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

**The primary objective of DORA (Regulation (EU) 2022/2554) is to strengthen the digital operational resilience of the EU financial sector against ICT disruptions, including cyberattacks, system failures, and third-party risks.** Enacted December 14, 2022, and applying from January 17, 2025, it mandates ICT risk management, incident reporting, resilience testing, third-party oversight, and information sharing for 20 financial entity types and critical ICT third-party providers (CTPPs).

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

**DORA legally requires compliance from approximately 22,000 EU-regulated financial entities across 20 types, including credit institutions, insurance undertakings, investment firms, payment institutions, and crypto-asset service providers, plus critical ICT third-party providers (CTPPs).** CTPPs, such as cloud and data analytics firms, face direct ESA oversight, with ~1,000+ providers in the EU landscape; proportionality applies based on size, complexity, and risk exposure.

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

**DORA does not mandate external audits or third-party certification but requires risk-based digital operational resilience testing, including independent annual basic tests and triennial threat-led penetration testing (TLPT) for critical entities.** Results must be reported to authorities, with TLPT scopes validated by ESAs per Batch 2 RTS (July 17, 2024); third-party oversight includes contractual audit rights for CTPPs.

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

**DORA mandates annual basic ICT resilience tests, such as vulnerability assessments, and triennial advanced threat-led penetration testing (TLPT) for designated critical entities.** ICT risk management frameworks require annual reviews, with incident response exercises and third-party risk assessments conducted ongoing or as risks evolve, per proportionality principles.

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

**Non-compliance with DORA incurs administrative fines up to 2% of total global annual turnover for firms or €5 million (or 10% of annual salary) for individuals, imposed by ESAs or competent authorities.** Additional penalties include oversight fees up to €1 million annually for CTPPs, remediation orders, and public naming, with enforcement starting post-January 17, 2025.

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

**Yes, DORA's ICT risk management, incident reporting, testing, and third-party oversight elements can be mapped to other international frameworks, leveraging existing compliance for efficiency.** Financial entities often align DORA's proportional controls, such as recovery time objectives under 4 hours, with global standards, though finance-specific harmonization via RTS/ITS (2024) requires tailored gap analyses.

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

**The first step to implement DORA is conducting a gap analysis against the ICT risk management framework RTS (Batch 1, January 17, 2024) to identify deficiencies in strategies, policies, and controls.** Prioritize mapping ICT dependencies, establishing management body oversight, and developing incident classification protocols for major incidents impacting >5% users or €100,000+ losses.

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)).** It targets life sciences firms (pharma, biotech, devices) relying on electronic records in lieu of paper for regulated activities, or where electronic versions support decisions despite paper existence; exclusions apply to certain food records (§11.1(f)–(p)).

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, SOPs, and inspection readiness (§11.1(e)); FDA verifies during inspections, with predicate rules always enforceable regardless of 2003 guidance discretion on some elements.

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 use risk-based periodic reviews tied to change control and predicate rules.** The 2003 guidance recommends documenting scope/reliance decisions in SOPs, with reassessments during system changes, upgrades, or inspections to maintain 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 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, checks, training, signatures, and documentation; data integrity failures often trigger actions affecting product quality and patient safety.

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 computerized systems in GMP environments.** Shared principles include risk-based validation, audit trails, access controls, and electronic signatures, enabling harmonized compliance programs despite independent regulatory scopes.

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 decisions in SOPs/specifications per 2003 guidance, classifying systems as closed (§11.3(b)(4)) or open (§11.3(b)(9)) to define scope and controls.

DORA vs FDA 21 CFR Part 11

Standards Comparison

DORA

Mandatory

2023

EU regulation for digital operational resilience in financial sector

FDA 21 CFR Part 11

Mandatory

1997

FDA regulation for electronic records and signatures equivalence

Quick Verdict

DORA mandates ICT resilience for EU finance against cyber threats, while FDA 21 CFR Part 11 ensures electronic records' trustworthiness for life sciences. Financial firms adopt DORA for regulatory compliance; pharma uses Part 11 to enable paperless GxP operations securely.

Digital Operational Resilience

DORA

Regulation (EU) 2022/2554 Digital Operational Resilience Act

Cost

€€€€

Complexity

Medium

Implementation Time

12-18 months

Key Features

Mandates comprehensive ICT risk management frameworks
Standardizes 4-hour major incident reporting timelines
Requires triennial threat-led penetration testing
Oversees critical third-party ICT providers directly
Harmonizes resilience standards across 27 EU states

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 audit trails for record changes
Closed/open system access controls
Electronic signature uniqueness and linking
Risk-based system validation requirements
Signature manifestation and non-repudiation

Detailed Analysis

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

DORA Details

What It Is

Digital Operational Resilience Act (DORA), Regulation (EU) 2022/2554, is an EU regulation strengthening financial sector resilience against ICT risks like cyberattacks and outages. It uses a risk-based, proportional approach for 20 financial entity types and critical third-party providers (CTPPs), entering full force January 17, 2025.

Key Components

**ICT Risk ManagementFrameworks for identifying, mitigating risks with annual reviews.
**Incident Reporting4-hour initial, 72-hour updates for major incidents.
**Resilience TestingAnnual basic tests, triennial threat-led penetration testing (TLPT).
**Third-Party OversightContractual due diligence, ESAs supervision of CTPPs. No certification; focuses on mandatory reporting, testing, and governance.

Why Organizations Use It

Mandatory compliance avoids 2% turnover fines.
Mitigates systemic cyber threats, ensures continuity.
Builds trust, harmonizes cross-border operations.
Drives tool innovation, enhances competitiveness.

Implementation Overview

Gap analyses, framework builds, testing programs, vendor audits. Applies EU-wide to all financial sizes; proportionality for SMEs. Key by 2025 deadline with RTS guidance.

FDA 21 CFR Part 11 Details

What It Is

FDA 21 CFR Part 11 is a U.S. federal regulation establishing criteria for electronic records and electronic signatures to be considered trustworthy, reliable, and equivalent to paper records and handwritten signatures. It applies to FDA-regulated industries using electronic systems for predicate-rule-required records. The approach is risk-based, with narrow scope per 2003 FDA guidance, focusing on controls for closed/open systems and signatures.

Key Components

Subparts: General provisions, electronic records (§§11.10, 11.30), electronic signatures (§§11.50-11.300).
Core controls: validation, audit trails, access limits, operational/authority/device checks, training, documentation, signature linking/uniqueness.
Built on ALCOA+ principles for data integrity; no formal certification, but compliance via validation and inspection readiness.

Why Organizations Use It

Ensures legal equivalence for electronic records in pharma, devices, biologics.
Mitigates enforcement risks (warnings, holds); enables paperless operations.
Improves data integrity, auditability, efficiency; builds regulator/partner trust.

Implementation Overview

Phased: scoping, gap analysis, validation (IQ/OQ/PQ), SOPs/training, monitoring.
Targets life sciences; U.S.-focused but global alignment (Annex 11).
No certification; FDA inspections verify via records, systems, SOPs. (178 words)

Key Differences

Aspect	DORA	FDA 21 CFR Part 11
Scope	Digital operational resilience in finance	Electronic records/signatures trustworthiness
Industry	EU financial entities and ICT providers	Life sciences, pharma, medical devices US
Nature	Mandatory EU regulation with ESAs enforcement	US FDA regulation with enforcement discretion
Testing	Annual basic tests, triennial TLPT	Risk-based system validation IQ/OQ/PQ
Penalties	Up to 2% global turnover fines	Warning letters, product holds, injunctions

Scope

DORA

Digital operational resilience in finance

FDA 21 CFR Part 11

Electronic records/signatures trustworthiness

Industry

DORA

EU financial entities and ICT providers

FDA 21 CFR Part 11

Life sciences, pharma, medical devices US

Nature

DORA

Mandatory EU regulation with ESAs enforcement

FDA 21 CFR Part 11

US FDA regulation with enforcement discretion

Testing

DORA

Annual basic tests, triennial TLPT

FDA 21 CFR Part 11

Risk-based system validation IQ/OQ/PQ

Penalties

DORA

Up to 2% global turnover fines

FDA 21 CFR Part 11

Warning letters, product holds, injunctions

Frequently Asked Questions

Common questions about DORA and FDA 21 CFR Part 11

DORA FAQ

FDA 21 CFR Part 11 FAQ

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DORA

FDA 21 CFR Part 11

Quick Verdict

DORA

Key Features

FDA 21 CFR Part 11

Key Features

Detailed Analysis

DORA 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

DORA FAQ

What is the primary objective of DORA?

Who is legally or professionally required to comply with DORA?

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

How often should an assessment for DORA be performed?

What are the consequences of non-compliance with DORA?

Can DORA be mapped to other international frameworks?

What is the first step to begin implementing DORA?

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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