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)).** It ensures authenticity, integrity, confidentiality (when appropriate), and non-repudiation through controls for closed systems (§11.10) and open systems (§11.30), plus electronic signature requirements in Subparts B and C.

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 requirements, 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 life sciences firms maintaining records under predicate rules like 21 CFR Parts 211 or 820, regardless of company size.

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 validation, SOPs, training records, and inspection readiness (§11.1(e)), with systems and documentation subject to FDA inspection; predicate rules remain enforceable.

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.** FDA’s 2003 guidance supports ongoing fitness-for-use checks, with revalidation triggered by changes affecting accuracy, reliability, or integrity (§11.10(a),(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, or enforcement actions for predicate rule violations.** The 2003 guidance notes continued enforcement of access controls, checks, training, signatures, and documentation failures, potentially leading to import alerts or injunctions.

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 audit trails, access controls, and validation, though Part 11’s narrow scope and enforcement discretion differ; document mappings for harmonized compliance.

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.** Per FDA’s 2003 guidance, document whether electronic records replace paper or are relied upon for regulated activities in SOPs to define scope accurately.

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

**The primary objective of GRI is to provide a global common language for organizations to report their most significant economic, environmental, and social impacts.** GRI Standards enable transparency, accountability, and decision-useful disclosures through a modular system of **Universal Standards** (GRI 1: Foundation 2021, GRI 2: General Disclosures 2021, GRI 3: Material Topics 2021), **Sector Standards**, and **Topic Standards** like GRI 403: Occupational Health and Safety.

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

**No organization is legally required to comply with GRI, as it is a voluntary framework.** However, it is professionally expected for large corporates, multinationals, and listed companies facing stakeholder demands; 96% of G250 firms and 67% of N100 companies use GRI per KPMG 2020 data, especially in high-impact sectors with Sector Standards like Oil & Gas or Mining.

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

**GRI does not require external audit or third-party certification.** It mandates verifiability via the **GRI Content Index**, which lists all disclosures, locations, applied Standards, and omission reasons; assurance is encouraged through principles like accuracy, balance, and verifiability in GRI 1, with GRI 403-8 disclosing internal/external audit coverage percentages.

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

**A materiality assessment under GRI 3 must be performed ongoing, not confined to annual reporting cycles.** The four-step process—understand context, identify impacts, assess significance, prioritize—requires highest governance body oversight and documentation in Disclosures 3-1, 3-2, and 3-3 for each material topic.

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

**Non-compliance with GRI carries no direct penalties, as it is voluntary.** Indirect risks include reputational damage, stakeholder distrust, regulatory misalignment (e.g., with CSRD), and exclusion from investor or procurement preferences due to lack of comparable impact disclosures.

Can **GRI** be mapped to other international frameworks?

**Yes, GRI can be mapped to other international frameworks.** Its impact-centric approach complements investor standards, with joint GRI-SASB guidance enabling shared data; Universal Standards support interoperability for broad stakeholder reporting while Sector/Topic Standards align with sector-specific needs.

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

**The first step to implement GRI is to apply GRI 1: Foundation 2021 to understand “in accordance” requirements and reporting principles.** Follow with GRI 2 general disclosures and GRI 3 materiality assessment, documenting the process, material topics, and management approaches per Disclosure 3-3.

FDA 21 CFR Part 11 vs GRI

Standards Comparison

FDA 21 CFR Part 11

Mandatory

1997

FDA regulation for trustworthy electronic records and signatures

GRI

Voluntary

2021

Global standards for sustainability impact reporting.

Quick Verdict

FDA 21 CFR Part 11 mandates electronic records/signatures equivalence for life sciences compliance, while GRI enables voluntary sustainability impact reporting for all organizations. Companies adopt Part 11 for FDA enforcement avoidance; GRI for stakeholder transparency and benchmarking.

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 criteria for electronic records to paper
Mandates secure, time-stamped audit trails for changes
Requires validation ensuring accuracy and integrity detection
Enforces unique electronic signatures with non-repudiation
Distinguishes controls for closed versus open systems

Sustainability Reporting

GRI

Global Reporting Initiative (GRI) Standards

Cost

€€€€

Complexity

High

Implementation Time

12-18 months

Key Features

Impact-based materiality via structured GRI 3 process
Modular Universal, Sector, and Topic Standards
Mandatory GRI Content Index for traceability
Broad value chain and worker scope coverage
Interoperability with SASB, ISSB, and regulations

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 for validation, audit trails, retention, and legacy systems.

Key Components

**Subpart BControls for closed (§11.10) and open (§11.30) systems, including validation, audit trails, access checks.
**Subpart CElectronic signature requirements (§§11.50-11.300) for uniqueness, manifestation, linking, multi-component controls.
Core principles: authenticity, integrity, non-repudiation; no fixed control count, but enforced access, checks, training, policies.
Compliance via risk-based validation, no formal certification.

Why Organizations Use It

Mandated for electronic reliance in pharma, devices, biologics; mitigates enforcement risks like warning letters; enables paperless efficiency, data integrity, inspection readiness; builds stakeholder trust.

Implementation Overview

Phased: scope predicate records, gap analysis, CSV (IQ/OQ/PQ), SOPs, training; for life sciences globally; ongoing audits, change control; FDA inspections verify.

GRI Details

What It Is

Global Reporting Initiative (GRI) Standards are a modular framework for sustainability reporting. They provide a global common language for organizations to disclose significant economic, environmental, and social impacts. The core approach is impact materiality, requiring identification and prioritization of actual and potential impacts on stakeholders.

Key Components

Universal Standards (GRI 1: Foundation, GRI 2: General Disclosures, GRI 3: Material Topics) as baseline requirements.
Sector Standards for high-impact industries like oil & gas, mining.
Topic Standards (e.g., GRI 403 Occupational Health & Safety, GRI 308 Supplier Environmental Assessment) with specific disclosures.
Built on principles like accuracy, balance, verifiability; compliance via GRI Content Index; no formal certification, but assurance encouraged.

Why Organizations Use It

Meets regulatory alignment (e.g., EU CSRD) and investor demands.
Enhances risk management, benchmarking, stakeholder trust.
Drives governance of impacts, supply chain due diligence, competitive advantage via comparable data.

Implementation Overview

Phased approach: materiality assessment, data systems, management disclosures. Applies to all sizes/industries globally; involves cross-functional teams, no mandatory audit but verifiability key.

Key Differences

Aspect	FDA 21 CFR Part 11	GRI
Scope	Electronic records/signatures trustworthiness	Sustainability impacts on economy/environment/people
Industry	FDA-regulated life sciences (pharma/devices)	All industries/organizations worldwide
Nature	Mandatory US FDA regulation	Voluntary global reporting standards
Testing	Risk-based system validation (IQ/OQ/PQ)	Materiality assessments and disclosures
Penalties	Warning letters, enforcement actions	Reputational damage, no legal penalties

Scope

FDA 21 CFR Part 11

Electronic records/signatures trustworthiness

GRI

Sustainability impacts on economy/environment/people

Industry

FDA 21 CFR Part 11

FDA-regulated life sciences (pharma/devices)

GRI

All industries/organizations worldwide

Nature

FDA 21 CFR Part 11

Mandatory US FDA regulation

GRI

Voluntary global reporting standards

Testing

FDA 21 CFR Part 11

Risk-based system validation (IQ/OQ/PQ)

GRI

Materiality assessments and disclosures

Penalties

FDA 21 CFR Part 11

Warning letters, enforcement actions

GRI

Reputational damage, no legal penalties

Frequently Asked Questions

Common questions about FDA 21 CFR Part 11 and GRI

FDA 21 CFR Part 11 FAQ

GRI FAQ

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FDA 21 CFR Part 11

GRI

Quick Verdict

FDA 21 CFR Part 11

Key Features

GRI

Key Features

Detailed Analysis

FDA 21 CFR Part 11 Details

What It Is

Key Components

Why Organizations Use It

Implementation Overview

GRI 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?

GRI FAQ

What is the primary objective of GRI?

Who is legally or professionally required to comply with GRI?

Does GRI require an external audit or third-party certification?

How often should an assessment for GRI be performed?

What are the consequences of non-compliance with GRI?

Can GRI be mapped to other international frameworks?

What is the first step to begin implementing GRI?

You Might also be Interested in These Articles...

Unpacking the True Cost: A Guide to Calculating TCO for Modern Compliance Monitoring Software

Top 5 Audit Survival Secrets for Your First SOC 2 Type 2: What Auditors Really Check (and How to Pass)

CMMC Level 3 Implementation Guide: Integrating NIST SP 800-172 Enhanced Controls for APT Defense

Run Maturity Assessments with GRADUM

Check out these other Gradum.io Standards Comparison Pages

AS9110C vs ISO 21001

NIST 800-53 vs ISO 14064

PIPL vs ISO 37001