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 executed on paper.** Per §11.1(a), it ensures authenticity, integrity, and non-repudiation through controls like validation (§11.10(a)), secure audit trails (§11.10(e)), and signature linking (§11.70), applicable to records created, modified, maintained, archived, retrieved, or transmitted under predicate rules.

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

**FDA 21 CFR Part 11 applies to any organization using electronic records or signatures in lieu of paper for predicate rule-required records, where electronic versions are relied upon for regulated activities, or for FDA-accepted electronic submissions.** This includes pharmaceutical, biotech, medical device, and certain food/veterinary firms under regulations like 21 CFR Parts 211 or 820; paper printouts relied upon as official records are generally excluded per 2003 FDA guidance (§11.1(b)).

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 readily available for FDA review; predicate rules remain enforceable regardless.

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 be conducted periodically via risk-based change control, validation lifecycle reviews, and operational checks (§11.10(f),(k)).** FDA 2003 guidance recommends reassessing scope, reliance decisions, and fitness-for-use during system changes, periodic reviews, or inspections to ensure ongoing compliance with predicate rules.

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, import alerts, or injunctions, as predicate rules remain fully enforceable.** The 2003 guidance notes continued enforcement of access controls (§11.10(d)), signatures (§§11.50–11.300), and data integrity failures, often leading to inadequate investigations or CAPAs.

Can **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 signature non-repudiation align conceptually with frameworks like EU Annex 11, though no formal mapping is required or provided in FDA regulations or guidance.** Organizations often harmonize via risk-based approaches for global operations, focusing on shared principles like ALCOA+ data integrity.

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 as the official record).** Per 2003 FDA guidance, classify systems as closed (§11.3(b)(4)) or open (§11.3(b)(9)), prioritize enforced controls like access (§11.10(d)), and develop SOPs for scope.

What is the primary objective of **ISO 28000**?

**ISO 28000 specifies requirements for establishing, implementing, maintaining, and continually improving a security management system (SMS) with explicit relevance to supply chain security.** It operationalizes a Plan-Do-Check-Act (PDCA) cycle across Clauses 4–10, requiring organizations to assess security risks (malicious acts, disruptions, interdependencies), define scope including external processes, integrate leadership commitment, and ensure performance evaluation through audits and management reviews. The standard emphasizes holistic governance over prescriptive controls, aligning risk treatment with ISO 31000 guidance for value protection in volatile environments.

Who is legally or professionally required to comply with **ISO 28000**?

**ISO 28000 is not legally mandatory but is professionally required for organizations seeking supply chain security assurance, applicable to all types and sizes across sectors.** It targets entities influencing security, such as logistics providers, manufacturers, retailers, ports, and government agencies handling goods transport, storage, or information flows. Compliance arises from contractual "flow-down" requirements, customer demands, insurance incentives, or trade facilitation programs, with top management accountable for SMS integration into business processes.

Does **ISO 28000** require an external audit or third-party certification?

**ISO 28000 requires internal audits at planned intervals but supports optional third-party certification via ISO 28003 guidelines.** Clause 9.2 mandates a risk-based internal audit program to verify SMS conformity and effectiveness, with documented evidence. External certification involves Stage 1 (design review) and Stage 2 (implementation) audits by accredited bodies, followed by surveillance, providing assurance without being compulsory for conformity.

How often should an assessment for **ISO 28000** be performed?

**ISO 28000 requires risk assessments to be maintained continuously, with internal audits and management reviews at planned intervals.** Clause 8.3 demands an ongoing risk assessment and treatment process aligned with ISO 31000, considering changes in context or threats. Clause 9 specifies audits considering process importance and prior results, typically annually or risk-driven, while Clause 9.3 mandates top management reviews at planned intervals to evaluate performance and drive improvements.

What are the consequences of non-compliance with **ISO 28000**?

**Non-compliance with ISO 28000 results in operational vulnerabilities, loss of certification (if pursued), and failure to meet contractual or assurance expectations.** The standard enforces continual improvement via Clause 10, where nonconformities trigger corrective actions with risk-reviewed implementation. Without SMS discipline, organizations face heightened supply chain disruptions, regulatory scrutiny, denied market access, elevated insurance costs, and eroded stakeholder trust from unaddressed risks like theft or sabotage.

Can **ISO 28000** be mapped to other international frameworks?

**Yes, ISO 28000:2022 aligns structurally with ISO management system standards via its PDCA clause structure (Clauses 4–10).** Its bibliography references ISO 31000 for risk processes, ISO 22301 for security plans and resilience, and ISO 19011 for auditing, enabling integrated systems with shared governance, audits, and documentation. Clause 4 incorporates ISO 31000 principles, while Clause 8 enhances ISO 22301 consistency for response and recovery.

What is the first step to begin implementing **ISO 28000**?

**The first step is determining the context of the organization, interested parties, and SMS scope per Clause 4.** This involves mapping internal/external issues (e.g., supply chain dependencies, threats), identifying relevant requirements (legal, regulatory), and documenting boundaries including externally provided processes. This foundational analysis informs risk planning (Clause 6) and ensures tailored, proportionate SMS design.

FDA 21 CFR Part 11 vs ISO 28000

Standards Comparison

FDA 21 CFR Part 11

Mandatory

1997

FDA regulation for trustworthy electronic records and signatures

ISO 28000

Voluntary

2022

International standard for supply chain security management systems

Quick Verdict

FDA 21 CFR Part 11 ensures electronic records/signatures are trustworthy for life sciences compliance, while ISO 28000 builds supply chain security management systems. Pharma firms adopt Part 11 for FDA enforcement; logistics use ISO 28000 for resilience and certification.

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

Establishes equivalence criteria for electronic records to paper
Mandates secure time-stamped audit trails for changes
Requires unique multi-component electronic signatures
Differentiates controls for closed versus open systems
Enforces risk-based validation and access limitations

Supply Chain Security

ISO 28000

ISO 28000:2022 Security management systems — Requirements

Cost

€€€

Complexity

High

Implementation Time

12-18 months

Key Features

Risk-based supply chain security assessment and treatment
PDCA cycle for continual SMS improvement
Controls for external providers and interdependencies
Integration with ISO 31000, 22301, and Annex SL standards
Documented security plans and incident response procedures

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 defining criteria for electronic records and electronic signatures to be trustworthy, reliable, and equivalent to paper records and handwritten signatures. It targets FDA-regulated industries like pharmaceuticals and medical devices using computerized systems for predicate-rule records. Adopts a risk-based approach via 2003 guidance, with enforcement discretion on validation, audit trails, retention, and copies.

Key Components

**SubpartsGeneral provisions, electronic records (closed/open systems), electronic signatures.
Core controls: validation (§11.10(a)), audit trails (§11.10(e)), access limits (§11.10(d)), operational/authority/device checks (§11.10(f)-(h)), signature manifestation/linking (§11.50/11.70), multi-component signatures (§11.200).
Principles: authenticity, integrity, non-repudiation, ALCOA+.
Compliance model: system validation, SOPs, FDA inspection readiness; no third-party certification.

Why Organizations Use It

Ensures legal equivalence for paperless operations.
Mitigates data integrity risks, avoids warning letters.
Enables efficient traceability, faster inspections.
Builds regulator trust, supports digital transformation.

Implementation Overview

Phased: scoping, gap analysis, CSV (IQ/OQ/PQ), training, change control.
Applies to life sciences firms under FDA predicate rules.
Focuses on high-risk systems; ongoing monitoring required.

ISO 28000 Details

What It Is

ISO 28000:2022 is an international certification standard for establishing, implementing, and improving a security management system (SMS) focused on supply chain security. It adopts a risk-based, PDCA (Plan-Do-Check-Act) approach to manage threats like theft, sabotage, and disruptions across organizational processes and external dependencies.

Key Components

Clauses 4-10 cover context, leadership, planning, support, operation, evaluation, and improvement.
Emphasizes risk assessment aligned with ISO 31000, security policies, operational controls, and supplier interdependencies.
Built on harmonized ISO structure for integration; supports third-party certification per ISO 28003.

Why Organizations Use It

Reduces security incidents, ensures compliance with regulations/contracts.
Enhances resilience, insurance benefits, market access, and partner trust.
Provides governance for distributed supply chains in logistics, manufacturing, ports.

Implementation Overview

Phased: gap analysis, risk assessment, controls deployment, audits.
Scalable for all sizes/industries; involves training, documentation, management reviews.
Certification via Stage 1/2 audits by accredited bodies, with surveillance.

Key Differences

Aspect	FDA 21 CFR Part 11	ISO 28000
Scope	Electronic records/signatures trustworthiness	Supply chain security management system
Industry	FDA-regulated life sciences, pharma, devices	Logistics, manufacturing, all supply chains
Nature	Mandatory US FDA regulation	Voluntary international management standard
Testing	Risk-based system validation, audit trails	Internal audits, management reviews, certification
Penalties	Warning letters, enforcement actions	No legal penalties, loss of certification

Scope

FDA 21 CFR Part 11

Electronic records/signatures trustworthiness

ISO 28000

Supply chain security management system

Industry

FDA 21 CFR Part 11

FDA-regulated life sciences, pharma, devices

ISO 28000

Logistics, manufacturing, all supply chains

Nature

FDA 21 CFR Part 11

Mandatory US FDA regulation

ISO 28000

Voluntary international management standard

Testing

FDA 21 CFR Part 11

Risk-based system validation, audit trails

ISO 28000

Internal audits, management reviews, certification

Penalties

FDA 21 CFR Part 11

Warning letters, enforcement actions

ISO 28000

No legal penalties, loss of certification

Frequently Asked Questions

Common questions about FDA 21 CFR Part 11 and ISO 28000

FDA 21 CFR Part 11 FAQ

ISO 28000 FAQ

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FDA 21 CFR Part 11

ISO 28000

Quick Verdict

FDA 21 CFR Part 11

Key Features

ISO 28000

Key Features

Detailed Analysis

FDA 21 CFR Part 11 Details

What It Is

Key Components

Why Organizations Use It

Implementation Overview

ISO 28000 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 28000 FAQ

What is the primary objective of ISO 28000?

Who is legally or professionally required to comply with ISO 28000?

Does ISO 28000 require an external audit or third-party certification?

How often should an assessment for ISO 28000 be performed?

What are the consequences of non-compliance with ISO 28000?

Can ISO 28000 be mapped to other international frameworks?

What is the first step to begin implementing ISO 28000?

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Singapore PDPA Implementation Guide: Mastering Part 6A Breach Notification Thresholds and Timelines from Primary Statute

SOC 2 Audit Survival Guide: 10 Red Flags Auditors Flag and Model Answers for Walkthroughs

Run Maturity Assessments with GRADUM

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