TheArtOfService
Cross-Framework Mapping

BSI IT-GrundschutzvsFDA 21 CFR Part 11

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

12
Controls Mapped
43
Gaps Found
20%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

BSI IT-Grundschutz maps to FDA 21 CFR Part 11 with 20% coverage across 11 directly mapped controls. Analysis of 55 BSI IT-Grundschutz controls identifies 44 compliance gaps — primarily concentrated in Operations.

Source: TheArtOfService Knowledge Graph | 55 controls analysed | 718 frameworks | 332K+ cross-framework mappings

Control Mappings

Showing 12 of 12 mapped controls across 4 domains. Sign up to explore all 332K+ mappings across 718 frameworks.

BSI IT-Grundschutz: Access Control & Identity(5 mappings)

BSI-02Access enforcement and least privilege
→Part11.AccessAndAuthAccess control + authority + device checks (21 CFR §11.10(d) + (f) + (g) + (h))
BSI-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))
BSI-04Remote access controls
→Part11.AccessAndAuthAccess control + authority + device checks (21 CFR §11.10(d) + (f) + (g) + (h))
BSI-05Wireless access restrictions
→Part11.AccessAndAuthAccess control + authority + device checks (21 CFR §11.10(d) + (f) + (g) + (h))

BSI IT-Grundschutz: System & Communications Protection(1 mappings)

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

BSI IT-Grundschutz: Risk Assessment & Management(3 mappings)

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

BSI IT-Grundschutz: Audit & Accountability(3 mappings)

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

Related Comparisons

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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 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 mappingsVermont Artificial Intelligence and Consumer Data Act (AICDA) vs FDA 21 CFR Part 115 mappingsPrivacy Act 1988 (Australia) vs FDA 21 CFR Part 115 mappings

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What are the key differences between BSI IT-Grundschutz and FDA 21 CFR Part 11?

BSI IT-Grundschutz has 55 controls across its framework, while FDA 21 CFR Part 11 covers 13 controls. Direct mapping analysis identifies 11 overlapping controls (20% coverage). The frameworks diverge most significantly in Operations, where 5 BSI IT-Grundschutz controls have no direct FDA 21 CFR Part 11 equivalent.

How many controls map between BSI IT-Grundschutz and FDA 21 CFR Part 11?

Of 55 total BSI IT-Grundschutz controls, 11 map directly to FDA 21 CFR Part 11 controls — representing 20% coverage. The remaining 44 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping BSI IT-Grundschutz to FDA 21 CFR Part 11?

44 BSI IT-Grundschutz controls have no direct equivalent in FDA 21 CFR Part 11. The highest concentration of gaps is in Operations 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 BSI IT-Grundschutz and FDA 21 CFR Part 11?

The domain with the highest gap count is Operations (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

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