FDA 21 CFR Part 11
FDA regulation for electronic records/signatures equivalence to paper
EN 1090
EU standard for steel and aluminium structures execution
Quick Verdict
FDA 21 CFR Part 11 ensures electronic records' trustworthiness for US life sciences, while EN 1090 mandates CE-marked structural steel/aluminium execution for EU construction. Companies adopt Part 11 for data integrity compliance; EN 1090 for mandatory market access and liability protection.
FDA 21 CFR Part 11
21 CFR Part 11 Electronic Records; Electronic Signatures
Key Features
- Establishes equivalency criteria for electronic records/signatures to paper
- Mandates secure, time-stamped audit trails for changes
- Requires unique, linked electronic signatures with non-repudiation
- Differentiates controls for closed versus open systems
- Enforces risk-based validation and access checks
EN 1090
EN 1090 Execution of steel and aluminium structures
Key Features
- Risk-based Execution Classes (EXC1-EXC4)
- Factory Production Control (FPC) certification
- Responsible Welding Coordinator (rWC) requirement
- CE marking and Declaration of Performance
- Material and weld full traceability
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 U.S. regulation defining criteria for electronic records and electronic signatures to be trustworthy, reliable, and equivalent to paper records and handwritten signatures. It scopes FDA-regulated records under predicate rules, using a control-based approach with risk-based enforcement discretion per 2003 guidance.
Key Components
- **Subpart BClosed (§11.10)/open (§11.30) system controls including validation, audit trails, access/authority/device checks.
- **Subpart CSignature requirements (§§11.50-11.300) for manifestation, linking, uniqueness, multi-component controls.
- Enduring principles: data integrity, non-repudiation, ALCOA+. Compliance via inspection, no certification.
Why Organizations Use It
- Mandatory for electronic reliance to avoid enforcement.
- Ensures integrity for quality/safety decisions.
- Drives efficiency, digital transformation.
- Builds FDA trust, reduces inspection risks.
Implementation Overview
Risk-based: scope records, classify systems, CSV (URS, IQ/OQ/PQ), SOPs/training. Targets pharma/biotech/devices; multi-phase for any size, ongoing governance.
EN 1090 Details
What It Is
EN 1090 is the harmonized European standard family (EN 1090-1 for conformity assessment, EN 1090-2/3 for technical execution of steel/aluminium structures). It operationalizes the EU Construction Products Regulation (CPR), mandating CE marking for load-bearing components in the EEA. Its risk-based methodology employs Execution Classes (EXC 1-4) to scale controls by failure consequences, service, and production categories.
Key Components
- **Factory Production Control (FPC)Documented, NB-certified system for traceability, inspection, and processes.
- **Welding governanceResponsible Welding Coordinator (rWC), WPS/PQR/WPQR per ISO 3834.
- **Technical rulesMaterials, tolerances, NDT, corrosion protection.
- **CertificationInitial audits, ITT/ITC (manufacturer-led), ongoing surveillance.
Why Organizations Use It
- Mandatory for legal market access and CE marking.
- Mitigates liability via traceability and quality controls.
- Enables tenders, builds stakeholder trust.
- Drives operational maturity, reduces rework.
Implementation Overview
Phased roadmap: gap analysis, FPC design, personnel training, NB engagement. Targets steel/aluminium fabricators in EU/EEA; suits all sizes with welding focus. Requires NB certification and surveillance. (178 words)
Key Differences
| Aspect | FDA 21 CFR Part 11 | EN 1090 |
|---|---|---|
| Scope | Electronic records/signatures trustworthiness | Steel/aluminium structural execution/conformity |
| Industry | Life sciences, pharma, medical devices (US) | Construction, steel/aluminium fabrication (EU/EEA) |
| Nature | US FDA regulation with enforcement discretion | Mandatory EU harmonized standard for CE marking |
| Testing | Risk-based system validation, audit trails | FPC certification, ITT/ITC, NB surveillance audits |
| Penalties | Warning letters, product holds, enforcement | Certificate suspension, market exclusion, liability |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about FDA 21 CFR Part 11 and EN 1090
FDA 21 CFR Part 11 FAQ
EN 1090 FAQ
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