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 (§11.1(a)).** This equivalency enables electronic methods while ensuring authenticity, integrity, availability, and non-repudiation through controls like validation (§11.10(a)), secure audit trails (§11.10(e)), access limitations (§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**?

**FDA 21 CFR Part 11 applies to organizations using electronic records created, modified, maintained, archived, retrieved, or transmitted under FDA predicate rules, or submitted electronically to the FDA (§11.1(b)).** It targets life sciences firms (pharma, biotech, devices) relying on electronic records in lieu of paper for regulated activities, or where electronic versions are relied upon even if paper exists; exclusions apply to certain food records (§11.1(f)–(p)) and paper records transmitted electronically.

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 and documentation 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 prescribe a fixed frequency for assessments; they must occur periodically via risk-based change control, system reviews, and ongoing monitoring to maintain fitness for use.** Validation lifecycle, audit trail reviews, access audits, and periodic reviews align with predicate rules and changes (§11.10(k)); FDA guidance supports risk-based reassessment.

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, and injunctions, as predicate rules remain fully enforceable.** The 2003 guidance notes continued enforcement of access controls, checks, training, signatures, and documentation failures, often tied to data integrity issues in inspections.

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 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.** Mappings focus on shared principles of data integrity and equivalency without formal harmonization.

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) in SOPs or specifications.** FDA's 2003 guidance recommends this narrow scope assessment to identify Part 11 records before applying controls like those in §11.10 for closed systems.

What is the primary objective of **IFS Food**?

**IFS Food's primary objective is to audit product and process compliance ensuring manufacturers produce safe, legal products meeting customer specifications.** Version 8 (mandatory from 1 January 2024) uses a **Product and Process Approach (PPA)** with risk-based product sampling, traceability tests, and at least **50% audit time** in production areas to verify food safety, quality, legality, authenticity, and integrity via HACCP, PRPs, and operational controls like food fraud (4.20) and defense (4.21).

Who is legally or professionally required to comply with **IFS Food**?

**IFS Food applies to food product manufacturers processing food or packing loose products where contamination risk exists.** It is **site-specific** (one legal entity, one address, one certificate), covering all site products/processes with limited exclusions (Annex 4). Primarily demanded by **European retailers** for private-label suppliers; fully outsourced/traded products require **IFS Broker**. Scope must detail products/processes precisely, including partly outsourced activities.

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

**Yes, IFS Food mandates external audits by ISO/IEC 17065-accredited certification bodies using approved auditors.** Audits are annual full-scope (recertification), with **Product and Process Approach (PPA)** including risk-based sampling and traceability tests. Types include initial (after ≥3 months operations), follow-up (for Majors), and extension (for scope changes). Unannounced audits required at least every third audit since 1 January 2021.

How often should an assessment for **IFS Food** be performed?

**IFS Food requires annual full recertification audits covering all requirements.** Internal audits (KO 5.1.1) must cover the full scope yearly, risk-based (e.g., quarterly). Management reviews occur at least annually (1.3). Unannounced audits: at least once every third audit. Follow-up audits within 6 weeks–6 months post-Major; extensions for scope changes within certificate validity.

What are the consequences of non-compliance with **IFS Food**?

**Non-compliance with KO requirements (e.g., governance, CCP monitoring, traceability) or Majors blocks certification (KO D deducts 50%, Major 15%).** Certificate withdrawal occurs for recertification failures (within 2 working days, database notification). Unannounced access denial withdraws certificate immediately. Foundation Level requires ≥75% score; Higher Level ≥95%. Failed follow-up/extension triggers new initial audit.

An **IFS Food** be mapped to other international frameworks?

**Yes, IFS Food Version 8 is GFSI-benchmarked, aligning with schemes like BRCGS, FSSC 22000, and SQF on HACCP, PRPs, and FSMS.** It shares annual audits (vs. FSSC's surveillance/recertification), ISO 17065 accreditation (vs. FSSC's 17021), and scoring (Higher ≥95%, Foundation ≥75%). Differences: IFS emphasizes PPA/traceability; unannounced every third audit. Use for market-access equivalence.

What is the first step to begin implementing **IFS Food**?

**The first step is conducting a comprehensive gap analysis against IFS Food v8 checklist and Doctrine using PPA methodology.** Appoint senior management sponsor, define site-specific scope (all products/processes), contract ISO 17065-accredited body, disclose products/outsourcing/export history. Perform risk-based product sampling/traceability tests; prioritize 10 KO requirements (e.g., traceability 4.18.1, internal audits 5.1.1).

FDA 21 CFR Part 11 vs IFS Food

Standards Comparison

FDA 21 CFR Part 11

Mandatory

1997

FDA regulation for trustworthy electronic records and signatures

IFS Food

Voluntary

2023

Global standard for food safety and quality manufacturing

Quick Verdict

FDA 21 CFR Part 11 mandates electronic record trustworthiness for US-regulated pharma/food firms via validation and signatures. IFS Food certifies food manufacturers' processes for safety/quality through annual audits. Companies adopt Part 11 for FDA compliance; IFS for retailer market access.

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 records to paper
Mandates secure, time-stamped audit trails
Requires unique, non-repudiable electronic signatures
Differentiates controls for closed vs open systems
Enforces risk-based validation and access checks

Food Safety

IFS Food

IFS Food Version 8

Cost

€€€€

Complexity

High

Implementation Time

6-12 months

Key Features

Risk-based Product and Process Approach (PPA)
Minimum 50% on-site audit evaluation time
Traceability tests on risk-based product samples
Knock-Out requirements for critical controls
Food fraud and defense risk assessments

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 narrows scope to relied-upon electronic records, with enforcement discretion on validation, audit trails, retention, and copies.

Key Components

**Subpart AScope, implementation, definitions.
**Subpart BControls for closed (§11.10) and open (§11.30) systems, signature manifestation (§11.50), linking (§11.70).
**Subpart CSignature uniqueness (§11.100), components (§11.200), ID/password controls (§11.300). Core principles include audit trails, access limitations, validation, and non-repudiation. Compliance via documented risk assessments, no formal certification.

Why Organizations Use It

Ensures regulatory acceptance of digital records, mitigates enforcement risks like warning letters, supports data integrity for product quality. Provides efficiency in inspections, partnerships; mandatory for electronic reliance in pharma, devices, biotech.

Implementation Overview

Risk-based scoping, CSV (IQ/OQ/PQ), SOPs, training. Applies to life sciences firms using electronic records; involves vendor governance for SaaS. Ongoing via change control, audits; no external certification but FDA inspection readiness essential.

IFS Food Details

What It Is

IFS Food Version 8 is a GFSI-benchmarked certification standard for auditing product and process compliance in food manufacturing. It focuses on ensuring safe, legal, authentic products meeting customer specifications via a risk-based Product and Process Approach (PPA).

Key Components

Organized into governance, HACCP/PRPs, operational controls, and performance monitoring.
Over 200 checklist requirements with 10 Knock-Out (KO) criteria.
Built on HACCP principles, integrated pest management, and emerging risks like food fraud/defense.
Annual certification with scoring (Higher/Foundation levels) and unannounced audit options.

Why Organizations Use It

Meets European retailer demands for private-label supply chains.
Reduces audit duplication, enhances market access.
Mitigates recalls, fraud risks; builds trust via transparent database.
Drives operational excellence and food safety culture.

Implementation Overview

Phased gap analysis, FSMS design, training, internal audits.
Applies to food processors globally, site-specific.
Requires accredited body audits with ≥50% on-site time.

Key Differences

Aspect	FDA 21 CFR Part 11	IFS Food
Scope	Electronic records/signatures trustworthiness	Food manufacturing safety/quality processes
Industry	Life sciences, pharma, food (US-regulated)	Food manufacturers, packagers (global, Europe-focused)
Nature	Mandatory US FDA regulation	Voluntary GFSI certification standard
Testing	Risk-based system validation, audit trails	Annual on-site audits, traceability tests
Penalties	Warning letters, enforcement actions	Certification denial/withdrawal

Scope

FDA 21 CFR Part 11

Electronic records/signatures trustworthiness

IFS Food

Food manufacturing safety/quality processes

Industry

FDA 21 CFR Part 11

Life sciences, pharma, food (US-regulated)

IFS Food

Food manufacturers, packagers (global, Europe-focused)

Nature

FDA 21 CFR Part 11

Mandatory US FDA regulation

IFS Food

Voluntary GFSI certification standard

Testing

FDA 21 CFR Part 11

Risk-based system validation, audit trails

IFS Food

Annual on-site audits, traceability tests

Penalties

FDA 21 CFR Part 11

Warning letters, enforcement actions

IFS Food

Certification denial/withdrawal

Frequently Asked Questions

Common questions about FDA 21 CFR Part 11 and IFS Food

FDA 21 CFR Part 11 FAQ

IFS Food FAQ

You Might also be Interested in These Articles...

NIST CSF 2.0 Plain English Decoder: Translating Govern, Supply Chain, and Core Functions from Jargon to Actionable Insights

Demystify NIST CSF 2.0 jargon with plain English tables for Govern, Supply Chain & Core Functions. Actionable steps for risk oversight & vendor management. Empo

NIST CSF 2.0 Implementation Tiers Roadmap: Step-by-Step Guide from Partial to Adaptive Cybersecurity Maturity

Master NIST CSF 2.0 Implementation Tiers with a step-by-step roadmap. Assess your tier, build gap analyses, and advance from Partial (Tier 1) to Adaptive (Tier

NIST 800-53 Private Sector ROI Uncovered: 2025 Podcast Deep Dive into Control Family Impact on $10M+ Breach Aversions

Uncover NIST 800-53 ROI in healthcare & finance: RA, SI, IR controls break even after 1-2 incidents ($100K-$10M savings). Podcast deep dive with CISO metrics fo

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

ISO/IEC 42001:2023 vs MLPS 2.0 (Multi-Level Protection Scheme)

Compare ISO/IEC 42001:2023 AI governance vs China's MLPS 2.0 cybersecurity scheme. Discover risks, controls & compliance strategies for global AI success. Dive in now!

RoHS vs AS9120B

Compare RoHS vs AS9120B: Decode hazardous substance limits in EEE vs aerospace distributor QMS for traceability & counterfeit prevention. Ensure compliance—read now!

ISO 56002 vs ISO 28000

ISO 56002 vs ISO 28000: Innovation mgmt guidance vs supply chain security stds. Unpack PDCA alignment, leadership, risks & benefits. Drive excellence now!

FDA 21 CFR Part 11

IFS Food

Quick Verdict

FDA 21 CFR Part 11

Key Features

IFS Food

Key Features

Detailed Analysis

FDA 21 CFR Part 11 Details

What It Is

Key Components

Why Organizations Use It

Implementation Overview

IFS Food 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?

IFS Food FAQ

What is the primary objective of IFS Food?

Who is legally or professionally required to comply with IFS Food?

Does IFS Food require an external audit or third-party certification?

How often should an assessment for IFS Food be performed?

What are the consequences of non-compliance with IFS Food?

An IFS Food be mapped to other international frameworks?

What is the first step to begin implementing IFS Food?

You Might also be Interested in These Articles...

NIST CSF 2.0 Plain English Decoder: Translating Govern, Supply Chain, and Core Functions from Jargon to Actionable Insights

NIST CSF 2.0 Implementation Tiers Roadmap: Step-by-Step Guide from Partial to Adaptive Cybersecurity Maturity

NIST 800-53 Private Sector ROI Uncovered: 2025 Podcast Deep Dive into Control Family Impact on $10M+ Breach Aversions

Run Maturity Assessments with GRADUM

Check out these other Gradum.io Standards Comparison Pages

ISO/IEC 42001:2023 vs MLPS 2.0 (Multi-Level Protection Scheme)

RoHS vs AS9120B

ISO 56002 vs ISO 28000