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

**FDA 21 CFR Part 11 establishes criteria under which the Agency 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 limitation (§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**?

**Organizations using electronic records in lieu of paper for predicate-rule-required records, relying on electronic records for regulated activities, submitting accepted electronic records to FDA, or using legally binding electronic signatures must comply (§11.1(b)).** This applies to pharmaceutical, biotech, medical device, and related firms maintaining records under predicate rules like 21 CFR Parts 211 or 820; paper printouts relied upon as official records may exclude Part 11 scope per 2003 guidance.

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)); FDA verifies during inspections, enforcing predicate rules and core provisions like access controls and signatures without mandating external validation.

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

**Part 11 does not prescribe a fixed frequency for assessments; organizations must perform periodic reviews via change control, risk assessments, and inspection readiness activities.** FDA’s 2003 guidance supports risk-based approaches, with ongoing monitoring of systems, audit trails, and predicate rule compliance through lifecycle management and periodic revalidation where changes impact controls (§11.10(k)).

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, recalls, or enforcement actions for predicate rule violations.** Even with enforcement discretion on some elements (e.g., validation, audit trails), failures in enforced controls like access (§11.10(d)) or signatures (§11.100) lead to regulatory action, as records must remain trustworthy.

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

**Yes, FDA 21 CFR Part 11 controls can be mapped to frameworks like EU Annex 11 for computerized systems in GMP environments.** Common alignments include audit trails, validation, access controls, and electronic signatures, enabling harmonized approaches for global operations while satisfying Part 11’s equivalency criteria.

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

**The first step is to establish a formal applicability decision framework mapping predicate rules to records and assessing business reliance on electronic versions.** Document scope decisions in SOPs per 2003 guidance, classifying systems as closed (§11.3(b)(4)) or open (§11.3(b)(9)) to prioritize controls.

What is the primary objective of **ISO 26000**?

**ISO 26000 provides international guidance on social responsibility to help organizations integrate sustainable practices into their operations.** Published in 2010 and confirmed current in 2021, it defines social responsibility as accountability for impacts on society and the environment through transparent, ethical behavior that contributes to sustainable development, respects stakeholder expectations, complies with law, aligns with international norms, and embeds SR throughout the organization.

Who is legally or professionally required to comply with **ISO 26000**?

**No organization is legally required to comply with ISO 26000, as it is voluntary guidance applicable to all types regardless of size, location, or sector.** It targets private, public, and non-profit entities, including SMEs, multinationals, hospitals, schools, and charities, encouraging professional adoption for enhanced sustainability performance and stakeholder trust through its seven principles and core subjects.

Does **ISO 26000** require an external audit or third-party certification?

**No, ISO 26000 explicitly prohibits external audits or third-party certification.** Its Scope states it is not a management system standard, contains no requirements, and any certification claims constitute misrepresentation or misuse, emphasizing self-assessment, stakeholder engagement, and transparent reporting instead.

How often should an assessment for **ISO 26000** be performed?

**ISO 26000 recommends periodic self-assessments at appropriate intervals aligned with organizational needs and stakeholder expectations.** Organizations should review SR performance regularly—typically annually or tied to management reviews—covering objectives, achievements, shortfalls, and improvement plans across the seven core subjects, using tools like materiality assessments and stakeholder dialogue.

What are the consequences of non-compliance with **ISO 26000**?

**There are no direct legal consequences for non-compliance with ISO 26000, as it imposes no mandatory requirements.** Indirect risks include reputational damage, stakeholder distrust, lost market access, and misalignment with international norms, potentially amplifying exposure to related regulations on human rights, labor, or environment.

Can **ISO 26000** be mapped to other international frameworks?

**Yes, ISO 26000 aligns with frameworks like OECD Guidelines, UN Global Compact, GRI, and UN SDGs through official ISO linkage documents.** It complements them by providing practical guidance on seven core subjects and principles, supporting integrated use in management systems via IWA 26:2017 without implying certification.

What is the first step to begin implementing **ISO 26000**?

**The first step is to recognize social responsibility and engage stakeholders per Clause 5 to understand the organization’s impacts and context.** This involves mapping impacts across seven core subjects, identifying relevant issues through dialogue, and prioritizing based on significance to inform governance and integration strategies.

FDA 21 CFR Part 11 vs ISO 26000

Standards Comparison

FDA 21 CFR Part 11

Mandatory

1997

FDA regulation for trustworthy electronic records and signatures

ISO 26000

Voluntary

2010

International guidance standard for social responsibility.

Quick Verdict

FDA 21 CFR Part 11 mandates electronic records/signatures equivalence for life sciences compliance, while ISO 26000 provides voluntary social responsibility guidance for all organizations. Pharma adopts Part 11 for FDA enforcement; others use ISO 26000 for ethical governance and stakeholder trust.

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 electronic records/signatures equivalent to paper
Mandates secure, time-stamped audit trails
Requires closed/open system access controls
Enforces unique multi-component electronic signatures
Applies risk-based enforcement discretion

Social Responsibility

ISO 26000

ISO 26000:2010 Guidance on social responsibility

Cost

€€€

Complexity

High

Implementation Time

12-18 months

Key Features

Seven principles underpinning socially responsible behavior
Seven core subjects covering governance to community development
Stakeholder engagement for issue prioritization
Non-certifiable guidance for all organization types
Integration into existing management systems

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 defining 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 with narrow scope interpretation per 2003 FDA guidance.

Key Components

**SubpartsGeneral provisions, electronic records (closed/open systems), electronic signatures.
Core controls: validation, audit trails, access limits, operational/authority/device checks, training, accountability policies.
~20 key requirements focused on authenticity, integrity, non-repudiation.
Compliance via risk-based validation, no formal certification but FDA inspection enforcement.

Why Organizations Use It

Ensures data integrity for regulated activities, avoids enforcement actions, supports digital transformation. Mandatory for electronic reliance in pharma, devices, biologics; reduces recalls, accelerates inspections, builds stakeholder trust.

Implementation Overview

Phased: scoping, gap analysis, validation (IQ/OQ/PQ), SOPs/training, ongoing monitoring. Targets life sciences; high complexity for mid-large firms; audit readiness via predicate rule alignment.

ISO 26000 Details

What It Is

ISO 26000:2010 is the international guidance standard on social responsibility (SR), providing a voluntary framework for organizations to integrate SR into operations. It applies universally across sectors, sizes, and locations, using a principles-based, stakeholder-engaged approach rather than prescriptive requirements.

Key Components

**Seven principlesAccountability, transparency, ethical behavior, respect for stakeholder interests, rule of law, international norms, human rights.
**Seven core subjectsOrganizational governance, human rights, labor practices, environment, fair operating practices, consumer issues, community involvement.
No certifiable requirements; focuses on holistic integration and self-assessment.

Why Organizations Use It

Enhances sustainability commitment, risk management, and stakeholder trust.
Aligns with SDGs, OECD, GRI; supports ESG reporting without certification burden.
Drives resilience, reputation, and competitive edge via credible SR practices.

Implementation Overview

Phased: materiality assessment, stakeholder engagement, policy integration, training, reporting.
Applicable to all organizations; no audits required, but transparency via ISO Communication Protocol recommended.

Key Differences

Aspect	FDA 21 CFR Part 11	ISO 26000
Scope	Electronic records/signatures trustworthiness	Social responsibility principles/core subjects
Industry	FDA-regulated life sciences/pharma	All organizations/sectors worldwide
Nature	Mandatory US regulation/enforced	Voluntary global guidance/non-certifiable
Testing	Risk-based system validation/audit trails	Self-assessment/stakeholder engagement
Penalties	Warning letters/fines/enforcement	No legal penalties/reputational risk

Scope

FDA 21 CFR Part 11

Electronic records/signatures trustworthiness

ISO 26000

Social responsibility principles/core subjects

Industry

FDA 21 CFR Part 11

FDA-regulated life sciences/pharma

ISO 26000

All organizations/sectors worldwide

Nature

FDA 21 CFR Part 11

Mandatory US regulation/enforced

ISO 26000

Voluntary global guidance/non-certifiable

Testing

FDA 21 CFR Part 11

Risk-based system validation/audit trails

ISO 26000

Self-assessment/stakeholder engagement

Penalties

FDA 21 CFR Part 11

Warning letters/fines/enforcement

ISO 26000

No legal penalties/reputational risk

Frequently Asked Questions

Common questions about FDA 21 CFR Part 11 and ISO 26000

FDA 21 CFR Part 11 FAQ

ISO 26000 FAQ

You Might also be Interested in These Articles...

How to Implement CIS Controls v8.1 as a ‘Control Backbone’ for NIS2 & DORA (Step-by-Step Implementation Guide)

Deploy CIS Controls v8.1 as a control backbone for NIS2 & DORA compliance. Step-by-step roadmap (IG1→IG2), deliverables, metrics & evidence model for hybrid/clo

From Reactive Gatekeeper to Proactive Strategist: How Compliance Software Reshapes the Compliance Professional's Day

Discover how compliance software automates monitoring, delivers real-time insights, and transforms compliance pros from reactive gatekeepers to proactive strate

Your Compliance Command Center: How Modern Tools Orchestrate Cross-Departmental Adherence

Unlock your compliance command center with modern tools for real-time monitoring, automation & integrations across IT, HR, Legal & Finance. Slash non-compliance

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

K-PIPA vs PDPA

K-PIPA vs PDPA: Compare Korea's strict consent rules, CPO mandates & 72h breaches with Singapore/Thailand's flexible principles. Key insights for Asia compliance. Dive in!

UL Certification vs ISO 41001

UL Certification vs ISO 41001: Compare product safety marks (Listed/Recognized) with FM systems for compliance. Boost safety, efficiency & sustainability—discover key differences now!

GDPR vs COPPA

Dive into GDPR vs COPPA: EU's global privacy powerhouse vs US child data shield. Unpack scopes, consent rules, fines & enforcement. Master compliance now!

FDA 21 CFR Part 11

ISO 26000

Quick Verdict

FDA 21 CFR Part 11

Key Features

ISO 26000

Key Features

Detailed Analysis

FDA 21 CFR Part 11 Details

What It Is

Key Components

Why Organizations Use It

Implementation Overview

ISO 26000 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?

ISO 26000 FAQ

What is the primary objective of ISO 26000?

Who is legally or professionally required to comply with ISO 26000?

Does ISO 26000 require an external audit or third-party certification?

How often should an assessment for ISO 26000 be performed?

What are the consequences of non-compliance with ISO 26000?

Can ISO 26000 be mapped to other international frameworks?

What is the first step to begin implementing ISO 26000?

You Might also be Interested in These Articles...

How to Implement CIS Controls v8.1 as a ‘Control Backbone’ for NIS2 & DORA (Step-by-Step Implementation Guide)

From Reactive Gatekeeper to Proactive Strategist: How Compliance Software Reshapes the Compliance Professional's Day

Your Compliance Command Center: How Modern Tools Orchestrate Cross-Departmental Adherence

Run Maturity Assessments with GRADUM

Check out these other Gradum.io Standards Comparison Pages

K-PIPA vs PDPA

UL Certification vs ISO 41001

GDPR vs COPPA