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 in closed (§11.10) and open (§11.30) systems, plus 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 relied upon for regulated activities.** Scope includes firms maintaining such records in lieu of paper, using electronic versions for decisions despite paper existence, submitting accepted electronic records to FDA (§11.1(b)), or employing legally binding electronic signatures (§11.100(c)). Predicate rules (e.g., 21 CFR 211, 820) determine records; documentation of reliance decisions is required.

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, training records, and inspection readiness (§11.1(e)). FDA verifies during inspections; predicate rules remain enforceable, and organizations must provide systems, records, and documentation readily available (§11.10(b)–(k)).

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; they must occur via change control, periodic reviews, and risk-based validation lifecycle.** Ongoing monitoring includes operational checks (§11.10(f)), authority checks (§11.10(g)), audit trail reviews, training refreshers (§11.10(i)), and revalidation for changes affecting accuracy, integrity, or predicate compliance per 2003 guidance.

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, import alerts, fines, or injunctions, as predicate rules remain fully enforceable.** Enforcement focuses on enforced controls like access (§11.10(d)), signatures (§§11.100–300), and data integrity failures impacting investigations or CAPA, per 2003 guidance.

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, though mappings require risk-based analysis.** The 2003 guidance emphasizes predicate rule compliance; organizations document equivalency for global systems without direct harmonization.

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 (e.g., in SOPs) per 2003 guidance narrow interpretation, classifying systems as closed/open and prioritizing high-risk controls like access and signatures.

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

**COBIT's primary objective is to help organizations create value from I&T initiatives, manage risk, and optimize resources through a tailored governance system.** COBIT 2019 defines 40 governance and management objectives across five domains (**EDM**, **APO**, **BAI**, **DSS**, **MEA**) that translate stakeholder needs via the goals cascade into actionable practices, supported by six governance system principles and seven components (processes, structures, information, etc.).

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

**No organizations are legally required to comply with COBIT, as it is a voluntary framework maintained by ISACA, not a regulation.** Professionally, it is recommended for enterprises relying on I&T for value creation, particularly in regulated sectors like finance and utilities, where boards and executives use it to demonstrate EGIT maturity through design factors and capability assessments.

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

**COBIT does not require external audit or third-party certification, unlike ISO standards.** Organizations may conduct internal capability assessments using the CMMI-based performance management model (levels 0-5) or engage ISACA-accredited assessors for voluntary assurance via **MEA04 Managed Assurance**, focusing on evidence of governance system effectiveness.

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

**COBIT assessments should be performed annually or upon significant changes in design factors, using the CMMI-aligned performance management scheme.** Routine monitoring via **MEA** domain practices ensures ongoing capability measurement (levels 0-5), with formal gap analyses tied to enterprise goals cascade updates, typically quarterly for high-priority objectives like **APO02 Managed Strategy**.

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

**Non-compliance with COBIT carries no direct legal penalties, as it is a non-mandatory framework.** Indirect consequences include increased enterprise risk exposure, audit deficiencies in demonstrating EGIT, suboptimal I&T value delivery, and challenges aligning with regulations, potentially leading to operational failures or regulatory scrutiny in I&T-dependent sectors.

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

**Yes, COBIT 2019 explicitly supports mapping to other international frameworks through its governance framework principles of alignment and openness.** The core model of 40 objectives and components enables integration via published ISACA crosswalks, allowing tailored governance systems to incorporate standards while maintaining a unified EGIT structure.

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

**The first step to implement COBIT is to evaluate enterprise context using the 11 design factors and goals cascade to define a tailored governance system scope.** Per the COBIT 2019 Design Guide, conduct a current-state capability assessment (CMMI levels 0-5) via **APO02.02**, prioritizing objectives like **EDM01** for stakeholder alignment and roadmap development.

FDA 21 CFR Part 11 vs COBIT

Standards Comparison

FDA 21 CFR Part 11

Mandatory

1997

FDA regulation for trustworthy electronic records and signatures

COBIT

Voluntary

2019

Global framework for enterprise IT governance and management

Quick Verdict

FDA 21 CFR Part 11 mandates controls for trustworthy electronic records in life sciences, while COBIT provides a voluntary framework for enterprise IT governance. Regulated firms use Part 11 for compliance; all organizations adopt COBIT to align IT with business goals.

Electronic Records

FDA 21 CFR Part 11

21 CFR Part 11: Electronic Records; Electronic Signatures

Cost

€€€€

Complexity

Medium

Implementation Time

18-24 months

Key Features

Establishes equivalency of electronic records to paper records
Mandates secure time-stamped audit trails for integrity
Requires unique non-repudiable electronic signatures
Differentiates controls for closed and open systems
Enforces risk-based validation and access limitations

IT Governance

COBIT

COBIT 2019 Governance and Management Objectives

Cost

€€€€

Complexity

High

Implementation Time

12-18 months

Key Features

Tailors governance with 11 design factors
40 objectives across 5 domains EDM-APO-BAI-DSS-MEA
CMMI-based capability levels 0-5 for performance
Goals cascade links stakeholders to IT metrics
Separates governance from management responsibilities

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 US regulation establishing criteria for electronic records and electronic signatures to be trustworthy, reliable, and equivalent to paper records and handwritten signatures. It scopes to FDA predicate rules in life sciences, applying when electronic records replace paper. Uses a risk-based approach narrowed by 2003 guidance with enforcement discretion on some elements.

Key Components

**Subpart BClosed/open system controls (§11.10/§11.30) including validation, audit trails, access, operational/authority/device checks.
**Subpart CElectronic signatures (§11.50-11.300) for uniqueness, manifestation, linking, multi-component authentication.
Core principles: authenticity, integrity, non-repudiation, ALCOA+. No formal certification; compliance demonstrated via inspections.

Why Organizations Use It

Mandatory for electronic reliance in regulated activities to avoid warnings/recalls.
Ensures data integrity, supports investigations/CAPA, enables paperless efficiency.
Builds regulator trust, reduces inspection risks, aids global harmonization.

Implementation Overview

Phased risk-based CSV: scoping, gap analysis, IQ/OQ/PQ validation, SOPs/training, supplier governance. Targets pharma/biotech/devices; all sizes. FDA enforces via inspections, no third-party audits.

COBIT Details

What It Is

COBIT 2019, or Control Objectives for Information and Related Technologies, is a comprehensive framework developed by ISACA for enterprise governance and management of IT (EGIT). Its primary purpose is to help organizations create value from IT, manage risks, and optimize resources by translating stakeholder needs into actionable objectives. The approach is tailoring-focused, using design factors and a governance system workflow for customized implementation.

Key Components

40 governance and management objectives grouped into **5 domainsEDM (governance), APO (planning), BAI (delivery), DSS (operations), MEA (assurance).
6 governance system principles and 3 framework principles.
7 components (e.g., processes, structures, culture, skills).
CMMI-based performance management with capability levels 0-5; no formal certification, but capability assessments.

Why Organizations Use It

Aligns IT with business strategy via goals cascade.
Supports compliance (e.g., SOX, GDPR) and risk management.
Enhances assurance, stakeholder trust, and digital transformation.
Provides competitive edge through optimized resources and measurability.

Implementation Overview

**Phased approachassess gaps, design via toolkit, pilot objectives, train staff, monitor via MEA.
Suits enterprises of all sizes/industries; global applicability; requires audits but no certification.

Key Differences

Aspect	FDA 21 CFR Part 11	COBIT
Scope	Electronic records/signatures trustworthiness	Enterprise I&T governance/management
Industry	FDA-regulated life sciences	All industries worldwide
Nature	Mandatory US regulation	Voluntary governance framework
Testing	Risk-based system validation	Capability/maturity assessments
Penalties	Warning letters, enforcement actions	No legal penalties

Scope

FDA 21 CFR Part 11

Electronic records/signatures trustworthiness

COBIT

Enterprise I&T governance/management

Industry

FDA 21 CFR Part 11

FDA-regulated life sciences

COBIT

All industries worldwide

Nature

FDA 21 CFR Part 11

Mandatory US regulation

COBIT

Voluntary governance framework

Testing

FDA 21 CFR Part 11

Risk-based system validation

COBIT

Capability/maturity assessments

Penalties

FDA 21 CFR Part 11

Warning letters, enforcement actions

COBIT

No legal penalties

Frequently Asked Questions

Common questions about FDA 21 CFR Part 11 and COBIT

FDA 21 CFR Part 11 FAQ

COBIT FAQ

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FDA 21 CFR Part 11

COBIT

Quick Verdict

FDA 21 CFR Part 11

Key Features

COBIT

Key Features

Detailed Analysis

FDA 21 CFR Part 11 Details

What It Is

Key Components

Why Organizations Use It

Implementation Overview

COBIT 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?

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?

COBIT FAQ

What is the primary objective of COBIT?

Who is legally or professionally required to comply with COBIT?

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

How often should an assessment for COBIT be performed?

What are the consequences of non-compliance with COBIT?

Can COBIT be mapped to other international frameworks?

What is the first step to begin implementing COBIT?

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CMMC Level 2 Implementation Guide for Small DIB Contractors: First 5 Steps to C3PAO Certification with Infographic

NIST CSF 2.0 Deep Dive: Mastering the Updated Framework Core Functions

Run Maturity Assessments with GRADUM

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ISO 27032 vs WELL

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