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 Agency 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 limitation (§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 predicate rules, or electronic records/signatures relied upon for regulated activities (§11.1(b)).** This includes pharmaceutical, biotech, medical device firms, and CROs/CMOs maintaining predicate-rule-required records (e.g., 21 CFR Parts 211, 820) electronically in lieu of paper, or submitting accepted electronic records to FDA.

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. FDA’s 2003 guidance emphasizes risk-based approaches 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 through the system lifecycle via change control, periodic reviews, and risk-based validation (§11.10(a), (k)).** FDA’s 2003 guidance supports ongoing monitoring aligned with predicate rules, including periodic audit trail reviews and revalidation upon changes affecting record integrity or fitness for use.

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 (§11.10(d)), operational checks (§11.10(f)), electronic signatures (§§11.100–11.300)), and inspection readiness (§11.1(e)), with violations often tied to data integrity failures impacting product quality.

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

**FDA 21 CFR Part 11 can be mapped to other frameworks through shared principles of data integrity, validation, and electronic signatures, though it remains distinct.** Organizations often align controls like audit trails and access management with comparable requirements, using risk-based approaches per FDA’s 2003 guidance to demonstrate equivalency without formal crosswalks specified in Part 11.

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.** Per FDA’s 2003 guidance, document scope decisions (e.g., electronic in lieu of paper) in SOPs/specifications to determine Part 11 records, classify systems as closed (§11.3(b)(4)) or open (§11.3(b)(9)), and prioritize risk-based controls.

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

**The primary objective of GLBA is to require financial institutions to explain their information-sharing practices and safeguard consumers’ nonpublic personal information (NPI).** Enacted in 1999, GLBA’s Title V implements this through the **Privacy Rule (16 C.F.R. Part 313)** mandating initial and annual notices plus opt-out rights for certain nonaffiliated third-party sharing, and the **Safeguards Rule (16 C.F.R. Part 314)** requiring a comprehensive written information security program with administrative, technical, and physical safeguards.

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

**GLBA applies to any “financial institution” under FTC jurisdiction that collects or handles NPI, including non-banks like mortgage brokers, payday lenders, debt collectors, tax preparers, and auto dealers arranging financing.** The activity-based definition covers entities offering financial products or services like loans or insurance; exemptions apply to those with fewer than 5,000 customers for some written requirements, but core safeguards remain mandatory.

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

**No, GLBA does not mandate external audits or third-party certification.** The **Safeguards Rule** requires internal risk assessments, vulnerability scans (semi-annually), penetration testing (annually for critical systems), and service provider oversight with due diligence like SOC reports, but enforcement relies on demonstrable evidence such as logs, remediation records, and board reports rather than formal certification.

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

**Risk assessments under GLBA’s Safeguards Rule must be performed periodically, at least annually, and upon material changes in operations, technology, or threats.** Written assessments must inventory NPI, evaluate internal/external risks, define evaluation criteria, and drive control updates; testing includes semi-annual vulnerability scans and annual penetration tests for critical systems.

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

**Non-compliance with GLBA exposes institutions to civil penalties up to $100,000 per violation, $10,000 per violation for individuals, and up to 5 years imprisonment for willful violations.** FTC enforcement examples include Equifax, PayPal, and TaxSlayer cases with multimillion-dollar settlements, plus reputational harm; since May 13, 2024, breaches affecting 500+ consumers require FTC notification within 30 days.

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

**Yes, GLBA’s Safeguards Rule maps directly to frameworks like NIST CSF, NIST SP 800-53, and ISO 27001 for risk assessments, access controls, encryption, and incident response.** Privacy Rule elements align with notice and consent models, enabling integrated programs while standing alone as the U.S. federal baseline for financial NPI protection.

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

**The first step for GLBA implementation is to determine applicability by scoping NPI flows and designating a Qualified Individual to oversee the security program.** Conduct a data inventory across systems/vendors, perform an initial written risk assessment, and establish board reporting to align with Privacy and Safeguards Rules.

FDA 21 CFR Part 11 vs GLBA

Standards Comparison

FDA 21 CFR Part 11

Mandatory

1997

FDA regulation for trustworthy electronic records and signatures

GLBA

Mandatory

1999

U.S. federal law for financial privacy and data safeguards

Quick Verdict

FDA 21 CFR Part 11 ensures electronic records/signatures are trustworthy for life sciences, while GLBA mandates privacy notices and security programs for financial institutions. Companies adopt Part 11 for FDA compliance; GLBA to protect consumer financial data and avoid FTC penalties.

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

1. Establishes equivalency criteria for electronic records and signatures to paper
2. Requires secure, computer-generated, time-stamped audit trails
3. Mandates risk-based system validation for accuracy and integrity
4. Differentiates controls for closed versus open systems
5. Enforces unique, manifested, and linked electronic signatures

Financial Privacy

GLBA

Gramm-Leach-Bliley Act (GLBA)

Cost

€€€€

Complexity

High

Implementation Time

6-12 months

Key Features

Privacy notices and opt-out rights for NPI sharing
Comprehensive Safeguards Rule security program
Qualified Individual designation and board reporting
30-day FTC breach notification for 500+ consumers
Broad scope for non-bank financial institutions

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 setting criteria under which electronic records and electronic signatures are trustworthy, reliable, and equivalent to paper records and handwritten signatures. It targets FDA-regulated industries using electronic systems for predicate-rule records like batch, quality, and submission data. Applies a risk-based, narrow scope per 2003 guidance, focusing on reliance over blanket application.

Key Components

**SubpartsGeneral provisions, electronic records (closed/open systems controls), electronic signatures.
Core controls: validation (§11.10(a)), audit trails (§11.10(e)), access/authority/device checks (§11.10(d)-(h)), training/policies (§11.10(i)-(j)), signature uniqueness/linking (§§11.50-11.300).
Built on ALCOA+ principles; enforcement discretion for some (e.g., audit trails), full enforce on access/signatures. No certification; compliance via inspection readiness.

Why Organizations Use It

Mandatory when relying on electronic records for regulated activities; prevents warnings, holds, recalls. Drives data integrity, efficient investigations/CAPA, paperless operations, stakeholder trust.

Implementation Overview

Risk-based phases: scoping/mapping, CSV (URS/IQ/OQ/PQ), controls deployment, SOPs/training, vendor governance. For pharma/devices/biotech; all sizes; FDA inspections verify.

GLBA Details

What It Is

The Gramm-Leach-Bliley Act (GLBA) is a U.S. federal regulation enacted in 1999. It establishes baseline protections for consumer financial privacy and security, focusing on nonpublic personal information (NPI). GLBA uses a risk-based approach through the Privacy Rule and Safeguards Rule.

Key Components

Privacy Rule (16 C.F.R. Part 313): Initial/annual notices, opt-out for nonaffiliated sharing.
Safeguards Rule (16 C.F.R. Part 314): Comprehensive security program with 9+ elements including risk assessments, Qualified Individual, encryption, MFA, vendor oversight.
**Pretexting provisionsAnti-social engineering protections. Built on transparency, choice, and security; enforced by FTC for non-banks, no formal certification but ongoing compliance.

Why Organizations Use It

Mandatory for financial institutions (broad scope: banks, lenders, tax firms).
Mitigates enforcement risks (fines up to $100K/violation).
Enhances trust, operational resilience, vendor management.

Implementation Overview

Phased: scoping, risk assessment, governance (Qualified Individual, board reports), controls/testing, training. Applies to U.S. financial entities; audits via enforcement exams. (178 words)

Key Differences

Aspect	FDA 21 CFR Part 11	GLBA
Scope	Electronic records/signatures trustworthiness in FDA-regulated activities	Consumer financial privacy notices and information security programs
Industry	Life sciences, pharma, medical devices (US FDA-regulated)	Financial institutions including non-banks (US-wide)
Nature	Mandatory FDA regulation with enforcement discretion	Mandatory federal regulation enforced by FTC/banking regulators
Testing	Risk-based system validation, audit trails	Risk assessments, penetration testing, vulnerability scans
Penalties	Warning letters, product holds, enforcement actions	Civil penalties up to $100K/violation, criminal exposure

Scope

FDA 21 CFR Part 11

Electronic records/signatures trustworthiness in FDA-regulated activities

GLBA

Consumer financial privacy notices and information security programs

Industry

FDA 21 CFR Part 11

Life sciences, pharma, medical devices (US FDA-regulated)

GLBA

Financial institutions including non-banks (US-wide)

Nature

FDA 21 CFR Part 11

Mandatory FDA regulation with enforcement discretion

GLBA

Mandatory federal regulation enforced by FTC/banking regulators

Testing

FDA 21 CFR Part 11

Risk-based system validation, audit trails

GLBA

Risk assessments, penetration testing, vulnerability scans

Penalties

FDA 21 CFR Part 11

Warning letters, product holds, enforcement actions

GLBA

Civil penalties up to $100K/violation, criminal exposure

Frequently Asked Questions

Common questions about FDA 21 CFR Part 11 and GLBA

FDA 21 CFR Part 11 FAQ

GLBA FAQ

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FDA 21 CFR Part 11

GLBA

Quick Verdict

FDA 21 CFR Part 11

Key Features

GLBA

Key Features

Detailed Analysis

FDA 21 CFR Part 11 Details

What It Is

Key Components

Why Organizations Use It

Implementation Overview

GLBA 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?

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

What is the first step to begin implementing FDA 21 CFR Part 11?

GLBA FAQ

What is the primary objective of GLBA?

Who is legally or professionally required to comply with GLBA?

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

How often should an assessment for GLBA be performed?

What are the consequences of non-compliance with GLBA?

Can GLBA be mapped to other international frameworks?

What is the first step to begin implementing GLBA?

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Beyond the Burden: How Intuitive Compliance Software Transforms Daily Workflows

PDPA Cross-Border Transfer Rules Decoded: Singapore, Thailand, and Taiwan Mechanisms Compared with Practical Implementation Templates

Why applying the NIST CSF Standard is a Life-Saver!

Run Maturity Assessments with GRADUM

Check out these other Gradum.io Standards Comparison Pages

Six Sigma vs K-PIPA

Six Sigma vs ISO 26000

IEC 62443 vs BREEAM