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.** As stated in §11.1(a), it ensures authenticity, integrity, and, where appropriate, confidentiality of records created, modified, maintained, archived, retrieved, or transmitted under predicate rules. Controls in Subparts B (§§11.10 closed systems, §11.30 open systems) and C (§§11.50–11.300 electronic signatures) support non-repudiation and inspection readiness (§11.1(e)).

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 or signatures under FDA predicate rules, such as those in 21 CFR Parts 211, 820, or 58.** Per §11.1(b), it covers records relied upon in lieu of paper for regulated activities, electronic submissions accepted under docket 92S-0251, or legally binding electronic signatures. The 2003 FDA guidance narrows scope to business reliance; paper printouts relied upon as official records may exclude Part 11 applicability if documented.

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)). Systems and documentation must be available for FDA inspection; the 2003 guidance emphasizes predicate rule enforcement 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; they must occur via change control, periodic reviews, and risk-based validation lifecycle management.** Per §11.10(k), controls over documentation require revision and change procedures; the 2003 guidance supports risk-based approaches with ongoing fitness-for-use checks, especially post-changes or for legacy systems pre-August 20, 1997.

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, or injunctions, as predicate rules remain fully enforceable.** The 2003 guidance notes continued enforcement of access controls (§11.10(d)), checks (§§11.10(f)–(h)), training (§11.10(i)), policies (§11.10(j)), and signatures, leading to data integrity violations and potential civil penalties.

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

**Yes, FDA 21 CFR Part 11 controls can align with other frameworks through shared principles like data integrity and validation, though no formal mapping is required.** Common alignments include risk-based validation (§11.10(a)) and audit trails (§11.10(e)) with ALCOA+ principles; organizations document equivalency in SOPs for global operations.

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 electronic records and assessing business reliance.** Per 2003 FDA guidance, document in SOPs whether records are Part 11 scope (e.g., relied upon electronically vs. paper), classify systems as closed (§11.3(b)(4)) or open (§11.3(b)(9)), and prioritize non-discretionary controls like access (§11.10(d)).

What is the primary objective of **AS9120B**?

**AS9120B's primary objective is to establish a quality management system (QMS) for organizations that procure, store, split, and resell aerospace parts without altering product characteristics.** Built on ISO 9001:2015's 10-clause structure, it adds over 100 aerospace-specific requirements addressing distribution risks like traceability loss, counterfeit parts, documentation errors, and external provider controls to ensure chain-of-custody integrity.

Who is legally or professionally required to comply with **AS9120B**?

**AS9120B applies to stockist distributors, pass-through distributors, and those performing batch splitting in aviation, space, and defense supply chains.** It targets organizations that purchase, store, and resell parts without modification; certification is not legally mandatory but is a commercial requirement from OEMs and primes for supply chain approval, with ~2,442 global certifications as of 2023.

Oes **AS9120B** require an external audit or third-party certification?

**Yes, AS9120B requires third-party certification through accredited bodies following a two-stage audit process per AS9101.** Stage 1 reviews documentation and scope; Stage 2 verifies implementation effectiveness, leading to OASIS listing for visibility. Ongoing surveillance audits ensure continual compliance.

How often should an assessment for **AS9120B** be performed?

**AS9120B requires internal audits at planned intervals to cover all processes annually, plus management reviews at defined intervals.** Assessments include monitoring key metrics (e.g., nonconformities, supplier performance), with full recertification audits every three years and annual surveillance by certification bodies.

What are the consequences of non-compliance with **AS9120B**?

**Non-compliance with AS9120B risks exclusion from OEM supply chains, loss of OASIS listing, and commercial disqualification.** It can lead to audit nonconformities, contract penalties, recalls, reputational damage, and safety liabilities from counterfeit parts or traceability failures, often resulting in major findings during certification.

An **AS9120B** be mapped to other international frameworks?

**AS9120B aligns directly with ISO 9001:2015's high-level structure, enabling seamless mapping of its 10 clauses.** It shares PDCA logic, risk-based thinking, and core processes, allowing integrated QMS implementation while adding aerospace distributor controls like counterfeit prevention.

What is the first step to begin implementing **AS9120B**?

**The first step is conducting a gap analysis against AS9120B clauses using a cross-functional team to assess current processes.** Document scope (Clause 4.3), justify "not applicable" determinations (e.g., 8.3 Design), identify risks, and prioritize distributor-specific gaps like traceability and supplier controls.

FDA 21 CFR Part 11 vs AS9120B

Standards Comparison

FDA 21 CFR Part 11

Mandatory

1997

FDA regulation for trustworthy electronic records and signatures

AS9120B

Mandatory

2016

Aerospace standard for distributors' quality management systems

Quick Verdict

FDA 21 CFR Part 11 mandates electronic records/signatures trustworthiness for life sciences, while AS9120B is a voluntary QMS standard for aerospace distributors ensuring traceability and counterfeit prevention. Organizations adopt Part 11 for FDA compliance; AS9120B for market access and supply chain trust.

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 equivalency of electronic records to paper records
Mandates secure, time-stamped audit trails for changes
Requires risk-based system validation for integrity
Differentiates controls for closed vs open systems
Enforces unique, non-repudiable electronic signatures

Quality Management

AS9120B

AS9120B Quality Management Systems - Requirements

Cost

€€€€

Complexity

High

Implementation Time

6-12 months

Key Features

Counterfeit and suspect parts prevention processes
Traceability and chain-of-custody controls
External provider evaluation and flowdown
Configuration management for distribution
Risk-based operational planning and preservation

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. The risk-based approach, clarified in 2003 guidance, narrows scope to relied-upon electronic records, with enforcement discretion for validation, audit trails, retention, and copies.

Key Components

**Subpart BControls for closed (§11.10) and open (§11.30) systems, including access limits, audit trails, checks, signatures manifestation/linking.
**Subpart CElectronic signature rules (§§11.50-11.300) for uniqueness, multi-component authentication, non-repudiation.
Core principles: authenticity, integrity, confidentiality, accountability. No fixed control count; focuses on system validation, training, policies.
Compliance via risk-based validation (CSV), no formal certification.

Why Organizations Use It

Ensures regulatory acceptance of electronic systems, avoids enforcement actions, supports data integrity for quality decisions. Mitigates risks like warning letters; enables efficiency, inspection readiness, partnerships.

Implementation Overview

Phased: scoping, gap analysis, validation (IQ/OQ/PQ), SOPs/training, ongoing monitoring. Targets pharma, devices, biotech; U.S.-focused but global relevance. Involves audits, supplier governance.

AS9120B Details

What It Is

AS9120B is the IAQG quality management system standard for aerospace distributors, built on ISO 9001:2015's 10-clause structure. It targets organizations procuring, storing, and reselling parts without alteration, emphasizing risk-based thinking to mitigate supply chain hazards like traceability loss and counterfeits.

Key Components

Over 100 aerospace-specific requirements in Clauses 4-10.
Core areas: context analysis, leadership, planning, support, operations (traceability, preservation, counterfeit prevention), evaluation, improvement.
Built on PDCA cycle; requires documented information, not a full manual.
Certification via accredited bodies, OASIS listing.

Why Organizations Use It

Commercial necessity for OEM/Tier-1 approval.
Reduces risks of nonconformities, recalls; builds trust.
Enhances efficiency, market access (2,442 global certifications).

Implementation Overview

6-12 months phased: gap analysis, process design, training, audits.
Applies to aviation/space/defense distributors globally.
Involves cross-functional teams, internal audits, Stage 1/2 certification.

Key Differences

Aspect	FDA 21 CFR Part 11	AS9120B
Scope	Electronic records/signatures trustworthiness	Aerospace distribution QMS/traceability
Industry	Life sciences/pharma/devices US-focused	Aerospace distributors global
Nature	Mandatory FDA regulation/enforcement discretion	Voluntary IAQG certification standard
Testing	Risk-based system validation/audit trails	Internal audits/management reviews/certification
Penalties	Warning letters/product holds/enforcement	Loss of certification/market exclusion

Scope

FDA 21 CFR Part 11

Electronic records/signatures trustworthiness

AS9120B

Aerospace distribution QMS/traceability

Industry

FDA 21 CFR Part 11

Life sciences/pharma/devices US-focused

AS9120B

Aerospace distributors global

Nature

FDA 21 CFR Part 11

Mandatory FDA regulation/enforcement discretion

AS9120B

Voluntary IAQG certification standard

Testing

FDA 21 CFR Part 11

Risk-based system validation/audit trails

AS9120B

Internal audits/management reviews/certification

Penalties

FDA 21 CFR Part 11

Warning letters/product holds/enforcement

AS9120B

Loss of certification/market exclusion

Frequently Asked Questions

Common questions about FDA 21 CFR Part 11 and AS9120B

FDA 21 CFR Part 11 FAQ

AS9120B FAQ

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FDA 21 CFR Part 11

AS9120B

Quick Verdict

FDA 21 CFR Part 11

Key Features

AS9120B

Key Features

Detailed Analysis

FDA 21 CFR Part 11 Details

What It Is

Key Components

Why Organizations Use It

Implementation Overview

AS9120B 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?

AS9120B FAQ

What is the primary objective of AS9120B?

Who is legally or professionally required to comply with AS9120B?

Oes AS9120B require an external audit or third-party certification?

How often should an assessment for AS9120B be performed?

What are the consequences of non-compliance with AS9120B?

An AS9120B be mapped to other international frameworks?

What is the first step to begin implementing AS9120B?

You Might also be Interested in These Articles...

NIST CSF 2.0 Deep Dive: Mastering the Updated Framework Core Functions

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

Step-by-Step Implementation Guide to ISO 27701: Building a Privacy Information Management System (PIMS) on Your ISO 27001 Foundation

Run Maturity Assessments with GRADUM

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GDPR vs ISO 17025

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