Cross-Framework Mapping

CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0vsFDA 21 CFR Part 11

Name: CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0 to FDA 21 CFR Part 11 Control Mapping Dataset
Creator: TheArtOfService

See exactly how CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0 controls map to FDA 21 CFR Part 11. Pre-computed mappings, identified gaps, and coverage analysis.

Controls Mapped

Gaps Found

23%

Coverage

According to the TheArtOfService Compliance Knowledge Graph:

CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0 maps to FDA 21 CFR Part 11 with 23% coverage across 9 directly mapped controls. Analysis of 35 CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0 controls identifies 30 compliance gaps — primarily concentrated in Device Security.

Source: TheArtOfService Knowledge Graph | 35 controls analysed | 719 frameworks | 428K+ cross-framework mappings

Control Mappings

Showing 15 of 15 mapped controls across 5 domains. Sign up to explore all 428K+ mappings across 719 frameworks.

Account Security(4 mappings)

CPG-1.AChanging Default Passwords

→Part11.300Controls for identification codes and passwords (21 CFR §11.300)

CPG-1.CUnique Credentials3 targets

→Part11.10Controls for closed systems (21 CFR §11.10)

→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))

Data Security(5 mappings)

CPG-3.ALog Collection

→Part11.30Controls for open systems (21 CFR §11.30)

CPG-3.BSecure Log Storage

→Part11.30Controls for open systems (21 CFR §11.30)

CPG-3.CStrong and Agile Encryption3 targets

→Part11.30Controls for open systems (21 CFR §11.30)

→Part11.AuditTrailAudit trail requirements - secure computer-generated time-stamped (21 CFR §11.10(e))

→Part11.RecordRetentionRecord protection + retention + readiness for inspection (21 CFR §11.10(b) + (c))

Governance & Training(2 mappings)

CPG-4.CBasic Cybersecurity Training2 targets

→Part11.10Controls for closed systems (21 CFR §11.10)

→Part11.300Controls for identification codes and passwords (21 CFR §11.300)

Governance and Training(2 mappings)

CPG-4.CBasic Cybersecurity Training2 targets

→Part11.10Controls for closed systems (21 CFR §11.10)

→Part11.300Controls for identification codes and passwords (21 CFR §11.300)

Network Segmentation(2 mappings)

CPG-8.ANetwork Segmentation

→Part11.AccessAndAuthAccess control + authority + device checks (21 CFR §11.10(d) + (f) + (g) + (h))

CPG-8.CEncrypted DNS

→Part11.30Controls for open systems (21 CFR §11.30)

Related Comparisons

Other CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0 comparisons

CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0 vs AWS Well-Architected Security Pillar14 mappings CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0 vs Azure Security Benchmark14 mappings CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0 vs OWASP ASVS14 mappings CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0 vs TISAX - Trusted Information Security Assessment Exchange14 mappings CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0 vs PAS 1192-5:2015 - Security-Minded Approach to BIM and Digital Built Environments13 mappings CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0 vs New Zealand Information Security Manual (NZISM)13 mappings CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0 vs MARS-E - Minimum Acceptable Risk Standards for Exchanges13 mappings CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0 vs South Korea Cloud Security Assurance Program (CSAP)13 mappings

Other FDA 21 CFR Part 11 comparisons

Annex 11 to EU GMP - Computerised Systems vs FDA 21 CFR Part 119 mappings AWWA Cybersecurity Guidance for the Water Sector (American Water Works Association) vs FDA 21 CFR Part 117 mappings UK Defence Standard 05-138 - Cyber Security for Defence Suppliers vs FDA 21 CFR Part 116 mappings US Consumer Product Safety Commission (CPSC) - Connected Product Safety vs FDA 21 CFR Part 116 mappings Azure Security Benchmark vs FDA 21 CFR Part 116 mappings AWS Well-Architected Security Pillar vs FDA 21 CFR Part 116 mappings ASD Strategies to Mitigate Cyber Security Incidents vs FDA 21 CFR Part 116 mappings Spain ENS vs FDA 21 CFR Part 115 mappings

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What are the key differences between CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0 and FDA 21 CFR Part 11?

CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0 has 35 controls across its framework, while FDA 21 CFR Part 11 covers 13 controls. Direct mapping analysis identifies 9 overlapping controls (23% coverage). The frameworks diverge most significantly in Device Security, where 8 CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0 controls have no direct FDA 21 CFR Part 11 equivalent.

How many controls map between CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0 and FDA 21 CFR Part 11?

Of 35 total CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0 controls, 9 map directly to FDA 21 CFR Part 11 controls — representing 23% coverage. The remaining 30 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0 to FDA 21 CFR Part 11?

30 CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0 controls have no direct equivalent in FDA 21 CFR Part 11. The highest concentration of gaps is in Device Security with 8 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 CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0 and FDA 21 CFR Part 11?

The domain with the highest gap count is Device Security (8 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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