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

**The primary objective of LGPD (Lei Geral de Proteção de Dados Pessoais, Law No. 13.709/2018) is to protect the fundamental rights of privacy and freedom of natural persons through comprehensive regulation of personal data processing.** Enacted August 14, 2018, it unifies fragmented norms, mandating 10 core principles (Art. 6)—including purpose limitation, necessity, transparency, security, prevention, non-discrimination, and accountability—to govern controllers and processors. LGPD applies extraterritorially (Art. 3) to any processing in Brazil, targeting Brazilian residents, or collecting data therein, exempting only anonymized data (Art. 12) if irreversible.

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

**All controllers and processors handling personal data of identified or identifiable natural persons located in Brazil must comply with LGPD, regardless of organization size or location.** No employee/revenue thresholds exist; scope covers public/private entities in sectors like e-commerce, fintech, healthcare, and cloud services (Art. 1). Controllers decide purposes/means (Art. 5, VI); processors execute instructions (Art. 5, VII). Extraterritorial reach mandates global firms adapt, with DPO appointment required for controllers (Art. 41, public disclosure).

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

**LGPD does not mandate external audits or third-party certification.** The **Autoridade Nacional de Proteção de Dados (ANPD)** conducts audits (Art. 55), requesting records, DPIAs, and reports on demand. Controllers must maintain Records of Processing Activities (Art. 37, simplified for small entities per CD/ANPD 02/2022) and demonstrate compliance via internal governance, security measures, and incident logs (5 years).

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

**LGPD requires ongoing assessments, with DPIAs mandatory for high-risk processing like legitimate interests or large-scale sensitive data (Art. 38), performed before initiation and updated as needed.** ANPD guidance (e.g., CD/ANPD 15/2024) implies quarterly internal reviews of Records of Processing Activities, annual risk audits, and ad-hoc for changes, incidents, or ANPD requests to ensure principles like minimization and accountability.

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

**Non-compliance with LGPD triggers graduated ANPD sanctions, including fines up to 2% of Brazilian revenue (capped at R$50 million per infraction), data processing suspension (up to 6 months, extendable), deletion/blocking, and publicity (Art. 52-53).** Factors include gravity, cooperation, and safeguards; applies to B2B/employee data. Civil claims for damages (Art. 42) and reputational harm follow.

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

**Yes, LGPD maps closely to international frameworks due to shared principles, rights, and extraterritoriality, enabling hybrid compliance programs.** Its 10 principles expand on common ones (purpose limitation, minimization); 10 legal bases offer flexibility; data subject rights mirror standards. Multinationals leverage overlaps for efficiency, adapting nuances like Brazil revenue-based fines.

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

**The first step to implement LGPD is appointing a Data Protection Officer (DPO) and conducting data mapping to create a Record of Processing Activities (RoPA).** Secure executive sponsorship, inventory data flows/purposes/bases (Art. 37), identify sensitive data/high-risk activities, and prioritize governance per phased methodology.

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, confidentiality (when appropriate), and non-repudiation through controls like validation (§11.10(a)), audit trails (§11.10(e)), and signature linking (§11.70).

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 submitted electronically to FDA (§11.1(b)).** This includes life sciences firms relying on electronic records in lieu of paper for regulated activities, such as batch records or submissions accepted under docket 92S-0251; paper printouts relied upon as official records generally fall outside scope 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 (§11.10(a)), SOPs, training (§11.10(i)), and inspection readiness (§11.1(e)), with systems and documentation subject to FDA inspection; predicate rules remain enforceable regardless of enforcement discretion.

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 risk-based periodic reviews tied to change control, system lifecycle, and predicate rules.** This includes reassessing scope reliance, validating changes (§11.10(k)(2)), reviewing audit trails, and ensuring fitness-for-use, with annual management reviews recommended for sustained compliance.

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.** Data integrity failures often lead to inadequate investigations, CAPA issues, recalls, and civil penalties up to $10,000 per violation, with systems subject to inspection (§11.1(e)).

An **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 direct equivalency is not guaranteed and requires risk-based analysis.** Organizations document alignments for harmonized compliance, focusing on shared principles of data integrity and trustworthiness.

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 scope decisions in SOPs (per 2003 guidance), classify systems as closed (§11.3(b)(4)) or open (§11.3(b)(9)), and prioritize non-discretionary controls like access limitation (§11.10(d)).

LGPD vs FDA 21 CFR Part 11

Standards Comparison

LGPD

Mandatory

2020

Brazil's comprehensive regulation for personal data protection

FDA 21 CFR Part 11

Mandatory

1997

FDA regulation for trustworthy electronic records and signatures

Quick Verdict

LGPD mandates comprehensive personal data protection for Brazilian residents across industries, while FDA 21 CFR Part 11 ensures electronic records' trustworthiness in life sciences. Companies adopt LGPD for Brazil compliance and Part 11 for FDA-regulated electronic equivalence.

Data Privacy

LGPD

Lei Geral de Proteção de Dados Pessoais (Law 13.709/2018)

Cost

€€€€

Complexity

High

Implementation Time

12-18 months

Key Features

Extraterritorial scope for Brazilian residents' data worldwide
10 core principles including prevention and non-discrimination
Fines up to 2% Brazilian revenue capped at R$50M
Mandatory DPO appointment and public disclosure for controllers
3-business-day breach notifications to ANPD and subjects

Electronic Records

FDA 21 CFR Part 11

21 CFR Part 11, Electronic Records; Electronic Signatures

Cost

€€€€

Complexity

High

Implementation Time

12-18 months

Key Features

Equivalency criteria for electronic records to paper
Closed/open system controls with encryption
Secure time-stamped computer-generated audit trails
Multi-component unique electronic signatures
Risk-based validation and enforcement discretion

Detailed Analysis

A comprehensive look at the specific requirements, scope, and impact of each standard.

LGPD Details

What It Is

Lei Geral de Proteção de Dados Pessoais (LGPD), Law No. 13.709/2018, is Brazil's comprehensive data protection regulation. Enacted in 2018 and enforced since 2021, it safeguards personal data with a risk-based approach, applying extraterritorially to any processing targeting Brazilian residents.

Key Components

**10 core principlespurpose limitation, necessity, transparency, security, accountability, and unique additions like prevention/non-discrimination.
10 legal bases for processing, including consent, contracts, legitimate interests.
**Data subject rightsaccess, correction, deletion, portability, anonymization.
ANPD enforcement via audits, graduated sanctions up to 2% revenue (R$50M cap).

Why Organizations Use It

Legal compliance avoids multimillion fines, operational halts.
Enhances trust, reputation in Brazil's digital economy.
Mitigates breach risks with 3-day notifications.
Enables cross-border transfers via SCCs by 2025, competitive advantages.

Implementation Overview

**Phased risk-based methodologygovernance/DPO appointment, data mapping/RoPA, policies/controls, DSR/incident processes, audits.
Applies to all sizes/industries processing Brazilian data; no certification but ANPD oversight.

FDA 21 CFR Part 11 Details

What It Is

FDA 21 CFR Part 11 is a U.S. federal regulation setting criteria for electronic records and electronic signatures to be trustworthy, reliable, and equivalent to paper records and handwritten signatures. It targets FDA-regulated industries like pharmaceuticals, biotech, and medical devices using electronic systems for predicate-rule records. Employs a risk-based approach per 2003 FDA guidance, narrowing scope to relied-upon electronic records.

Key Components

**Subpart AScope, implementation, definitions (closed/open systems).
**Subpart BRecord controls (validation, audit trails, access, copies; §11.10/11.30).
**Subpart CSignature controls (manifestation, linking, uniqueness; §11.50-11.300). Built on authenticity, integrity, non-repudiation principles; ~20 core controls; compliance via FDA inspection, no certification.

Why Organizations Use It

Meets predicate rule obligations, avoids enforcement (warnings, holds).
Ensures data integrity, supports investigations/CAPA.
Enables efficient paperless operations, faster approvals.
Builds inspector confidence, competitive edge in regulated markets.

Implementation Overview

Phased risk-based: scope records/systems, CSV (IQ/OQ/PQ), controls/SOPs/training, vendor governance. For mid-large FDA-impacted firms (U.S./global); ongoing change control, audits. (178 words)

Key Differences

Aspect	LGPD	FDA 21 CFR Part 11
Scope	Personal data processing, rights, transfers	Electronic records/signatures equivalence
Industry	All sectors, Brazil residents, extraterritorial	Life sciences, FDA-regulated products, US
Nature	Mandatory comprehensive data protection law	Regulation for electronic record trustworthiness
Testing	DPIAs for high-risk, ANPD audits	Risk-based system validation IQ/OQ/PQ
Penalties	2% Brazilian revenue fines, up to R$50M	Warning letters, product holds, injunctions

Scope

LGPD

Personal data processing, rights, transfers

FDA 21 CFR Part 11

Electronic records/signatures equivalence

Industry

LGPD

All sectors, Brazil residents, extraterritorial

FDA 21 CFR Part 11

Life sciences, FDA-regulated products, US

Nature

LGPD

Mandatory comprehensive data protection law

FDA 21 CFR Part 11

Regulation for electronic record trustworthiness

Testing

LGPD

DPIAs for high-risk, ANPD audits

FDA 21 CFR Part 11

Risk-based system validation IQ/OQ/PQ

Penalties

LGPD

2% Brazilian revenue fines, up to R$50M

FDA 21 CFR Part 11

Warning letters, product holds, injunctions

Frequently Asked Questions

Common questions about LGPD and FDA 21 CFR Part 11

LGPD FAQ

FDA 21 CFR Part 11 FAQ

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LGPD

FDA 21 CFR Part 11

Quick Verdict

LGPD

Key Features

FDA 21 CFR Part 11

Key Features

Detailed Analysis

LGPD Details

What It Is

Key Components

Why Organizations Use It

Implementation Overview

FDA 21 CFR Part 11 Details

What It Is

Key Components

Why Organizations Use It

Implementation Overview

Key Differences

Scope

Industry

Nature

Testing

Penalties

Frequently Asked Questions

LGPD FAQ

What is the primary objective of LGPD?

Who is legally or professionally required to comply with LGPD?

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

How often should an assessment for LGPD be performed?

What are the consequences of non-compliance with LGPD?

An LGPD be mapped to other international frameworks?

What is the first step to begin implementing LGPD?

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?

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

The Tool Landscape for Reaching and Maintaining ISO 27001 Compliance

Run Maturity Assessments with GRADUM

Check out these other Gradum.io Standards Comparison Pages

CSA vs SAMA CSF

HITRUST CSF vs IATF 16949

LGPD vs CIS Controls