TheArtOfService
Cross-Framework Mapping

Spain ENSvsFDA 21 CFR Part 11

See exactly how Spain ENS controls map to FDA 21 CFR Part 11. Pre-computed mappings, identified gaps, and coverage analysis.

11
Controls Mapped
41
Gaps Found
19%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

Spain ENS maps to FDA 21 CFR Part 11 with 19% coverage across 10 directly mapped controls. Analysis of 52 Spain ENS controls identifies 42 compliance gaps — primarily concentrated in Spain ENS: Incident Response.

Source: TheArtOfService Knowledge Graph | 52 controls analysed | 719 frameworks | 428K+ cross-framework mappings

Control Mappings

Showing 11 of 11 mapped controls across 4 domains. Sign up to explore all 428K+ mappings across 719 frameworks.

Spain ENS: Access Control & Identity(4 mappings)

ES-ENS-02Access enforcement and least privilege
→Part11.AccessAndAuthAccess control + authority + device checks (21 CFR §11.10(d) + (f) + (g) + (h))
ES-ENS-03Multi-factor authentication requirements2 targets
→Part11.300Controls for identification codes and passwords (21 CFR §11.300)
→Part11.AccessAndAuthAccess control + authority + device checks (21 CFR §11.10(d) + (f) + (g) + (h))
ES-ENS-05Wireless access restrictions
→Part11.AccessAndAuthAccess control + authority + device checks (21 CFR §11.10(d) + (f) + (g) + (h))

Spain ENS: System & Communications Protection(1 mappings)

ES-ENS-08Cryptographic protection of data
→Part11.30Controls for open systems (21 CFR §11.30)

Spain ENS: Risk Assessment & Management(3 mappings)

ES-ENS-13Risk assessment procedures
→Part11.CSVComputer system validation + risk-based approach (21 CFR §11.10(a) + 2003 FDA Scope and Application Guidance + 2023 CSA draft)
ES-ENS-15Security categorization
→Part11.CSVComputer system validation + risk-based approach (21 CFR §11.10(a) + 2003 FDA Scope and Application Guidance + 2023 CSA draft)
ES-ENS-17Continuous monitoring strategy
→Part11.CSVComputer system validation + risk-based approach (21 CFR §11.10(a) + 2003 FDA Scope and Application Guidance + 2023 CSA draft)

Spain ENS: Audit & Accountability(3 mappings)

ES-ENS-28Audit event logging and storage
→Part11.AuditTrailAudit trail requirements - secure computer-generated time-stamped (21 CFR §11.10(e))
ES-ENS-29Audit record review and analysis
→Part11.AuditTrailAudit trail requirements - secure computer-generated time-stamped (21 CFR §11.10(e))
ES-ENS-31Audit log protection and retention
→Part11.AuditTrailAudit trail requirements - secure computer-generated time-stamped (21 CFR §11.10(e))

Related Comparisons

Other Spain ENS comparisons

Spain ENS vs FISMA20 mappingsSpain ENS vs BSI IT-Grundschutz20 mappingsSpain ENS vs Saudi NCA ECC20 mappingsSpain ENS vs Ghana Cybersecurity Act20 mappingsSpain ENS vs NIST SP 800-53 Rev 519 mappingsSpain ENS vs AWS Well-Architected Security Pillar18 mappingsSpain ENS vs Azure Security Benchmark18 mappingsSpain ENS vs South Korea ISMS-P18 mappings

Other FDA 21 CFR Part 11 comparisons

Annex 11 to EU GMP - Computerised Systems vs FDA 21 CFR Part 119 mappingsAWWA Cybersecurity Guidance for the Water Sector (American Water Works Association) vs FDA 21 CFR Part 117 mappingsUK Defence Standard 05-138 - Cyber Security for Defence Suppliers vs FDA 21 CFR Part 116 mappingsUS Consumer Product Safety Commission (CPSC) - Connected Product Safety vs FDA 21 CFR Part 116 mappingsAzure Security Benchmark vs FDA 21 CFR Part 116 mappingsAWS Well-Architected Security Pillar vs FDA 21 CFR Part 116 mappingsASD Strategies to Mitigate Cyber Security Incidents vs FDA 21 CFR Part 116 mappingsCISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0 vs FDA 21 CFR Part 116 mappings

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What are the key differences between Spain ENS and FDA 21 CFR Part 11?

Spain ENS has 52 controls across its framework, while FDA 21 CFR Part 11 covers 13 controls. Direct mapping analysis identifies 10 overlapping controls (19% coverage). The frameworks diverge most significantly in Spain ENS: Incident Response, where 5 Spain ENS controls have no direct FDA 21 CFR Part 11 equivalent.

How many controls map between Spain ENS and FDA 21 CFR Part 11?

Of 52 total Spain ENS controls, 10 map directly to FDA 21 CFR Part 11 controls — representing 19% coverage. The remaining 42 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping Spain ENS to FDA 21 CFR Part 11?

42 Spain ENS controls have no direct equivalent in FDA 21 CFR Part 11. The highest concentration of gaps is in Spain ENS: Incident Response with 5 unmapped controls. These gaps represent areas where additional controls, policies, or documentation must be created to achieve compliance with both frameworks.

Which control domains have the most gaps between Spain ENS and FDA 21 CFR Part 11?

The domain with the highest gap count is Spain ENS: Incident Response (5 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.

Related Resources

How to Map Controls Across Frameworks|Multi-Framework Compliance Guide|Compliance Glossary

This platform provides educational compliance tools, not legal, regulatory, or professional compliance advice. Cross-framework mappings are AI-assisted interpretations and do not reproduce or replace official standards. Framework names and trademarks belong to their respective owners. Consult qualified professionals for your specific compliance requirements. See our Terms of Service.