EU AI Act**?

**Providers, deployers, importers, distributors, and authorized representatives of AI systems with outputs used in the EU must comply with the EU AI Act.** Providers develop or place systems on the market (Article 3(3)); deployers are professional users (Article 3(4)). Scope includes third-country entities via extraterritorial reach (Article 2), covering high-risk systems (Annexes I/III) and GPAI models.

Does **EU AI Act** require an external audit or third-party certification?

**High-risk AI systems require conformity assessment, which may involve third-party notified bodies and certification for certain cases.** Article 43 mandates internal (Annex VI) or third-party (Annex VII) assessment; notified bodies (Articles 28–39) issue certificates enabling CE marking (Article 48) and EU database registration (Article 49), especially for Annex III biometrics or law enforcement uses.

How often should an assessment for **EU AI Act** be performed?

**Conformity assessments for high-risk AI systems must be performed before market placement and after substantial modifications, with continuous post-market monitoring.** Article 43 requires pre-market evaluation; Article 72 mandates ongoing monitoring; logs retained at least six months (Article 12); serious incidents reported without delay (Article 73).

What are the consequences of non-compliance with **EU AI Act**?

**Non-compliance with the EU AI Act incurs tiered administrative fines up to 7% of worldwide annual turnover or €40 million for prohibited practices.** Article 99–101 impose up to 7% for Article 5 violations, 4% (€20M) for high-risk obligations, 2% (€10M) for others; includes market bans, CE marking withdrawal, and personal liability.

Can **EU AI Act** be mapped to other international frameworks?

**No, the EU AI Act cannot be directly mapped to other international frameworks in this FAQ, as it must stand alone.** Its unique risk-based structure (prohibited/high/limited/minimal), conformity assessments (Articles 43–49), and GPAI rules (Articles 51–56) require standalone compliance.

What is the first step to begin implementing **EU AI Act**?

**The first step to implement the EU AI Act is to inventory all AI systems and classify them by risk tier.** Map assets to prohibited practices (Article 5), high-risk (Article 6, Annexes I/III), GPAI (Chapter V), or transparency obligations (Article 50), documenting decisions for authority review.

FDA 21 CFR Part 11 vs EU AI Act

Standards Comparison

FDA 21 CFR Part 11

Mandatory

1997

FDA regulation for trustworthy electronic records and signatures

EU AI Act

Mandatory

2024

EU regulation for risk-based AI safety and governance

Quick Verdict

FDA 21 CFR Part 11 ensures trustworthy electronic records for US life sciences, while EU AI Act regulates high-risk AI systems EU-wide with conformity assessments. Companies adopt Part 11 for FDA compliance, AI Act for EU market access and risk mitigation.

Electronic Records

FDA 21 CFR Part 11

21 CFR Part 11: Electronic Records; Electronic Signatures

Cost

€€€€

Complexity

Medium

Implementation Time

12-18 months

Key Features

Establishes equivalency for electronic records and signatures
Mandates secure, time-stamped audit trails for traceability
Requires validation and operational system checks
Enforces unique multi-component electronic signatures
Distinguishes controls for closed and open systems

Artificial Intelligence

EU AI Act

Artificial Intelligence Act (Regulation (EU) 2024/1689)

Cost

€€€

Complexity

Medium

Implementation Time

18-24 months

Key Features

Risk-based four-tier AI classification framework
Prohibitions on unacceptable-risk AI practices
High-risk conformity assessment and CE marking
GPAI model systemic risk obligations
Post-market monitoring and incident reporting

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, employing a risk-based approach narrowed by 2003 guidance with enforcement discretion on select elements.

Key Components

**Subpart BControls for closed (§11.10) and open (§11.30) systems, including validation, audit trails, access limits, checks, and signatures.
**Subpart CElectronic signature requirements for uniqueness, manifestation (§11.50), linking (§11.70), and controls (§11.100-300).
Core principles: authenticity, integrity, non-repudiation; no formal certification, but FDA inspection enforcement.

Why Organizations Use It

Ensures compliance with predicate rules, mitigates data integrity risks, avoids warning letters, enables paperless operations, builds stakeholder trust, and supports efficient inspections.

Implementation Overview

Risk-based scoping, CSV (IQ/OQ/PQ), SOPs, training; phased for pharma/biotech/devices; ongoing via change control, audits; applies globally to U.S.-regulated activities.

EU AI Act Details

What It Is

The EU Artificial Intelligence Act (Regulation (EU) 2024/1689) is a comprehensive regulation providing the world's first horizontal AI framework. It ensures safe, transparent, and rights-respecting AI across sectors via a **risk-based approachprohibiting unacceptable risks, regulating high-risk systems, transparency for limited-risk, and minimal oversight for others.

Key Components

Prohibited practices (Art. 5), high-risk obligations (Ch. III: risk management Art. 9, data governance Art. 10, documentation Arts. 11-13, oversight Art. 14, cybersecurity Art. 15)
GPAI rules (Ch. V), transparency (Ch. IV)
Conformity assessments, CE marking, EU database; lifecycle controls in QMS (Art. 17)

Why Organizations Use It

Mandatory for EU market access, fines up to 7% global turnover
Mitigates risks, builds stakeholder trust, enables compliant innovation
Competitive advantages in high-impact sectors like employment, healthcare

Implementation Overview

Phased (6-36 months): inventory/classify AI, build RMS/QMS, assessments
Global providers/deployers; cross-functional, documentation-intensive; notified bodies for some high-risk

Key Differences

Aspect	FDA 21 CFR Part 11	EU AI Act
Scope	Electronic records/signatures trustworthiness	AI systems risk-based classification
Industry	FDA-regulated life sciences US	All sectors using AI in EU
Nature	Mandatory US FDA regulation	Mandatory EU regulation
Testing	Risk-based system validation	Conformity assessments notified bodies
Penalties	Warning letters enforcement discretion	Fines up to 7% global turnover

Scope

FDA 21 CFR Part 11

Electronic records/signatures trustworthiness

EU AI Act

AI systems risk-based classification

Industry

FDA 21 CFR Part 11

FDA-regulated life sciences US

EU AI Act

All sectors using AI in EU

Nature

FDA 21 CFR Part 11

Mandatory US FDA regulation

EU AI Act

Mandatory EU regulation

Testing

FDA 21 CFR Part 11

Risk-based system validation

EU AI Act

Conformity assessments notified bodies

Penalties

FDA 21 CFR Part 11

Warning letters enforcement discretion

EU AI Act

Fines up to 7% global turnover

Frequently Asked Questions

Common questions about FDA 21 CFR Part 11 and EU AI Act

FDA 21 CFR Part 11 FAQ

EU AI Act FAQ

You Might also be Interested in These Articles...

CMMC Scoping Mastery for Defense Supply Chains: Enclave Mapping, Subcontractor Flow-Down, and CUI Inventory Blueprint

Master CMMC scoping for DIB: delineate FCI/CUI boundaries, segment enclaves, manage subcontractor flow-down. Prevent 80% assessment failures with SSP templates,

Thailand PDPA Implementation Guide: Subordinate Regulations for 72-Hour Breach Reporting and Cross-Border Transfers (2022-2024 Rules)

Step-by-step Thailand PDPA guide: 72-hour breach notifications, cross-border transfers (2022-2024 rules). Risk checklists, GDPR templates avoid THB 5M fines. Mu

Beyond the Boardroom: 5 Ways Modern Compliance Software Elevates Every Department

Discover 5 ways modern compliance software boosts HR, IT, finance & more: automate risks, enhance efficiency, ensure data integrity, stay audit-ready. Elevate y

Run Maturity Assessments with GRADUM

Transform your compliance journey with our AI-powered assessment platform

Assess your organization's maturity across multiple standards and regulations including ISO 27001, DORA, NIS2, NIST, GDPR, and hundreds more. Get actionable insights and track your progress with collaborative, AI-powered evaluations.

100+ Standards & Regulations

AI-Powered Insights

Collaborative Assessments

Actionable Recommendations

Check out these other Gradum.io Standards Comparison Pages

GMP vs ISO 21001

Explore GMP vs ISO 21001: GMP (FDA cGMP) safeguards pharma manufacturing; ISO 21001 boosts educational systems. Key differences, risks, history & strategies for compliance success. (152 characters)

ISO 37001 vs SOX

Discover ISO 37001 vs SOX: Global anti-bribery system meets US financial controls law. Mitigate bribery risks, ensure ICFR—key differences, benefits & implementation guide.

ISO 9001 vs Basel III

Compare ISO 9001 vs Basel III: ISO's QMS for 1M+ certified excellence & PDCA mastery vs Basel's capital buffers, LCR/NSFR for bank resilience. Unlock key diffs!

FDA 21 CFR Part 11

EU AI Act

Quick Verdict

FDA 21 CFR Part 11

Key Features

EU AI Act

Key Features

Detailed Analysis

FDA 21 CFR Part 11 Details

What It Is

Key Components

Why Organizations Use It

Implementation Overview

EU AI Act Details

What It Is

Key Components

Why Organizations Use It

Implementation Overview

Key Differences

Scope

Industry

Nature

Testing

Penalties

Frequently Asked Questions

FDA 21 CFR Part 11 FAQ

What is the primary objective of FDA 21 CFR Part 11?

Who is legally or professionally required to comply with FDA 21 CFR Part 11?

Does FDA 21 CFR Part 11 require an external audit or third-party certification?

How often should an assessment for FDA 21 CFR Part 11 be performed?

What are the consequences of non-compliance with FDA 21 CFR Part 11?

Can FDA 21 CFR Part 11 be mapped to other international frameworks?

What is the first step to begin implementing FDA 21 CFR Part 11?

EU AI Act FAQ

What is the primary objective of EU AI Act?

Who is legally or professionally required to comply with EU AI Act?

Does EU AI Act require an external audit or third-party certification?

How often should an assessment for EU AI Act be performed?

What are the consequences of non-compliance with EU AI Act?

Can EU AI Act be mapped to other international frameworks?

What is the first step to begin implementing EU AI Act?

You Might also be Interested in These Articles...

CMMC Scoping Mastery for Defense Supply Chains: Enclave Mapping, Subcontractor Flow-Down, and CUI Inventory Blueprint

Thailand PDPA Implementation Guide: Subordinate Regulations for 72-Hour Breach Reporting and Cross-Border Transfers (2022-2024 Rules)

Beyond the Boardroom: 5 Ways Modern Compliance Software Elevates Every Department

Run Maturity Assessments with GRADUM

Check out these other Gradum.io Standards Comparison Pages

GMP vs ISO 21001

ISO 37001 vs SOX

ISO 9001 vs Basel III