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

**The primary objective of COPPA is to protect the online privacy of children under 13 by requiring verifiable parental consent before operators collect their personal information.** Enacted in 1998 and effective April 21, 2000, COPPA mandates that operators of commercial websites, online services, mobile apps, and IoT devices directed to children—or with actual knowledge of collecting data from them—post privacy policies, limit data collection to necessities, ensure data security, and grant parents rights to review, delete, and revoke consent [1][2][7].

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

**Operators of commercial websites, online services, mobile apps, and IoT devices that are directed to children under 13 or have actual knowledge of collecting personal information from them must comply with COPPA.** This includes entities collecting or benefiting from such data (e.g., ad networks), with extraterritorial application to services processing U.S. children's data; non-profits are exempt if not commercial [2][3][7][9].

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

**COPPA does not require mandatory external audits or third-party certification for all operators, but participation in FTC-approved safe harbor programs (e.g., iKeepSafe, ESRB) involves self-regulatory audits.** Operators must implement reasonable security procedures and document compliance, with safe harbors providing FTC-approved alternatives to direct enforcement [1][3][7].

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

**COPPA does not prescribe a fixed frequency for assessments, but operators should conduct regular internal reviews, particularly when implementing new features, tracking technologies, or in response to FTC regulatory updates.** Ongoing monitoring is essential due to evolving enforcement, such as post-2013 amendments, and data retention limited to necessities with deletion thereafter [1][7][9].

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

**Non-compliance with COPPA results in civil penalties up to $43,792 per violation enforced by the FTC as unfair or deceptive practices, plus potential state AG actions.** High-profile cases include YouTube's $170 million fine in 2019 for unconsented tracking on child-directed content [3][7].

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

**Yes, COPPA can be mapped to other international frameworks through shared principles like parental consent, data minimization, and child privacy protections.** Its stringent under-13 threshold and verifiable consent mechanisms align with global standards, aiding multinational operators via safe harbors and precedents [2][3][10].

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

**The first step to implement COPPA is to conduct an audience analysis to determine if your service is directed to children under 13 or has actual knowledge of their data collection.** This involves reviewing content appeal (e.g., cartoons, games), behavioral signals, and analytics, followed by posting a comprehensive privacy policy [2][7][10].

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 applies to records created, modified, maintained, archived, retrieved, or transmitted under predicate rules, ensuring authenticity, integrity, and non-repudiation through controls like validation (§11.10(a)), audit trails (§11.10(e)), and access limitations (§11.10(d)).

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-required records, relying on electronic records for regulated activities, submitting accepted electronic records to FDA, or using legally binding electronic signatures must comply.** Per 2003 guidance, this includes life sciences firms maintaining GxP records (e.g., batch records, clinical data); paper printouts relied upon as official records may exclude systems.

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, and inspection readiness (§11.1(e)); FDA verifies during inspections. Organizations must maintain systems, documentation, and records readily available for review.

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

**Assessments for FDA 21 CFR Part 11 should be performed periodically as part of change control, system lifecycle reviews, and risk-based validation maintenance.** FDA 2003 guidance supports ongoing fitness-for-use checks; enforce via SOPs for changes (§11.10(k)), annual reviews, or post-inspection, tied to predicate rules.

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, and fines under predicate rules.** Guidance notes continued enforcement of access controls, signatures, and documentation; violations undermine data integrity, leading to recalls or import alerts.

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 align with frameworks like EU Annex 11.** Organizations often harmonize via risk-based approaches, documenting mappings for global systems while meeting Part 11 predicate requirements.

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 2003 guidance, document in SOPs whether records are Part 11 scope (e.g., relied upon vs. paper official), classifying systems as closed (§11.3(b)(4)) or open (§11.3(b)(9)).

COPPA vs FDA 21 CFR Part 11

Standards Comparison

COPPA

Mandatory

1998

U.S. regulation requiring parental consent for children's online data

FDA 21 CFR Part 11

Mandatory

1997

FDA regulation for electronic records and signatures equivalence

Quick Verdict

COPPA protects children's online privacy via parental consent for websites/apps, while FDA 21 CFR Part 11 ensures electronic records/signatures are trustworthy for life sciences. Companies adopt COPPA for child data compliance, Part 11 for regulatory record equivalence and inspections.

Children Privacy

COPPA

Children's Online Privacy Protection Act (COPPA)

Cost

€€€€

Complexity

High

Implementation Time

6-12 months

Key Features

Verifiable parental consent required for under-13 data collection
Targets operators with child-directed content or actual knowledge
Expansive PII definition includes persistent IDs and geolocation
FTC enforcement with up to $43,792 per-violation fines
Parental rights to access, review, and delete data

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

Secure, time-stamped audit trails for changes
Electronic signatures equivalent to handwritten
Closed and open system controls
Risk-based system validation requirements
Unique access and authority checks

Detailed Analysis

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

COPPA Details

What It Is

Children's Online Privacy Protection Act (COPPA), enacted in 1998 and effective 2000, is a U.S. federal regulation enforced by the FTC. It safeguards children under 13 from unauthorized online personal data collection by commercial websites, apps, and services directed at kids or with actual knowledge of users' age. Primary purpose: empower parents via verifiable consent before any collection, use, or disclosure, using a strict parental-control approach updated in 2013 for modern tracking.

Key Components

Verifiable parental consent (VPC) via 11+ methods (e.g., credit card, video call)
Comprehensive privacy policies and notices
Broad **personal information (PII)names, persistent IDs, geolocation, audio/video
Parental access, review, deletion rights
Data minimization, security, no-conditioning on consent Built on FTC Section 5 unfair practices; safe harbors for self-regulation.

Why Organizations Use It

Mandatory compliance avoids crippling fines ($43,792/violation, e.g., YouTube's $170M). Enhances trust, enables child-safe services globally, mitigates enforcement/reputation risks amid rising kids' online activity. Strategic for edtech, gaming, adtech.

Implementation Overview

Assess child-directed status, post policies, deploy age gates/VPC, secure data. Applies to U.S./foreign operators targeting U.S. kids, all sizes. No certification; FTC audits, optional safe harbors (e.g., ESRB). Key steps: audience analysis, tech integration, audits. Typical for SMBs: 6-12 months.

FDA 21 CFR Part 11 Details

What It Is

FDA 21 CFR Part 11 is a U.S. regulation defining criteria for electronic records and electronic signatures to be trustworthy, reliable, and equivalent to paper records and handwritten signatures. It governs FDA-regulated records in pharma, devices, biologics, using a risk-based approach narrowed by 2003 FDA guidance, applying when electronic records replace or are relied on over paper under predicate rules.

Key Components

Closed systems (§11.10): validation, audit trails, access limits, operational/authority/device checks, training, policies, documentation controls.
Open systems (§11.30): encryption, digital signatures.
Signatures (Subparts B/C): manifestation, linking, uniqueness, multi-component controls (§§11.50-11.300).
Core on data integrity (ALCOA+); compliance via validation, no formal certification.

Why Organizations Use It

Legal compliance for electronic use in regulated activities.
Mitigates enforcement risks (warnings, holds), ensures inspection readiness.
Drives efficiency, quality, non-repudiation; builds stakeholder trust.

Implementation Overview

Phased: scoping, gap analysis, risk assessment, CSV (IQ/OQ/PQ), SOPs, training, vendor governance. For life sciences; FDA audits via inspections.

Key Differences

Aspect	COPPA	FDA 21 CFR Part 11
Scope	Child privacy online data collection under 13	Electronic records/signatures trustworthiness equivalence
Industry	Online services, apps, websites targeting kids	Pharma, biotech, medical devices, life sciences
Nature	Mandatory FTC regulation with civil penalties	Mandatory FDA regulation with enforcement discretion
Testing	Verifiable parental consent mechanisms	Risk-based system validation IQ/OQ/PQ
Penalties	$43,792 per violation, $170M fines	Warning letters, product holds, injunctions

Scope

COPPA

Child privacy online data collection under 13

FDA 21 CFR Part 11

Electronic records/signatures trustworthiness equivalence

Industry

COPPA

Online services, apps, websites targeting kids

FDA 21 CFR Part 11

Pharma, biotech, medical devices, life sciences

Nature

COPPA

Mandatory FTC regulation with civil penalties

FDA 21 CFR Part 11

Mandatory FDA regulation with enforcement discretion

Testing

COPPA

Verifiable parental consent mechanisms

FDA 21 CFR Part 11

Risk-based system validation IQ/OQ/PQ

Penalties

COPPA

$43,792 per violation, $170M fines

FDA 21 CFR Part 11

Warning letters, product holds, injunctions

Frequently Asked Questions

Common questions about COPPA and FDA 21 CFR Part 11

COPPA FAQ

FDA 21 CFR Part 11 FAQ

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COPPA

FDA 21 CFR Part 11

Quick Verdict

COPPA

Key Features

FDA 21 CFR Part 11

Key Features

Detailed Analysis

COPPA 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

COPPA FAQ

What is the primary objective of COPPA?

Who is legally or professionally required to comply with COPPA?

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

How often should an assessment for COPPA be performed?

What are the consequences of non-compliance with COPPA?

Can COPPA be mapped to other international frameworks?

What is the first step to begin implementing COPPA?

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?

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