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, and non-repudiation through controls for closed (§11.10) and open systems (§11.30), plus 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 relied upon for regulated activities (§11.1(b)).** This includes pharmaceutical, biotech, medical device, and CRO/CMO firms where electronic records replace paper or are the record of record; paper printouts relied upon exclusively may exclude systems 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 key provisions like access controls and signatures without mandating external validation.

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

**FDA 21 CFR Part 11 does not prescribe a fixed frequency for assessments; organizations must perform periodic reviews via change control, risk assessments, and operational checks (§11.10(f)–(k)).** Best practice ties reassessments to system changes, annual management reviews, or predicate rule timelines, ensuring ongoing fitness for use per 2003 guidance.

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 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 trigger actions affecting product quality and safety.

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 electronic records and signatures.** Common alignments include validation, audit trails, access controls, and data integrity (ALCOA+), enabling harmonized GxP compliance; however, Part 11 scope is narrower per 2003 guidance, focusing on FDA predicate rules.

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.** Document decisions in SOPs (per 2003 guidance) to define scope, classify systems as closed/open, and prioritize risk-based controls like access and signatures.

What is the primary objective of **FSSC 22000**?

**The primary objective of FSSC 22000 is to provide independent third-party certification of Food Safety Management Systems (FSMS) ensuring organizations consistently provide safe food across food chain categories.** It combines **ISO 22000:2018**, sector-specific **PRPs** (e.g., **ISO/TS 22002-1** for manufacturing), and **FSSC Additional Requirements** like food defense and allergen management. This GFSI-benchmarked scheme (since 2010) supports supply-chain trust via a public register of 40,059 certified sites.

Who is legally or professionally required to comply with **FSSC 22000**?

**FSSC 22000 is not legally mandatory but professionally required by retailers, manufacturers, and foodservice operators for supply-chain participation.** It applies to **ISO 22003-1:2022** categories B–K, including food manufacturing (C), packaging (I), transport/storage (G), catering (E), and brokers (FII). Over 134 licensed Certification Bodies enforce it for market access.

Does **FSSC 22000** require an external audit or third-party certification?

**Yes, FSSC 22000 mandates external audits and third-party certification by licensed Certification Bodies per ISO/IEC 17021-1:2015 and ISO 22003-1:2022.** Initial certification includes Stage 1 (readiness) and Stage 2 (implementation), with at least 50% audit time on operational PRPs and controls. Certificates are issued for 3 years with annual surveillance.

How often should an assessment for **FSSC 22000** be performed?

**FSSC 22000 requires annual surveillance audits and full recertification every 3 years by licensed Certification Bodies.** Internal audits must cover the full FSMS at least annually, including **PRP verification** (e.g., monthly site inspections) and management reviews. Certified sites notify CBs of serious events within **3 working days**.

What are the consequences of non-compliance with **FSSC 22000**?

**Non-compliance with FSSC 22000 results in nonconformity classification, mandatory corrective actions, potential certificate suspension or withdrawal, and removal from the public register.** Severe issues trigger BoS reviews; repeat failures lead to CB blacklisting. Market impacts include supply-chain de-listing and lost GFSI recognition.

Can **FSSC 22000** be mapped to other international frameworks?

**Yes, FSSC 22000 maps directly to ISO 22000:2018 clauses 4–10 and integrates with ISO-based systems via its harmonized structure.** PRP standards like **ISO/TS 22002-x** align with sector GMPs; Additional Requirements support quality (e.g., **2.5.9**) and culture objectives, enabling shared audits and processes without cross-references.

What is the first step to begin implementing **FSSC 22000**?

**The first step to implement FSSC 22000 is to define the certification scope per ISO 22003-1:2022 categories and conduct a gap analysis against ISO 22000:2018, applicable PRPs, and Additional Requirements.** Download free Scheme Parts 1–5 from Foundation FSSC, classify activities (e.g., C for manufacturing), and convene leadership for context analysis (Clause 4).

FDA 21 CFR Part 11 vs FSSC 22000

Standards Comparison

FDA 21 CFR Part 11

Mandatory

1997

FDA regulation for electronic records and signatures equivalency

FSSC 22000

Voluntary

2023

GFSI-benchmarked certification scheme for food safety management.

Quick Verdict

FDA 21 CFR Part 11 mandates electronic record integrity for regulated industries, while FSSC 22000 certifies food safety systems globally. Companies adopt Part 11 for FDA compliance, FSSC 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

12-18 months

Key Features

Establishes equivalency of electronic to paper records
Requires secure, computer-generated audit trails
Differentiates controls for closed and open systems
Mandates unique, linked electronic signatures
Enforces access, authority, and device checks

Food Safety

FSSC 22000

Food Safety System Certification 22000

Cost

€€€€

Complexity

High

Implementation Time

6-12 months

Key Features

Integrates ISO 22000 with sector-specific PRPs
GFSI-benchmarked for global supply chain recognition
Mandates food defense and fraud mitigation plans
Requires allergen management validation and verification
Enforces operational audits with PRP verification

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 records relied upon electronically, with enforcement discretion for validation, audit trails, retention, and legacy systems.

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); signature linking.
**Subpart CSignature uniqueness, multi-component controls, non-repudiation. Built on ALCOA+ principles; no certification, but inspection readiness required.

Why Organizations Use It

Ensures data integrity for compliance; mitigates enforcement risks (warnings, holds); enables paperless efficiency, faster inspections, quality improvements. Mandatory for electronic reliance in pharma, devices, biologics.

Implementation Overview

Risk-based CSV (GAMP5): scope records, validate systems (IQ/OQ/PQ), implement controls, train personnel, govern vendors. Phased: gap analysis, design, validation, go-live, monitoring. Targets life sciences; audited via FDA inspections.

FSSC 22000 Details

What It Is

FSSC 22000 (Food Safety System Certification 22000) is a GFSI-benchmarked certification scheme for Food Safety Management Systems (FSMS) across food chain categories like manufacturing, packaging, and logistics. It uses a risk-based PDCA approach integrating ISO standards, PRPs, and additional controls.

Key Components

ISO 22000:2018 for FSMS clauses 4–10
Sector-specific PRPs (e.g., ISO/TS 22002-1 manufacturing)
FSSC Additional Requirements (17 total: food defense, allergens, culture) Built on HACCP principles; requires third-party audits per ISO 22003-1.

Why Organizations Use It

Meets retailer mandates and regulatory alignment
Reduces recall risks, fraud, and contamination
Enhances global market access and trust
Supports quality integration and SDGs

Implementation Overview

Phased: gap analysis, FSMS design, PRP/HACCP rollout, training, audits. Suits food sector firms; 6–24 months typical. Includes Stage 1/2 certification, surveillance.

Key Differences

Aspect	FDA 21 CFR Part 11	FSSC 22000
Scope	Electronic records/signatures trustworthiness	Food safety management systems, PRPs, HACCP
Industry	FDA-regulated pharma, devices, some food	Global food chain manufacturing, packaging, logistics
Nature	Mandatory US FDA regulation	Voluntary GFSI-benchmarked certification scheme
Testing	Risk-based system validation, audit trails	ISO audits, PRP verification, surveillance cycles
Penalties	Warning letters, enforcement actions	Loss of certification, market access denial

Scope

FDA 21 CFR Part 11

Electronic records/signatures trustworthiness

FSSC 22000

Food safety management systems, PRPs, HACCP

Industry

FDA 21 CFR Part 11

FDA-regulated pharma, devices, some food

FSSC 22000

Global food chain manufacturing, packaging, logistics

Nature

FDA 21 CFR Part 11

Mandatory US FDA regulation

FSSC 22000

Voluntary GFSI-benchmarked certification scheme

Testing

FDA 21 CFR Part 11

Risk-based system validation, audit trails

FSSC 22000

ISO audits, PRP verification, surveillance cycles

Penalties

FDA 21 CFR Part 11

Warning letters, enforcement actions

FSSC 22000

Loss of certification, market access denial

Frequently Asked Questions

Common questions about FDA 21 CFR Part 11 and FSSC 22000

FDA 21 CFR Part 11 FAQ

FSSC 22000 FAQ

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FDA 21 CFR Part 11

FSSC 22000

Quick Verdict

FDA 21 CFR Part 11

Key Features

FSSC 22000

Key Features

Detailed Analysis

FDA 21 CFR Part 11 Details

What It Is

Key Components

Why Organizations Use It

Implementation Overview

FSSC 22000 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?

FSSC 22000 FAQ

What is the primary objective of FSSC 22000?

Who is legally or professionally required to comply with FSSC 22000?

Does FSSC 22000 require an external audit or third-party certification?

How often should an assessment for FSSC 22000 be performed?

What are the consequences of non-compliance with FSSC 22000?

Can FSSC 22000 be mapped to other international frameworks?

What is the first step to begin implementing FSSC 22000?

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