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

**The primary objective of CCPA is to grant California residents enforceable rights over their personal information held by qualifying businesses.** Enacted in 2018 and effective January 1, 2020, as amended by CPRA effective January 1, 2023, it establishes consumer rights to know, delete, opt-out of sales/sharing, correct, and limit use of sensitive personal information, alongside business obligations for notices, data inventories, and reasonable security.

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

**For-profit businesses doing business in California must comply if they meet any applicability threshold in the preceding calendar year.** Thresholds include annual gross revenues exceeding **$25 million** (adjusted to $26.625 million in 2025), buying/selling/sharing personal information of **100,000+** California consumers/households/devices annually (updated from original 50,000 by CPRA), or deriving **50%+** of revenue from selling/sharing personal information; applies extraterritorially to entities processing California residents' data.

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

**No, CCPA does not mandate external audits or third-party certification.** Businesses must conduct internal assessments, implement reasonable security, and maintain records of compliance activities like data inventories and vendor contracts; high-revenue entities disclose request metrics publicly, but enforcement relies on CPPA/AG investigations, subpoenas, and self-reported practices without required certifications.

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

**CCPA assessments should be performed annually to confirm applicability thresholds and compliance gaps.** Thresholds (revenue, data volume, sales/sharing revenue) are evaluated based on the preceding calendar year; ongoing monitoring includes periodic data mapping, vendor audits, and program reviews every 6-12 months to address regulatory updates, business changes, and CPRA evolutions like risk assessments by 2026 for high-risk processing.

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

**Non-compliance with CCPA incurs administrative fines of up to **$2,500** per unintentional violation and **$7,500** per intentional violation (adjusted to $2,663/$7,988 in 2025), with higher penalties for minors' data.** CPPA and Attorney General enforce via subpoenas and 30-day cure notices; private right of action for certain unencrypted breaches awards **$100-$750** per consumer per incident, as in Zoom's $85M and Sephora's $1.2M settlements, plus reputational and operational costs.

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

**Yes, CCPA consumer rights and controls map closely to GDPR's data subject rights and processing safeguards.** CCPA's know/delete/opt-out/correct/limit sensitive PI align with GDPR Articles 15-22; data minimization, purpose limitation, and vendor contracts mirror GDPR requirements, enabling shared data inventories, DSAR workflows, and security measures for multi-jurisdictional programs.

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

**The first step is conducting a legal applicability assessment against CCPA thresholds and mapping personal information flows.** Evaluate revenue (> **$25M**), data volume (> **100,000** CA consumers/households/devices), or revenue from sales/sharing (> **50%**); create a data inventory identifying PI categories, storage, flows, retention, and recipients to prioritize gaps in notices, requests, and vendor controls.

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 (as appropriate), and non-repudiation through controls like validation (§11.10(a)), audit trails (§11.10(e)), access limitations (§11.10(d)), 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 pharmaceutical, biotech, medical device, and CRO/CMO firms relying on electronic records in lieu of paper for regulated activities; paper printouts relied upon as official records may fall outside scope per 2003 guidance.

Oes **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, enforcing predicate rules and core provisions like access controls and signatures 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; organizations must perform risk-based periodic reviews tied to change control, system lifecycle, and predicate rules.** The 2003 guidance supports ongoing validation, audit trail reviews, access audits, and reassessments during changes to ensure fitness for use (§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, recalls, or injunctions, as predicate rules remain fully enforceable.** The 2003 guidance notes continued enforcement of access controls, signatures, and checks; data integrity failures (e.g., weak audit trails) often trigger actions affecting product quality and investigations.

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 align with frameworks like EU Annex 11, though direct mapping requires risk-based analysis.** The regulation's focus on trustworthiness supports harmonization, but FDA's narrow scope and enforcement discretion (§11.1(b)) must guide adaptations.

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 to determine Part 11 records, classify systems as closed/open (§11.3), and prioritize controls.

CCPA vs FDA 21 CFR Part 11

Standards Comparison

CCPA

Mandatory

2020

California regulation granting residents rights over personal data

FDA 21 CFR Part 11

Mandatory

1997

FDA regulation for trustworthy electronic records and signatures

Quick Verdict

CCPA grants California consumers data rights like know, delete, opt-out, while FDA 21 CFR Part 11 ensures electronic records/signatures match paper trustworthiness. Businesses adopt CCPA for privacy compliance, Part 11 for regulated life sciences validation.

Data Privacy

CCPA

California Consumer Privacy Act (CCPA/CPRA)

Cost

€€€€

Complexity

Medium

Implementation Time

6-12 months

Key Features

Opt-out of sale/sharing right
Delete personal information right
Know/access collected data right
Limit sensitive PI use right
Correct inaccurate PI right

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
Unique, multi-component electronic signatures
Closed and open system controls
Validation for accuracy and reliability
Access, authority, and device checks

Detailed Analysis

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

CCPA Details

What It Is

The California Consumer Privacy Act (CCPA), as amended by the California Privacy Rights Act (CPRA), is a state regulation establishing consumer privacy rights for California residents. It targets for-profit businesses meeting thresholds like $25M+ revenue or handling 100K+ consumers' data. Primary purpose: empower consumers with control over personal information (PI) via rights-based approach, including broad PI definitions covering households and inferences.

Key Components

Core rights: know/access, delete, opt-out of sales/sharing, correct, limit sensitive PI use.
Obligations: notices at collection, privacy policies, vendor contracts, DSAR handling within 45 days.
Enforcement by CPPA and AG; fines $2,500-$7,500 per violation; private breach actions.
Built on opt-out model with GPC signals; no certification, but audits recommended.

Why Organizations Use It

Mandatory for applicable businesses to avoid fines, litigation, reputational harm. Drives data governance, efficiency, trust; aligns with GDPR; enables market access and differentiation.

Implementation Overview

Phased: scoping/gap analysis (0-3 months), policies/contracts (1-4 months), technical controls (2-6 months), operationalization/training, audits. Applies globally to CA-data handlers; cross-functional, tech-heavy for mid-large orgs across industries.

FDA 21 CFR Part 11 Details

What It Is

FDA 21 CFR Part 11 (Electronic Records; Electronic Signatures) is a U.S. regulation setting criteria for electronic records and signatures to be trustworthy, reliable, and equivalent to paper records and handwritten signatures. It targets FDA-regulated records under predicate rules, using a risk-based approach clarified in 2003 guidance to narrow scope and apply enforcement discretion selectively.

Key Components

**Subparts A-CGeneral provisions, electronic records controls (§11.10 closed systems, §11.30 open systems), electronic signatures (§§11.50-11.300).
Core elements: validation, audit trails, access/authority/device checks, training, accountability policies, signature linking/manifestation.
Built on ALCOA+ principles; ~12 controls for closed systems, extras like encryption for open.
Compliance via demonstrated fitness-for-use, no formal certification.

Why Organizations Use It

Mandatory for life sciences using electronic records in FDA-regulated activities.
Ensures data integrity, inspection readiness, avoids warning letters.
Drives efficiency, non-repudiation, risk reduction; builds FDA/stakeholder trust.

Implementation Overview

**Risk-based CSVPhases include scoping, gap analysis, validation (IQ/OQ/PQ), SOPs/training, monitoring.
Applies to pharma/devices/biotech; U.S.-centric; FDA inspections verify.

Key Differences

Aspect	CCPA	FDA 21 CFR Part 11
Scope	Consumer privacy rights and data handling	Electronic records/signatures trustworthiness
Industry	All businesses handling CA resident data	Life sciences, pharma, medical devices
Nature	Mandatory state privacy regulation	FDA regulation for electronic equivalence
Testing	Data mapping, request workflow testing	Risk-based system validation IQ/OQ/PQ
Penalties	$2,500-$7,500 per violation, private actions	Warning letters, product holds, injunctions

Scope

CCPA

Consumer privacy rights and data handling

FDA 21 CFR Part 11

Electronic records/signatures trustworthiness

Industry

CCPA

All businesses handling CA resident data

FDA 21 CFR Part 11

Life sciences, pharma, medical devices

Nature

CCPA

Mandatory state privacy regulation

FDA 21 CFR Part 11

FDA regulation for electronic equivalence

Testing

CCPA

Data mapping, request workflow testing

FDA 21 CFR Part 11

Risk-based system validation IQ/OQ/PQ

Penalties

CCPA

$2,500-$7,500 per violation, private actions

FDA 21 CFR Part 11

Warning letters, product holds, injunctions

Frequently Asked Questions

Common questions about CCPA and FDA 21 CFR Part 11

CCPA FAQ

FDA 21 CFR Part 11 FAQ

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CCPA

FDA 21 CFR Part 11

Quick Verdict

CCPA

Key Features

FDA 21 CFR Part 11

Key Features

Detailed Analysis

CCPA 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

CCPA FAQ

What is the primary objective of CCPA?

Who is legally or professionally required to comply with CCPA?

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

How often should an assessment for CCPA be performed?

What are the consequences of non-compliance with CCPA?

An CCPA be mapped to other international frameworks?

What is the first step to begin implementing CCPA?

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?

Oes 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?

You Might also be Interested in These Articles...

Your Guide to Implementing PCI DSS in Your Organization

You Guide on how to Start Implementing NIST CSF in Your Organization

Step-by-Step Implementation Guide to ISO 27701: Building a Privacy Information Management System (PIMS) on Your ISO 27001 Foundation

Run Maturity Assessments with GRADUM

Check out these other Gradum.io Standards Comparison Pages

ISO 19600 vs ISO 41001

LGPD vs WCAG

ISO 20000 vs ISO 41001