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

**OSHA's primary objective is to assure safe and healthful working conditions for every working man and woman in the nation, as stated in Section 2 of the Occupational Safety and Health Act of 1970.** This mission is achieved through developing and enforcing standards under 29 CFR Parts 1910 (general industry), 1926 (construction), 1928 (agriculture), and 1915–1919 (maritime), alongside research via NIOSH, compliance assistance, and the General Duty Clause (Section 5(a)(1)) requiring workplaces free from recognized hazards likely to cause death or serious harm.

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

**All private-sector employers engaged in businesses affecting interstate commerce are legally required to comply with OSHA, with limited exemptions for self-employed individuals, family farms with 10 or fewer employees, and certain low-hazard workplaces under 29 CFR 1904.** Coverage includes most U.S. workplaces, territories, and federal contractors; state-approved plans in 22 states and Puerto Rico must be at least as effective as federal standards. Host employers and staffing agencies share responsibility for temporary workers' hazard communication, training, and recordkeeping.

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

**No, OSHA does not require external audits or third-party certification for compliance.** Enforcement occurs through prioritized inspections (imminent dangers, fatalities, complaints) by OSHA compliance officers, who review records, conduct walkarounds, and issue citations. Voluntary programs like VPP recognize mature systems but are not mandatory; employers self-certify OSHA 300A summaries annually.

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

**OSHA requires hazard assessments at least initially and whenever conditions change, with ongoing monitoring per specific standards like noise (1910.95, action level 85 dBA TWA) and lead (1910.1025, every 6 months if above action level).** Annual program evaluations, periodic inspections (e.g., LOTO 1910.147), and injury/illness record reviews support continuous compliance; electronic 300A submissions occur yearly via ITA.

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

**Non-compliance with OSHA results in civil penalties up to $165,514 per willful/repeated violation and $16,550 per serious violation (as of January 15, 2025, inflation-adjusted).** Additional consequences include failure-to-abate fines ($16,550/day), citations within 6 months, potential criminal prosecution for willful violations causing death, operational shutdowns for imminent dangers, and reputational harm from public data.

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

**OSHA is not designed for direct mapping to other international frameworks and stands alone as U.S. federal law under the OSH Act.** While concepts like hierarchy of controls align broadly with global practices, OSHA's codified standards (29 CFR 1910 et seq.), General Duty Clause, and enforcement via OSHRC differ fundamentally; employers should prioritize OSHA-specific compliance without cross-referencing.

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

**The first step to implement OSHA is to conduct a comprehensive hazard identification and assessment, including Job Hazard Analyses (JHAs) for high-risk tasks.** Map operations to applicable standards (e.g., 29 CFR 1910 Subparts), develop a written safety policy with management commitment, and establish an Injury and Illness Prevention Program per OSHA guidelines, prioritizing the hierarchy of controls.

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)).** This equivalency enables electronic methods while requiring controls for authenticity, integrity, confidentiality, and non-repudiation across closed (§11.10) and open (§11.30) systems, plus specific electronic signature rules (Subparts B and C).

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 (§11.1(b)).** This applies to pharmaceutical, biotech, medical device, and related firms maintaining records under predicate rules like 21 CFR Parts 211 or 820, with scope determined by business reliance, not all electronic data.

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 validation, SOPs, training records, and inspection readiness (§11.1(e)), with FDA evaluating systems, controls, and documentation during inspections; predicate rules remain enforceable regardless.

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 system lifecycle.** Per 2003 guidance and GAMP practices, reassess scope, validation, and controls during changes, annually for high-risk systems, or as triggered by inspections, ensuring ongoing 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 enforcement actions for predicate rule violations.** The 2003 guidance notes continued enforcement of access controls, checks, training, signatures, and documentation; data integrity failures often lead to CAPA inadequacies and public health risks.

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 similar electronic record/signature equivalency.** Common alignments include audit trails, access controls, validation, and signatures, enabling harmonized risk-based approaches despite independent scopes.

What is the first step to begin implementing **FDA 21 CFR Part 11**?

**The first step is to establish a formal applicability framework mapping predicate rules to records and assessing business reliance on electronic versions.** Document scope decisions in SOPs (§11.1(b), 2003 guidance), classifying systems as closed/open and prioritizing high-risk areas for controls.

OSHA vs FDA 21 CFR Part 11

Standards Comparison

OSHA

Mandatory

1970

US federal regulation assuring workplace safety standards

FDA 21 CFR Part 11

Mandatory

1997

FDA regulation for trustworthy electronic records and signatures

Quick Verdict

OSHA ensures safe workplaces via hazard standards and inspections for all US industries, while FDA 21 CFR Part 11 validates electronic records/signatures for pharma/devices. Companies adopt OSHA for compliance, Part 11 for digital trust in regulated data.

Occupational Safety

OSHA

Occupational Safety and Health Act of 1970

Cost

€€€€

Complexity

High

Implementation Time

6-12 months

Key Features

General Duty Clause enforces recognized hazard-free workplaces
Hierarchy of controls prioritizes engineering over PPE
Codified standards across 29 CFR 1910-1928 subparts
Risk-based inspections target high-hazard industries
Electronic injury reporting via Injury Tracking Application

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
Validation of systems for accuracy and reliability
Access controls for authorized users only
Electronic signatures with linking and manifestation
Risk-based controls for closed and open systems

Detailed Analysis

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

OSHA Details

What It Is

Occupational Safety and Health Administration (OSHA), established by the Occupational Safety and Health Act of 1970 (OSH Act), is a US federal regulation enforcing workplace safety and health standards codified in 29 CFR Parts 1910-1928. Its primary purpose is assuring safe conditions nationwide via standards enforcement, inspections, and the General Duty Clause for recognized hazards. It uses a performance-based, hierarchy-of-controls approach prioritizing elimination, substitution, and engineering.

Key Components

Subparts covering walking-working surfaces, PPE, hazardous materials, toxic substances (Subpart Z), emergency plans.
Over 1,000 standards with PELs, recordkeeping (Part 1904), reporting.
Core principles: hierarchy of controls, worker rights, state plans.
Enforcement model with citations, penalties up to $165K.

Why Organizations Use It

Legal compliance avoids fines, shutdowns.
Reduces injuries, workers' comp costs; enhances productivity, reputation.
Builds stakeholder trust via data transparency.

Implementation Overview

Phased: gap analysis, written programs (IIPP, HazCom), training, audits.
Applies to most private employers; scales by size/industry.
No certification; inspections verify compliance.

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 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 narrowed scope per 2003 FDA guidance, focusing on reliance on electronic records.

Key Components

Controls for closed systems (§11.10: validation, audit trails, access limits) and open systems (§11.30: encryption, digital signatures).
Electronic signature requirements (Subparts B/C: uniqueness, manifestation, linking, multi-component controls).
Core principles: authenticity, integrity, non-repudiation; enforcement on access, checks, training, policies.
Compliance via validation, SOPs; no formal certification but inspection readiness.

Why Organizations Use It

Meets legal obligations for GxP records in pharma, devices, biotech.
Mitigates enforcement risks (warnings, holds); enables paperless operations.
Enhances data integrity, efficiency, inspection readiness; builds stakeholder trust.

Implementation Overview

Phased: scoping, risk assessment, CSV (IQ/OQ/PQ), training, change control.
Targets life sciences; risk-based for any size; audited via FDA inspections.

Key Differences

Aspect	OSHA	FDA 21 CFR Part 11
Scope	Workplace safety, health hazards, recordkeeping	Electronic records, signatures trustworthiness
Industry	All general industry, construction, agriculture US	Pharma, devices, biologics, food safety US
Nature	Mandatory federal regulations, enforced inspections	Mandatory for electronic records, enforcement discretion
Testing	No system validation, compliance inspections	Risk-based system validation, IQ/OQ/PQ
Penalties	Civil fines up to $165k willful, daily abatement	Warning letters, product holds, injunctions

Scope

OSHA

Workplace safety, health hazards, recordkeeping

FDA 21 CFR Part 11

Electronic records, signatures trustworthiness

Industry

OSHA

All general industry, construction, agriculture US

FDA 21 CFR Part 11

Pharma, devices, biologics, food safety US

Nature

OSHA

Mandatory federal regulations, enforced inspections

FDA 21 CFR Part 11

Mandatory for electronic records, enforcement discretion

Testing

OSHA

No system validation, compliance inspections

FDA 21 CFR Part 11

Risk-based system validation, IQ/OQ/PQ

Penalties

OSHA

Civil fines up to $165k willful, daily abatement

FDA 21 CFR Part 11

Warning letters, product holds, injunctions

Frequently Asked Questions

Common questions about OSHA and FDA 21 CFR Part 11

OSHA FAQ

FDA 21 CFR Part 11 FAQ

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OSHA

FDA 21 CFR Part 11

Quick Verdict

OSHA

Key Features

FDA 21 CFR Part 11

Key Features

Detailed Analysis

OSHA 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

OSHA FAQ

What is the primary objective of OSHA?

Who is legally or professionally required to comply with OSHA?

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

How often should an assessment for OSHA be performed?

What are the consequences of non-compliance with OSHA?

Can OSHA be mapped to other international frameworks?

What is the first step to begin implementing OSHA?

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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