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 Agency considers electronic records and electronic signatures trustworthy, reliable, and equivalent to paper records and handwritten signatures executed on paper (§11.1(a)).** This equivalency enables electronic methods while ensuring authenticity, integrity, confidentiality (when appropriate), and non-repudiation through controls for closed (§11.10) and open systems (§11.30), plus specific 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 rule requirements, or submitted electronically to FDA (§11.1(b)).** This includes pharmaceutical, biotech, medical device, and related firms relying on electronic records in lieu of paper for regulated activities, or where electronic versions are relied upon even if paper exists; electronic signatures intended as legally binding equivalents trigger requirements (§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, SOPs, and inspection readiness (§11.1(e)), with systems, documentation, and records readily available for FDA review; FDA’s 2003 guidance emphasizes enforcement of predicate rules and key controls without mandating external validation.

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; organizations must use a risk-based approach with periodic reviews tied to change control, system lifecycle, and predicate rule needs.** Ongoing monitoring includes operational checks (§11.10(f)), periodic training (§11.10(i)), access reviews, and revalidation for changes; FDA’s 2003 guidance supports risk assessments to ensure fitness for use.

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 enforcement actions including Form 483 observations, warning letters, product holds, recalls, or injunctions, as predicate rules remain fully enforceable.** The 2003 guidance notes continued enforcement of access controls, checks, training, signatures, and documentation; data integrity failures often lead to broader CGMP violations affecting product quality and public health.

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

**Yes, FDA 21 CFR Part 11 control objectives such as audit trails, access controls, and electronic signatures can be mapped to frameworks like EU Annex 11, though Part 11 stands alone with its narrow scope and enforcement discretion per 2003 guidance.** Organizations often harmonize via risk-based approaches for closed/open systems and data integrity (ALCOA+ principles).

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 assessing business reliance on electronic versions versus paper.** Document scope decisions in SOPs (§11.1(b)), classify systems as closed or open (§11.3), and prioritize enforced controls like access limitation (§11.10(d)) and signatures (§11.100).

What is the primary objective of **REACH**?

**The primary objective of REACH is to ensure a high level of protection for human health and the environment from chemical risks while enhancing EU industry competitiveness and promoting alternative testing methods.** REACH (Regulation (EC) No 1907/2006) shifts responsibility to industry for registering substances, evaluating hazards, authorizing SVHCs on Annex XIV, and restricting unacceptable risks via Annex XVII.

Who is legally or professionally required to comply with **REACH**?

**REACH legally requires manufacturers, importers, downstream users, and distributors placing substances, mixtures, or certain articles on the EU/EEA market to comply.** Obligations trigger for substances manufactured or imported >**1 tonne/year per legal entity**; non-EU manufacturers appoint an **Only Representative**. Downstream users must implement exposure scenarios and respond to Article 33 SVHC inquiries within **45 days**.

Does **REACH** require an external audit or third-party certification?

**No, REACH does not require external audits or third-party certification.** Compliance is enforced through Member State inspections coordinated by ECHA's Forum; ECHA conducts dossier evaluations (Articles 40-42), but no certification is issued—dossiers must be maintained via REACH-IT.

How often should an assessment for **REACH** be performed?

**REACH assessments must be performed continuously as a living obligation, with updates triggered by events like tonnage changes, new hazards, Candidate List additions, or Annex updates.** Annual tonnage reviews and immediate dossier/SDS updates ("without delay") are required; recordkeeping spans **10 years** post-cessation.

What are the consequences of non-compliance with **REACH**?

**Non-compliance with REACH results in Member State penalties that must be effective, proportionate, and dissuasive under Article 126.** Outcomes include fines, product seizures, market bans, and potential criminal sanctions; enforcement varies by country via national authorities and ECHA coordination.

Can **REACH** be mapped to other international frameworks?

**Yes, REACH elements such as data requirements and risk assessments can be mapped to other frameworks, though it remains a standalone EU regulation.** Common alignments include hazard classification (CLP/GHS), exposure modeling, and substance tracking, enabling data reuse where confidentiality permits.

What is the first step to begin implementing **REACH**?

**The first step to implement REACH is conducting a gap analysis to inventory substances by legal entity, tonnage (>1 tonne/year), and Annex status.** Prioritize via master substance list, map roles (manufacturer/importer/downstream), and establish governance for IUCLID dossiers and supplier data flows.

FDA 21 CFR Part 11 vs REACH

Standards Comparison

FDA 21 CFR Part 11

Mandatory

1997

FDA regulation for trustworthy electronic records and signatures

REACH

Mandatory

2007

EU regulation for chemical registration, evaluation, authorisation, restriction.

Quick Verdict

FDA 21 CFR Part 11 ensures electronic records' trustworthiness for US life sciences, while REACH mandates chemical risk management for EU market access. Companies adopt Part 11 for FDA compliance and digitized GxP, REACH to legally supply substances and avoid market bans.

Electronic Records

FDA 21 CFR Part 11

21 CFR Part 11: Electronic Records; Electronic Signatures

Cost

€€€€

Complexity

Medium

Implementation Time

18-24 months

Key Features

1. Establishes equivalency criteria for electronic records to paper
2. Mandates secure, time-stamped audit trails for changes
3. Requires unique, linked, non-repudiable electronic signatures
4. Enforces access, authority, operational, and device checks
5. Distinguishes risk-based controls for closed/open systems

Chemical Safety

REACH

Regulation (EC) No 1907/2006 on REACH

Cost

€€€

Complexity

Medium

Implementation Time

18-24 months

Key Features

Industry bears burden for chemical hazard data generation
Registration mandatory above 1 tonne/year per entity
SVHC Candidate List triggers supply-chain notifications
Authorisation regime with sunset dates for high-concern substances
Annex XVII lists EU-wide restrictions and bans

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. federal 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 guidance emphasizing reliance on electronic records.

Key Components

**Subpart AScope, definitions (closed/open systems).
**Subpart BControls (§11.10 closed systems: validation, audit trails, access; §11.30 open systems: encryption/digital signatures).
**Subpart CSignature rules (§11.50-11.300: manifestation, linking, uniqueness, multi-component controls).
Core principles: authenticity, integrity, non-repudiation; no formal certification, but inspection readiness required.

Why Organizations Use It

Mandated for electronic records in pharma, devices, biologics; mitigates enforcement risks (warnings, holds); enables paperless operations, data integrity, faster inspections; builds stakeholder trust via validated systems.

Implementation Overview

Risk-based CSV (GAMP5): scope records, validate (IQ/OQ/PQ), implement controls, train, change control. Applies to life sciences globally; phased (6-24 months); ongoing audits, no external cert but FDA inspections.

REACH Details

What It Is

REACH (Regulation (EC) No 1907/2006) is a directly applicable EU regulation governing Registration, Evaluation, Authorisation and Restriction of Chemicals. Its primary purpose is to ensure a high level of protection for human health and the environment from chemical risks by shifting responsibility to industry for generating and managing safety data. It adopts a risk-based lifecycle approach covering substances, mixtures, and articles.

Key Components

Four pillars: Registration, Evaluation, Authorisation, Restriction.
Detailed annexes (e.g., Annex XIV for Authorisation List, Annex XVII for Restrictions).
Core principles: industry-led data generation, supply-chain communication via Safety Data Sheets (SDS), tonnage-based requirements.
No certification; compliance via dossier submission to ECHA and national enforcement.

Why Organizations Use It

Legal obligation for EU market access (mandatory for >1 tonne/year importers/manufacturers).
Mitigates fines, market bans, recalls; enhances risk management.
Drives substitution, innovation, supply-chain transparency; builds stakeholder trust.

Implementation Overview

Phased: gap analysis, substance inventory, dossier preparation, monitoring.
Applies to chemical-dependent firms across EU/EEA; complex for globals.
Continuous audits, no formal certification but inspection readiness essential.

Key Differences

Aspect	FDA 21 CFR Part 11	REACH
Scope	Electronic records/signatures trustworthiness in FDA-regulated activities	Chemical substance registration, evaluation, authorisation, restriction
Industry	Life sciences, pharma, medical devices (US-focused)	Chemicals, manufacturing, importers across all sectors (EU/EEA)
Nature	US FDA regulation with enforcement discretion	Mandatory EU regulation with national enforcement
Testing	Risk-based system validation, IQ/OQ/PQ	Hazard/exposure testing by tonnage bands, dossier submission
Penalties	Warning letters, product holds, CGMP violations	Fines, market bans, effective/proportionate/dissuasive penalties

Scope

FDA 21 CFR Part 11

Electronic records/signatures trustworthiness in FDA-regulated activities

REACH

Chemical substance registration, evaluation, authorisation, restriction

Industry

FDA 21 CFR Part 11

Life sciences, pharma, medical devices (US-focused)

REACH

Chemicals, manufacturing, importers across all sectors (EU/EEA)

Nature

FDA 21 CFR Part 11

US FDA regulation with enforcement discretion

REACH

Mandatory EU regulation with national enforcement

Testing

FDA 21 CFR Part 11

Risk-based system validation, IQ/OQ/PQ

REACH

Hazard/exposure testing by tonnage bands, dossier submission

Penalties

FDA 21 CFR Part 11

Warning letters, product holds, CGMP violations

REACH

Fines, market bans, effective/proportionate/dissuasive penalties

Frequently Asked Questions

Common questions about FDA 21 CFR Part 11 and REACH

FDA 21 CFR Part 11 FAQ

REACH FAQ

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FDA 21 CFR Part 11

REACH

Quick Verdict

FDA 21 CFR Part 11

Key Features

REACH

Key Features

Detailed Analysis

FDA 21 CFR Part 11 Details

What It Is

Key Components

Why Organizations Use It

Implementation Overview

REACH 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?

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

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

REACH FAQ

What is the primary objective of REACH?

Who is legally or professionally required to comply with REACH?

Does REACH require an external audit or third-party certification?

How often should an assessment for REACH be performed?

What are the consequences of non-compliance with REACH?

Can REACH be mapped to other international frameworks?

What is the first step to begin implementing REACH?

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Top 5 Audit Survival Secrets for Your First SOC 2 Type 2: What Auditors Really Check (and How to Pass)

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